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Assessing Value in Cancer Care: Advances in UGI Malignancies as a Case Study

Assessing Value in Cancer Care: Advances in UGI Malignancies as a Case Study. Moving the Bar in UGI Malignancies: A Review of Recent UGI Phase III Studies—Clinically Meaningful or Just Statistically Positive?. Neal J. Meropol, M.D. Chief, Division of Hematology and Oncology

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Assessing Value in Cancer Care: Advances in UGI Malignancies as a Case Study

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  1. Assessing Value in Cancer Care:Advances in UGI Malignancies as a Case Study Moving the Bar in UGI Malignancies: A Review of Recent UGI Phase III Studies—Clinically Meaningful or Just Statistically Positive? Neal J. Meropol, M.D. Chief, Division of Hematology and Oncology University Hospitals Case Medical Center Case Western Reserve University Cleveland, OH

  2. What the media tells us • “Targeted therapy save lives!” • “We’re going to bankrupt the economy!” • “The pharmaceutical industry is evil!”

  3. What we should be asking • What does this mean for individual patients and their decisions about treatment? • What does this mean for how we invest in, develop, and pay for new cancer treatments?

  4. US Health Expenditures and GDP Adapted from C. Borger, et al. Health Affairs 25(2): w61-w73, 2006; Reproduced in Meropol and Schulman, J ClinOncol, 2007

  5. Source: Organisation for Economic Co-operation and Development (2010), "OECD Health Data", OECD Health Statistics (database). doi: 10.1787/data-00350-en (Accessed on 14 February 2011). Notes: Data from Australia and Japan are 2007 data. Figures for Belgium, Canada, Netherlands, Norway and Switzerland, are OECD estimates.

  6. Health Expenditures and Life Expectancy Fuchs and Milstein, NEJM 2011

  7. Growth in healthcare spending is greater than growth in GDP (but this has moderated recently) Healthcare Costs: A Primer, Kaiser Family Foundation, 2007

  8. NIH Estimates for Cancer Costs in the United States: 2010 • Total costs: $264 billion • $103 billion for direct medical costs • US spends ~$2.5 trillion on healthcare per year

  9. Factors contributing to high cost of cancer care Demand • Use of treatments with small benefit and high cost (overutilization) • Physician commitment to individual patients • Neither patient nor physician incentivized to consider cost (moral hazard) • Diagnostics (Dinan et al. JAMA 2010) Demographics • Aging of population Unit cost • Exclusivity-patent protection • High cost of drug development/manufacture Regulatory • Medicare standard: “reasonable and necessary” – not value • Medicare unable to negotiate price Schnipper, Meropol, Brock, Clin Cancer Res, 2010 Peppercorn, Sikora, Zalcberg, Meropol, Lancet Oncol, in press.

  10. Oncology Drug Contribution to Spending Growth - 2009 Growth Rate All clinic drug expenditures 5.1% Antineoplastics 9.5% *Cancer drugs are #1 among hospital and clinic drug expenditures *In general, drugs account for only 10% of healthcare spending *>1/3 of Medicare drug spending is cancer-related Doloresco F et al. Am J Health-SystPharm, 2011 MEDPAC Data Book, 2010

  11. Influences on drug expenditure trends • Growth in spending is moderating overall • Increased supply: generics • Decreased demand: recession, unemployment, cost-sharing, fewer new drugs to market • 2006: 8.9% > 2007: 4% > 2008: 1.8% • Health reform • Increased specialty drugs Hoffman JM et al. Am J Health-SystPharm, 2010

  12. Patients The Cost of Care Has Wide Impact Payers Employers Producers Providers

  13. Cancer is a substantial financial burden on individuals Bernard et al. JCO, 2011

  14. What is the value?

  15. What is the clinical benefit? Very low Modest Higher Moore, JCO 2007; Llovet, NEJM 2008; Bang, Lancet 2010; Valle, NEJM 2010; Raymond, NEJM 2011; Yao, NEJM 2011

  16. What is an ICER (Incremental Cost Effectiveness Ratio)? COSTnew - COSTstandard ICER = EFFECTnew - EFFECTstandard

  17. Survey of US Oncologists What do you think is a reasonable definition of "good value for money" or cost-effectiveness per life-year gained? $0–$50,000 21% $50,001–$100,000 49% $100,001–$150,000 19% $150,001–$200,000 6% >$200,000 5% Neumann et al. Health Affairs, 2010

  18. ToGA: Cisplatin/Fluoropyrimidine +/- Trastuzumab in Gastric Cancer Bang Y-J et al. Lancet 2010

  19. Comparison of results of Trastuzumab in metastatic breast cancer and gastric cancer Slamon DJ. NEJM, 2001 Bang Y-J et al. Lancet 2010

  20. NICE assessment of Trastuzumab • Issues for NICE • What is the appropriate comparitor for ICER calculation? ECF? CF? EOF? • What HER2 subgroup? • Incurable disease, size of population? • Comparitor: epirubicin 3-drug regimens • ICER = >£63,100-£71,500 per QALY for licensed population • ICER = £45,000-50,000 per QALY for IHC 3+ population -- APPROVED

  21. Cost Effectiveness of new oral therapies for cancer: British payor perspective Renal Studies OS PFS ICER Sunitinib vs. IFN 1st line 26 vs 22 mo 11 vs 5 mo £71,462 Everolimusvs BSC 2nd line Too early 4 vs 2 mo £51,613 Liver cancer Sorafenib vs. BSC 10.7 vs. 7.9 mo 6 vs. 3 mo £64,754 NET Studies Sunitinib vs. BSC 11 vs. 6 mo. Everolimus vs. BSC 11 vs. 5 mo. Coon et al. Health Technology Assessment 14 (2):2010 Motzer et al, Lancet 372:449-56, 2008.  Motzer et al, NEJM 356:115-24, 2007.Motzer et al, J ClinOncol 27: 3584-90, 2009 www.nice.org.uk/guidance/TA189

  22. What is the clinical benefit? Very low Modest Higher Moore, JCO 2007; Llovet, NEJM 2008; Bang, Lancet 2010; Valle, NEJM 2010; Raymond, NEJM 2011; Yao, NEJM 2011

  23. What is the drug value? Based on AWP for oral drugs, ASP for IV

  24. What does the tras story tell us about the future of oncology clinical trials and oncology care? • Diagnostics development must begin early in clinical development • All cancers will become “rare” cancers • “Blockbusters” are dinosaurs • The bar must be set high early in clinical development • Treatment based on site of origin is being replaced by treatment based on phenotype

  25. The impact of the cost of the diagnostic • Everyone gets the diagnostic test • Only a subset get treated (i.e. the test results in fewer patients treated) • Cost-effectiveness of diagnostic improves as: • Cost of diagnostic decreases • Discrimination ability of diagnostic improves (who wont benefit at all; who will benefit greatly with treatment) • If treatment improves overall, diagnostic becomes less cost-effective

  26. Impact of personalized medicine on pharma Peppercorn, Sikora, Zalcberg, Meropol. Lancet Oncology, in press.

  27. Where we need to go • Reduce overutilization – eliminate non-beneficial interventions • Raise the bar for approval • Link payment to value – cost-sharing • Authorize CMS to negotiate price • Reduce incentives for development of marginal advances • Improve evidence base: comparative effectiveness research Schnipper, Meropol, Brock, Clin Cancer Res, 2010 Peppercorn, Sikora, Zalcberg, Meropol, Lancet Oncol, in press.

  28. Value-based insurance design • Not all effective treatments have equivalent value • Cost sharing can be used to discourage low value treatment and encourage high value treatment (contrast with current plans that base coverage on cost ) • Potential for different coverage based on disease/stage

  29. What defines value? How can we move from implicit to explicit and transparent decisions regarding allocation of scarce resources? Cancer? Politics is the third dimension Drummond et al. Can J ClinPharmacol, 2009

  30. Our new cancer hospital

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