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Economic Evaluation of Toric Intraocular Lens in Cataract Patients

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Economic Evaluation of Toric Intraocular Lens in Cataract Patients Powered By Docstoc
					         New Toric IOLs Improve
       Outcomes and Reduce Costs
      Compared to Conventional IOLs

                 Robert Pineda1, Svetlana Denevich2, Won Chan Lee3,
                  Curtis Waycaster4, Sarah Pennie3, Chris L. Pashos2
                           1   Massachusetts Eye and Ear Infirmary, Boston, MA
                           2   HERQuLES, Abt Bio-Pharma Solutions, Inc., Lexington, MA
                           3   HERQuLES, Abt Bio-Pharma Solutions, Inc., Bethesda, MD
                           4   Alcon Labs, Fort Worth, TX


                                             Supported by Alcon Labs
S Denevich, WC Lee, S Pennie, and CL Pashos are employees of Abt Bio-Pharma Solutions Inc., an independent research organization. C Waycaster is
                                                          an employee of Alcon Labs
                       Background and Introduction

      Approx. 30% of people ≥ 65 are affected by cataracts1
         – 15-29% of patients with cataract also have some degree of
           astigmatism2
      Astigmatism is routinely corrected at the time of cataract
       treatment using:
         – Corneal surgery and/or
         – Implanting a toric intraocular lens (IOL)3
      Toric IOLs effectively improve visual acuity and quality of life
       in astigmatism patients compared to conventional
       monofocal IOLs4,5,6
      Medicare does not cover the correction of astigmatism so
       the additional costs must be paid by cataract patients

1. Dick, et al. Ophthalmol Clin North Am 2006. 2. American Academy of Ophthalmology. www.aao.org/ppp. 3. Gills. Curr Opin Ophthalmol 2002.
4. Ruhswurm, et al. J Cataract Refract Surg 2000. 5. Mendicute et al. J Cataract Refract Surg 2008. 6. DHHS Ruling 2007.                     2
                   Objectives

   Our objective was to analyze the economic
    value of a toric IOL from the perspective
    of cataract patients with astigmatism
   We hypothesized that the use of toric IOLs
    would prove cost-effective over the long-
    term through improved uncorrected visual
    acuity and reduced spectacle need


                                                 3
                                  Study Design
 A decision analytic cost-effectiveness model was developed using MS Excel®
  software
 Data Sources
     – Systematic literature review
     – Surveys of 60 U.S. practicing cataract/refractive surgeons who
           Performed ≥ 20 cataract procedures per month using conventional or toric IOLs
           Performed ≥ 10 surgical corrections of astigmatism per month
           Practiced for ≥ 2 years & spent ≥ 50% of time in clinical setting
   Clinical Inputs
     – Distance vision spectacle independence
     – Proportion of patients achieving UCVA level ≥ 20/25
   Clinical Pathway
     – All patients underwent cataract removal
     – Some patients could further transition to the second intervention (surgical or non-
       surgical) to correct residual refractive cylinder, and to the third intervention (a repeat
       refractive surgery) to optimize vision if needed
   Outcomes
     – Average per patient cost of cataract surgery including the concomitant correction of
       astigmatism
     – Incremental cost-effectiveness ratio (ICER) of cataract surgery with concomitant
       correction of astigmatism
           The effectiveness measure used was the proportion of patients achieving a UCVA level ≥
            20/25
           ICER = (Cost A – Cost B)/(proportion ≥ 20/25 A – proportion ≥ 20/25 B)
                                                                                                     4
                                      Decision Analysis Tree
                                      Cataract surgery                                               Post-cataract correction                                  Re-treatment
                                      (Intervention A)                                                   (Intervention B)                                    (Intervention C)
                                              0.67/0.53/0.63                        0.57/0.62/0.58
                                              No further correction required        Glasses

                       Treatment 1:                                                 0.10/0.12/0.11
                       Toric IOL                                                    Contact lenses
                                                                                                                       0.99/0.99/0.99*
                                                                                                                       No re-treatment
                                              0.33/0.47/0.37                        0.16/0.13/0.16
                                              Distance vision correction required   LVC                                                                LVC
                                                                                                                       0.01/0.01/0.01*
                                                                                                                       Re-treatment required           ICS (LRI/AK)

                       Treatment 2:                                                                                                                    CK
                                                                                                                       0.82/0.82/0.82*
                       Conv. Monofocal                                                                                 No re-treatment
   Cataract patients   IOL                                                          0.14/0.11/0.12
   age ≥ 65 with       without intra-                                               ICS (LRI/AK)                                                       LVC
   ≤3.0 D, for whom    operative refractive                                                                            0.18/0.18/0.18*
   distance vision     correction                                                                                      Re-treatment required           ICS (LRI/AK)
   correction was                                                                                                                                      CK
   ultimate goal                                                                                                       0.75/0.75/0.75*
                                                                                                                       No re-treatment
                                                                                    0.04/0.03/0.04
                                                                                    CK                                                                 LVC
                                                                                                                       0.25/0.25/0.25*
                                                                                                                       Re-treatment required           ICS (LRI/AK)
                       Treatment 3:                                                                                                                    CK
                       Conv. Monofocal
                       IOL with intra-
                       operative
                       LRI/PCRI                                                                               Legend
                                                                                                              XX/XX/XX = Probability of Treatment 1/ Treatment 2/ Treatment 3
                                                                                                                   = End node


* The probability of re-treatment after Intervention B was assumed to be the same regardless of the treatment received during Intervention A



Abbreviations: AK=astigmatic keratotomy; CK=Conductive Keratoplasty; ICS=Incision Corneal Surgery; IOL=Intraocular Lens; LRI=Limbal Relaxing
Incision; LVC=Laser Vision Correction; PCRI=Peripheral Corneal Relaxing Incision
                                                                                                                                                                         5
                                    Cost Assessment
           Total costs
              – FY 2008 Medicare physician and ambulatory surgical facility fee
                reimbursement amounts
              – Patient out-of-pocket costs
           Cost components
              – Short term costs (1st year post cataract removal): costs of
                procedures (cataract and refractive surgery), cost of one year of
                wearing glasses/contact lenses
              – Long term costs (all years following the 1st year post cataract
                removal): cost associated with glasses/contact lens wear
           Cost Calculation
              – Costs were assessed through 1st year post cataract surgery and
                over an average remaining lifetime
                       Remaining lifetime was estimated at 17 years, based on the average life
                        expectancy for a general US population at 65 years of age1
              – Lifetime costs combined the 1st year costs and the costs over
                remaining lifetime
              – The lifetime costs were discounted at 3% annually
1. CDC. US Life tables 2008.                                                                      6
                                                       Unit Costs
     Medical Costs of Services, Procedures and Devices per Patient1,2,3
                                                                                                              Patient                Total
Cost components                                                                                                Cost                  Cost
Cataract treatment options
  Toric IOL                                                                                                   $ 1,750              $ 5,040
  Conventional IOL without intra-operative refractive correction                                                $ 823              $ 4,113
  Conventional monofocal IOL with intra-operative LRI/PCRI                                                    $ 1,544              $ 4,834

Follow-up intervention to optimize vision
   Glasses (over 1st year post cataract surgery)                                                                 $ 59               $ 297
   Glasses (over each of the following years post cataract surgery)                                             $ 313               $ 313
   Contacts (over 1st year post cataract surgery)                                                               $ 198               $ 319
   Contacts (over each of the following years post cataract surgery)                                            $ 335               $ 335
   LVC spectrum procedures                                                                                    $ 4,085             $ 4,085
   ICS                                                                                                          $ 721               $ 721
   CK                                                                                                         $ 3,092             $ 3,092

Abbreviations: AK=astigmatic keratotomy; CK=Conductive Keratoplasty; ICS=Incision Corneal Surgery; IOL=Intraocular Lens; LRI=Limbal Relaxing Incision;
LVC=Laser Vision Correction; PCRI=Peripheral Corneal Relaxing Incision
                                                                                                                                            7
1. Alcon Labs Inc. 2008. 2. AMA 2008. 3. CMS 2008.
    Results – Average Costs per Patient
 Toric IOL yielded better clinical outcomes than the conventional IOL with and
  without intra-operative refractive correction: 67%, 63%, and 53% of patients
  achieved spectacle independence, and 53%, 48%, and 44% of patients had
  UCVA ≥20/25, respectively.
 Toric IOLs incurred the highest first year costs compared to the other two
  treatment options. However, once life time costs were accrued the Toric
  provided an average cost savings to patients.

Total Cost of Cataract and Follow-up Astigmatism Correction Treatments




                        8000                                          $7578     $7477              Legend
                                                            $7343
                                                                                        Treatment Arms:
                        7000
                                                                                        1. Toric IOL
                        6000   $5529                                                    2. Conventional Monofocal IOL
    Cost (US 2008 $$)




                                                 $5365                3408
                                                             3379               3387
                        5000            $4678                                              with glasses
                                                                                        3. Conventional Monofocal IOL
                        4000   3379                                                        with LRI/PCRI
                                                     3388
                        3000             3408                         4170      4090      Medicare payments
                                                             3964
                        2000                                                              Patient payments

                        1000   2150
                                                     1977
                                         1270
                           0
                                11         22         3
                                                      3       1
                                                              4        25        3
                                                                                 6

                                        First Year
                                       First-Year                    Lifetime
                                                                    Life-Time                                   8
                      Results – Cost-Effectiveness
      In the first year, both astigmatism-correcting cataract treatments were cost-
       ineffective compared to the conventional monofocal IOL with glasses/contacts.
      Once lifetime costs were considered, the Toric IOL proved the better value
       compared to either a conventional monofocal IOL with LRI/PCRI or a
       conventional monofocal IOL with glasses/contacts. Toric ICERs were lower
       (better) due to a larger proportion of patients achieving an uncorrected visual
       acuity of ≥ 20/25


                                Incremental cost             ICER per patient            Incremental cost            ICER per patient
                                  of treatment*                 with UCVA                  of treatment*                with UCVA
                                                                 ≥ 20/25*                                                ≥ 20/25*
                                                    First Year                                               Lifetime
   Toric IOL
      Total costs                       $ 851                      $ 9,768                    $ -235.15                       $- 2,699
      Patient costs                     $ 880                     $ 10,099                    $ -206.29                       $ -2,368
   CM IOL with intra-
   operative LRI/PCRI
     Total costs                        $ 687                     $ 16,567                      $ -100                        $ -2,417
     Patient costs                      $ 707                     $ 17,060                       $ -80                        $ -1,925
*CM IOL without intra-operative refractive correction was used as a baseline comparator
CM=conventional monofocal; ICER = Incremental Cost Effectiveness Ratio; IOL=Intraocular Lens; LRI=Limbal Relaxing Incision;
                                                                                                                                         9
PCRI=Peripheral Corneal Relaxing Incision
                                 Sensitivity Analysis
     To test the robustness of the model results, we varied the cost of toric IOL to account for possible cost range
     Proportion of patients achieving distance vision independence was also varied to account for possible better
      and worse outcomes as identified in clinical studies.

      Parameter                                            Best-case       Default model value       Worse-case
                                                         scenario value                             scenario value
      Patient cost of cataract surgery with toric IOL    $750 per eye          $825 per eye         $1,000 per eye

      Probability of distance vision spectacle               90%                   67%                   50%
      independence with toric IOL

     All best-case scenarios indicated better value (negative ICER) with the toric IOL compared to that obtained
      with default model values. Results were more sensitive to the change in distance vision spectacle
      independence than in the cost of the toric IOL. Result sensitivity was greatest when the probability of
      distance vision spectacle independence and toric IOL cost were modified simultaneously.


                                                     Best-case:                                   Worse-case:
                                               ICERs with toric IOL vs.                      ICERs with toric IOL vs.
                                             conventional monofocal IOL                    conventional monofocal IOL
                                                             -                    $1,000 per             +$20
    Cost of toric IOL               $750 per eye           $2,90                     eye                  1
                                                             0
                                                             -
                                                                                                        +$12,
    Spectacle independence              90%                $15,0                     50%
                                                                                                         670
                                                            00

                                                              -
    Simultaneous modifying          $750 per eye                                  $1,000 per            +$16,
                                                            $17,5
    of both parameters                  90%                                        eye 50%               000
                                                             00
                                                                                                                        10
                             Conclusion
   The Toric IOL is the economically dominant treatment for the correction
    of astigmatism in cataract patients compared to conventional monofocal
    IOLs with either glasses or intra-operative refractive surgery.
   Nearly all of the cost savings afforded by the Toric IOL are accrued by
    the patient.
   These results may be informative to physicians and patients regarding
    the value and long-term benefits of the toric IOL to treat cataract with
    preexisting astigmatism.
   Future research quantifying lost productivity and other intangible costs
    of wearing glasses/lenses is warranted to ensure that the outcomes of
    alternative treatments are as comprehensively evaluated as possible.
   Our findings should be cautiously applied to patients who require
    correction of more than three diopters or patients whose likelihood of
    becoming distance vision spectacle independent is low.



                                                                          11
                                        References
Alcon Laboratories Inc. 2008 Market Scope Reports. Alcon data on file.
American Academy of Ophthalmology. Cataract in the Adult Eye, Preferred Practice Pattern. Available at:
   www.aao.org/ppp Accessed June, 2007. www.aao.org/ppp
American Medical Association. CPT Code/Relative Value Search. Available at:
   https://catalog.amaassn.org/Catalog/cpt/cpt_search.jsp?_requestid=18642?checkXwho=done,
   Accessed August, 2008.
Center for Disease Control and Prevention. US Life tables. Available at:
    http://www.cdc.gov/nchs/data/hus/hus07.pdf#027. Accessed August, 2008.
Center for Medicare and Medicaid Services. Ambulatory Surgical Payments. Available
    at:http://www.cms.hhs.gov/ASCPayment/01_Overview.asp . Accessed August, 2008.

Department of Health and Human Services. Ruling No. CMS-1536-R. Jan.22, 2007.
Dick HB, Dell S. Single optic accommodative intraocular lenses. Ophthalmol Clin North Am 2006; 19(1):107-
    24.
Gills JP. Treating astigmatism at the time of cataract surgery. Curr Opin Ophthalmol 2002; 13(1):2-6.
Mendicute J, Irogoyen C, Aramberri J, Ondarra A, Montes-Mico R. Foldable toric intraocular lens for
   astigmaticsm correction in cataract patients. J Cataract Refract Surg 2008; 34(4):601-607.
Ruhswurm I, Scholz U, Zehetmayer M, Hanselmayer G, Vass C, Skorpik C. Astigmatism correction with a
   foldable toric intraocular lens in cataract patients. J Cataract Refract Surg 2000; 26(7):1022-1027.



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