What Does Breast Cancer Treatment Cost and What Is It Worth?

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2 What Does Breast Cancer Treatment Cost and What Is It Worth? Elena B. Elkin, PhD Center for Health Policy and Outcomes Memorial Sloan-Kettering Cancer Center

3 Is This Drug Worth the Cost? Ixabepilone added to capecitabine in taxane/anthracycline-resistant metastatic BC > Increased objective response rate 2.5-fold > Extended progression-free survival 1.6 months > Increased peripheral neuropathy and hematologic toxicity Ixabepilone added $4,200 per cycle (2008$) > Median 5 cycles > $31,000 additional cost per patient > Is it worth the cost? Is there sufficient value for the money?

4 Direct Medical Spending on Cancer ($ Billions) We Spend A Lot on Cancer Care 100 Nominal Direct Medical Spending ($ Billions) CPI-U Adjusted Direct Medical Spending (2009$ Billions) Year

5 Per Capita Health Expenditure We Spend A Lot on Health Care $9,000 $8,000 Per Capita Health Expenditures by GDP, 2010 United States $7,000 $6,000 $5,000 $4,000 $3,000 $2,000 $1,000 $0 $25,000 $30,000 $35,000 $40,000 $45,000 $50,000 $55,000 $60,000 $65,000 Per Capita GDP

6 We Keep Spending More

7 Do We Have Better Outcomes?

8 Life Expectancy at Birth It s Not Clear Female Life Expectancy by Per Capita Health Expenditure, United States 80 $0 $1,000 $2,000 $3,000 $4,000 $5,000 $6,000 $7,000 $8,000 $9,000 Per Capita Health Expenditure

9 It s Not Clear 150 Mortality from Causes Amenable to Health Care (Deaths per 100,000 Population, Age <75)

10 Breast Cancer is Largest Share of Cancer Care Spending Yabroff et al. CEBP 2011;20:

11 Spending by Phase of Care Average Annualized Net Costs of Care For Breast Cancer Phase Age <65 Age 65+ Initial $27,700 $23,000 Continuing $2,200 $2,200 Last year of life* $94,300 $62,900 Costs in 2010 $US Net costs costs attributable to cancer *Among women whose cause of death was cancer Mariotto et al. JNCI 2011;103:1-12

12 Where Do the Dollars Go? Spending for Initial Phase of Care, 2012* Patients Receiving Treatment Average $ for Those Receiving Treatment Total 100% $27,000 Surgery 91% $7,000 Radiation 51% $6,000 Chemotherapy 24% $16,000 Other inpatient 23% $21,000 Medicare fee-for-service beneficiaries age 65+ Utilization estimates, Medicare 2002 Costs updated to 2012 $US Warren et al. JNCI 2008;100:

13 Where Do the Dollars Go? Spending for Initial Phase of Care, 2002 Total Total Medicare Payments $1.06 billion Percent of Total Surgery $261 million 25% Chemotherapy $157 million 15% Radiation $117 million 11% Other inpatient $194 million 18% Medicare fee-for-service beneficiaries age 65+ Total payment includes other services in addition to the treatments shown Warren et al. JNCI 2008;100:

14 Surgery and Radiation Breast conserving surgery + radiation > $15,000 to $26,000 Mastectomy > $10,000 to $13,000 Mastectomy with reconstruction > $23,000 Barlow et al. JNCI 2001;93: Palit et al. Am J Surg 2000;179(6):

15 Radiation Therapy Cost Comparison Technique Whole-breast radiotherapy Cost WBRT $7,400 WBRT with boost $9,500 WBRT-accelerated schedule $5,400 WBRT-IMRT $17,900 Accelerated partial breast irradiation APBI-3DCRT $7,200 APBI-IMRT $9,200 APBI-balloon catheter brachytherapy $17,800 APBI-multi-cath interstitial brachytherapy $16,800 Assumes 60-year old patient, stage I BC, hospital outpatient facility Cost to payer, 2003 $US Suh et al. IJROBP 2005;62:

16 The Cost of Chemotherapy Estimates from Medicare population likely underestimate average costs across all age groups Estimates from older datasets do not include the costs of newer, more expensive drugs and regimens

17 High The Cost of Chemotherapy Chemotherapy for curative intent > $23,000-$31,000 per patient One year of trastuzumab > $50,000-$60,000 per patient Adverse effects > $1,000-$5,000 per patient Campbell and Ramsey, Pharmacoecon 2009;27: Hassett et al. JNCI 2006;98: Hedden et al. Oncologist 2012: Kurian et al. JCO 2007;25: Bennett and Calhoun, Oncologist 2007;12:

18 Increasing The Cost of Chemotherapy Updated from Bach, NEJM 2009

19 Increasing The Cost of Chemotherapy Updated from Bach, NEJM 2009

20 Increasing The Cost of Chemotherapy Updated from Bach, NEJM 2009

21 The Cost of Imaging Imaging accounts for a small but growing proportion of costs associated with breast cancer treatment and follow-up care Overuse of imaging is a target of initiatives to reduce unnecessary care that is not supported by evidence

22 Increasing The Cost of Imaging Costs of Breast Cancer Care and Imaging in the 2 Years Following Diagnosis Year of Diagnosis Annual increase Total costs $23,500 $31,400 $33,600 4% Imaging costs $840 $1,500 $1,700 10% % of total 4% 5% 5% N=8,876 Medicare beneficiaries Costs reported in 2008 $US Dinan et al. JAMA 2010;303:

23 Imaging Cost as % of Total Cost Increasing The Cost of Imaging 10% 9% 8% 7% 6% 5% 4% 3% Breast Colorectal Leukemia Lung NHL Prostate 2% 1% 0% Dinan et al. JAMA 2010;303:

24 Increasing The Cost of Imaging Mean Scans Per Patient Year of Diagnosis Annual increase Bone density study % CT scan % Echocardiogram % MRI scan % Nuclear medicine % PET scan < % Radiograph % Ultrasound % N=8,876 Medicare beneficiaries Costs reported in 2008 $US Dinan et al. JAMA 2010;303:

25 Overuse of Imaging in Breast Cancer Don t perform PET, CT, and radionuclide bone scans in the staging of early breast cancer at low risk for metastasis Don t perform surveillance testing (biomarkers) or imaging (PET, CT, and radionuclide bone scans) for asymptomatic individuals who have been treated for breast cancer with curative intent 2013 American Society of Clinical Oncology

26 Projected Spending, 2020 Yabroff et al. CEBP 2011;20:

27 Why Are Costs Increasing? Increase in quantity > Aging population increasing incidence > New technology expands markets Therapies for previously untreatable conditions Less toxic therapies for patients who previously would be poor candidates for treatment Increase in price > Increase in costs of drug development Technology, regulatory burden, third parties > Prohibitions on negotiation, cost consideration > Rational economic behavior > Profiteering

28 Why Should We Care? In the past 12 months, have you or a family member in your household done this because of the cost? Skipped dental care or checkups Relied on home remedies or over-the-counter drugs instead of going to see a doctor Put off or postponed getting health care you needed Skipped a recommended medical test or treatment Not filled a prescription for a medicine Cut pills in half or skipped doses of medicine Had problems getting mental health care 31% 28% 26% 22% 20% 16% 9% Did any of the above 45% Source: Kaiser Family Foundation Health Tracking Poll (conducted June 17-22, 2010)

29 Why Should We Care? Estimated Out-of-Pocket Costs for Breast Cancer Treatment In 3 Massachusetts Health Plans Patient expense due to Plan A Plan D Plan C Deductibles N/A $4,767 $4,300 Coinsurance N/A N/A $5,447 Co-pays $2,004 $2,869 $3,160 Non-covered services $0 $0 $0 Total out-of-pocket costs $2,004 $7,641 $12,907 Percent of total costs* 1% 5% 9% *$143,180 total allowed charges over 87 weeks Coverage When it Counts, Georgetown University Health Policy Institute, May 2009

30 Financial Toxicity Because treatments can be financially toxic, imposing out-of-pocket costs that may impair patients' well-being, we contend that physicians need to disclose the financial consequences of treatment alternatives just as they inform patients about treatments' side effects. Ubel et al. NEJM 2013;369:

31 Impact on Practice Oncologists say Patients out-of-pocket cost influences my treatment recommendations The cost of new cancer drugs influences my treatment recommendations More cost-sharing by patients for cancer drug costs is needed More use of cost-effectiveness data in coverage and payment decisions is needed National survey of oncologists, 2008 (n=787) 84% 56% 29% 80% Neumann PJ et al. Health Aff 2010;29:

32 The Value of New Cancer Therapies Cost-effectiveness analysis (CEA) > Method for estimating value for money > Health benefit defined in clinical units Compare new treatment to prior standard > Incremental cost-effectiveness ratio (ICER) ICER DC DE C 2 -C 1 E 2 - E 1

33 Effectiveness in CEA ICER will tell us the cost per gained by choosing one intervention instead of another > progression-free day > cancer prevented > life saved > life-year > quality-adjusted life-year

34 Quality-Adjusted Life-Years QALYs A measure of survival duration that also incorporates health-related quality of life Captures impact of disease and intervention on mortality and morbidity Comparable across diseases, interventions

35 Cost-Effectiveness Plane DC C 1 >C 2 $10,000 $20,000/QALY (Drug 1 vs. Drug 2) 0.5 QALYs DE E 1 >E 2

36 Cost-Effectiveness Plane DC Drug 1 is dominated by Drug 2 C 1 >C 2 E 1 <E 2 DE

37 Cost-Effectiveness Plane DC Drug 2 dominates Drug 1 C 1 >C 2 E 1 <E 2 DE

38 Selected ICERs in Breast Cancer Intervention BRCA1/2 testing (age 35+, fam hx BC/OC) Raloxifene risk reduction (white women age 55) Letrozole vs. anastrozole (post-meno, HR+) Lapatininb+capecit vs. capecit (HER2+ MBC) Annual screen MRI vs. film mammo (BRCA1) Bev+paclitaxel vs. paclitaxel (HER2- MBC) Ixabepilone+capecit vs. capecit (AT-resist MBC) Partial breast irrad vs. WBRT (stage I, ER+, post) All digital screen mammo vs. film, age 40+ QALY: quality-adjusted life-year All costs updated to 2012 $US ICER $5,400 per QALY $22,000 per QALY $26,000 per QALY $170,000 per QALY $210,000 per QALY $280,000 per QALY $380,000 per QALY $730,000 per QALY $930,000 per QALY

39 So What s A Good Value? Depends on willingness to pay for health gain In the US there is no consensus criterion > In the UK and elsewhere, more explicit threshold Common perception > <$50,000/QALY: low ICER, good value > $50,000/QALY to $100,00/QALY: judgment call > >$100,000/QALY: high ICER, justify on clinical grounds

40 Where Do We Draw the Line? Adjusting for health care inflation $50,000 (1982) = $197,000 per QALY (2007) WHO: 3-times per-capita GDP = $140,100 per QALY in 2008 $US Modern (2003) vs. pre-modern (1950) eras of medical care = $183,700 per LY Hillner and Smith, JCO 2009;27:

41 Selected ICERs in Breast Cancer Intervention BRCA1/2 testing (age 35+, fam hx BC/OC) Raloxifene risk reduction (white women age 55) Letrozole vs. anastrozole (post-meno, HR+) Lapatininb+capecit vs. capecit (HER2+ MBC) Annual screen MRI vs. film mammo (BRCA1) Bev+paclitaxel vs. paclitaxel (HER2- MBC) Ixabepilone+capecit vs. capecit (AT-resist MBC) Partial breast irrad vs. WBRT (stage I, ER+, post) All digital screen mammo vs. film, age 40+ QALY: quality-adjusted life-year All costs updated to 2012 $US ICER $5,400 per QALY $22,000 per QALY $26,000 per QALY $170,000 per QALY $210,000 per QALY $280,000 per QALY $380,000 per QALY $730,000 per QALY $930,000 per QALY

42 The Ixabepilone Decision In the US > Approved as monotherapy or in combination with capecitabine for AT-resistant MBC In Europe > After negative opinion on review, application for marketing authorization withdrawn In the UK > No appraisal from National Institute for Clinical Excellence (NICE) without EMA marketing authorization

43 Increasing The Cost of Chemotherapy Updated from Bach, NEJM 2009

44 The Pertuzumab Story In the US > Approved in 2012 in combination with trastuzumab and docetaxel for HER2+ MBC > Approved in 2013 in combination with trastuzumab and docetaxel for neoadjuvant treatment in HER2+, locally advanced, inflammatory, and early stage disease (N+ or T>2) In Europe > Authorization granted in 2012 for MBC or recurrent locally advanced unresectable disease

45 The Pertuzumab Story In the UK > Pertuzumab in combination with trastuzumab and docetaxel not recommended for HER2+ positive MBC or locally recurrent unresectable BC > Benefit in PFS, but too much uncertainty in OS > The manufacturer s cost-effectiveness estimates were outside the range normally considered to be cost-effective use of NHS resources 0% probability of being cost effective at a willingness-topay of 30,000 per QALY gained

46 Who Should Decide? Who should determine whether a drug provides good value? Physicians 60% Nonprofit organizations 57% Patients 37% Government 21% Insurance companies 6% National survey of oncologists, 2008 (n=787) Neumann PJ et al. Health Aff 2010;29:

47 Who Will Decide?