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Prior Authorization Criteria_AARP_Enhanced

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					                                                                                                                         AARP MedicareRx Enhanced plan




         PRIOR AUTHORIZATION CRITERIA


                                                                                                   Age
                                Exclusion                                                                      Prescriber       Coverage
Drugs         Covered Uses                     Required Medical Information                        Restrict-                                         Other Criteria
                                Criteria                                                                       Restrictions     Duration
                                                                                                   ions
Alimta        Malignant                        Malignant Pleural Mesothelioma                                                   Length of the        Alimta will be
              Pleural Meso-                    1. Disease is unresectable or patient is not a                                   therapy              approved for
              thelioma (MPM)                      candidate for curative surgery; AND                                                                continuation
                                               2. Used in combination with cisplatin.                                                                of prior
              Non-Small Cell                                                                                                                         therapy.
              Lung Cancer                      Non-Small Cell Lung Cancer:
              (NSCLC)                          1. Confirmed diagnosis of locally advanced or
                                                  metastatic (Stage III or IV) NSCLC; AND
                                               2. Prior history of first-line chemotherapy
                                                  treatment for NSCLC.

Amevive       Plaque            CD4+ T-         Initial Therapy for Plaque Psoriasis:              ≥18 years   Prescribed by    Initial Therapy:     Amevive will
              Psoriasis         lymphocyte      1. Diagnosis of moderate-to-severe plaque                      a                12 weeks             be
                                cell count <       psoriasis involving a minimum body surface of               dermatologist.                        reauthorized
              All FDA           250 cells per      10%; AND                                                                     Re-                  only if it has
              approved          microliter.   . 2. Failure to both phototherapy and systemic                                    authorization:       been at least
              indications not                      therapy with standard agents.                                                12 weeks (total      12 weeks
              otherwise                                                                                                         treatment limited    since patient’s
              excluded from                    Reauthorization for Plaque Psoriasis:                                            to 2 cycles; or 24   last treatment
              Part D                           1. Patient has achieved a scoring of almost                                      doses/weeks)
                                                  "clear" by Physician Global Assessment; AND
                                               2. CD4+ T-Lymphocyte cell count > 250 cells per
                                                  microliter.




                                                                                                                                                              10/06/08
                                                                                                Age
                               Exclusion                                                                     Prescriber     Coverage
Drugs        Covered Uses                  Required Medical Information                         Restrict-                                        Other Criteria
                               Criteria                                                                      Restrictions   Duration
                                                                                                ions
Amitiza      Chronic                       Chronic Idiopathic Constipation:                     ≥ 18 years                  12 months
             Idiopathic                    Failure to standard treatment.                       and older.
             Constipation
                                           Irritable Bowel Syndrome with Constipation
             Irritable Bowel               in women:
             Syndrome with                 Failure to standard treatment.
             Constipation

             All FDA
             approved
             indications not
             otherwise
             excluded from
             Part D

Anadrol-50   Acquired                      Acquired Aplastic Anemia:                                                        Length of the
             Aplastic                      1. History of failure; OR                                                        therapy for
             Anemia                        2. Used in combination with, antilymphocyte                                      hypoplastic
                                              globulin or both antilymphocyte globulin and                                  anemia. For
             Congenital                       corticosteroid treatment.                                                     other uses,
             Aplastic                                                                                                       authorization will
             Anemia                        Hypoplastic Anemia:                                                              be granted for 12
             (Faconi's                     1. Diagnosis of hypoplastic anemia due to                                        months.
             Anemia)                          myelotoxic drugs; AND
                                           2. Failure to an erythropoietic stimulating agent.
             Myelofibrosis
                                           Pure Red Cell Aplasia:
             Hypoplastic                   Failure to immunosuppressive therapy.
             Anemia
                                           Chronic Renal Failure:
             Pure Red Cell                 1. Hemoglobin (Hgb) < 33% OR hematocrit (Hct)
             Aplasia                          < 11 gm/dL; AND
                                           2. Failure to an erythropoietic stimulating agent.
             Chronic Renal
             Failure

             All FDA
             approved
             indications not
             otherwise
             excluded from
             Part D


                                                                                                                                                         10/06/08
                                                                                                   Age
                            Exclusion                                                                          Prescriber     Coverage
Drugs     Covered Uses                       Required Medical Information                          Restrict-                                     Other Criteria
                            Criteria                                                                           Restrictions   Duration
                                                                                                   ions
Apokyn    Advanced                           Advanced Parkinson’s Disease:                                                    1 year             Apokyn will
          Parkinson's                        1. Confirmed diagnosis of advanced Parkinson’s                                                      only be
          Disease                               disease; AND                                                                                     approved for
                                             2. Unable to control "off" symptoms with                                                            intermittent
                                                adequate combinations of conventional oral                                                       subcutaneous
                                                therapy; AND                                                                                     injection.
                                             3. Used in combination with a non-5-HT3
                                                antagonist antiemetic for initial therapy; AND
                                             4. Not used in combination with 5-HT3
                                                antagonists.

Aranesp   Anemia Due to     Chronic          Initial Therapy for Chronic Renal Failure:            .                          Initial Therapy:   Aranesp is
          Chronic Renal     Renal            1. Hct < 33% OR Hgb < 11 gm/dl; AND                                              Three months for   subject to Part
          Failure (CRF)     Failure:         2. Verification of iron evaluation for adequate                                  chemotherapy       B vs. Part D
                            1. Patient is       iron stores.                                                                  and MDS. Six       review.
          Anemia in            on dialysis                                                                                    months for CRF.
          cancer patients      (covered      Reauthorization for Chronic Renal Failure:                                                          Chemo-
          on                   under Part    1. Verification that average Hct was below 36%                                   Reauthorization:   therapy-
          chemotherapy         B).              over a 3-month period; AND                                                    12 months for      Induced
                            2. Chemo-        2. Verification of iron evaluation for adequate                                  CRF and MDS        Anemia:
          Refractory           therapy          iron stores; AND                                                                                 Hgb/Hct levels
          anemia in            patient       3. One of the following:                                                                            must be
          Myelodysplastic      does not         a. Hct reached target range (30% to 36%);                                                        collected
          Syndrome             receive             OR                                                                                            within prior
          (MDS)                cancer           b. Decrease in blood transfusion; OR                                                             two weeks of
                               chemo-           c. Hgb is ≥ 1 g/dL from pre-treatment level.                                                     request.
                               therapy;
                               OR patient    Initial Therapy for Chemotherapy:                                                                   All other
                               has a         1. Verification that other causes of anemia have                                                    uses:
                               malignan-        been ruled out; AND                                                                              Hgb/Hct levels
                               cy for        2. Verification of iron evaluation for adequate                                                     must be
                               which            iron stores with one of the following:                                                           collected
                               Aranesp is       a. Hct < 36%; OR                                                                                 within prior 30
                               contra-          b. Hgb < 12 gm/dl;                                                                               days of
                               indicated.    3. Verification that the cancer is a non-myeloid                                                    request.
                                                malignancy.
                                             4. AND one of the following:
                                                a. Verification that the patient is concurrently
                                                   on chemotherapy; OR
                                                b. Will be on concomitant chemotherapy for 2
                                                   months; OR
                                                c. The anemia is caused by cancer
                                                   chemotherapy.

                                                                                                                                                          10/06/08
                                                                                             Age
                           Exclusion                                                                     Prescriber     Coverage
Drugs      Covered Uses                Required Medical Information                          Restrict-                                      Other Criteria
                           Criteria                                                                      Restrictions   Duration
                                                                                             ions
                                       Reauthorization for Chemotherapy:
                                       1. Hct < 36% OR Hgb < 12 gm/dl; AND
                                       2. Hct reached target range (30% to 36%); AND
                                       3. One of the following:
                                          a. Decrease in blood transfusion; OR
                                          b. Hgb is 1 g/dL; OR
                                          c. greater from pre-treatment level.
                                       4. One of the following:
                                          a. Verification that the patient is concurrently
                                             on chemotherapy; OR
                                          b. Will be on concomitant chemotherapy for 2
                                             months; OR
                                          c. The anemia is caused by cancer
                                             chemotherapy.

                                       Initial Therapy for Myelodysplastic
                                       Syndrome:
                                       1. Hct < 33%; OR Hgb < 11 g/dL; AND
                                       2. One of the following:
                                          a. Serum erythropoietin of ≤ 500 mU/mL; OR
                                          b. Diagnosis of transfusion-dependent MDS.
                                       3. Verification of adequate iron stores.

                                       Reauthorization of Myelodysplastic
                                       Syndrome:
                                       1. Verification that average Hct was below 36%
                                          over a 3 month period; AND
                                       2. One of the following:
                                          a. Verification that Hct reached target (30% to
                                             36%); OR
                                          b. Decrease in blood transfusion; OR
                                          c. Hgb increase ≥ 1 g/dL from pre-treatment
                                             level.
Arcalyst   Cryopyrin-                  Treatment of Cryopyrin-Associated Periodic            12 years                   Indefinite, long-
           Associated                  Syndromes (CAPS), including Familial Cold             and older                  term therapy
           Periodic                    Autoinflammatory Syndrome (FCAS) and                                             (open-ended)
           Syndromes,                  Muckle-Wells Syndrome (MWS)
           including
           Familial Cold
           Auto-
           inflammatory
           Syndrome and
           Muckle-Wells
           Syndrome
                                                                                                                                                    10/06/08
                                                                                                    Age
                             Exclusion                                                                          Prescriber      Coverage
Drugs       Covered Uses                      Required Medical Information                          Restrict-                                       Other Criteria
                             Criteria                                                                           Restrictions    Duration
                                                                                                    ions
Avastin     Colorectal       NSCLC:           Colorectal Cancer:                                                Renal Cell      Length of therapy   Avastin will be
            Cancer           1. Squa-         1. Diagnosis of metastatic colorectal cancer;                     Cancer,                             approved for
                                mous cell     AND                                                               Breast                              continuation
            Non-Small Cell      his-tology.   2. Used in combination with:                                      Cancer:                             of prior
            Lung Cancer      2. History of       a. 5-FU; OR                                                    Prescribed by                       therapy.
            (NSCLC)             hemop-           b. oxaliplatin plus capecitabine; OR                           or in
                                tysis.           c. capecitabine.                                               consultation                        Renal Cell
            Renal Cell       3. CNS meta-     Non-Small Cell Lung Cancer:                                       with an                             Cancer:
            Cancer              stases.       1. Diagnosis of unresectable locally advanced                     oncologist.                         Used in
                             4. On-going         recurrent or metastatic NSCLC; AND                                                                 combination
            Breast Cancer       thera-        2. Used in combination with paclitaxel and                        ARMD:                               with
                                peutic           carboplatin.                                                   Prescribed or                       interferon-
            Age-related         anticoagul                                                                      recommended                         alpha or
            Macular             ation         Renal Cell Cancer:                                                by retina                           refractory to
            Degenerat-ion                     1. Diagnosis of metastatic renal cell cancer; AND                 specialist                          either
            (ARMD)                            2. Used in combination with interferon-alpha or                                                       interferon
                                                 refractory to either interferon alpha or                                                           alpha or
                                                 interleukin-2.                                                                                     interleukin-2.

                                              Breast Cancer:
                                              1. Diagnosis of metastatic breast cancer; AND
                                              2. Used in combination with paclitaxel.

                                              Age-Related Macular Degeneration:
                                              1. Failure to FDA-approved therapies; OR
                                              2. Likely to have greater benefit from the use of
                                                 intravitreal bevacizumab.

Avonex      Relapsing                         Relapsing Multiple Sclerosis:                                                     1 year
            forms of                          1. Recent history of a first clinical demyelinating
            Multiple                             event; AND
            Sclerosis (MS)                    2. MRI-detected brain lesions consistent with
                                                 MS.
                                              Trial on an alternative MS agent.




Betaseron   Relapsing                         Relapsing Multiple Sclerosis:                                                     1 year
            forms of                          1. Patients with relapsing form of MS; OR
            Multiple                          2. Patients with secondary progressive MS who
            Sclerosis                            continue to experience relapses.
                                              Trial on an alternative MS agent.
                                                                                                                                                             10/06/08
                                                                                          Age
                         Exclusion                                                                      Prescriber         Coverage
Drugs   Covered Uses                 Required Medical Information                         Restrict-                                             Other Criteria
                         Criteria                                                                       Restrictions       Duration
                                                                                          ions
Botox   Strabismus and               Initial Therapy for Primary Axillary                 VII cranial   Initial therapy    Hyperhidrosis:       Reauthoriza-
        Blepharospasm                Hyperhidrosis:                                       nerve         for Migraine :     One prescription     tion for
                                     1. History of failure to topical prescription        disorders:    Prescribed by                           Hyper-
        Benign                          strength drying agents; AND                       ≥ 12 years    a neurologist      Back Pain:           hidrosis,
        Essential                    2. One of the following:                             of age        or pain            One treatment        Achalasia,
        Blepharospasm                   a. Score of 3 or 4 on the Hyperhidrosis                         specialist.        (may be              Anal Fissure,
                                           Disease Severity Scale (HDSS); OR              Initial                          reauthorized for a   Back pain:
        Synkinetic                      b. Skin maceration with secondary infection.      Therapy       Initial            maximum of two       If at least 4-6
        Closure of the                                                                    for           Therapy for        treatments per       months have
        eyelid                       Reauthorization for Hyperhidrosis:                   Chronic       Chronic Back       year).               elapsed since
                                     At least a 2-point improvement in HDSS.              Back          Pain:                                   the last series
        Cervical                                                                          Pain:         Prescribed by      Other uses:          of injections
        Dystonia                     Initial Therapy for Migraine:                        ≥ 18 years    a neurologist,     6 months
                                     1. Failure or contraindication to 5-HT1 agonists;    of age        neuro-
        Spasmodic                       AND                                                             surgeon,
        Dysphonia                    2. At least two prophylactic therapies for                         orthopedist, or
                                        migraine: AND.                                                  pain specialist.
        Spastic                      3. Submission of chart documentation
        Torticollis                     documenting complete evaluation of the
                                        patient.
        Dynamic
        Muscle                       Reauthorization for Migraine:
        Contracture in               1. Reduction in headache frequency; AND
        pediatric                    2. Submission of chart notes documenting
        cerebral palsy                  decreased utilization of pain medications or
        patients                        triptans, or a reduction in the number of
                                        emergency room visits.
        Treatment of
        Muscle                       Initial Therapy for Achalasia:
        Spasticity                   1. High risk of complication from pneumatic
                                        dilation or surgical myotomy; OR
        Oro-mandibular               2. Failure to prior pneumatic dilation or surgical
        Dystonia                        myotomy; OR
                                     3. Prior dilation caused esophageal perforation;
        Focal Hand                      OR patient has an epiphrenic diverticulum or
        Dystonia                        hiatal hernia.

        Hyperhidrosis                Reauthorization for Achalasia:
        (axillary)                   1. Documentation of improvement or reduction in
                                        symptoms of achalasia; AND
        Migraine                     2. Anal Fissure (Initial): Failure of two
                                        conventional therapies.
        Achalasia
                                     Reauthorization for Anal Fissure:
                                                                                                                                                         10/06/08
                                                                                                Age
                                Exclusion                                                                    Prescriber     Coverage
Drugs         Covered Uses                  Required Medical Information                        Restrict-                                       Other Criteria
                                Criteria                                                                     Restrictions   Duration
                                                                                                ions
              Chronic Anal                  1. Incomplete healing of fissure or recurrence of
              Fissure                           fissure; AND
                                            2. Improved symptoms with prior treatment with
              Chronic Back                      Botox.
              Pain
                                            Initial Therapy for Chronic Back Pain:
              All FDA                       1. Confirmed history of persistent low back pain
              approved                         > 6 months duration; AND
              indications not               2. Failure to NSAIDs and opioids.
              otherwise
              excluded from                 Reauthorization for Back Pain:
              Part D                        Confirmed improvement in symptoms with initial
                                            Botox treatment.

Byetta        Type 2                        Type 2 Diabetes:                                    ≥ 18 years                  Length of therapy
              Diabetes                      1. Diagnosis of type 2 diabetes; AND
                                            2. For patients who have not achieved adequate
                                               glycemic control despite treatment with a
                                               maximally tolerated dose of two of the
                                               following (unless the patient has a
                                               contraindication to the specified agents):
                                               a. Metformin; OR
                                               b. A sulfonylurea; OR
                                               c. A thiazolidinedione.; AND
                                            3. Used in combination with one of the following:
                                               a. Metformin; OR
                                               b. A sulfonylurea; OR
                                               c. A thiazolidinedione; OR
                                               d. Combination of metformin and a
                                                   sulfonylurea; OR
                                               e. Combination of metformin and a
                                                   thiazolidinedione.

Cellcept      Transplant                    Transplant                                                                      Length of therapy   Cellcept is
Intravenous                                 1. Patient received a renal (kidney), cardiac                                                       subject to Part
              Lupus Nephritis                  (heart), or hepatic (liver) transplant; AND                                                      B vs. Part D
                                            2. Patient is unable to take oral formulations of                                                   review.
                                               mycophenolate.
                                                                                                                                                Cellcept will
                                            Lupus Nephritis:                                                                                    be approved
                                            1, Diagnosis of lupus nephritis; AND                                                                for
                                            2. Failure to combination therapy with                                                              continuation
                                               corticosteroids and cyclophosphamide.                                                            of prior
                                                                                                                                                therapy.
                                                                                                                                                         10/06/08
                                                                                             Age
                             Exclusion                                                                   Prescriber      Coverage
Drugs      Covered Uses                  Required Medical Information                        Restrict-                                        Other Criteria
                             Criteria                                                                    Restrictions    Duration
                                                                                             ions
Cellcept   Transplant                    Transplant:                                                                     Length of therapy    Cellcept is
                                         1. Patient received a renal (kidney), cardiac                                                        subject to Part
           Lupus                            (heart), or hepatic (liver) transplant.                                                           B vs. Part D
           Nephritis,                    2. Patient received a bone marrow/stem cell                                                          review.
                                            transplant.
           Obliterative                                                                                                                       Cellcept will
           Bronchiolitis                 Lupus Nephritis:                                                                                     be approved
                                         1. Diagnosis of lupus nephritis; AND                                                                 for
                                         2. Failure to combination therapy with                                                               continuation
                                            corticosteroids and cyclophosphamide.                                                             of prior
                                                                                                                                              therapy.
                                         Obliterative Bronchiolitis:
                                         Diagnosis of obliterative bronchiolitis following
                                         lung transplantation.

Cesamet    Nausea and                    Nausea and Vomiting Associated with                                             Authorization will   Cesamet is
           Vomiting                      Cancer Chemotherapy:                                                            be issued for 6      subject to Part
           Associated with               1. Patient is receiving cancer chemotherapy                                     months               B vs. Part D
           Cancer                        2. Failure to 5HT-3 receptor antagonist                                                              review.
           Chemotherapy                  3. Failure to one of the following agents:
                                            a. Antihistamine; OR                                                                              Cesamet will
                                            b. Corticosteroid; OR                                                                             be approved
                                            c. Prokinetic agent; OR                                                                           for therapy
                                            d. Antipsychotic                                                                                  continuation
                                                                                                                                              covered under
                                                                                                                                              Part B

Cimzia     Moderate to                   Initial Therapy:                                    18 years    Prescribed or   Initial Therapy:
           severe Crohn's                1. Failure to conventional therapy and failure to   and older   recommended     2 months
           disease                          Humira or Remicade; AND                                      by gastro-
                                         2. Verification that patient has been evaluated                 enterologist    Reauthorization:
                                            for tuberculosis and treated accordingly.                                    12 months

                                         Reauthorization:
                                         Demonstrated remission or significant clinical
                                         response to Cimzia therapy.

Copaxone   Relapsing-                    Relapsing Remitting Multiple Sclerosis:                                         1 year
           remitting form                For patients with relapsing-remitting form of
           of Multiple                   multiple sclerosis. Trial on an alternative MS
           Sclerosis                     agent.



                                                                                                                                                       10/06/08
                                                                                                  Age
                              Exclusion                                                                        Prescriber       Coverage
Drugs       Covered Uses                    Required Medical Information                          Restrict-                                         Other Criteria
                              Criteria                                                                         Restrictions     Duration
                                                                                                  ions
Emend       Acute Chemo-                    Acute Chemotherapy-Induced Nausea and                                               Acute CINV,         Emend is
            therapy -                       Vomiting:                                                                           Delayed CINV,       subject to Part
            induced                                                                                                             PONV:               B vs. Part D
            Nausea and                      1. Patient is currently receiving moderately or                                     6 months            review.
            Vomiting                           highly emetogenic chemotherapy; AND
            (CINV)                          2. Patient is concurrently on both a corticosteroid
                                               and a 5-HT3 receptor antagonist.
            Delayed
            Chemotherapy                    Delayed Chemotherapy-Induced Nausea and
            -induced                        Vomiting:
            Nausea and
            Vomiting                        1. Patient is currently receiving highly
                                               emetogenic chemotherapy and a steroid; OR
            Prevention,                     2. Patient is on an anthracycline and
            Postoperative                      cyclophosphamide.
            Nausea and
            Vomiting                        Prevention of Postoperative Nausea and
            (PONV)                          Vomiting:

                                            For the prevention of postoperative nausea and
                                            vomiting when administered prior to the
                                            induction of anesthesia.

Enbrel,     Rheumatoid        Con-current   Rheumatoid Arthritis:                                 RA, PsA,     Initial          Initial Therapy:    All diagnoses
Enbrel      Arthritis (RA)    use of        1. Diagnosis of moderate-to-severe RA; AND            AS, PPs:     Therapy for      3 months for        require
Sureclick                     anakinra.     2. Failed methotrexate or 2 DMARDs for 3              ≥ 18 years   RA, JRA,         plaque psoriasis;   verification
            Juvenile                           months.                                                         PsA, AS:         12 months for       that the
            Rheumatoid                                                                            JRA:         Prescribed or    other uses          patient has
            Arthritis (JRA)                 Juvenile Rheumatoid Arthritis / Juvenile              ≥ 2 years    recommend-                           been
                                            Idiopathic Arthritis:                                              ed by a          Reauthorization:    evaluated for
            Psoriatic                       Diagnosis of moderate-to-severe poly-articular                     rheumatolo-      12 months for all   tuberculosis
            Arthritis (PsA)                 course                                                             gist.            uses                and has been
                                                                                                                                                    treated
            Plaque                          Juvenile Rheumatoid Arthritis:                                     Initial                              accordingly
            Psoriasis (PPs)                 Failed NSAID or steroid and DMARD for three                        Therapy for
                                            months.                                                            PPs:                                 Reauthoriza-
            Ankylosing                                                                                         Prescribed or                        tion of Enbrel
            Spondylitis                     Psoriatic Arthritis:                                               recommend-                           for PPs
            (AS)                            1. Diagnosis of active PsA.                                        ed by a                              requires a
                                            2. Failed methotrexate or 2 DMARDs for 3                           dermatologist.                       dosage of 50
                                               months.                                                                                              mg or less per
                                                                                                                                                    week or less.
                                            Ankylosing Spondylitis:
                                            1. Diagnosis of AS.
                                                                                                                                                             10/06/08
                                                                                                 Age
                            Exclusion                                                                        Prescriber     Coverage
Drugs     Covered Uses                       Required Medical Information                        Restrict-                                    Other Criteria
                            Criteria                                                                         Restrictions   Duration
                                                                                                 ions
                                             2. Failed 2 NSAIDs for 3 months.

                                             Plaque Psoriasis:
                                             1. Diagnosis moderate-to-severe plaque psorisis
                                                with min BSA 10%.
                                             2. Failed phototherapy and systemic therapy.

                                             Reauthorization:
                                             Demonstration of clinical response to therapy.

Epogen,   Anemia Due to     Chemo-           Anemia due to Chronic Renal Failure:                                           Initial Therapy   Epoetin will be
Procrit   Chronic Renal     therapy:         1. Hematocrit (Hct) less than 33%; OR                                          Pre-Op:           subject to Part
          Failure (CRF)     Patient is not   2. Hemoglobin (Hgb) less than 11 gm/dl.                                        1 month           B vs. Part D
                            receiving                                                                                                         review.
          Anemia in HIV-    cancer           Reauthorization of CRF:                                                        Chemo, HCV,
          infected          chemo-           1. Average Hct was below 36% over 3-months:                                    and MDS:          For
          patients (HIV)    therapy; OR      AND                                                                            3 months.         Chemotherap
                            Patient has      2. One of the following:                                                                         y-Induced
          Anemia in         malign-nancy        a. Hct reached target (30% to 36%); OR                                      CRF, HIV:         Anemia,
          cancer patients   for which           b. Decrease in blood transfusion; OR                                        6 months          Hgb/Hct levels
          on chemo-         therapy with        c. Hgb is 1 g/dL or greater from pre-treatment                                                must be
          therapy           epoetin is             level.                                                                   Reauthorization   collected
          (Chemo)           contra-                                                                                         CRF, HIV, MDS:    within prior
                            indicated.       Anemia in HIV-infected patients:                                               12 months         two weeks of
          Pre-operative                      1. Anemia is due to zidovudine treatment or due                                                  request.
          use in patients                       to HIV infection; AND                                                       Chemo, HCV:
          undergoing                         2. Hgb less than 12 g/dL or Hct less than 36%.                                 3 months.         For all other
          surgery for                                                                                                                         indications,
          reduction of                       Reauthorization in HIV:                                                                          Hgb/Hct levels
          allogeneic                         1, Hct was below 36% over 3 months; AND                                                          must be
          blood                              2. One of the following:                                                                         collected
          transfusion                           a. Hct reached target (30% to 36%); OR                                                        within prior 30
          (Pre-op)                              b. Decrease in blood transfusion; OR                                                          days of
                                                c. Hgb is 1 g/dL or greater from pre-treatment                                                request.
          Refractory                               level.
          anemia in
          Myelo-                             Anemia in cancer patients on Chemotherapy:
          dysplastic                         1. Verify other causes of anemia have been
          Syndrome                              ruled out; AND
          (MDS)                              2. Hct less than 36% or Hgb less than 12 gm/dl.
                                             3. Cancer is a non-myeloid malignancy; AND
          Treatment of                       4. Concurrently on chemo, will be on
          anemia in HCV-                        concomitant chemo for 2 months OR anemia
          infected                              is caused by cancer chemotherapy.
                                                                                                                                                       10/06/08
                                                                                          Age
                          Exclusion                                                                   Prescriber     Coverage
Drugs   Covered Uses                  Required Medical Information                        Restrict-                             Other Criteria
                          Criteria                                                                    Restrictions   Duration
                                                                                          ions
        patients due to
        ribavirin in                  Reauthorization in Chemo:
        combination                   1. Hct less than 36% or Hgb less than 12 gm/dl;
        with interferon               AND
        or peg-                       2. One of the following; AND:
        interferon                       a. Hct reached target (30% to 36%)
        (HCV)                            b. Decrease in blood transfusion
                                         c. Hgb is 1 g/dL or greater from pre-treatment
                                         level.
                                      3. Concurrently on chemotherapy for 2 months
                                         or anemia is caused by cancer chemo.

                                      Preoperative use in patients undergoing
                                      surgery for reduction of allogeneic blood
                                      transfusion (Pre-op):
                                      1. Hgb greater than 10 to less than 13 g/dL
                                         scheduled to undergo elective, non-
                                         cardiac/vascular surgery to reduce blood
                                         transfusions; OR
                                      2. Patient at high risk for peri-operative
                                         transfusions with expected blood loss of 2
                                         units or greater.

                                      Refractory anemia in Myelodysplastic
                                      Syndrome:
                                      1. Hct less than 33% or Hgb less than 11 g/dL;
                                      AND
                                      2. One of the following:
                                      a. Serum erythropoietin of 500 mU/mL or less
                                      b. Diagnosis of transfusion-dependent MDS.

                                      Reauthorization for MDS:
                                      1. Avg Hct was below 36% over a 3 months;
                                         AND
                                      2. One of the following:
                                         a. Hct reached target (30% to 36%)
                                         b. Decrease in blood transfusion
                                         c. Hgb increase of 1 g/dL or more from pre-
                                            treatment level.

                                      Treatment of anemia in HCV-infected patients
                                      due to ribavirin in combination with
                                      interferon or peg-interferon:
                                      1. Hgb less than 12 g/dL or Hct less than 36%;
                                                                                                                                        10/06/08
                                                                                                 Age
                                Exclusion                                                                    Prescriber     Coverage
Drugs          Covered Uses                 Required Medical Information                         Restrict-                                      Other Criteria
                                Criteria                                                                     Restrictions   Duration
                                                                                                 ions
                                                AND
                                            2. Is concurrently on ribavirin and interferon or
                                                peg-interferon alfa for the treatment of HCV
                                                and the anemia is due to treatment.

                                            Reauthorization of HCV:
                                            1. Avg Hct was below 36% over a 3 months; And
                                            2. One of the following:
                                               a. Hct reached target (30% to 36%)
                                               b. Decrease in blood transfusion
                                               c. Hgb is 1 g/dL or greater from pre-treatment
                                                  level.

                                            All uses:
                                            Verify iron evaluation for adequate Fe stores.

Erbitux        Head and Neck                Head and Neck Cancer:                                                           Length of therapy   Erbitux will be
               Cancer                       1. One of the following:                                                                            approved for
                                               a. Confirmed diagnosis of locally or regionally                                                  continuation
               Colorectal                         advanced squamous cell carcinoma of the                                                       of prior
               Cancer.                            head and neck                                                                                 therapy.
                                               b. Recurrent or metastatic squamous cell
                                                  head and neck cancer; AND
                                            2. One of the following:
                                               a. Used in combination with radiation therapy
                                               b. After failure of platinum-based
                                                  chemotherapy.

                                            Colorectal Cancer:
                                            1. Confirmed diagnosis of metastatic carcinoma
                                                of the colon or rectum; AND
                                            2. One of the following:
                                            a. Used in combination with irinotecan-based
                                                chemotherapy
                                            b. Intolerance to irinotecan-based chemotherapy
                                            c. Failure of irinotecan or oxaliplatin-based
                                                chemotherapy regimens.

Actiq,         Malignant pain               Cancer Pain:                                                                    Length of therapy
fentanyl                                    1. Confirmed diagnosis of malignant pain; AND
citrate oral                                2. Failure or contraindication to an immediate-
trans-                                         release opioid; AND
mucosal,                                    3. Demonstrated tolerance to opioids.
Fentora
                                                                                                                                                         10/06/08
                                                                                                   Age
                             Exclusion                                                                         Prescriber     Coverage
Drugs      Covered Uses                      Required Medical Information                          Restrict-                                      Other Criteria
                             Criteria                                                                          Restrictions   Duration
                                                                                                   ions
Forteo     Osteoporosis      1. Paget's      Osteoporosis:                                                                    2 years             Forteo is
                                disease      1. Patient has a history of fracture resulting from                                                  subject to Part
                                history         minimal trauma (or BMD T score of -2.5 or                                                         B vs. Part D
                             2. Bone            less); OR                                                                                         review.
                                meta-        2. Both of the following:
                                stases          a. Failure to a formulary alternative
                             3. Radiation       b. BMD T score of -3.0 or less and a previous
                             4. Bone               fracture resulting from minimal trauma.
                                disease
                                other than
                                osteo-
                                porosis
                             5. Con-
                                current
                                use of
                                bisphos-
                                phonate.

Gamastan   Hepatitis A                       Hepatitis A:                                                                     Length of therapy
S/D                                          For use before or soon after exposure.
           Measles
                                             Measles:
           Varicella                         For use in susceptible individuals exposed fewer
                                             than 6 days previously.
           Rubella
                                             Varicella:
           All FDA                           For use in immunocompromised patients when
           approved                          Varicella Zoster Immune Globulin is not
           indications not                   available.
           otherwise
           excluded from                     Rubella:
           Part D                            For pregnant women who will not consider a
                                             therapeutic abortion.

Gleevec    Chronic                           Chronic Myeloid Leukemia (Adults):                                               Length of therapy   Gleevec will
           Myeloid                           Diagnosis of Philadelphia chromosome positive                                                        be approved
           Leukemia                          CML.                                                                                                 for
           (CML)                                                                                                                                  continuation
                                             Chronic Myeloid Leukemia (Children):                                                                 of prior
           Acute                             1. Diagnosis of Philadelphia chromosome                                                              therapy.
           Lymphoblastic                        positive (Ph+) chronic phase CML; AND
           Leukemia (ALL)                    2. One of the following:
                                                a. Not candidates for stem cell transplantation
           Myelo-                               b. Disease has recurred after stem cell
                                                                                                                                                           10/06/08
                                                                                                     Age
                                Exclusion                                                                        Prescriber       Coverage
Drugs         Covered Uses                      Required Medical Information                         Restrict-                                         Other Criteria
                                Criteria                                                                         Restrictions     Duration
                                                                                                     ions
              dysplastic or                          transplant
              myelo-                              c. Patients who are resistant to interferon-alfa
              proliferative                          therapy.
              diseases
              (MDS/MPD)                         Acute Lymphoblastic Leukemia:
                                                Adult patients with Philadelphia chromosome
              Aggressive                        positive ALL.
              systemic
              masto-cytosis                     Myelodysplastic/Myeloproliferative disease:
              (ASM)                             Adults diagnosed with MDS/MPD diseases
                                                associated with platelet-derived growth factor
              Hypereosino-                      receptor gene rearrangements.
              philic syndrome
              (HES) and                         Aggressive systemic mastocytosis:
              chronic                           1. Adults diagnosed with aggressive systemic
              eosinophilic                         mastocytosis; AND
              leukemia (CEL)                    2. One of the following:
               Dermatofibro-                       a. Patient is without the D816V c-Kit mutation
              sarcoma                              b. c-Kit mutation status unknown.
              protuberans
              (DFSP)                            Hypereosinophilic syndrome and chronic
                                                eosinophilic leukemia :
              Gastro-                           Adults diagnosed with HES or CEL.
              intestinal
              Stromal                           Dermatofibrosarcoma protuberans:
              Tumors (GIST)                     Adults with unresectable, recurrent and/or
                                                metastatic DFSP.

                                                Gastrointestinal Stromal Tumors:
                                                Patients with a confirmed diagnosis of
                                                unresectable and/or metastatic GIST.

Growth        Growth            Chidhood        GHD Children:                                                    GHD (Child),     Length of therapy
Hormones:     Hormone           Onset           1. Diagnosis of GH deficiency based on two GH                    AOGH,            for GHD in adults.
Genotropin,   Deficiency        Growth             stimulation tests or low Insulin-like growth                  COGHDA,          One year for all
Genotropin    (GHD) in          Hormone            factor 1 (IGF-1) levels; AND                                  IGHDA, Initial   other uses.
Miniquick,    Children          Deficiency      2. Demonstrate growth failure based on growth                    Therapy for
Humatrope,                      in Adults:         velocity or height shorter than 2 standard                    TS or NS,
Humatrope     Prader-Willi      1. Males with      deviations (SD) below the mean height for                     GRCRF, and
Combo         Syndrome             bone age        age.                                                          ISS:
Pack,         (PWS)                greater                                                                       Prescribed by
Norditropin                        than 17      Prader-Willi Syndrome or Small for                               an endo-
Cartridge,    Small for            yrs or       Gestational Age:                                                 crinologist.
Norditropin   Gestational          females      1. Diagnosis of PWS confirmed by genetic
                                                                                                                                                               10/06/08
                                                                                                        Age
                                  Exclusion                                                                         Prescriber     Coverage
Drugs          Covered Uses                         Required Medical Information                        Restrict-                             Other Criteria
                                  Criteria                                                                          Restrictions   Duration
                                                                                                        ions
Nordiflex      Age (SGA)             with bone         testing; OR
Pen,                                 age            2. Diagnosis of SGA confirmed by birth wt of less
Nutropin,      Turner                greater           than 2500g at gestation of more than 37 wks
Nutropin Aq,   Syndrome (TS)         than 15           or at birth weightt or length below the 3rd
Nutropin Aq                          years             percentile for gestational age who failed to
Pen,           Noonan             2. Closed            catch up by 2 years of age.
Omnitrope,     Syndrome (NS)         bone epi-
Saizen,                              physes on      Turner Syndrome, Noonan Syndrome:
Saizen         Growth                radio-         1. Treatment of short stature in females w/bone
Click.Easy,    Retardation           graph             age less than 15 years associated w/TS or
Tev-Tropin     associated with    3. Growth            NS; OR
               Chronic Renal         velocity       2. Treatment of short stature in males w/bone
               Insufficiency         less than 2       age less than 17 years associated w/NS.
               (GRCRF)               cm/year
                                     during         Growth Retardation associated with Chronic
               Idiopathic Short      previous       Renal Insufficiency:
               Stature (ISS)         year of        1. Diagnosis of chronic renal insufficiency; AND
                                     treatment      2. Height shorter than or equal to 2 SD below the
               Adult Onset           unless            median age for children or where growth
               Growth                COGHD             velocity falls to below 4.5 cm/year.
               Hormone               criteria are
               Deficiency            met.           Reauthorization for GHD in Children, PWS,
               (AOGHD),                             SGA, TS, NS, GRCRF:
                                                    1. Increase in growth velocity of at least 2
               Childhood                               cm/year during previous year of treatment;
               Onset GH                                AND
               Deficiency in                        2. Males with bone age less than 17 yrs or
               Adults                                  females with bone age less than 15 years.
               (COGHDA)
                                                    Idiopathic Short Stature:
               Isolated GH                          1. Height less than or equal to 2.25 SD below
               Deficiency in                           the mean height for age. Growth velocity less
               Adults (IGHDA)                          than the 25th percentile for bone age; AND
                                                    2. Verify open epiphyses on last bone age
                                                       radiograph; AND
                                                    3. Absence of comorbid conditions that should
                                                       be observed or treated by other means.

                                                    Reauthorization of ISS:
                                                    1. Increase in growth velocity of at least 4.5
                                                        cm/year during previous year of treatment;
                                                        AND
                                                    2. Males w/bone age less than 17 years or
                                                        females w/bone age less than 15 years.
                                                                                                                                                      10/06/08
                                                                                        Age
                       Exclusion                                                                    Prescriber     Coverage
Drugs   Covered Uses               Required Medical Information                         Restrict-                             Other Criteria
                       Criteria                                                                     Restrictions   Duration
                                                                                        ions

                                   Adult Onset Growth Hormone Deficiency:
                                   1. Pts who have GHD alone or multiple hormone
                                       deficiencies because of pituitary
                                       disease/insult, hypothalamic disease, surgery,
                                       or radiation treatment; AND
                                   2. IGF-1 level less than 77 mcg/L or 2 SD below
                                       the mean value, matched by age and gender.

                                   Childhood Onset GH Deficiency in Adults:
                                   1. Childhood onset in patients who were GH
                                      deficient during childhood who have GH
                                      deficiency confirmed as an adult before
                                      replacement treatment with GH is started;
                                      AND
                                   2. Persistent deficiency of GH documented by
                                      GH stimulation tests.

                                   Isolated GH Deficiency in Adults:
                                   Documented deficiency of GH documented by 2
                                   GH stimulation tests.




                                                                                                                                      10/06/08
                                                                                                  Age
                                  Exclusion                                                                    Prescriber       Coverage
Drugs           Covered Uses                   Required Medical Information                       Restrict-                                          Other Criteria
                                  Criteria                                                                     Restrictions     Duration
                                                                                                  ions
Humira,         Moderate to       Concurrent   Rheumatoid Arthritis:                              RA, PsA,     RA, PsA, AS,     Initial              RA:
Humira Pen,     severe active     use of       1. Diagnosis of moderate-to-severe RA; AND         CD, AS,      JIA:             Authorization:       Authorization
Humira Pen-     Rheumatoid        anakinra     2. Failed methotrexate or 2 DMARDs for 3           Plaque       Prescribed or    4 months for         is for 40 mg
Crohns          Arthritis (RA)                    months.                                         Psoria-      recommend-       Plaque Psoriasis;    every other
Disease                                                                                           sis:         ded by a         6 months for other   week unless
                Psoriatic                      Juvenile Rheumatoid Arthritis / Juvenile           18 years     rheuma-          uses.                documented
                Arthritis (PsA)                Idiopathic Arthritis:                              and older.   tologist.                             treatment
                                               Diagnosis of moderate-to-severe poly-articular                                   Reauthorization      failure to
                Ankylosing                     course                                             JIA:         Plaque           12 months            Humira every
                Spondylitis                                                                       4 years      Psoriasis:                            other week
                (AS)                           Juvenile Rheumatoid Arthritis:                     and older.   Prescribed or                         dosing. Then
                                               Failed NSAID or steroid and DMARD for three                     recommend-                            Humira may
                Crohn's                        months.                                                         ded by a                              be approved
                disease (CD)                                                                                   dermatologist.                        for every
                                               Psoriatic Arthritis:                                                                                  week dosing if
                Juvenile                       1. Diagnosis of active PsA.                                     CD:                                   other criteria
                Idiopathic                     2. Failed methotrexate or 2 DMARDs for 3                        Prescribed or                         met.
                Arthritis (JIA)                   months.                                                      recommend-
                                                                                                               ded by gastro-                        All
                Plaque                         Ankylosing Spondylitis:                                         enterologist.                         diagnoses:
                Psoriasis (PP)                 1. Diagnosis of AS.                                                                                   Verification
                                               2. Failed 2 NSAIDs for 3 months.                                                                      that the
                                                                                                                                                     patient has
                                               Plaque Psoriasis:                                                                                     been
                                               1. Diagnosis moderate-to-severe plaque psorisis                                                       evaluated for
                                                  with min BSA 10%.                                                                                  TB and
                                               2. Failed phototherapy and systemic therapy.                                                          treated
                                                                                                                                                     accordingly.
                                               Crohn's disease:
                                               1. Diagnosis of moderate to severe CD; AND
                                               2. Failed conventional therapies.

                                               Reauthorization:
                                               Demonstration of clinical response to therapy.

Immune          Idiopathic                     Idiopathic Thrombocytopenic Purpura:               BMT:         MG:              BMT:                 Immune
Globulin:       Thrombo-                       1. For patients with ITP who require a rapid       20 years     Prescribed by    100 days after       Globulin is
Carimune        cytopenic                         temporary increase in platelet count or to      and older.   a neurologist.   transplant           subject to Part
Nanofiltered,   Purpura (ITP)                     control excessive bleeding; AND                                                                    B vs. Part D
Flebogamma                                     2. Platelet count less than 20 x 10^9/L (or less   HIV:                          KD:                  review.
,               Kawasaki                          than 30 x 10^9/L with active bleeding or less   13 years                      1 month
Gammagard       Disease (KD)                      than 50 x 10^9/L with symptoms of severe        or
Liquid,                                           bleeding).                                      younger.                      MG, GBS:
Gamunex,        B-cell Chronic                                                                                                  1 treatment
                                                                                                                                                              10/06/08
                                                                                                    Age
                                   Exclusion                                                                    Prescriber     Coverage
Drugs           Covered Uses                   Required Medical Information                         Restrict-                                Other Criteria
                                   Criteria                                                                     Restrictions   Duration
                                                                                                    ions
Iveegam En,     Lymphocyt-ic                   Kawasaki Disease:                                                               course
Octagam,        Leukemia(CLL)                  Confirmed diagnosis of KD.
Panglobulin,                                                                                                                   ITP, LEMS:
Panglobulin     Bone Marrow                    B-cell Chronic Lymphocytic Leukemia:                                            6 months
Nf,             Transplantation                1. Documented hypogammaglobulinemia (IgG
Panglobulin.,   (BMT)                             less than 600mg/dL); OR                                                      Other Uses:
Polygam                                        2. History of bacterial infections associated with                              1year
S/D,            Chronic                           B-cell CLL.
Vivaglobin      Inflammatory
                De-myelinating                 Bone Marrow Transplantation:
                Poly-                          1. Confirmed allogeneic BMT within the last 100
                neuropathy                        days; AND
                (CIDP)                         2. Documented severe hypogammaglobulinemia
                                                  (IgG less than 400 mg/dL)
                Dermato-
                myositis                       Dermatomyositis:
                                               Failure or intolerance to standard therapy.
                Multifocal Motor
                Neuropathy                     HIV:
                (MMN)                          Documented hypogammaglobulinemia (IgG less
                                               than 400 mg/dL).
                Pediatric HIV
                (HIV)                          Guillane-Barre Syndrome:
                                               1. Confirmed diagnosis of severe GBS; AND
                Guillane-Barre                 2. Patients with severe disease requiring aid to
                Syndrome                          walk; AND
                (GBS)                          3. Onset of muscle weakness within the last 4
                                                  weeks.
                Lambert-Eaton
                Myasthenic                     Acute Myasthenia Gravis Exacerbation :
                Syndrome                       1. Confirmed diagnosis of myasthenia gravis
                (LEMS)                            with myasthenic exacerbation, defined by one
                                                  of the following:
                Acute                             a. Difficulty swallowing
                Myasthenia                        b. Acute respiratory failure
                Gravis                            c. Major functional disability responsible for
                Exacerba-tion                        the discontinuation of physical activity.
                (MG)
                                               Relapsing-Remitting Multiple Sclerosis :
                Relapsing-                     Failure to two standard MS agents.
                Remitting
                Multiple                       Stiff Person Syndrome :
                Sclerosis (MS),                Chart documentation confirming a diagnosis of
                                               stiff-person syndrome.
                                                                                                                                                     10/06/08
                                                                                                Age
                                 Exclusion                                                                   Prescriber     Coverage
Drugs          Covered Uses                  Required Medical Information                       Restrict-                                         Other Criteria
                                 Criteria                                                                    Restrictions   Duration
                                                                                                ions
               Stiff Person
               Syndrome

               All FDA
               approved
               indications not
               otherwise
               excluded from
               Part D

Infergen       Hepatitis C                   Hepatitis C - Treatment Naive Patients:            Hepatitis                   Treatment-
                                             For patients with Chronic Hepatitis C with         C in                        Naive:
                                             compensated liver disease with positive HCV        Treat-                      genotypes 2, 3,
                                             antibody and HCV RNA.                              ment                        5, 6:
                                                                                                Naive                       6 months
                                             Hepatitis C - Continuation of Therapy:             patients:
                                             For genotypes 2,3,5, or 6: Loss of detectable      18 years                    Genotypes 1, 4
                                             HCV RNA from serum or 100 fold drop or more        and older.                  or HIV/HCV:
                                             in HCV RNA level.                                                              12 months

                                                                                                                            Continuation of
                                                                                                                            treatment in
                                                                                                                            genotypes 2, 3,
                                                                                                                            5, 6:
                                                                                                                            6 months

Insulin-like   IGF-1                         IGF-1 deficiency                                                               All Uses:
Growth         deficiency                    1. All of the following:                                                       Insulin-like growth
Factor:        Growth                           a. Diagnosis of severe primary IGF-1                                        factor will be
Increlex,      Hormone gene                         deficiency.                                                             approved for 1
Iplex          deletion                         b. Height standard deviation score of -3.0 or                               year.
                                                    less.
                                                c. Basal IGF-1 standard deviation score of -
                                                    3.0 or less.
                                                d. Normal or elevated growth hormone.
                                                e. Open finger epiphyses on last bone
                                                    radiograph

                                             GH gene deletion:
                                             a. Diagnosis of growth hormone gene deletion
                                                who have developed neutralizing antibodies
                                                to GH; AND
                                             b. Have open finger epiphyses on last bone
                                                radiograph.
                                                                                                                                                          10/06/08
                                                                                               Age
                              Exclusion                                                                    Prescriber     Coverage
Drugs       Covered Uses                  Required Medical Information                         Restrict-                                       Other Criteria
                              Criteria                                                                     Restrictions   Duration
                                                                                               ions
Intron-A,   Hepatitis B -                 Hepatitis B - HBeAg positive:                        Hep B -                    HepB+:               Intron A will
Intron-A    HBeAg positive                1. HBsAg positive for at least 6 months; AND         HBeAg                      6 months to          be approved
W/Diluent   (HepB (+))                    2. HBV DNA level greater than 100,000                positive,                  1year.               for
                                             copies/mL; AND.                                   Hep B -                                         continuation
            Hepatitis B -                 3. Compensated liver disease; AND                    HBeAg                      HepC:                of prior
            HBeAg                         4. One of the following: persistent ALT 2 times      negative:                  genotypes 2, 3,      therapy for
            negative (HepB                   ULN or moderate to severe hepatitis or            1 year of                  5, 6:                neoplastic
            (-))                             fibrosis on biopsy.                               age or                     6 months             diseases.
                                                                                               older.
            Hepatitis C -                 Hepatitis B - HBeAg negative:                                                   HepC:
            Treatment                     1. HBsAg positive for at least 6 months; AND         Hep C -                    genotypes 1, 4,
            Naive Patients                2. HBV DNA level of 2000 IU/mL or more or            Treatment                  HIV/HCV:
            (HepC Naive)                     11,200 copies/mL; AND                             Naive                      12 months
                                          3. Compensated liver disease; AND                    Patients,
            Hepatitis C -                 4. One of the following: persistent ALT 2 times      Non-                       Acute HepC,
            Continuation of                  ULN or moderate to severe hepatitis or            Hepatitis                  HCL, Kaposi:
            Therapy                          fibrosis on biopsy.                               Diagno-                    6 months.
            (HepC-Con't)                                                                       ses,
                                          Hepatitis C - Treatment Naive Patients:              Acute                      Warts:
            Non-Hepatitis                 For patients with Chronic Hepatitis C with           Hep C:                     3 weeks.
            Diagnoses                     compensated liver disease with positive HCV          18 years
                                          antibody and HCV RNA.                                old and                    Other uses:
            Acute Hepatitis                                                                    older.                     1year
            C (Acute HepC)                Hepatitis C - Continuation of Therapy:
                                          For genotypes 2,3,5, or 6: loss of detectable
            All FDA                       HCV RNA from serum or 100 fold drop or more
            approved                      in HCV RNA level.
            indications not
            otherwise                     Non-Hepatitis Diagnoses
            excluded from                 Diagnosis of one of the following:
            Part D                        1. Malignant Melanoma
                                          2. Hairy cell leukemia
                                          3. Stage III or IV follicular Non-Hodgkin's
                                          Lymphoma, 4. Condylomata acuminate
                                          5. AIDS-related Kaposi's sarcoma
                                          6. Multiple Myeloma.

                                          Acute Hepatitis C:
                                          Patients with acute hepatitis C.

Ketek       Community-                    Community-Acquired Pneumonia:                                                   Ketek will be
            Acquired                      1. Diagnosis of CAP in an adult outpatient; AND                                 approved for the
            Pneumonia                     2. Resistance or failure to either azithromycin or                              length of therapy.
            (CAP)                            clarithromycin.
                                                                                                                                                        10/06/08
                                                                                               Age
                             Exclusion                                                                     Prescriber      Coverage
Drugs      Covered Uses                    Required Medical Information                        Restrict-                                       Other Criteria
                             Criteria                                                                      Restrictions    Duration
                                                                                               ions
Kineret    Rheumatoid        Concurrent    Initial Therapy for Rheumatoid Arthritis:                       RA:             Initial Therapy
           Arthritis         use of TNF-   1. Moderate to severe active RA with at least 6                 Prescribed or   for RA:
                             blockers or      swollen joints and at least 6 tender/painful                 recommend-      Kineret will be
                             Orencia          joints; AND                                                  ded by a        approved for 6
                                           2. One of the following:                                        rheumatolo-     months.
                                              a. More than 45 minutes of morning stiffness                 gist.
                                              b. Elevated ESR                                                              Reauthorization
                                              c. Elevated CRP; AND                                                         for RA:
                                           3. Failure with a TNF-alpha-blocker. Failure on                                 Kineret will be
                                              either methotrexate or at least 2 DMARDs for                                 approved for 1
                                              at least 3 months.                                                           year.

                                           Reauthorization for RA:
                                           1. At least 20% improvement in the tender and
                                               swollen joint count; AND
                                           2. At least 20% improvements in 3 of the
                                           following:
                                               a. MD or patient's global assessment
                                               b. Patient's assessment of pain
                                               c. Degree of disability
                                               d. Acute-phase reactant concentration; OR
                                           3. Submission of chart documentation
                                               demonstrating the clinical equivalent of the
                                               above criteria.

Letairis   Pulmonary                       Pulmonary Arterial Hypertension:                                                Length of therapy
           Arterial                        Patients with a confirmed diagnosis of
           Hypertension                    pulmonary arterial hypertension (modified WHO
           (PAH)                           Group I) in WHO functional class II or III.

Leukine    Bone                            Bone Marrow/Stem Cell Transplant:                   AML:                        BMSCT, AML:
           Marrow/Stem                     1. Patients with non-myeloid malignancies           Greater                     6 weeks
           Cell Transplant                    undergoing myeloablative chemotherapy            than or
           (BMSCT)                            followed by autologous/allogeneic BMT; OR        equal to                    NDDC, CFN:
                                           2. Mobilization of hematopoietic progenitor cells   55 years                    One month or
           Acute Myeloid                      into the peripheral blood for collection by      old.                        duration of
           Leukemia                           leukapheresis; OR                                                            treatment.
           Induction or                    3. Peripheral stem cell transplant patients who
           Consolidation                      have received myeloablative chemotherapy.                                    FN:
           Therapy (AML)                                                                                                   6 weeks or
                                           Acute Myeloid Leukemia Induction or                                             duration of
           Neutropenia                     Consolidation Therapy:                                                          chemotherapy
           associated with                 For patients with AML following induction or
           dose dense                      consolidation chemotherapy.                                                     HIVN:
                                                                                                                                                       10/06/08
                                                                                                    Age
                             Exclusion                                                                           Prescriber        Coverage
Drugs      Covered Uses                        Required Medical Information                         Restrict-                                          Other Criteria
                             Criteria                                                                            Restrictions      Duration
                                                                                                    ions
           chemotherapy                                                                                                            One month, or
           (NDDC)                              Neutropenia associated with dose dense                                              three months with
                                               chemotherapy:                                                                       risk factors
           Chemotherapy                        1. Patient is receiving the National
           with risk of                           Comprehensive Cancer Network’s (NCCN's)
           febrile                                Breast Intergroup, INT C9741 dose dense
           neutropenia                            chemotherapy protocol for primary breast
           (CFN)                                  cancer; OR
                                               2. A dose-dense regimen for which the incidence
           Febrile                                of febrile neutropenia is unknown.
           Neutropenia
           (FN)                                Chemotherapy with risk of febrile
                                               neutropenia:
           HIV-related                         1. Patient is receiving a chemotherapy regimen
           neutropenia                            associated with more than 20% incidence of
           (HIVN)                                 febrile neutropenia; OR
                                               2. Patient is receiving chemotherapy regimen
           All FDA                                associated with 10-20% incidence of febrile
           approved                               neutropenia and has risk factors associated
           indications not                        with chemotherapy-induced infection, febrile
           otherwise                              neutropenia or neutropenia.
           excluded from
           Part D                              Febrile Neutropenia:
                                               1. For patients receiving myelosuppressive
                                                  anticancer drugs associated with neutropenia;
                                                  AND
                                               2. Patient either has febrile neutropenia or has a
                                                  history of febrile neutropenia during a
                                                  previous course of chemotherapy.

                                               HIV-related neutropenia:
                                               HIV-infected patients with an Absolute
                                               Neutrophil Count (ANC) less than or equal to
                                               1,000 cells/mm3 with or without one or more risk
                                               factors for developing chronic neutropenia.


Lotronex   Severe            Initial therapy   Initial Therapy for Irritable Bowel Syndrome:        18 years     Verification      Initial Therapy:
           Diarrhea-         for IBS in the    1. Confirmed diagnosis of (IBS) with diarrhea        and older.   that physician    12 weeks
           Predominant       male gender.         predominant symptoms for at least 6 months;                    has enrolled in
           Irritable Bowel                        AND                                                            the               Reauthorization:
           Syndrome                            2. Failure to an antispasmodic and an anti-                       GlaxoSmithKli     6 months
           (IBS)                                  diarrhea agent.                                                ne Prescribing
                                                                                                                 Program.
                                                                                                                                                               10/06/08
                                                                                                  Age
                               Exclusion                                                                      Prescriber     Coverage
Drugs        Covered Uses                  Required Medical Information                           Restrict-                                       Other Criteria
                               Criteria                                                                       Restrictions   Duration
                                                                                                  ions
                                           Reauthorization for IBS:
                                           1. Recurrence of diarrhea-predominant IBS;
                                           AND
                                           2. Documentation of positive clinical response
                                              while on Lotronex.

Lyrica       Treatment of                  Seizure Disorder:                                                                 Length of therapy    Lyrica will be
             Seizure                       1. History of failure to a formulary anticonvulsant;                                                   approved for
             Disorder                         AND                                                                                                 continuation
                                           2. As add-on therapy for the diagnosis of partial                                                      of prior
             Diabetic                         seizure.                                                                                            therapy.
             Neuropathy
                                           Diabetic Neuropathy:
             Post-herpetic                 1, Diagnosis of Diabetes Mellitus; AND
             Neuropathic                   2. Diagnosis of peripheral neuropathy; AND
             Pain                          3. Failure to one formulary anticonvulsant.

             Fibromyalgia                  Post-herpetic Neuropathic Pain:
                                           Failure to one formulary anticonvulsant.

Marinol,     Nausea and                    Nausea and Vomiting Associated with                                               CINV, AIDS           Marinol is
dronabinol   Vomiting                      Cancer Chemotherapy:                                                              anorexia: length     subject to Part
             Associated with               1. Patient is receiving cancer chemotherapy;                                      of therapy           B vs. Part D
             Cancer                        AND                                                                                                    review.
             Chemotherapy                  2. Failure to 5HT-3 receptor antagonist; AND
             (CINV)                        3. Failure to one of the following agents:                                                             CINV:
                                              a. Antihistamine                                                                                    Marinol will be
             Anorexia in                      b. Corticosteroid                                                                                   approved for
             Patients with                    c. Prokinetic agent                                                                                 continuation
             AIDS                             d. Antipsychotic.                                                                                   covered under
                                                                                                                                                  Part B when
                                           AIDS Anorexia:                                                                                         patient is
                                           Diagnosis of anorexia with weight loss in                                                              receiving
                                           patients with AIDS.                                                                                    chemotherapy
                                                                                                                                                  .
Mepro-       Anxiety                       For treatment of anxiety                                                          4 months
bamate

miacalcin    Post-                         Postmenopausal Osteoporosis:                                                      Post-                Miacalcin is
injectable   menopausal                    1. Failure to a bisphosphonate or selective                                       menopausal           subject to Part
             Osteoporosis                     estrogen-receptor modulator (SERM); AND                                        Osteoporosis:        B vs. Part D
                                           2. Failure to Miacalcin Nasal Spray; AND                                          Miacalcin will be    review.
             Paget's                       3. History of vertebral compression fractures, or                                 approved for the
             Disease                          fractures of the hip or distal radius resulting                                length of therapy.
                                                                                                                                                           10/06/08
                                                                                              Age
                             Exclusion                                                                    Prescriber     Coverage
Drugs      Covered Uses                  Required Medical Information                         Restrict-                                     Other Criteria
                             Criteria                                                                     Restrictions   Duration
                                                                                              ions
                                            from minimal trauma, or T score of -2.5 or
           Hypercalcemia                    less.                                                                        Paget's disease:
                                                                                                                         6 months.
                                         Initial Therapy for Paget's Disease:
                                         History of failure or intolerance to oral                                       Hypercalcemia:
                                         bisphosphonates.                                                                One time only.

                                         Reauthorization for Paget's Disease:
                                         Serum alkaline phosphatase concentration fails
                                         to normalize after the previous 6 months of
                                         therapy.

                                         Hypercalcemia:
                                         1. Corrected total serum calcium of 12 mg/dl; OR
                                         2. Greater or corrected total serum calcium of 6
                                            mEq/L or greater.

Neulasta   Chemotherapy                  Chemotherapy with risk of febrile                                               CFN, NDDC:
           with risk of                  neutropenia :                                                                   One month or
           febrile                       1. Patient is receiving a chemotherapy regimen                                  duration of
           neutropenia                      associated with more than 20% incidence of                                   treatment.
           (CFN)                            febrile neutropenia; OR
                                         2. a. Patients is receiving chemotherapy regimen                                FN:
           Neutropenia                         associated with 10-20% incidence of febrile                               One month or
           associated with                     neutropenia; AND                                                          duration of
           dose dense                       b. Has risk factors associated with                                          chemotherapy.
           chemotherapy                        chemotherapy-induced infection, febrile
           (NDDC)                              neutropenia or neutropenia.

           Febrile                       Neutropenia associated with dose dense
           Neutropenia                   chemotherapy :
           (FN)                          1. Patients is receiving NCCN's Breast
                                            Intergroup, INT C9741 dose dense
                                            chemotherapy protocol for primary breast
                                            cancer; OR
                                         2. A dose-dense regimen for which the incidence
                                            of febrile neutropenia is unknown.

                                         Febrile Neutropenia:
                                         1. For patients receiving myelosuppressive
                                            anticancer drugs associated with neutropenia;
                                            AND
                                         2. Patient either has febrile neutropenia or has a
                                            history of febrile neutropenia during a
                                                                                                                                                    10/06/08
                                                                                                    Age
                             Exclusion                                                                          Prescriber     Coverage
Drugs      Covered Uses                      Required Medical Information                           Restrict-                                       Other Criteria
                             Criteria                                                                           Restrictions   Duration
                                                                                                    ions
                                                previous course of chemotherapy.

Neumega    Severe            Thrombo-        Severe thrombocytopenia following                                                 3 week intervals
           thrombocytope     cytopenia       myelosuppressive chemotherapy                                                     for up to 6 cycles
           nia following     following       1. Verification that the cancer is a non-myeloid                                  post-
           myelo-            chemo-             malignancy; AND                                                                chemotherapy.
           suppressive       therapy:        2. Platelet count is less than 50,000
           chemo-therapy     Following          cells/microliter; AND
                             myeloablative   3. Patients with one or more of the following risk
           All FDA           chemo-             factors:
           approved          therapy.           a. Extensive prior cytotoxic chemotherapy
           indications not                      b. Prior severe chemotherapy-induced
           otherwise                               thrombocytopenia
           excluded from                        c. Receiving chemotherapy regimens
           Part D                                  associated with high risk for
                                                   thrombocytopenia.

Neupogen   Bone Marrow                       Bone Marrow/Stem Cell Transplant:                                                 BMSCT, AML,
           or Stem Cell                      1. For patients with non-myeloid malignancies                                     NDDC, CFN, FN:
           Transplant                           undergoing myelo-ablative chemotherapy                                         One month or
           (BMSCT)                              followed by autologous or allogeneic BMT;                                      treatment
                                                OR                                                                             duration.
           Acute Myeloid                     2. For mobilization of hematopoietic progenitor
           Leukemia                             cells into the peripheral blood for collection by                              SCN, HCN:
           Induction or                         leukapheresis; OR                                                              Treatment
           Consolidat-ion                    3. For peripheral stem cell transplant patients                                   duration.
           Therapy (AML)                        who have received myelo-ablative
                                                chemotherapy.                                                                  HIVN:
           Neutropenia                                                                                                         One month; three
           associated with                   Acute Myeloid Leukemia Induction or                                               months with risk
           dose dense                        Consolidation Therapy:                                                            factors.
           chemotherapy                      For patients with AML following induction or
           (NDDC)                            consolidation chemotherapy.

           Chemotherapy                      Neutropenia associated with dose dense
           with risk of                      chemotherapy:
           febrile                           1. Patient is receiving NCCN's Breast Intergroup,
           neutropenia                          INT C9741 dose dense chemotherapy
           (CFN)                                protocol for primary breast cancer; OR
                                             2. A dose-dense regimen for which the incidence
           Febrile                              of febrile neutropenia is unknown.
           Neutropenia
           (FN)                              Chemotherapy with risk of febrile
                                             neutropenia:
                                                                                                                                                            10/06/08
                                                                                                 Age
                            Exclusion                                                                         Prescriber      Coverage
Drugs     Covered Uses                      Required Medical Information                         Restrict-                                      Other Criteria
                            Criteria                                                                          Restrictions    Duration
                                                                                                 ions
          Severe Chronic                    1. Patient is receiving a chemotherapy regimen
          Neutropenia                          associated with more than 20% incidence of
          (SCN)                                febrile neutropenia; OR
                                            2. Patient is receiving a chemotherapy regimen
          Hepatitis-C                          associated with 10-20% incidence of febrile
          Treatment of                         neutropenia and has risk factors associated
          Related                              with chemotherapy-induced infection, febrile
          Neutropenia                          neutropenia or neutropenia.
          (HCN)
                                            Febrile Neutropenia:
          HIV-related                       1. For patients receiving myelosuppressive
          neutropenia                          anticancer drugs associated with neutropenia;
          (HIVN)                               AND
                                            2. Patient either has febrile neutropenia or has a
          All FDA                              history of febrile neutropenia during a
          approved                             previous course of chemotherapy.
          indications not
          otherwise                         Severe Chronic Neutropenia:
          excluded from                     For patients with severe chronic neutropenia.
          Part D
                                            Hepatitis-C Treatment of Related
                                            Neutropenia:
                                            1. Neutropenia in Hepatitis C virus infected
                                               patients undergoing treatment with Peg-Intron
                                               or Pegasys after dose reduction; OR
                                            2. For patients with HIV co-infection or status
                                               post liver transplant, or established cirrhosis
                                               who experience interferon-induced
                                               neutropenia due to treatment with Peg-Intron
                                               or Pegasys.

                                            HIV-related neutropenia:
                                            HIV-infected patients with an ANC less than or
                                            equal to 1,000 cells/mm3 with or without one or
                                            more risk factors for developing chronic
                                            neutropenia.

Orencia   Rheumatoid        Initial         Rheumatoid Arthritis:                                RA:          RA:             Initial Therapy
          Arthritis (RA)    Therapy for     1. Diagnosis of moderate-to-severe RA; AND           18 years     Prescribed or   for RA and JIA:
                            RA:             2. Failed methotrexate or 2 DMARDs for 3             and older.   recommend-      6 months.
          Juvenile          Concurrent         months.                                                        ded by a
          Idiopathic        use with                                                             JIA:         rheumatolo-     Reauthorization
          Arthritis (JIA)   anakinra or a   Juvenile Rheumatoid Arthritis / Juvenile             6 years      gist.           for RA, JIA:
                            TNF             Idiopathic Arthritis:                                and older.                   1 year
                                                                                                                                                        10/06/08
                                                                                                 Age
                               Exclusion                                                                     Prescriber     Coverage
Drugs         Covered Uses                   Required Medical Information                        Restrict-                                      Other Criteria
                               Criteria                                                                      Restrictions   Duration
                                                                                                 ions
                               antagonist.   Diagnosis of moderate-to-severe poly-articular
                                             course

                                             Juvenile Rheumatoid Arthritis:
                                             Failed NSAID or steroid and DMARD for three
                                             months.

Oxandrin,     Weight Gain                    Weight gain:                                                                   Initial therapy:
oxandrolone                                  1. Patients with extensive surgery; OR                                         3 months
              Bone Pain                      2. Chronic infections causing unremitting weight
                                                loss; OR                                                                    Reauthorization:
              AIDS wasting/                  3. Severe trauma; OR                                                           Length of therapy
              cachexia                       4. Failure to gain or maintain normal weight
                                                without definite pathophysiologic reasons; OR
                                             5. To offset the protein catabolism associated
                                                with prolonged administration of
                                                corticosteroids.

                                             Bone Pain:
                                             Diagnosis of bone pain due to osteoporosis.

                                             Initial Therapy for AIDS Wasting:
                                             Diagnosis of AIDS wasting/cachexia and failure
                                             to hormone replacement therapy in patients with
                                             hypogonadism.

                                             Reauthorization for Weight Gain:
                                             Verification that the patient’s weight has
                                             increased a minimum of 2% while taking

                                             Reauthorization of Oxandrin:
                                             Verification that the patient’s weight has
                                             increased a minimum of 2% while taking
                                             Oxandrin.

Pegasys       Hepatitis B -                  Hepatitis B - HBeAg positive patients:              For all                    Hepatitis B:
              HBeAg positive                 1. HBsAg positive for at least 6 months; AND        covered                    1year.
                                             2. HBV DNA level greater than 100,000               uses:
              Hepatitis B -                     copies/mL; AND.                                  18 years                   Hepatitis C
              HBeAg                          3. Compensated liver disease; AND                   and older                  Genotypes 5, 6:
              negative                       4. One of the following:                                                       12 weeks;
                                                a. ALT (liver enzyme) 2 times upper limits of                               Genotypes 2, 3:
              Hepatitis C -                        normal (ULN)                                                             24 weeks;
              Treatment                         b. Moderate-to-severe hepatitis or fibrosis on                              Genotypes 1, 4:
                                                                                                                                                        10/06/08
                                                                                          Age
                          Exclusion                                                                   Prescriber     Coverage
Drugs   Covered Uses                  Required Medical Information                        Restrict-                                        Other Criteria
                          Criteria                                                                    Restrictions   Duration
                                                                                          ions
        Naive Patients                     biopsy.                                                                   (HIV/HCV co-
                                                                                                                     infected patients):
        Hepatitis C -                 Hepatitis - HBeAg negative patients:                                           48wk.
        Continuation of               1. HBsAg positive for at least 6 months; AND
        Therapy                       2. HBV DNA level of 2000 IU/mL or more or                                      Hepatitis C
                                         11,200 copies/mL; AND                                                       Continuation
        Hepatitis C                   3. Compensated liver disease; AND                                              therapy:
        Retreatment.                  4. One of the following:                                                       Genotypes 1,3:
                                         a. ALT 2 times ULN                                                          24 weeks,
                                         b. Moderate-to-severe hepatitis or fibrosis on                              Genotypes 5, 6:
                                            biopsy.                                                                  36wk.

                                      Hepatitis C - Treatment Naive Patients:                                        Hepatitis C
                                      1. Chronic Hepatitis C with compensated liver                                  Retreatment:
                                         disease; AND                                                                1year
                                      2. Positive HCV antibody HCV RNA; AND
                                      3. HCV RNA level measurement; AND
                                      4. Genotype test result; AND
                                      5. For patients who have not previously been
                                         treated with interferon.

                                      Continuation of Therapy:
                                      A. For genotypes 5 or 6:
                                         1. Loss of detectable HCV RNA from serum
                                            or 100 fold drop or more in HCV RNA level.

                                      B. For genotype 1:
                                         1. Undetectable HCV RNA after 24 weeks of
                                            therapy; AND
                                         2. One of the following:
                                            a. HCV RNA more than 50 IU/mL at 4
                                               weeks into treatment
                                            b. Less than 100 fold drop or detectable
                                               HCV RNA 12 weeks into therapy.

                                      C. For genotype 3:
                                         1. Baseline HCV RNA more than 600,000
                                            IU/mL; AND
                                         2. Steatosis or advanced fibrosis on liver
                                            biopsy.

                                      Hepatitis C Retreatment:
                                      1. One of the following
                                         a. Retreatment in patients who have failed or
                                                                                                                                                   10/06/08
                                                                                            Age
                             Exclusion                                                                   Prescriber     Coverage
Drugs         Covered Uses               Required Medical Information                       Restrict-                                       Other Criteria
                             Criteria                                                                    Restrictions   Duration
                                                                                            ions
                                               relapsed following standard or pegylated
                                               interferon monotherapy; OR
                                            b. For non-responders or relapsers who have
                                               significant fibrosis or cirrhosis who have
                                               undergone previous regimens of treatment
                                               using non-pegylated interferon. AND
                                         2. Used in combination with ribavirin.

Peg-Intron,   Hepatitis C                Hepatitis C - Treatment Naive Patients:            Treatment                   Genotypes 5, 6:
Peg-Intron                               1. Chronic Hepatitis C with compensated liver      Naive                       12 weeks
Redipen                                     disease; AND                                    Patients:
                                         2. Positive HCV antibody HCV RNA; AND              18 years                    Genotypes 2, 3:
                                         3. HCV RNA level measurement; AND                  and older.                  24 weeks
                                         4. Genotype test result; AND
                                         5. For patients who have not previously been                                   Genotypes 1, 4,
                                            treated with interferon.                                                    co-infection with
                                                                                                                        HIV/HCV:
                                         Hepatitis C (Continuation):                                                    48 weeks.
                                         A. For genotypes 5 or 6:
                                            1. Loss of detectable serum HCV RNA; OR                                     Hepatitis C
                                            2. 100 fold drop or more in HCV RNA level.                                  Continuation:
                                                                                                                        Genotypes 1, 3:
                                         B. For genotype 1:                                                             24 weeks
                                            1. Undetectable HCV RNA after 24 weeks of                                   Genotypes: 5, 6:
                                               therapy; AND                                                             36 weeks.
                                            2. One of the following:
                                               a. HCV RNA more than 50 IU/mL at 4                                       Hepatitis C
                                                  weeks into treatment                                                  Retreatment:
                                               b. Less than 100 fold drop or detectable                                 1 year
                                                  HCV RNA 12 weeks into therapy.

                                         C. For genotype 3:
                                            1. Baseline HCV RNA more than 600,000
                                               IU/mL; AND
                                            2. Steatosis or advanced fibrosis on liver
                                               biopsy.

                                         Hepatitis C (Retreatment):
                                         1. One of the following:
                                            a. Retreatment in patients who have failed or
                                               relapsed following standard or pegylated
                                               interferon monotherapy; OR
                                            b. For non-responders or relapsers who have
                                               significant fibrosis or cirrhosis who have
                                                                                                                                                    10/06/08
                                                                                                 Age
                                Exclusion                                                                    Prescriber     Coverage
Drugs         Covered Uses                  Required Medical Information                         Restrict-                                       Other Criteria
                                Criteria                                                                     Restrictions   Duration
                                                                                                 ions
                                                 undergone previous regimens of treatment
                                                 using non-pegylated interferon. AND
                                            2. Used in combination with ribavirin.

Prograf       Transplant                    Transplant:                                                                     Prograf will be      Prograf is
intravenous                                 1. One of the following:                                                        approved for the     subject to Part
                                               a. Patient received a renal (kidney), cardiac                                length of therapy.   B vs. Part D
                                                  (heart), lung, pancreas, small bowel, or                                                       review:
                                                  hepatic (liver) transplant.
                                               b. Patient received a bone marrow/stem cell
                                                  transplant. AND
                                            2. Patient is unable to take oral tacrolimus.

Prograf       Severe Uveitis                Severe Uveitis:                                                                 Length of therapy    Prograf is
                                            Failure to corticosteroids.                                                                          subject to Part
              Transplant                                                                                                                         B vs. Part D
                                            Transplant:                                                                                          review : Not
                                            1. Patient received a renal (kidney), cardiac                                                        limited to new
                                               (heart), lung, pancreas, small bowel, hepatic                                                     starts only
                                               (liver) transplant, bone marrow/stem cell                                                         Approve
                                               transplant; AND                                                                                   Prograf for
                                            2. Diagnosis of graft vs. host disease in patients                                                   continuation
                                               receiving bone marrow transplants.                                                                of prior
                                                                                                                                                 therapy if Part
                                                                                                                                                 D.



Proleukin     Metastatic                    Metastatic Renal Cell Carcinoma or                   All uses:                  1 course of          All uses:
              Renal Cell                    Metastatic Melanoma:                                 18 years                   therapy per          Proleukin will
              Carcinoma                     1. Measurable, histologically confirmed              and older                  request              be approved
                                               metastatic renal cell carcinoma or metastatic                                                     for
              Metastatic                       melanoma; AND                                                                                     continuation
              Melanoma                      2. Good neurologic or ambulatory performance                                                         of prior
                                               status; AND                                                                                       therapy.
              All FDA                       3. Adequate organ function determined by all of
              approved                         the following:                                                                                    Metastatic
              indications not                  a. Normal cardiac stress test results                                                             Renal Cell
              otherwise                        b. FEV1 greater than 2 L on pulmonary                                                             Carcinoma or
              excluded from                       function tests                                                                                 Melanoma:
              Part D                           c. Creatinine concentration 1.5 mg/dL or less                                                     Administered
                                                  or calculated creatinine clearance > 60                                                        in a hospital
                                                  ml/min                                                                                         setting.
                                               d. Bilirubin concentration of 1.5 mg/dL or less
                                                                                                                                                          10/06/08
                                                                                                Age
                             Exclusion                                                                      Prescriber     Coverage
Drugs      Covered Uses                     Required Medical Information                        Restrict-                                    Other Criteria
                             Criteria                                                                       Restrictions   Duration
                                                                                                ions
                                                   f. SGOT/AST less than 150 IU or 4x upper                                                  Additional
                                                   limit of normal. AND                                                                      treatment
                                            4. Platelet count greater than or equal to                                                       given only if
                                               100,000/ mcL; AND                                                                             there is some
                                            5. Hemoglobin greater than or equal to 10 g/dL;                                                  tumor
                                               AND                                                                                           shrinkage
                                            6. WBC greater than or equal to 3,500 / mcL;                                                     following the
                                               AND                                                                                           last course
                                            7. At least 7 weeks since prior therapy and                                                      and if
                                               complete recovery from therapy-related side                                                   retreatment is
                                               effects.                                                                                      not contra-
                                                                                                                                             indicated.

Provigil   Narcolepsy        Initial        Narcolepsy:                                                                    Narcolepsy, MS
                             Therapy for    Submission of sleep study confirming the                                       Fatigue,
           Obstructive       SWSD:          diagnosis of narcolepsy, as defined by the                                     Idiopathic
           Sleep Apnea       Symptoms do    International Classification of Sleep Disorders                                Hypersomnia:
           /Hypopnea         not meet       (1997).                                                                        Length of
           Syndrome          criteria for                                                                                  treatment
           (OSAHS)           any other      Initial Therapy for Obstructive Sleep
                             sleep          Apnea/Hypopnea Syndrome:                                                       OSAHS, SWSD:
           Shift Work        disorder       1. More than 5 obstructive apneas, each greater                                3 months
           Sleep Disorder    producing         than 10 seconds in duration, per hour of sleep
           (SWSD)            insomnia or       confirmed by a sleep study; AND                                             Reauthorization
                             excessive      2. One of the following:                                                       for OSAHS:
           Fatigue           sleepiness.       a. Frequent arousals from sleep associated                                  12 months
           Associated with                        with apneas
           Multiple                            b. Bradycardia
           Sclerosis (MS)                      c. Arterial oxygen desaturation in association
                                                  with apneas. AND
           Idiopathic                       3. Fully compliant and concurrently using
           Hyper-somnia                        continuous positive airway pressure (CPAP);
                                               AND
                                            4. Symptoms of excessive daytime sleepiness.

                                            Reauthorization for Obstructive Sleep
                                            Apnea/Hypopnea Syndrome:
                                            Patient continues to be fully compliant on
                                            concurrent CPAP and is experiencing relief of
                                            symptomatic hypersomnolence with Provigil use.

                                            Shift Work Sleep Disorder:
                                            1. One of the following:
                                               a. Symptoms of excessive sleepiness or
                                                                                                                                                     10/06/08
                                                                                                   Age
                             Exclusion                                                                         Prescriber       Coverage
Drugs       Covered Uses                       Required Medical Information                        Restrict-                                        Other Criteria
                             Criteria                                                                          Restrictions     Duration
                                                                                                   ions
                                                     insomnia, for at least 3 months, which is
                                                     temporally associated with a work period
                                                     that occurs during the habitual sleep phase
                                                  b. Sleep study demonstrating loss of a normal
                                                     sleep-wake pattern. AND
                                               2. Sleep disturbance causes significant distress
                                                  or significant impairment; AND
                                               3. No other disorder accounts for the symptoms.

                                               Reauthorization for Shift Work Sleep
                                               Disorder:
                                               1. Patient is experiencing relief with use of
                                                  Provigil for excessive sleepiness; AND
                                               2. Sleep disturbance continues to cause
                                                  clinically significant distress or significant
                                                  impairment in occupational functioning.

                                               Idiopathic Hypersomnia:
                                               Submission of sleep study confirming the
                                               diagnosis of Idiopathic Hypersomnia as defined
                                               by the International Classification of Sleep
                                               Disorders.

Qualaquin   Chloroquine-     1. Severe or      Chloroquine-sensitive malaria:                                                   7 days
            sensitive P.        complicat-     1. Diagnosis of Malaria; AND
            falciparum          ed P. falci-   2. History of failure, contraindication or
            malaria             parum             intolerance to chloroquine.
                                malaria.
            Chloroquine-     2. Prevent-       Chloroquine-resistant malaria:
            resistant P.        ion of         Diagnosis of malaria.
            falciparum          Malaria
            malaria          3. For
                                treatment
                                or prevent-
                                ion of
                                nocturnal
                                leg
                                cramps.

Ranexa      Chronic Angina   1. Pre-           Chronic Angina:                                                 Prescribed by    Length of therapy
                                existing       1. Diagnosis of chronic stable angina; AND                      a cardiologist
                                QT             2. Failure to two of the following standard                     or cardiology
                                prolongat-        therapies: a. beta-blocker,                                  consult.
                                ion               b. calcium channel blocker
                                                                                                                                                            10/06/08
                                                                                                  Age
                              Exclusion                                                                       Prescriber      Coverage
Drugs          Covered Uses                   Required Medical Information                        Restrict-                                      Other Criteria
                              Criteria                                                                        Restrictions    Duration
                                                                                                  ions
                              2. CYP3A           c. long-acting nitrate. AND
                                 inhibitors   3. Used in combination with one of the following:
                              3. QT              a. amlodipine
                                 prolong-        b. beta-blocker
                                 ing drugs.      c. nitrate
                              4. Liver
                                 disease.
                              5. Doses
                                 higher
                                 than 2,000
                                 mg/day.

Raptiva        Plaque                         Initial Therapy for Plaque psoriasis:                           Prescribed by   Initial Therapy:
               psoriasis                      1. Diagnosis of moderate to severe chronic                      a dermatolo-    12 weeks
                                                 (greater than or equal to 6 months) plaque                   gist.
                                                 psoriasis involving a minimum body surface of                                Reauthorization:
                                                 10%; AND                                                                     1 year
                                              2. Failure or intolerance to phototherapy
                                                 (ultraviolet light B, pulse dye laser, or
                                                 psoralen with ultraviolet light A or photo-
                                                 chemotherapy); AND
                                              3. Systemic therapy with at least one standard
                                                 therapy; AND
                                              4. Platelet count greater than 130,000 cells per
                                                 microliter at baseline.

                                              Reauthorization for Plaque psoriasis:
                                              1. Patient has achieved a scoring of "minimal" or
                                                 almost "clear" by Physician Global
                                                 Assessment; AND
                                              2. Platelet count greater than 130,000 cells per
                                                 microliter.

Rebif, Rebif   Relapsing                      Relapsing forms of Multiple Sclerosis:                                          1 year
Titration      forms of                       1. Patients with relapsing forms of MS: OR
Pack           Multiple                       2. Patients with secondary progressive MS who
               Sclerosis                         continue to experience relapses; AND
                                              3. Trial on an alternative MS agent.

Regranex       Diabetic                       Diabetic Neuropathic Ulcers                                                     6 months
               Neuropathic                    1. Debridement at least once weekly; AND
               Ulcers                         2. At least two of the following are present:
                                                 a. Stage III or IV wound
                                                 b. Wound at least 1 cm x 1 cm
                                                                                                                                                         10/06/08
                                                                                              Age
                             Exclusion                                                                     Prescriber        Coverage
Drugs      Covered Uses                    Required Medical Information                       Restrict-                                  Other Criteria
                             Criteria                                                                      Restrictions      Duration
                                                                                              ions
                                             c. Long-standing wound that does not heal
                                                with standard care
                                             d. Patients at high risk for amputation
                                                (peripheral neuropathy, peripheral vascular
                                                disease, skin or nail abnormalities,
                                                previous foot ulcer amputation).

Remicade   Rheumatoid        RA, PsA:      Rheumatoid Arthritis:                              RA, PsA,     RA, AS, PsA:      12 months   Verification
           Arthritis (RA)    Used in       1. Diagnosis of moderate-to-severe RA              AS,          Prescribed or                 that the
                             combination   2. Failure to methotrexate or 2 DMARDs for 3       Plaque       recommended                   patient has
           Crohn's           with             months.                                         Psoriasis,   by a                          been
           Disease (CD)      anakinra.                                                        UC:          rheumatolo-                   evaluated for
                                           Psoriatic Arthritis:                               18 years     gist.                         tuberculosis
           Fistulizing                     1. Diagnosis of active disease                     and older.                                 (TB) and
           Crohn's                         2. Failure to methotrexate or 2 DMARDs for 3                    Crohn's                       treated
           Disease (FCD)                      months.                                         Crohn's      Disease,                      accordingly.
                                                                                              Disease:     Fistulizing
           Ankylosing                      Ankylosing Spondylitis:                            6 years      Crohn's
           Spondylitis                     1. Diagnosis of AS                                 and older.   Disease, UC:
           (AS)                            2. Failed 2 NSAIDs for 3 months                                 Prescribed by
                                                                                                           a gastro-
           Psoriatic                       Plaque Psoriasis:                                               enterologist or
           Arthritis (PsA)                 1. Moderate-to-severe plaque psoriasis (10%                     by gastro-
                                              body surface); AND                                           enterologist
           Ulcerative                      2. Failed phototherapy and systemic therapy.                    consult.
           Colitis (UC)
                                           Crohn's Disease:                                                Plaque
           Plaque                          1. Moderate to severe CD; AND                                   Psoriasis:
           Psoriasis                       2. Failed standard treatment.                                   Prescribed or
                                                                                                           recommend-
           Sarcoidosis                     Fistulizing Crohn's Disease:                                    ed by a
                                           1. Draining fistulas for 3 months; AND                          dermatologist.
                                           2. On or failed standard treatment.
                                                                                                           Sarcoidosis:
                                           Ulcerative Colitis:                                             Prescribed or
                                           1. Moderate to severe UC; AND                                   recommended
                                           2. Failed standard treatment.                                   by a
                                                                                                           pulmonologist.
                                           Sarcoidosis:
                                           Failed steroids and an immunosuppressant.

                                           Reauthorization:
                                           Demonstration of clinical response to therapy

                                                                                                                                                 10/06/08
                                                                                                      Age
                                Exclusion                                                                          Prescriber       Coverage
Drugs         Covered Uses                      Required Medical Information                          Restrict-                                         Other Criteria
                                Criteria                                                                           Restrictions     Duration
                                                                                                      ions
Remodulin     Pulmonary                         Pulmonary Arterial Hypertension                                                     Length of therapy   Remodulin is
              Arterial                          1. Patients with a confirmed diagnosis of                                                               subject to Part
              Hypertension                         pulmonary arterial hypertension (modified                                                            B vs. Part D
              (PAH)                                WHO Group I); AND                                                                                    review.
                                                2. Patients in WHO functional class II, III, or IV.

Revatio       Pulmonary         PAH:            Pulmonary Arterial Hypertension:                                                    Length of therapy
              Arterial          Patients        1. Confirmed diagnosis of pulmonary arterial
              Hypertension      using organic      hypertension (modified WHO group I); AND
              (PAH)             nitrates.       2. Patients in WHO functional class II, III or IV.

Revlimid      Myelo-                            Myelo-dysplastic Syndrome:                                         MDS, Multiple    MDS, Multiple       Revlimid will
              dysplastic                        1. Diagnosis of myelodysplastic syndrome                           Myeloma:         Myeloma:            be approved
              Syndrome                             associated with a deletion 5q cytogenic                         Prescribed by    6 months            for
              (MDS)                                abnormality; AND                                                an oncologist                        continuation
                                                2. Patient is transfusion dependent.                               or                                   of prior
              Multiple                                                                                             hematologist                         therapy.
              Myeloma                           Multiple Myeloma:                                                  or by oncology
                                                1. Relapsed or refractory to one prior therapy for                 or hematology
              All FDA                              multiple myeloma; OR                                            consult.
              approved                          2. All of the following:
              indications not                      a. Diagnosis of advanced multiple myeloma
              otherwise                                (Durie-Salmon state II and stage III)
              excluded from                        b. Used in combination with dexamethasone.
              Part D

Copegus,      Hepatitis C                       Hepatitis C:                                                                        Length of therapy
Rebetol,                                        Diagnosis of Hepatitis C with compensated liver
Ribapak,                                        disease, and verification of concurrent use with
Ribasphere,                                     an alfa-interferon product.
Ribatab,
ribavirin

Rituxan       Non-Hodgkin's                     Non-Hodgkin's Lymphoma:                               RA:          RA:              Rituxan will be     Rituxan will be
              Lymphoma                          One of the following:                                 18 years     Prescribed by    approved for one    approved for
                                                1. As first-line treatment of diffuse large B-cell,   and older.   a rheumatolo-    course of therapy   continuation
              Chronic                              CD20-positive, non-Hodgkin’s lymphoma in                        gist.            (2 doses) for RA.   of prior
              Lymphocytic                          combination with CHOP (cyclophosphamide,                                                             therapy for
              Leukemia                             doxorubicin, vincristine, prednisone) or other                                   Rituxan will be     neoplastic
                                                   anthracycline-based chemotherapy regimens                                        approved for the    diseases.
              Immune or                         2. As first-line treatment of follicular, CD20-                                     length of therapy
              idiopathic                           positive, B-cell non-Hodgkin's lymphoma in                                       for other uses
              thrombocytope                        combination with CVP (cyclophoshamide,
              nic purpura                          vincristine, prednisolone/prednisone)
                                                                                                                                                                 10/06/08
                                                                                                   Age
                                Exclusion                                                                      Prescriber     Coverage
Drugs         Covered Uses                  Required Medical Information                           Restrict-                                    Other Criteria
                                Criteria                                                                       Restrictions   Duration
                                                                                                   ions
                                               chemotherapy
              Waldenstrom’s                 3. For the treatment of low-grade, CD20-positive,
              macro-                           B-cell non-Hodgkin's lymphoma in patients
              globulinemia                     with stable disease or who achieve a partial or
                                               complete response following first-line
              Rheumatoid                       treatment with CVP chemotherapy
              Arthritis (RA)                4. Confirmed diagnosis of relapsed or refractory,
                                               low grade or follicular CD20-positive, B-cell
                                               non-Hodgkin’s lymphoma.

                                            Initial Therapy for Rheumatoid Arthritis:
                                            1. Diagnosis of moderate/severe RA defined by
                                               at least 6 swollen joints and 6 painful joints; &
                                            2. One of the following:
                                               a. More than 45 minutes of morning stiffness
                                               b. Elevated ESR/CRP. AND
                                            3. Used in combination with methotrexate; AND
                                            4. Failure to a TNF antagonist.

                                            Reauthorization for Rheumatoid Arthritis:
                                            1. At least 20% improvement in the tender and
                                                swollen joint count; AND
                                            2. At least 20% improvements in 3 of the
                                            following:
                                                a. Patient global assessment
                                                b. Physician global assessment
                                                c. Patient's assessment of pain
                                                d. Degree of disability
                                                e. Acute phase reactant OR
                                            3. Documentation demonstrating the clinical
                                                equivalent of the above criteria; AND
                                            4. At least 24 weeks since last Rituxan
                                                treatment.

octreotide    Acromegaly                    Acromegaly:                                                                       Initial Therapy
acetate,                                    1. Inadequate response to surgery and/or                                          for Acromegaly
Sandostatin   Carcinoid                         radiotherapy                                                                  and tumors:
              Tumors                        2. Patients who are not a surgical and/or                                         6 months.
                                                radiotherapy candidate
              All FDA                       3. Diagnosis of acromegaly by one of the                                          Reauthorization
              approved                      following:                                                                        for Acromegaly:
              indications not                   a. Serum growth hormone (GH) level greater                                    12 months.
              otherwise                            than 1 ng/mL after a 2-hour oral glucose
              excluded from                        tolerance test
                                                                                                                                                        10/06/08
                                                                                              Age
                               Exclusion                                                                  Prescriber     Coverage
Drugs         Covered Uses                 Required Medical Information                       Restrict-                                    Other Criteria
                               Criteria                                                                   Restrictions   Duration
                                                                                              ions
              Part D                          b. Elevated serum IGF-1 levels as compared
                                                 to normal reference values by age and
                                                 gender.

                                           Reauthorization for Acromegaly:
                                           1. Patient is on a dose that has stabilized GH
                                              levels to less than 5.0 ng/mL; OR
                                           2. Normalized (or near-normalized) IGF-1 levels
                                              (age and gender matched); OR
                                           3. Positive clinical response by one of the
                                              following:
                                              a. Reduction of tumor mass
                                              b. Reduction of signs and symptoms of
                                                  acromegaly
                                              c. Improvement of significant co-morbidities.

                                           Carcinoid Tumors:
                                           Diagnosis of metastatic carcinoid tumor for
                                           symptomatic treatment of severe diarrhea or
                                           flushing.

                                           Vasoactive Intestinal Peptide Tumors:
                                           Diagnosis of metastatic vasoactive peptide
                                           tumor, for symptomatic treatment of diarrhea
                                           associated with vasoactive peptide tumor.

                                           Cancer Chemotherapy Induced Diarrhea:
                                           1. Diagnosis of diarrhea due to concurrent
                                           cancer chemotherapy.
                                           2. History of failure to standard therapy.

                                           AIDS-related Diarrhea:
                                           1. Diagnosis of AIDS-related diarrhea.
                                           2. History of failure to standard therapy

Sandostatin   Acromegaly                   Acromegaly:                                                                   Initial therapy
LAR Depot                                  1. Inadequate response to surgery and/or                                      for Acromegaly
              Carcinoid                        radiotherapy;                                                             and tumors:
              Tumors                       2. Patients who are not a surgical and/or                                     for 6 months
                                               radiotherapy candidate.
              Vasoactive                   3. Diagnosis of acromegaly by one of the                                      Reauthorization
              Intestinal                   following:                                                                    for Acromegaly:
              Peptide Tumors                   a. Serum growth hormone (GH) level greater                                12 months
                                                  than 1 ng/mL after a 2-hour oral glucose
                                                                                                                                                   10/06/08
                                                                                         Age
                          Exclusion                                                                  Prescriber     Coverage
Drugs      Covered Uses               Required Medical Information                       Restrict-                                        Other Criteria
                          Criteria                                                                   Restrictions   Duration
                                                                                         ions
           Cancer                          tolerance test                                                           Chemo-induced
           Chemotherapy                 b. Elevated serum IGF-1 levels as compared                                  diarrhea/AIDS-
           Induced                         to normal reference values by age and                                    related diarrhea:
           Diarrhea                        gender                                                                   3 months

           AIDS-related               Reauthorization for Acromegaly:
           Diarrhea                   1. Patient is on a dose that has stabilized GH
                                         levels to less than 5.0 ng/mL; OR
                                      2. Normalized (or near-normalized) IGF-1 levels
                                         (age and gender matched); OR
                                      3. Positive clinical response defined by one of
                                         the following:
                                         a. Reduction of tumor mass
                                         b. Reduction of signs and symptoms of
                                             acromegaly
                                         c. Improvement of significant co-morbidities.

                                      Carcinoid Tumors:
                                      1. Diagnosis of metastatic carcinoid tumor, for
                                         symptomatic treatment of severe diarrhea or
                                         flushing; AND
                                      2. Patient has been shown to respond to and
                                         tolerate octreotide.

                                      Vasoactive Intestinal Peptide Tumors:
                                      1. Diagnosis of metastatic vasoactive peptide
                                         tumor, for symptomatic treatment of diarrhea
                                         associated with vasoactive peptide tumor;
                                         AND
                                      2. Patient has been shown to respond to and
                                         tolerate octreotide.

Serostim   AIDS                       Initial Therapy for AIDS associated cachexia                                  Initial therapy for
           associated                 or wasting:                                                                   AIDS wasting:
           cachexia or                1. Documented AIDS-associated cachexia or                                     3 months
           wasting                       wasting defined as one of the following:
                                         a. 10% unintentional weight loss over 12                                   Re-authorization
                                             months                                                                 for AIDS
                                         b. 7.5% unintentional weight loss over 6                                   wasting:
                                             months                                                                 2 months.
                                         c. 5% BCM loss within 6 months, or BMI less
                                             than 20 kg/m2. AND
                                      2. Nutritional evaluation since onset of wasting
                                         first occurred.
                                                                                                                                                  10/06/08
                                                                                             Age
                            Exclusion                                                                    Prescriber     Coverage
Drugs        Covered Uses               Required Medical Information                         Restrict-                                      Other Criteria
                            Criteria                                                                     Restrictions   Duration
                                                                                             ions
                                        3. For male patients: Screen for hypogonadism
                                           (obtain free testosterone levels)
                                        4. For male patients: Failure to respond to
                                           testosterone replacement therapy in patients
                                           with hypogonadism.

                                        Reauthorization for AIDS associated
                                        cachexia or wasting:
                                        Men:
                                        1. Positive response to therapy based on greater
                                            than or equal to 2% increase in body weight
                                            and/or BCM. BCM less than 35% or total BW
                                            or BMI less than 27 kg/m2.
                                        2. If BCM is greater than 35% of total BW or BMI
                                            greater than 27 kg/m2, treatment should be
                                            discontinued for an 8-week observation
                                            period.
                                        3. Treatment may continue if wasting is still
                                            evident after observation period, based on
                                            BCM less than 35% of total BW or BMI less
                                            than 27 kg/m2 after the observation period, or
                                            greater than or equal to 5% unintentional
                                            weight loss during observation period.
                                        Women:
                                        1. Positive response to therapy based on greater
                                            than or equal to 2% increase in body weight
                                            and/or BCM . BCM less than 23% or total BW
                                            or BMI less than 27 kg/m2.
                                        2. If BCM is greater than 23% of total BW or BMI
                                            greater than 27 kg/m2, treatment should be
                                            discontinued for an 8-week observation
                                            period.
                                        3. Treatment may continue if wasting is still
                                            evident after observation period, based on
                                            BCM less than 23% of total BW or BMI less
                                            than 27 kg/m2 after the observation period, or
                                            greater than or equal to 5% unintentional
                                            weight loss during observation period.

Somatuline   Acromegaly                 Acromegaly:                                                                     Indefinite, long-
Depot                                   1. Patients who require long-term treatment due                                 term therapy
                                           to:                                                                          (open-ended)
                                           a. Inadequate response to surgery and/or
                                               radiotherapy; OR
                                                                                                                                                    10/06/08
                                                                                              Age
                             Exclusion                                                                    Prescriber     Coverage
Drugs      Covered Uses                  Required Medical Information                         Restrict-                                      Other Criteria
                             Criteria                                                                     Restrictions   Duration
                                                                                              ions
                                            b. Who are not surgical and/or radiotherapy
                                                candidates. AND
                                         2. Diagnosis of acromegaly by one of the
                                            following:
                                            a. Serum growth hormone level greater than 1
                                                ng/mL after a 2-hour oral glucose tolerance
                                                test; OR
                                            b. Elevated serum IGF-1 levels as compared
                                                to normal reference values by age and
                                                gender.

Somavert   Acromegaly                    Initial Therapy for Acromegaly:                                                 12 weeks
                                         1. One of the following:
                                             a. Inadequate response to surgery and/or
                                                radiation therapy
                                             b. Not a candidate for surgery or radiation.
                                                AND
                                         2. Inadequate response or intolerance to
                                             octreotide, or IGF-1 value greater than 900
                                             ng/mL.

                                         Reauthorization for Acromegaly:
                                         Serum IGF-1 level within the age-adjusted
                                         normal range.

Sporanox   Fungal                        Fungal Infection:                                                               Length of therapy
           Infection                     1. Diagnosis of one of the following:
                                             a. Blastomycosis
           All FDA                           b. Histoplasmosis
           approved                          c. Aspergillosis
           indications not                   d. Onychomycosis
           otherwise                     2. In patients unable to swallow tablets; OR
           excluded from                 3. Diagnosis of febrile neutropenia with
           Part D                            suspected fungal infection, or oropharyngeal
                                             or esophageal candidiasis.

Sprycel    Chronic                       Chronic Myeloid Leukemia:                                                       Length of therapy   Sprycel will be
           Myeloid                       1. Diagnosis of Philadelphia chromosome                                                             approved for
           Leukemia                         positive or BCR-ABL positive chronic,                                                            continuation
           (CML)                            accelerated, or myeloid or lymphoid blast                                                        of prior
                                            phase chronic myeloid leukemia; AND                                                              therapy.
           Acute                         2. Failure to Gleevec.
           Lymphoblastic
           Leukemia (ALL)                Acute Lymphoblastic Leukemia:
                                                                                                                                                      10/06/08
                                                                                                  Age
                               Exclusion                                                                       Prescriber     Coverage
Drugs        Covered Uses                      Required Medical Information                       Restrict-                                       Other Criteria
                               Criteria                                                                        Restrictions   Duration
                                                                                                  ions
                                               1. Diagnosis of Philadelphia chromosome-
                                                  positive acute lymphoblastic leukemia; AND
                                               2. Failure to Gleevec.

Striant      Hypogonadism                      Hypogonadism:                                                                  Length of therapy
                                               Diagnosis of hypogonadism in men with a pre-
                                               treatment testosterone level of less than 280
                                               ng/dL.

Symlin,      Diabetes          Known           Diabetes Mellitus:                                 18 years                    Length of therapy
Symlinpen    Mellitus (DM)     diagnosis of    1. Type 1 or type 2 diabetes with hemoglobin       and older.
                               gastroparesis      A1c level of less than or equal to 9.0%
             All FDA                           2. Type 1 diabetic patients with a previous
             approved                             history of insulin therapy and concurrently
             indications not                      using insulin therapy
             otherwise                         3. Type 2 diabetic patients with a previous
             excluded from                        history of insulin therapy and concurrently
             Part D                               using insulin therapy with or without
                                                  sulfonylurea and/or metformin.

Tasigna      Chronic                           Chronic Myelogenous Leukemia:                                                  Length of therapy   Tasigna will
             Myelogenous                       1. Diagnosis of Philadelphia chromosome                                                            be approved
             Leukemia                             positive chronic or accelerated phase chronic                                                   for
                                                  myeloid leukemia; AND                                                                           continuation
                                               2. Failure to Gleevec.                                                                             of prior
                                                                                                                                                  therapy.

Topical      Hypogonadism                      Hypogonadism:                                                                  Length of therapy
testost-                                       Diagnosis of hypogonadism in men with a pre-
erone:                                         treatment testosterone level below normal
Androderm,                                     physiological value of 280 ng/dL or below normal
Androgel,                                      reference level provided by the physician
Androgel                                       laboratory.
Pump,
Testim

Thalomid     Erythema                          Erythema Nodosum Leprosum:                                                     AS: 1 month         Thalomid will
             Nodosum                           Confirmed diagnosis of moderate to severe ENL.                                                     be approved
             Leprosum                                                                                                         ENL, MM: Length     for
             (ENL)                             Multiple Myeloma:                                                              of treatment        continuation
                                               1. For newly diagnosed multiple myeloma in                                                         of prior
             Multiple                              combination with dexamethasone or                                          WM, GVHD, and       therapy.
             Myeloma (MM)                          conventional dose chemotherapy; OR                                         Primary Brain
                                               2. In combination with high dose chemotherapy                                  Tumors: 6
                                                                                                                                                          10/06/08
                                                                                          Age
                        Exclusion                                                                     Prescriber     Coverage
Drugs   Covered Uses                Required Medical Information                          Restrict-                                  Other Criteria
                        Criteria                                                                      Restrictions   Duration
                                                                                          ions
        Waldenstrom’s                   with stem cell rescue; OR                                                    months
        Macro-                      3. Salvage therapy in refractory or relapsed
        globulinemia                    multiple myeloma after primary therapy; OR                                   Other Uses: 3
        (WM)                        4. In combination with dexamethasone,                                            months
                                        doxorubicin, cyclophosphamide, and
        Aphthous                        etoposide as part of induction regimen prior to
        stomatitis or                   autologous transplant.
        ulcers (AS)
                                    Waldenstrom’s Macro-globulinemia:
        Crohn’s                     Disease progression on an alkylating agent,
        Disease,                    nucleoside analog, or rituximab.

        Graft-versus-               Aphthous stomatitis or ulcers:
        Host Disease                1. One of the following:
        (GVHD)                         a. Diagnosis of HIV-associated aphthous
                                          ulcers
        Primary Brain                  b. Recurrent aphthous stomatitis in
        Tumors                            immunocompromised patients. AND
                                    2. Refractory to alternative therapies.
        AIDS-related
        cachexia or                 Crohn’s Disease:
        wasting                     Patient is refractory to all of the following
                                    standard treatment regimens:
        Renal Cell                  1. Corticosteroids
        Carcinoma                   2. 5-aminodalicylic acid
                                    3. Immunomodulators
                                    4. Remicade.

                                    Graft-versus-Host Disease:
                                    1. Diagnosis of chronic or refractory GVHD; AND
                                    2. In patient unresponsive to all of the following:
                                        a. Corticosteroids
                                        b. Azathioprine
                                        c. Tacrolimus
                                        d. Cyclosporine
                                        e. Antithymocyte globulin.

                                    Primary Brain Tumors:
                                    1. As adjuvant therapy to current cytotoxic
                                       therapies; OR
                                    2. Previous failure to cytotoxic therapies and/or
                                       tumor resection.

                                    Initial Therapy for AIDS-related cachexia or
                                                                                                                                             10/06/08
                                                                                                  Age
                                  Exclusion                                                                   Prescriber     Coverage
Drugs          Covered Uses                   Required Medical Information                        Restrict-                                      Other Criteria
                                  Criteria                                                                    Restrictions   Duration
                                                                                                  ions
                                              wasting:
                                              1. Diagnosis of AIDS wasting or cachexia
                                                 defined as chronic unremitting weight loss of
                                                 more than 10% body weight in the previous 4
                                                 months; AND
                                              2. Nutritional evaluation since onset of wasting
                                                 first occurred. Screened for hypogonadism;
                                                 AND
                                              3. Failure to respond to hormone replacement
                                                 therapy in patients with hypogonadism; AND
                                              4. Failure, contraindication or intolerance to
                                                 standard treatments.

                                              Reauthorization for AIDS-related cachexia or
                                              wasting:
                                              Weight has stabilized or improved but not at goal
                                              weight.

                                              Advanced Renal Cell Carcinoma:
                                              1. Confirmed diagnosis of metastatic renal cell
                                                 carcinoma; AND
                                              2. Patient is refractory to, or unsuitable of the
                                                 following:
                                                 a. Interferon-alfa-2b
                                                 b. Interleukin-2
                                                 c. Sorafenib
                                                 d. Sunitanib.

Tigan,         Post-operative                 For the treatment of postoperative nausea and                                  Length of therapy
trimethobenz   nausea and                     vomiting or nausea associated with
-amide         vomiting                       gastroenteritis

               Nausea with
               gastro-enteritis

               All FDA
               approved
               indications not
               otherwise
               excluded from
               Part D




                                                                                                                                                         10/06/08
                                                                                                Age
                             Exclusion                                                                      Prescriber       Coverage
Drugs      Covered Uses                  Required Medical Information                           Restrict-                                        Other Criteria
                             Criteria                                                                       Restrictions     Duration
                                                                                                ions
Topamax,   Seizure                       Seizure Disorder:                                                  Migraine         Length of therapy   Topamax will
Topamax    Disorder                      History of failure or contraindication to two                      Prophylaxis:                         be approved
Sprinkle                                 formulary alternatives.                                            Prescribed by                        for
           Migraine                                                                                         a neurologist.                       continuation
           Prophylaxis                   Migraine Prophylaxis:                                                                                   of prior
                                         1. Patients experiencing 2 or more migraine                        Bipolar                              therapy.
           Bipolar                          headaches monthly that result in disability;                    Disorder:
           Disorder                         AND                                                             Prescribed by
                                         2. History of an adequate trial of 2 to 3 months to                a psychiatrist
           Neuropathic                      formulary alternatives for migraine                             or by
           Pain                             prophylaxis.                                                    psychiatric
                                                                                                            consultation.
           Essential                     Bipolar Disorder:
           Tremor                        1. History of treatment failure, contraindication or
                                            intolerance to two formulary alternatives; OR
           All FDA                       2. History of topamax therapy initiated during a
           approved                         hospitalization.
           indications not
           otherwise                     Neuropathic Pain:
           excluded from                 History of failure or contraindication to formulary
           Part D                        alternatives.

                                         Essential Tremor:
                                         History of failure or intolerance propranalol or
                                         primidone.

Tracleer   Pulmonary                     Pulmonary Arterial Hypertension:                                                    Length of therapy
           Arterial Hyper-               Patients with a confirmed diagnosis of
           tension                       pulmonary arterial hypertension (modified WHO
                                         Group I) and in WHO functional class III or IV.

Treanda    Chronic                                                                                                           6 months
           lymphocytic
           leukemia

Tykerb     Breast Cancer                 Breast Cancer:                                                                      Length of therapy   Tykerb will be
                                         1, Diagnosis of HER2-positive advanced or                                                               approved for
                                            metastatic breast cancer                                                                             continuation
                                         2. History of prior therapy with an anthracycline,                                                      of prior
                                            a taxane, and Herceptin.                                                                             therapy.
                                         3. Used in combination with Xeloda.
                                         4. Confirmation of normal left ventricular ejection
                                            fraction.

                                                                                                                                                         10/06/08
                                                                                           Age
                            Exclusion                                                                   Prescriber        Coverage
Drugs      Covered Uses                 Required Medical Information                       Restrict-                                           Other Criteria
                            Criteria                                                                    Restrictions      Duration
                                                                                           ions
Tysabri    Relapsing                    Relapsing forms of Multiple Sclerosis:             Initial      Initial           Initial Therapy:     For
           forms of                     Failure to one of the following: Avonex,           therapy      Therapy -         Tysabri will be      Relapsing
           Multiple                     Betaseron, Copaxone, Rebif.                        for CD:      Relapsing MS      authorized for 1     MS:
           Sclerosis (MS)                                                                  18 years     and CD:           year for MS and 3    Tysabri will
                                        Initial Therapy for Crohn's Disease:               and older.   Prescribing       months for CD        not be
           Crohn's                      1. Moderate-to-severe Crohn's disease with                      physician is                           authorized in
           Disease (CD)                    evidence of inflammation; AND                                enrolled in the   Reauthorization:     combination
                                        2. History of conventional therapy. History of a                CD TOUCH          Tysabri will be      with Avonex,
                                           TNF blocker. Patient is not receiving immuno-                Prescribing       reauthorized for 6   Betaseron,
                                           suppressants.                                                Program.          months for           Copaxone, or
                                                                                                                          patients on          Rebif.
                                        Reauthorization for Crohn's Disease:                                              steroids.
                                        Demonstrated remission or significant clinical                                    Otherwise, 3
                                        response to Tysabri.                                                              months.

Vancocin   Pseudo-                      Pseudo-membranous Colitis:                                                        Length of therapy
           membranous                   1. Diagnosis of pseudo-membranous colitis due
           Colitis                         to Clostridium difficile; AND
                                        2. Failure to oral Flagyl.

Vectibix   Colorectal                   Colorectal Cancer:                                                                Length of therapy    Vectibix will
           Cancer                       1. Diagnosis of metastatic colorectal cancer;                                                          be approved
                                        AND                                                                                                    for
                                        2. Relapsed, refractory, or disease progression                                                        continuation
                                           on one standard chemotherapy regimen                                                                of prior
                                           containing a fluoropyrmidine, oxaliplatin, or                                                       therapy.
                                           irinotecan.

Ventavis   Pulmonary                    Pulmonary Arterial Hypertension                                                   Length of therapy    Ventavis is
           Arterial                     Patients with a confirmed diagnosis of                                                                 subject to Part
           Hypertension                 pulmonary arterial hypertension (modified WHO                                                          B vs. Part D
                                        Group I) and in WHO functional class III or IV.                                                        review.




                                                                                                                                                        10/06/08
                                                                                              Age
                             Exclusion                                                                     Prescriber       Coverage
Drugs      Covered Uses                  Required Medical Information                         Restrict-                                        Other Criteria
                             Criteria                                                                      Restrictions     Duration
                                                                                              ions
Xolair     Allergic Asthma               Initial Therapy for Allergic Asthma:                 Initial      Initial          Initial Therapy:
                                         1. Diagnosis of moderate-to-severe persistent        treatment:   Therapy:         16 weeks
                                            allergic asthma, defined by one of the            6 years      Prescribed by
                                            following:                                        and older.   a pulmonolog-    Reauthorization:
                                            a. Daily asthmatic symptoms                                    ist or           1 year
                                            b. Daily use of inhaled short-acting beta                      allergist/imm-
                                                agonists                                                   unologist.
                                            c. Exacerbations affect/limit activity
                                            d. Exacerbations 2 or more times per week
                                            e. Nocturnal symptoms once a week or more
                                            f.. Forced expiratory volume in one second or
                                                peak expiratory flow less than or equal to
                                                80% of predicted
                                            g. PEF variability greater than 30%. AND
                                         2. Baseline IgE level greater than or equal to 30
                                            IU/mL; AND
                                         3. Documented failure to combination therapy
                                            with an inhaled corticosteroid at the maximum
                                            dosage and a long-acting beta-agonist.

                                         Reauthorization for Allergic Asthma:
                                         1. Documented reduction in the frequency of
                                            asthma exacerbations while treated with
                                            Xolair; AND
                                         2. Documented reduction in the use of rescue
                                            medications or inhaled corticosteroids while
                                            treated with Xolair.

Zorbtive   Short Bowel                   Short Bowel Syndrome:                                                              4 weeks
           Syndrome                      1. All of the following:
           (SBS)                            a. Diagnosis of SBS.
                                            b. BMI 17 to 28 kg/m2.
                                            d. At least 2 months post-resection.
                                            e. Patient is currently on parenteral nutrition
                                             f. Patient is able to ingest some food
                                             g. Intact stomach and duodenum




                                                                                                                                                       10/06/08
                                                                                            Age
                          Exclusion                                                                     Prescriber     Coverage
Drugs   Covered Uses                  Required Medical Information                          Restrict-                             Other Criteria
                          Criteria                                                                      Restrictions   Duration
                                                                                            ions
Zyvox   Infections                    Infections:                                                                      28 days.
                                      One of the following:
        All FDA                       1. Infections caused by vancomycin-resistant
        approved                          enterococci (VRE) documented by culture and
        indications not                   sensitivity report.
        otherwise                     2. Nosocomial pneumonia caused by methicillin-
        excluded from                     resistant Staphylococcus aureus (MRSA)
        Part D                            documented by culture and sensitivity report
                                      3. Complicated skin and skin structure infections
                                          (including diabetic foot infections) without
                                          osteomyelitis caused by MRSA documented
                                          by culture and sensitivity report.
                                      4. Empirical treatment of patients with
                                          community-acquired complicated skin and
                                          skin structure infections without osteomyelitis
                                          where MRSA infection is likely, in patients
                                          who have failed previous antibiotics.
                                      5. As continuation of therapy when transitioning
                                          from intravenous daptomycin, intravenous
                                          vancomycin, or intravenous Zyvox therapy.




                                                                                                                                          10/06/08
The following drugs may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the
use and setting of the drug to make the determination:
   • Abelcet                                     • Cytoxan                                        • Ondansetron
   • Accuneb                                     • Doxil                                          • Ondansetron ODT
   • Acetylcysteine                              • Doxorubicin                                    • Orthoclone
   • Acyclovir                                   • Duoneb                                         • Perforomist
   • Adriamyc                                    • Engerix-B                                      • Premasol
   • Adriamycin                                  • Foscarnet                                      • Procalamine
   • Albuterol                                   • Foscavir                                       • Prosol
   • Albuterol/ipratropium                       • Freamine HBC                                   • Pulmicort
   • Ambisome                                    • Freamine III                                   • Pulmozyme
   • Aminess                                     • Gengraf                                        • Rapamune
   • Aminosyn                                    • Granisetron                                    • Recombiva HB
   • Amphotec                                    • Granisol                                       • Renamin
   • Amphotericin                                • Hepatamine                                     • Sandimmune
   • Anzemet                                     • Hepatasol                                      • Simulect
   • Atgam                                       • Intal                                          • Thymoglobulin
   • Brovana                                     • Intralipid                                     • Tobi
   • Clinimix                                    • Ipratropium bromide                            • Travasol
   • Clinimix E                                  • Kytril                                         • Trophamine
   • Clinisol SF                                 • Metaproterenol                                 • Xopenex
   • Cromolyn Sodium                             • Myfortic                                       • Zenapax
   • Cyclophosphamide                            • Nebupent                                       • Zofran
   • Cyclosporine                                • Neoral                                         • Zofran ODT
   • Cyclosporine Modified                       • Nephramine
   • Cytovene                                    • Novamine




                                                                                                                                               10/06/08

				
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