After completing the request form please fax to the by Breathe Carolina

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									         HCV Medication Therapy Information Sheet and Request Form                                                                                      P a g e |1




                                                Arkansas Medicaid Prescription Drug Program
                              Hepatitis C Virus (HCV) Medication Therapy Information Sheet and Request Form

 After completing the request form please fax to the Arkansas Medicaid Pharmacy Program. Fax: 501-683-4124
For questions call: 501-683-4120.                       All supporting documentation must accompany this form.
PART 1: TO BE COMPLETED BY PHYSICIAN
PHYSICIAN                                                                                                   PATIENT INFORMATION
AR MEDICAID ID NUMBER:
                                                                                        RECIPIENT
Physician Name:                                                                         MEDICAID ID NUMBER:

Address:                                                                                Patient Name:

City:                                        State:          Zip:                       Address:

Phone (           )                                                                     City:                                             State:       Zip:

FAX   (     )                                                  Patient’s date of birth:        /            /
Adherence with prescribed therapy is a condition for payment for continuation therapy for up to the allowed timeframe for
each HCV genotype. The recipient’s Medicaid drug history will be reviewed prior to approval. See page 3 for summary.

 Genotype 1, 4, 5 or 6: Submission of genotype and baseline quantitative HCV RNA viral load required and initial approval will be for
12 weeks. Submission of quantitative HCV RNA viral load at 12 weeks required for continuation of therapy; depending on response to
therapy, submission of quantitative HCV RNA viral load at 24 weeks may also be required for continuation requests. Continuation of
PA will depend on compliance with and response to therapy, up to a maximum 48 weeks of therapy.

Genotype 2 or 3: Submission of genotype and baseline quantitative HCV RNA viral load required and initial approval will be for 12
weeks. Initial approval will be for 12 weeks. Submission of quantitative HCV RNA viral load at 12 weeks required for continuation
request. Continuation of PA will depend on compliance with and response to therapy, up to maximum of 24 weeks therapy.

HIV/HCV co-infection: Submission of genotype and baseline quantitative HCV RNA viral load required and initial approval will be for
12 weeks. Compliance with HIV therapy mandatory for HCV therapy approval and continuation; initial approval will be for 12 weeks.
Submission of quantitative HCV RNA viral load at 12 weeks required for continuation request. Continuation of PA will depend on
compliance with and response to therapy, up to a maximum of 48 weeks of therapy.

Medications included in prior approval of HCV therapy include the following:
                                                                                                                                                   Indicate ALL drugs &
Brand Name (for reference only);                                                                        Generic                                    dose requested below
Copegus tab, Rebetol cap/soln, Ribapak tab, Ribasphere cap/tab, Ribatab tab, Ribavirin cap/tab          Ribavirin
PegIntron® kit or pen injection kit                                                                     Peginterferon Alfa -2B
Pegasys® kit or vial                                                                                    Peginterferon Alfa-2A
**Infergen vial                                                                                         Interferon Alfacon-1, 15 mcg/0.5 ml
**Infergen vial                                                                                         Interferon Alfacon-1, 9 mcg/0.3 ml
**The currently recommended therapy of chronic HCV infection is the combination of pegylated interferon alfa (PEG-Intron® or Pegasys®) and ribavirin
                                                                 1
over the standard interferon alfa (Infergen®) and r bavirin . Therefore, without additional supporting documentation accompanying a request for
Infergen® or a non-pegylated interferon alfa, AR Medicaid will approve only a pegylated interferon alfa and r bavirin for HCV therapy.
*****************************************************************************************************************************************************************************

1. Indicate reason for request:             Acute Hepatitis C                Chronic Hepatitis C                    Other            Define other: ______________

2. What is patient’s HCV genotype?___________________________ (Genotype 1                                            2      3    4    5     6)

3. What is patient’s baseline quantitative HCV RNA viral load test results: _____________________ date measured:_________

4. Is the request for continuation of therapy?                       YES                        NO

    a)    At 12 weeks of therapy, for all Genotypes and for HIV/HCV co-infection patients: Repeat quantitative HCV RNA viral

load test and submit lab results: ___________________________                                   date measured:___________________
          HCV Medication Therapy Information Sheet and Request Form                                                                               P a g e |2




    b)     At 24 weeks, for Genotypes 1, 4, 5, 6: if HCV RNA remains detectable at 12 weeks, repeat quantitative HCV RNA viral

load test at 24 weeks and submit lab results: _____________________________                                    date measured:____________________


4. What is patient’s weight? __________ (lb or kg)                          month/year weighed: __________________


5. Does patient have HIV/HCV co-infection? YES                            NO

         If Yes, please note that when possible, patients receiving zidovudine (AZT) and especially didanosine (ddI) HIV medications
         should be switched to an equivalent antiretroviral agent before beginning therapy with ribavirin. HIV-infected patients with
         decompensated liver disease (CTP Class B or C) should not be treated with peginterferon alfa and ribavirin for HCV. 2


6. What are the patient’s liver enzyme levels?                   ALT/AST _____________                  Date measured: ________________


7. Has a liver biopsy been performed?                YES              NO              If Yes, date:_________           Please include copy of biopsy results.


8. Does the patient have a history of any of the following? Please mark all that apply.

             Anemia
             Thrombocytopenia
             Untreated hyperthyroidism
             Autoimmune disease
             Pregnancy (ribavirin causes significant teratogenic effects for as long as 6 months after completion of therapy 3 )
             Unstable CVD
             Chronic Kidney Disease (Stage 3 – Stage 5D)
             Kidney transplant
             Depression, irritability, suicidal ideation
             Other mental illnesses, including bipolar disorder, mood swings, mania, or schizophrenia


9. If applicable, has the patient been abstinent from IV drug use or alcohol abuse for > 6 months?

                 YES                  NO

          If NO, is patient currently enrolled in drug rehabilitation program?                     YES                   NO


10. If patient’s Medicaid eligibility changes during therapy and patient is no longer eligible for Medicaid prescription drug
    assistance, is the physician prepared to enroll the patient in other patient assistant drug programs to complete therapy?

                 YES                 NO


The above format is to assist the physician in providing medical documentation that Arkansas Medicaid requires to review
this request. Please provide copies of supporting lab documentation for above request.



1
  Ghany, Strader, Thomas, Seeff (2009, April). American Association for the Study of Liver Diseases (AASLD) Guidelines. Diagnosis, Management, and Treatment of
Hepatitis C: An Update. The Optimal Treatment of Chronic HCV. Hepatology, 49(4), 1342.
2
  Ghany, et al, (2009, April). American Association for the Study of Liver Diseases (AASLD) Guidelines. Diagnosis, Management, and Treatment of Hepatitis C: An
Update. Treatement of Persons with HIV Coinfection. Hepatology, 49(4),1353.
3
  Black box warning. Ribavirin causes significant teratrogenic effects. Copegus® (ribavirn) package insert. Roche Laboratories, Inc. Revised April 2009. Retrieved May
20, 2009, from http://www.rocheusa.com/products/copegus/pi.pdf.
     HCV Medication Therapy Information Sheet and Request Form                        P a g e |3




Physician Signature: ______________________________________________   Date: _____________________
                               HCV Medication Therapy Information Sheet and Request Form                                                                           P a g e |4




             Summary of Prior Approval Criteria of Persons with Chronic HCV Infection based on HCV therapy guidelines1
                                                                                                          12 WEEK
                                                                             1
                 OPTIMAL RECOMMENDED DRUG THERAPY (Peginterferon                                        RE-CHECK OF                    24 WEEK RE-CHECK OF                          TOTAL DURATION§
 GENOTYPE                        alfa + Ribavirin)                                                    SERUM HCV RNA                       SERUM HCV RNA                             for EVR PATIENTS
                                                                                                                               If complete EVR* not attained at
                                                                                                                               week 12, retest at week 24. If HCV
                                                                                                                               RNA viral load remains detectable,
       1         PEGASYS® or PegIntron®               RIBAVIRIN WT. BASED DOSE¶                   EVR* Required                discontinue treatment.                               48 WEEKS


     2&3         PEGASYS® or PegIntron®               RIBAVIRIN LOW DOSE (800 MG)                 EVR* Required                                                                     24 WEEKS
                                                                                       If complete EVR* not attained at
                                                                                       week 12, retest at week 24. If HCV
                                                                                       RNA viral load remains detectable,
       4         PEGASYS® or PegIntron® RIBAVIRIN WT. BASED DOSE¶      EVR* Required   discontinue treatment.                                                                       48 WEEKS
       5                               INSUFFICIENT DATA TO MAKE A RECOMMENDATION; Requests reviewed on case-by-case basis.
                                                                                       If complete EVR* not attained at
                                                                                       week 12, retest at week 24. If HCV
                                                                                       RNA viral load remains detectable,
       6         PEGASYS® or PegIntron® RIBAVIRIN                      EVR* Required   discontinue treatment.                                                                       48 WEEKS
  HIV/HCV
 co-infection    PEGASYS® or PegIntron®               RIBAVIRIN WT. BASED DOSE¶                   EVR* Required                                                                     48 WEEKS
 EVR* defined as >= 2 LOG reduction or complete absence of serum HCV RNA viral load at week 12 of therapy compared with baseline level.
 §
   Any requests to extend therapy beyond stated durations for each genotype is reviewed on a case-by-case basis and will require lab copies of serum HCV RNA tests performed at
 4 weeks, 12 weeks, and 24 weeks of therapy, and will require patient's adherence to prescribed therapy.
 ¶
   RIBAVIRIN WEIGHT-BASED DOSE: If using Peg-Intron 1.5 µg/kg/week, recommended weight-based ribavirin doses are 800 mg for pts < 65 kg; 1,000 mg for pts between 65 to 85
 kg; 1,200 mg for pts weighing 85 to 105 kg; and 1,400 mg for pts weighing > 105 kg but < 125 kg. If using Pegasys 180 µg/week, weight-based ribavirin doses are 1,000 mg for pts
 <= 75 kg and 1,200 mg for those pts who weigh > 75 kg.
                                                                                       Pricing and cost information
                                                                            REIMBURSE        EAC or                                                                                 REIMBURSE         EAC or
                                                                            RATE PER          MAC                                                                                   RATE per           MAC
 DRUG       STRENGTH                         FORM                           Tab or Cap       RATE       DRUG          STRENGTH                           FORM                       Each               RATE
Ribavirin   200 mg       tablet                                                      $1.27    MAC       PegIntron     50 mcg            Each, Redipen, vial, or kit                        $476.69      EAC
Ribavirin   200 mg       capsule                                                     $1.27    MAC       PegIntron     80 mcg            Each, Redipen, vial, or kit                        $500.48      EAC
Ribavirin   400 mg       tablet                                                     $13.27    EAC       PegIntron     120 mcg           Each, Redipen, vial, or kit                        $525.53      EAC
Ribapak®    400-400 mg   tablet, dose pak qty of 56 tablets                         $14.75    EAC       PegIntron     150 mcg           Each, Redipen, vial, or kit                        $551.81      EAC
Ribapak®    400-600 mg   tablet, dose pak qty of 28 of ea strength tablet           $18.29    EAC       Pegasys       180 mcg           Each, 1 ml vial                                    $527.75      EAC
Ribavirin   600 mg       tablet                                                     $19.91    EAC       Pegasys       180 mcg           Each Kit (which contains 4 prefilled syr.)       $2,111.00      EAC
Ribapak®    600-600 mg   tablet, dose pak qty of 56 tablets                         $21.95    EAC       (prices current as of 9/17/09; check Medicaid website for current MAC rates)     EAC rate is AWP=14%

								
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