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DES Economics:
Insights for 2010 and Beyond

          David J. Cohen, M.D., M.Sc.

      Director of Cardiovascular Research
     Saint Luke’s Mid America Heart Institute

             Professor of Medicine
         University of Missouri-Kansas City
DISCLOSURES
         David J. Cohen, MD
Consulting Fees
  – Medtronic CardioVascular, Inc., Cordis, a
    Johnson & Johnson company


Grants/Contracted Research
  – Abbott Vascular, Boston Scientific
    Corporation, Daiichi Sankyo, Inc. and Eli Lilly
    and Company, Edwards Lifesciences LLC
Cost-Effectiveness of Drug-Eluting Stents



    •• DES vs. BMS comparisons
       DES vs. BMS comparisons
       – Results based on early randomized trials
       – Results based on early randomized trials

    •• Impact of recent practice changes
        Impact of recent practice changes

    •• Impact of stent thrombosis and clopidogrel
        Impact of stent thrombosis and clopidogrel
       duration
        duration
Cost-Effectiveness of Drug-Eluting Stents



    •• DES vs. BMS comparisons
       DES vs. BMS comparisons
       – Results based on early randomized trials
       – Results based on early randomized trials

    •• Impact of recent practice changes
        Impact of recent practice changes

    •• Impact of stent thrombosis and clopidogrel
        Impact of stent thrombosis and clopidogrel
       duration
        duration
SIRIUS
                1-Year Medical Care Costs

                   ∆ = +$309 (p=0.64)
                   ∆
 $20,000
           $16,813 + 9737
                               $16,504 + 11,511

 $15,000
               $5,468                             Follow-up
                                   $8,040
                                                  Initial Hospitalization
 $10,000
                                                      C/E ratio ::
                                                      C/E ratio
                                                  $1650 per repeat
                                                  $1650 per repeat
               $11,345
  $5,000                                           revasc avoided
                                                    revasc avoided
                                   $8,464

                                                    $27,000 per
                                                     $27,000 per
     $0                                             QALY gained
                                                    QALY gained
             Sirolimus            Control
Cost-Effectiveness of DES in 2003:
                  Impact of Bare Metal Stent TVR Rate

                                                Healthcare system perspective
                                 $25,000
                                                                                      2003 Model Assumptions
Cost per repeat revasc avoided




                                                                                      • TVR risk reduction 75%
                                 $20,000
                                                                                      • Incremental DES cost =
                                                                                        $2000/stent
                                 $15,000
                                                                                      • 1.4 stents/pt

                                 $10,000
                                                                                      Conclusions
                                                                                       Conclusions
                                  $5,000                                              •• DES reasonably cost-
                                                                                         DES reasonably cost-
                                                                                         effective if bare stent
                                                                                         effective if bare stent
                                                                                         TVR rate > 14%
                                                                                         TVR rate > 14%
                                     $0
                                           5%      10%      15%      20%        25%
                                                 TVR rate with bare stent
Cost-Effectiveness of Drug-Eluting Stents



    •• DES vs. BMS comparisons
       DES vs. BMS comparisons
       – Results based on early randomized trials
       – Results based on early randomized trials

    •• Impact of recent practice changes
        Impact of recent practice changes

    •• Impact of stent thrombosis and clopidogrel
        Impact of stent thrombosis and clopidogrel
       duration
        duration
DES Economics

           Changes in Practice and Outcomes:
                     2010 vs. 2003

                            2003              2009


     Cost Difference        $2000/stent       $1000/stent


     Stents/case            1.4               1.6


     Clopidogrel duration   3 months          12+ months


     TVR relative risk      75% (early RCTs   50% (Kirtane meta-
     reduction              with angio f/u)   analysis)
Cost-Effectiveness of Drug-Eluting Stents:
                  2009 vs. 2003

                                            US Healthcare system perspective
                                 $25,000                                             New Assumptions
                                                                                     • Incremental cost per
Cost per repeat revasc avoided




                                                                                       DES = $1000
                                 $20,000
                                                                                     • DES per case = 1.6
                                 $15,000                                             • 50% reduction in TVR
                                                                                       with DES vs. BMS

                                 $10,000                                             • 12 months of clopidogrel
                                                                                       for all DES

                                  $5,000                                             Implications
                                                                                      Implications
                                                                                     •• DES reasonably cost-
                                                                                        DES reasonably cost-
                                     $0                                                 effective if bare stent
                                                                                        effective if bare stent
                                           5%     10%       15%        20%     25%      TVR rate > 11%
                                                                                        TVR rate > 11%
                                                   TVR rate with BMS
Cost-Effectiveness of Drug-Eluting Stents



    •• DES vs. BMS comparisons
       DES vs. BMS comparisons
       – Results based on early randomized trials
       – Results based on early randomized trials

    •• Impact of recent practice changes
        Impact of recent practice changes

    •• Impact of stent thrombosis and clopidogrel
        Impact of stent thrombosis and clopidogrel
       duration
        duration
Relative Impact of Restenosis and Mortality on
           Quality-Adjusted Life Expectancy


                10                         8.2

Reduction in    8
Quality-
Adjusted Life   6                 125x
Expectancy
(per event)     4

                2         0.07

                0
                     Restenosis          Death

                                          Cohen DJ et al. Circulation 2001
Impact of VLST on
Quality-Adjusted Sensitivity Analysis on
                 Life Expectancy
                                           Additional Risk of Stent Thrombosis in DES
                              12.12
                                                                                                  DES
                                                                                                  BMS
                                                                                            Threshold Values:
                              12.12                                                               Add_Increased_Risk_of_ST_in_DES = 0.0021
                                                                                                  EV = 12.11



                              12.11
      Expected Value (QALY)
             QALYs




                              12.11



                                                                                        Implication:
                              12.10
                                                                                        DES preferred over only if
                                                                                        excess LST < 0.2 %/yr
                              12.10




                              12.09
                                  0.0000    0.0010     0.0020      0.0030     0.0040     0.0050

                                  Excess Additional Risk of Stent Thrombosis in DES (per year)
                                         Risk of Late Stent Thrombosis

                                                                             Garg P et al. J Am Coll Cardiol 2008;51:1844-53
Impact of VLST Risk Duration
                                         0.45


                                         0.40
 Incremental Risk of VLST (% per year)




                                         0.35


                                         0.30


                                         0.25

                                         0.20

                                         0.15


                                         0.10


                                         0.05


                                         0.00
                                                2   3         4          5          6          7          8            9    10
                                                        Duration of Excess Thrombosis Risk (Years after Initial PCI)




                                                                                        Garg P et al. J Am Coll Cardiol 2008;51:1844-53
Cost-Effectiveness of DES

              Impact of a Thromboresistant Stent

              Cost-Effectiveness ($/QALY)
  $100,000                                             Model Assumptions
                              ∆ cost = $400/stent      • Background ST rate (early +
   $75,000                                               late + very late) = 1.5%

                                                       • ST cost = $17,000/event
                                                         (Reynolds et al, 2002)
   $50,000

                                                       Implications
                                                        Implications
   $25,000                                             •• Even at a cost premium of
                                                           Even at a cost premium of
                                                          $400/stent, a thrombo-
                                                           $400/stent, a thrombo-
                                                          resistant DES would be
                                                           resistant DES would be
        $0                                                reasonably cost-effective if
                                                           reasonably cost-effective if
             0%     25%      50%      75%       100%      reduced total ST by 25%
                                                           reduced total ST by 25%

                  ST Relative Risk Reduction
Cost-Effectiveness of DES

                    Impact of Clopidogrel Duration

           Cost per Repeat
           Revascularization Avoided
 $20,000       Take Home Message                     Assumptions
                                                 • DES to
               • As restenosis rates have continued cost = $2000/stent
 $15,000
                 decline, reductions in stent thrombosisreduction = 70%
                                                 • TVR risk
                 and clopidogrel duration are now more rate =14%
                                                 • BMS TVR
 $10,000         attractive targets for improved• DES of clopidogrel
                                                   1 month
                 design than further reductions in BMS
                                                   after

  $5,000
                 restenosis                      • No benefit of clopidogrel
                                                      other than prevention of
                                                      stent thrombosis
     $0
           0    6     12    18     24      30   36

                    Clopidogrel Duration
CHARISMA: Established Disease Subgroup
Cost-Effectiveness Results

                           Clopidogrel +    ASA             Difference
                               ASA          alone            (95% CI)


 Cost in trial               $13,502       $10,386              $3116

                                                               0.01
 Life-years in trial         2.58 yrs      2.57 yrs
                                                           (-0.01, 0.02)

                                                               -0.07
 Total life-years lost *     0.62 yrs      0.69 yrs
                                                           (-0.16, 0.01)
             Incremental Cost-Effectiveness Ratio
                 ∆C/∆E = $38,705/life-year gained
                                                    Chen J et al. Value in Health 2009
Summary

• Despite substantial changes in practice patterns over
  the past 6 years, most of the fundamental insights
  regarding the cost-effectiveness of drug-eluting stents
  have changed very little
   – DES are cost-saving for only a minority of the PCI population
   – Nonetheless, DES appear reasonably cost-effective compared
     with BMS for a substantial fraction of PCI patients (predicted
     BMS TVR > 10-11%)

• Given current clinical data, the most promising targets
  for improving the cost-effectiveness of DES relate to
  reductions in stent thrombosis or mandatory DAPT
  duration
Des economics  insights for 2010 and beyond

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Des economics insights for 2010 and beyond

  • 1. DES Economics: Insights for 2010 and Beyond David J. Cohen, M.D., M.Sc. Director of Cardiovascular Research Saint Luke’s Mid America Heart Institute Professor of Medicine University of Missouri-Kansas City
  • 2. DISCLOSURES David J. Cohen, MD Consulting Fees – Medtronic CardioVascular, Inc., Cordis, a Johnson & Johnson company Grants/Contracted Research – Abbott Vascular, Boston Scientific Corporation, Daiichi Sankyo, Inc. and Eli Lilly and Company, Edwards Lifesciences LLC
  • 3. Cost-Effectiveness of Drug-Eluting Stents •• DES vs. BMS comparisons DES vs. BMS comparisons – Results based on early randomized trials – Results based on early randomized trials •• Impact of recent practice changes Impact of recent practice changes •• Impact of stent thrombosis and clopidogrel Impact of stent thrombosis and clopidogrel duration duration
  • 4. Cost-Effectiveness of Drug-Eluting Stents •• DES vs. BMS comparisons DES vs. BMS comparisons – Results based on early randomized trials – Results based on early randomized trials •• Impact of recent practice changes Impact of recent practice changes •• Impact of stent thrombosis and clopidogrel Impact of stent thrombosis and clopidogrel duration duration
  • 5. SIRIUS 1-Year Medical Care Costs ∆ = +$309 (p=0.64) ∆ $20,000 $16,813 + 9737 $16,504 + 11,511 $15,000 $5,468 Follow-up $8,040 Initial Hospitalization $10,000 C/E ratio :: C/E ratio $1650 per repeat $1650 per repeat $11,345 $5,000 revasc avoided revasc avoided $8,464 $27,000 per $27,000 per $0 QALY gained QALY gained Sirolimus Control
  • 6. Cost-Effectiveness of DES in 2003: Impact of Bare Metal Stent TVR Rate Healthcare system perspective $25,000 2003 Model Assumptions Cost per repeat revasc avoided • TVR risk reduction 75% $20,000 • Incremental DES cost = $2000/stent $15,000 • 1.4 stents/pt $10,000 Conclusions Conclusions $5,000 •• DES reasonably cost- DES reasonably cost- effective if bare stent effective if bare stent TVR rate > 14% TVR rate > 14% $0 5% 10% 15% 20% 25% TVR rate with bare stent
  • 7. Cost-Effectiveness of Drug-Eluting Stents •• DES vs. BMS comparisons DES vs. BMS comparisons – Results based on early randomized trials – Results based on early randomized trials •• Impact of recent practice changes Impact of recent practice changes •• Impact of stent thrombosis and clopidogrel Impact of stent thrombosis and clopidogrel duration duration
  • 8. DES Economics Changes in Practice and Outcomes: 2010 vs. 2003 2003 2009 Cost Difference $2000/stent $1000/stent Stents/case 1.4 1.6 Clopidogrel duration 3 months 12+ months TVR relative risk 75% (early RCTs 50% (Kirtane meta- reduction with angio f/u) analysis)
  • 9. Cost-Effectiveness of Drug-Eluting Stents: 2009 vs. 2003 US Healthcare system perspective $25,000 New Assumptions • Incremental cost per Cost per repeat revasc avoided DES = $1000 $20,000 • DES per case = 1.6 $15,000 • 50% reduction in TVR with DES vs. BMS $10,000 • 12 months of clopidogrel for all DES $5,000 Implications Implications •• DES reasonably cost- DES reasonably cost- $0 effective if bare stent effective if bare stent 5% 10% 15% 20% 25% TVR rate > 11% TVR rate > 11% TVR rate with BMS
  • 10. Cost-Effectiveness of Drug-Eluting Stents •• DES vs. BMS comparisons DES vs. BMS comparisons – Results based on early randomized trials – Results based on early randomized trials •• Impact of recent practice changes Impact of recent practice changes •• Impact of stent thrombosis and clopidogrel Impact of stent thrombosis and clopidogrel duration duration
  • 11. Relative Impact of Restenosis and Mortality on Quality-Adjusted Life Expectancy 10 8.2 Reduction in 8 Quality- Adjusted Life 6 125x Expectancy (per event) 4 2 0.07 0 Restenosis Death Cohen DJ et al. Circulation 2001
  • 12. Impact of VLST on Quality-Adjusted Sensitivity Analysis on Life Expectancy Additional Risk of Stent Thrombosis in DES 12.12 DES BMS Threshold Values: 12.12 Add_Increased_Risk_of_ST_in_DES = 0.0021 EV = 12.11 12.11 Expected Value (QALY) QALYs 12.11 Implication: 12.10 DES preferred over only if excess LST < 0.2 %/yr 12.10 12.09 0.0000 0.0010 0.0020 0.0030 0.0040 0.0050 Excess Additional Risk of Stent Thrombosis in DES (per year) Risk of Late Stent Thrombosis Garg P et al. J Am Coll Cardiol 2008;51:1844-53
  • 13. Impact of VLST Risk Duration 0.45 0.40 Incremental Risk of VLST (% per year) 0.35 0.30 0.25 0.20 0.15 0.10 0.05 0.00 2 3 4 5 6 7 8 9 10 Duration of Excess Thrombosis Risk (Years after Initial PCI) Garg P et al. J Am Coll Cardiol 2008;51:1844-53
  • 14. Cost-Effectiveness of DES Impact of a Thromboresistant Stent Cost-Effectiveness ($/QALY) $100,000 Model Assumptions ∆ cost = $400/stent • Background ST rate (early + $75,000 late + very late) = 1.5% • ST cost = $17,000/event (Reynolds et al, 2002) $50,000 Implications Implications $25,000 •• Even at a cost premium of Even at a cost premium of $400/stent, a thrombo- $400/stent, a thrombo- resistant DES would be resistant DES would be $0 reasonably cost-effective if reasonably cost-effective if 0% 25% 50% 75% 100% reduced total ST by 25% reduced total ST by 25% ST Relative Risk Reduction
  • 15. Cost-Effectiveness of DES Impact of Clopidogrel Duration Cost per Repeat Revascularization Avoided $20,000 Take Home Message Assumptions • DES to • As restenosis rates have continued cost = $2000/stent $15,000 decline, reductions in stent thrombosisreduction = 70% • TVR risk and clopidogrel duration are now more rate =14% • BMS TVR $10,000 attractive targets for improved• DES of clopidogrel 1 month design than further reductions in BMS after $5,000 restenosis • No benefit of clopidogrel other than prevention of stent thrombosis $0 0 6 12 18 24 30 36 Clopidogrel Duration
  • 16. CHARISMA: Established Disease Subgroup Cost-Effectiveness Results Clopidogrel + ASA Difference ASA alone (95% CI) Cost in trial $13,502 $10,386 $3116 0.01 Life-years in trial 2.58 yrs 2.57 yrs (-0.01, 0.02) -0.07 Total life-years lost * 0.62 yrs 0.69 yrs (-0.16, 0.01) Incremental Cost-Effectiveness Ratio ∆C/∆E = $38,705/life-year gained Chen J et al. Value in Health 2009
  • 17. Summary • Despite substantial changes in practice patterns over the past 6 years, most of the fundamental insights regarding the cost-effectiveness of drug-eluting stents have changed very little – DES are cost-saving for only a minority of the PCI population – Nonetheless, DES appear reasonably cost-effective compared with BMS for a substantial fraction of PCI patients (predicted BMS TVR > 10-11%) • Given current clinical data, the most promising targets for improving the cost-effectiveness of DES relate to reductions in stent thrombosis or mandatory DAPT duration

Editor's Notes

  1. An absolute excess risk of 0.21% per year (years 1-3) associated with DES was identified as the threshold over which BMS would be preferred.