assessing value in cancer care: advances in ugi malignancies as a case study
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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 - PowerPoint PPT PresentationTRANSCRIPT
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Assessing Value in Cancer Care:Advances in UGI Malignancies as a Case Study
Neal J. Meropol, M.D.Chief, Division of Hematology and Oncology
University Hospitals Case Medical CenterCase Western Reserve University
Cleveland, OH
Moving the Bar in UGI Malignancies: A Review of Recent UGI Phase III Studies—Clinically Meaningful or Just Statistically Positive?
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What the media tells us
• “Targeted therapy save lives!”• “We’re going to bankrupt the
economy!”• “The pharmaceutical industry is
evil!”
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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?
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Adapted from C. Borger, et al. Health Affairs 25(2): w61-w73, 2006; Reproduced in Meropol and Schulman, J Clin Oncol, 2007
US Health Expenditures and GDP
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$25,000 $30,000 $35,000 $40,000 $45,000 $50,000 $55,000 $60,000 $65,000$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
$8,000
Australia
Austria
Belgium Canada
France
Germany
ItalyJapan
Netherlands
Norway
SpainSweden
Switzerland
U.K.
USA
Total Health Expenditure per Capita and GDP per Capita,
US and Selected Countries, 2008
GDP Per Capita
Per
Capi
ta H
ealt
h Sp
endi
ng
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.
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Health Expenditures and Life Expectancy
Fuchs and Milstein, NEJM 2011
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Growth in healthcare spending is greater than growth in GDP (but this has moderated recently)
Healthcare Costs: A Primer, Kaiser Family Foundation, 2007
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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
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Factors contributing to high cost of cancer care
Demographics• Aging of populationUnit cost• Exclusivity-patent protection• High cost of drug
development/manufactureRegulatory• Medicare standard:
“reasonable and necessary” – not value
• Medicare unable to negotiate price
Schnipper, Meropol, Brock, Clin Cancer Res, 2010Peppercorn, Sikora, Zalcberg, Meropol, Lancet Oncol, in press.
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)
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Oncology Drug Contribution to Spending Growth - 2009
Growth RateAll clinic drug expenditures5.1%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-Syst Pharm, 2011MEDPAC Data Book, 2010
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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-Syst Pharm, 2010
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The Cost of Care Has Wide Impact
PatientsProducers Providers
Payers Employers
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Cancer is a substantial financial burden on individuals
Bernard et al. JCO, 2011
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What is the value?
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PFS OS
Cont Exp HR P Cont Exp HR P
Pancreatic, Gem±Erlotinib
3.6 3.8 .77 .004 5.9 6.2 .82 .038
Hepatoma, BSC±Sorafenib
2.8 5.5 .58 <.001 7.9 10.7 .69 <.001
Gastric, FP/CP ±Trastuzumab
5.5 6.7 .71 .0002 11.1 13.8 .74 .0046
Biliary, Gem±Cisplatin
5.0 8.0 .63 <.001 8.1 11.7 .64 <.001
NET, BSC±Sunitinib
5.5 11.4 .42 <.001 early .41 .02
NET, BSC±Everolimus
4.6 11.0 .35 <.001 early 1.05 .59
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
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What is an ICER (Incremental Cost Effectiveness Ratio)?
ICER =
COSTnew - COSTstandard
EFFECTnew - EFFECTstandard
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Survey of US OncologistsWhat 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–$150,00019%$150,001–$200,0006%>$200,000 5%
Neumann et al. Health Affairs, 2010
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ToGA: Cisplatin/Fluoropyrimidine +/- Trastuzumab in Gastric Cancer
Control(N=290)
Trastuzumab(N=294)
Hazard Ratio P
Median Survival
11.1 mo. 13.8 mo. .74 (0.6 – 0.91) .0046
Median Survival – “High HER2”
11.8 mo. 16.0 mo. .65 (.51-.83) .036 for interaction
Progression Free Survival
5.5 mo. 6.7 mo. .71 (0.59-0.85) .0002
Progression Free Survival – “High HER2”
5.5 mo. 7.6 mo. .64 (.51-.79)
Response rate 35% 47% .002
Bang Y-J et al. Lancet 2010
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Comparison of results of Trastuzumab in metastatic breast cancer and gastric cancer
Trastuzumab in breast Trastuzumab in gastricControl (N=234)
Tras(N=235)
HR P Control (N=290)
Tras(N=294)
HR P
PFS 4.6 mo.
7.4 mo. .51 <.001 5.5 mo. 6.7 mo. .71 .0002
5.5 mo.High HER2
7.6 mo. .64
OS 20.3 mo.
25.1 mo.
.80 .046 11.1 mo. 13.8 mo. .74 .005
11.8 mo.High HER2
16.0 mo. .65
Resp Rate %
32% 50% .001 35% 47% .002
Slamon DJ. NEJM, 2001 Bang Y-J et al. Lancet 2010
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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
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Cost Effectiveness of new oral therapies for cancer: British payor perspective
Renal Studies OS PFS ICERSunitinib vs. IFN 1st line 26 vs 22 mo 11 vs 5 mo £71,462Everolimus vs BSC 2nd line Too early 4 vs 2 mo £51,613
Liver cancerSorafenib vs. BSC 10.7 vs. 7.9 mo 6 vs. 3 mo £64,754
NET StudiesSunitinib vs. BSC 11 vs. 6 mo. Everolimus vs. BSC 11 vs. 5 mo.
Coon et al. Health Technology Assessment 14 (2):2010Motzer et al, Lancet 372:449-56, 2008. Motzer et al, NEJM 356:115-24, 2007.Motzer et al, J Clin Oncol 27: 3584-90, 2009www.nice.org.uk/guidance/TA189
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PFS OS
Cont Exp HR P Cont Exp HR P
Pancreatic, Gem±Erlotinib
3.6 3.8 .77 .004 5.9 6.2 .82 .038
Hepatoma, BSC±Sorafenib
2.8 5.5 .58 <.001 7.9 10.7 .69 <.001
Gastric, FP/CP ±Trastuzumab
5.5 6.7 .71 .0002 11.1 13.8 .74 .0046
Biliary, Gem±Cisplatin
5.0 8.0 .63 <.001 8.1 11.7 .64 <.001
NET, BSC±Sunitinib
5.5 11.4 .42 <.001 early .41 .02
NET, BSC±Everolimus
4.6 11.0 .35 <.001 early 1.05 .59
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
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Clinical Benefit
New Drug Cost/Year of New Drug
Value?
Pancreatic, Gem±Erlotinib
Very low Erlotinib $53954 Very low
Hepatoma, BSC±Sorafenib
Modest Sorafenib $115866 Low
Gastric, FP/CP ±Trastuzumab
Modest Trastuzumab $51225(exclude load)
Modest
Biliary, Gem±Cisplatin
Modest Cisplatin $364 Higher
NET, BSC±Sunitinib
Higher Sunitinib $108569 Higher
NET, BSC±Everolimus
Higher Everolimus $201516 Modest
What is the drug value?
Based on AWP for oral drugs, ASP for IV
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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
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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
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Impact of personalized medicine on pharmaClear advantages Longer treatment durationPotential new indications, new marketCompetitive advantage with “personalized” approachCo-marketing of diagnosticClear disadvantagesReduced market sizeUncertainDevelopment time of new therapeuticSuccess in bringing pipeline therapeutic to marketImpact of higher-value therapeutic on pricing/willingness to pay
Peppercorn, Sikora, Zalcberg, Meropol. Lancet Oncology, in press.
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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, 2010Peppercorn, Sikora, Zalcberg, Meropol, Lancet Oncol, in press.
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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
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What defines value?How can we move from implicit to explicit and transparent decisions regarding allocation of scarce resources?
Drummond et al. Can J Clin Pharmacol, 2009
Cancer?
Politics is the third
dimension
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Our new cancer hospital