Value for the Oncologist, and Finding Common Ground Among Stakeholders

Transcription

1 Value for the Oncologist, and Finding Common Ground Among Stakeholders Douglas W. Blayney, M.D. Member, ASCO s Value of Cancer Care Task Force Ann & John Doerr Medical Director, Stanford Cancer Institute Professor of Medicine (Oncology), Stanford School of Medicine

2 Can We Find Common Ground? Stakeholder Perspectives on Value in Cancer Care Neal J. Meropol, MD Lowell E. Schnipper, MD Lee N. Newcomer, MD Gregory P. Rossi, PhD Ezekiel J. Emanuel, MD, PhD The Value of Cancer Care and the Professional and Ethical Obligations of the Practicing Oncologist: A Debate Beverly Moy, MD, MPH Daniel Sulmasy, MD, PhD Reshma Jagsi, MD, DPhil

3 Outline Case Examples The rationale for change The Ethical Dilemma Oncologists duty to patients Oncologists as stewards of society s resources Payer s perspective Pharma s perspective My synthesis

4 Case 1: 32F with HER2+ breast cancer Patient is s/p lumpectomy/alnd Pathology: 2.5 cm grade 3 invasive ductal cancer with 6/10 positive lymph nodes ER-, HER2+ Staging scans: no metastatic disease Dilemma: In addition to adjuvant chemotherapy plus trastuzumab, should she also get pertuzumab? Cost of pertuzumab: ~$4,890-$6,000 per cycle Presented by: Beverly Moy, MD, MPH

5 Pertuzumab for early stage breast cancer September 30, 2013: FDA Accelerated approval as neoadjuvant therapy for HER2+ early stage breast cancer Based on improvement in pcr rate (TH 21.5% vs. THP 39.3%). 1 No data demonstrating improvement in OS or EFS No data available for efficacy in the adjuvant setting 1 Gianni L, et al. Lancet Oncol 2012 Presented by: Beverly Moy, MD, MPH

6 Presented by:

7 Case 2: Non-Small Cell Lung Cancer A 48-year-old man with a long history of tobacco use cough and right upper quadrant pain Non-small cell lung cancer with liver and bone metastases (PS=1) Standard first-line therapy for this patient is carboplatin and paclitaxel Predicted median PFS of 3 months, Median overall survival 8.2 months, Moderately well tolerated. Modified from a presentation by: Lowell Schnipper, M.D.

8 Case 2: Non-Small Cell Lung Cancer Regimen OS (mos) HR PFS (mos) Palliation Time to Next Data Treatment Reported Toxicity Carboplatin + Paclitaxel 8.2 ( ) 3.0 ( ) n/a n/a Grades 3-5: Anemia 7%; Infection-5%; Peripheral Neuropathy (Gr.3)-9%; Arthralgia/myalgia-8%; Astenia- 10%; Nausea/Vomiting-6%; Diarrhea-2%; Renal Toxicity (Gr.3)-1% Cisplatin + Pemetrexed (vs. CisGem control) 4.8 n/a n/a Grade3/4: Anemia-5.6%; Febrile neutropenia-1.3%; Alopecia (any grade)-11.9%; Nausea-7.2%; Vomiting-6.1%; Dehydration (any grade)-3.6%; Fatigue-6.7% Bevacizumab + paclitaxel + carboplatin (vs. Carbo Taxol control) 6.2 n/a n/a Grade 3: Febrile neutropenia-4%; Headache-3%; Rash/desquamation-2.3%; Epistaxis-0.7%; Hemoptysis- 0.5%; Melena/GI bleeding-0.7%; Other hemorrhage-0.2% Grade 4: CNS hemorrhage-0.7%; Hemoptysis-0.2%; Melena/GI bleeding-0.2%; Other hemorrhage-0.2% Grade 5: Febrile neutropenia-1.2%; Hematemesis-0.5%; Hemoptysis-1.2% Modified from a presentation by: Lowell Schnipper, M.D.

9 Cost of cancer care 2009 NIH estimates of overall annual costs: Total cost: $216.6 billion Direct medical costs (total of all health expenditures): $86.6 billion Indirect mortality costs: $130 billion Economists predict by 2018: 50% of the average US household income will be required to pay out-of-pocket expenses and health insurance premiums Cancer therapy is ~5-11% of total health care budget and is the most rapidly growing segment of health care American Cancer Society. Cancer Facts & Figures Atlanta, Ga Young RA. Ann Fam Med 2012 Presented by: Beverly Moy, MD, MPH

10 Household Income Why Are We Having This Discussion? Premium and out-ofpocket costs diverge Premium and out-of-pocket costs cross line of 50% family income Year Source: Annals of Family Medicine: March/April 2012, vol. 10 no. 2,

11 Definitions of Value Warren Buffet: Price is what you pay, value is what you get Michael Porter, Elizabeth Teisberg: outcomes relative to cost; also say creation of value for patient determines the rewards for all others Affordable Care Act: uses the term value 200 times but doesn t define NICE: Value is based on scientific value judgments, including clinical and economic evaluation and social value judgment, including efficiency and effectiveness Modified from a presentation by: Diane Blum MSW

12 Value Defined V = Benefit Cost Assessments of value and cost effectiveness depend on the PERSPECTIVE taken Survival, Progression QOL Avoidance of toxicity Biomarker Therapy received Therapy avoided Management of toxicity Indirect costs

13 Current State in the US Approval of drugs based on safety and efficacy Producer sets price for new innovations Payers can t negotiate price: reasonable and necessary standard Consumers Choosers Historical protection by insurance is eroding Where is value?

14 What is the ethical dilemma The current tension Professional norm: First and foremost responsibility of oncologist is to do what is best for our patients Norm is eroding in the face of the ever-increasing growth of health care costs Presented by:

15 Ethical dilemma: Duty to patient vs. society Professional norm Professional norm Vs. Duty to patient: Physicians should be able to interpret the evidence and treat their patients with what they believe is the best available therapy. Duty to society: Physicians, as financial and professional stewards, have an obligation to serve not only their individual patients, but also society. Presented by: Beverly Moy, MD, MPH

16 Duty to Patient Vigorously object to the notion that cost-containment is best accomplished at the bedside Practicing clinical medicine is not practicing public policy or economics Bedside medicine is about individual patients and not about populations Medicine is an art as well as a science Application of our scientific knowledge to the care of individual patients Presented by:

17 Bedside Rationing is morally problematic Financial incentives (to providers) threaten the integrity of medicine Undermines the trust of patients In absence of transparent rules, those decisions will be arbitrary and unjust to patients Presented by: : Daniel Sulmasy, MD, PhD

18 Duty to Patient Practicing medicine is different from selling shoes. None of us will wake up tomorrow suddenly in need of $100,000 worth of shoes Any of us could wake up tomorrow suddenly in need of $100,000 worth of health care The true value of health care is not measured in dollars, but in the priceless dignity of the persons medicine serves Presented by: Daniel Sulmasy, MD, PhD

19 Rationing: Not whether but how Resources are finite Allocation must occur Physicians owe it to society to help ensure that resources are allocated in a way that is congruent with broader moral intuitions, as well as to reduce waste to maximize the value of our interventions Presented by: Reshma Jagsi, MD, DPhil

20 The Oncologists duty to society Moral duty to the patient is paramount Uniquely privileged professional role Specialized knowledge and skills Education --publically funded medical and graduate medical Training with volunteer patients Experienced with patients in our day jobs Because of our uniquely privileged education, training and experience, we have an obligation to serve not only our individual patients but society more broadly Modified from presentation by: Reshma Jagsi, MD, DPhil

21 Physician Stewardship Physician stewardship of society s scarce resources best accomplished at the societal rather than individual level Although some decisions may be tragic choices that may be difficult for society to confront openly, physicians must call attention to general areas of waste & develop solutions to improve efficiency Physicians must lead the development of a robust evidence base for the assessment of value, including studies to identify situations of overdiagnosis and overtreatment in healthcare Modified from presentation by: Reshma Jagsi, MD, DPhil

22 Eliminating Waste The moral issues are simpler in situations where the interests of the individual patient and society are aligned Established as non-inferior by randomized trials Short courses of RT for palliation of bony metastases Omit RT in adjuvant treatment of early breast cancer >70 yo Continues ADT in prostate cancer etc. Embracing such approaches reduces Direct cost Improves patient-centered outcomes Convenience indirect cost Modified from presentation by: Reshma Jagsi, MD, DPhil

23 Consider antibiotic stewardship Most physicians feel comfortable declining to prescribe an antibiotic in situations where the patient is unlikely to benefit, out of a recognized need to forestall resistance (in keeping with their duty to society) Financial stewardship in the context of oncology care is an analogous concept Presented by: Reshma Jagsi, MD, DPhil

24 Choosing Wisely The ABIM Foundation s Choosing Wisely campaign: professional organizations identify practices that may represent inappropriate use of finite societal resources ASCO top five to improve the quality and value of cancer care: Example of physicians attempting to fulfil their duty to society while also respecting their duties to individual patients Condensed from presentation by: Reshma Jagsi, MD, DPhil

25 The Top 5: For patients with advanced solid-tumor cancers who are unlikely to benefit, do not provide unnecessary anticancer therapy, such as chemotherapy, but instead focus on symptom relief and palliative care. 2. Do not use PET, CT and radionuclide bone scans in the staging of early prostate cancer at low risk for metastasis. 3. Do not use PET, CT and radionuclide bone scans in the staging of early breast cancer at low risk for metastasis. 4. For individuals who have completed curative breast cancer treatment and have no physical symptoms of cancer recurrence, routine blood tests for biomarkers and advanced imaging tests should not be used to screen for cancer recurrences. 5. Avoid administering colony stimulating factors (CSFs) to patients undergoing chemotherapy who have less than a 20 percent risk for febrile neutropenia Condensed from a presenttion by: Reshma Jagsi, MD, DPhil

26 The Top 5: Do not give patients starting on a chemotherapy regimen that has a low or moderate risk of causing nausea and vomiting anti-emetic drugs intended for use with a regimen that has a high risk of causing nausea and vomiting. 2. Do not use combination chemotherapy (multiple drugs) instead of chemotherapy with one drug when treating an individual for metastatic breast cancer unless the patient needs a rapid response to relieve tumor-related symptoms. 3. Avoid using PET or PET-CT scanning as part of routine follow-up care to monitor for a cancer recurrence in asymptomatic patients who have finished initial treatment to eliminate the cancer unless there is high-level evidence that such imaging will change the outcome. 4. Do not perform PSA testing for prostate cancer screening in men with no symptoms of the disease when they are expected to live less than 10 years. 5. Do not use a targeted therapy intended for use against a specific genetic aberration unless a patient s tumor cells have a specific biomarker that predicts an effective response to the targeted therapy. Presented by: Reshma Jagsi, MD, DPhil

27 Using Value for Coverage Lee Nisley Newcomer, MD United Health Group Presented by:

28 Insurance Benefit Design Issues Benefits are not cancer specific Value based insurance design is hard to implement Site of service distorts value Presented by: Lee Newcomer

29 Value Based Insurance Barriers External source for measurement ASCO Value in Cancer Care Task Force Consumer literacy Benefit gradients where to draw the line No payment categories Presented by: Lee Newcomer

30 Choosing Wisely: No Payment? High intensity anti-emetics only for highly emetogenic regimens Single agent chemotherapy for metastatic breast cancer No PET surveillance post therapy No PSA testing for men with less than 10 years life expectancy No targeted therapy without predictive biomarker Presented by: Lee Newcomer

31 Site of Service: What Value? UnitedHealthcare average costs for chemotherapy Physician office: CMS + 22% Hospital owned facilities: CMS + 146% Presented by: Lee Newcomer

32 Industry Perspective: Drug Development, Costs, and Return on Investment Gregory P. Rossi, PhD Astrazeneca UK Presented by:

33 Value Creation and Remaining Unmet Need Value Creation Number of Deaths by Disease category 2 (per 100,000 US popn.) 2.9 year gain in life expectancy if diagnosed in 2000 compared with 1988 (modeling based on data from SEER) Intentional self-harm (suicide) Nephritis, nephrotic syndrome and nephrosis Influenza and pneumonia an additional 23 million life years gained; worth $1.9 trillion of social value Diabetes mellitus Alzheimer s disease Accidents (unintentional injuries) % of additional wealth appropriated by producers ; rest accruing to society (patients). NBER report - Philipson et al 2009 Cerebrovascular diseases Chronic lower respiratory diseases Malignant neoplasms Diseases of heart : NBER working paper #15574: An economic evaluation of the war on cancer, December : National Vital Statistics Reports Volume 61, Number 6 August 14 33

34 Success Rates in Pharma Drug Development are ~5% Driving Cost per NME to $3Bn Cumulative success rate (clinical) : 5.6% 18 molecules entered for every 1 approved) cohort Preclinical 63% Phase I 42% Phase II 24% Phase III 61% Filing 84% Launch Average Approvals/year during period Average Spend/NME during period ($Bn) Data from Pharmaceutical Benchmarking Forum 2013 report: KMR group August 14 34

35 Value of Survival Gains in Cancer Average costs and benefits calculated from a recent cohort of 17 Oncology products in approved in the US between 2011 and 1014 (n=17) 1 Median survival improvements (average): 2.81 months (95%CI: 1.77;3.84) Drug Cost (Course of Treatment) $140, $120, $100, $80, $60, $40, y = x R² = Episode of care (average new drug cost): $64,091 (95% CI: $51,247; $76,936) $20, $ OS improvement (months) 1: From IMS Innovation in cancer care and implications for health systems: Global oncology trend report (Data abstracted form Manufacturers Prescribing Information used for clinical data.. Treatment costs calculations based on ASP from CMS report accessed on 3/4/2014) 35

36 What is the Right Willingness To Pay Threshold? Inflation adjusted 1982 $50K standard (Ubel 2003:$121K) WHO approach [3 x per capita GNI] (WHO 2002; $113K 2013: $150K) Braithwaite et al 2008; $183K $264K 0 $50K/QALY $100K/QALY $150K/QALY $200K/QALY $400K/QALY NICE threshold ( 30K) Recent estimate for dialysis ICER (Lee et al 2008; $129K) Severity adjusted ICER proposal (Zenios, personal communication 2008; $200K) Oncologists WTP threshold (LYG) (Nadler et al 2007; $300K) US survey estimate for WTP/LYG Derived from Lin et al 2013 August 14 36

37 Cancer Drugs Represent a Small Total of US Healthcare Expenditure (<2%) 10.0% 9.0% 8.0% 7.0% 6.0% 5.0% 4.0% 3.0% 2.0% 1.0% 0.0% Cancer treatment spending (% of total health care expenditure) 1,2 6.0% 4.8% 4.5% 4.7% 4.7% 5.7% Total drug expenditure Clinic administered drugs Clinic administered antineoplastic Recent Changes in annual Drug Expenditure (US) vs vs * vs / / % -0.7% 0.4% $326Bn 5.7% 2.1% 5.3% $41.1Bn NR -0.4% 0.0% $12.6Bn Oncology pharmacy 3 NR NR NR NR: Not reported $27.9Bn (2010) 1: National Cancer Institute: Cancer trends progress report ( Data based on CMS: 2: Cancer Prevalence and Cost of Care Projections: 3: Medicine Use and Shifting Costs of Healthcare. Report by the IMS Institute for Healthcare Informatics, January : Schumock et al 2014 Am J. Health-System Pharm Vol 71 August 14 37

38 Can We Take as Dynamic an Approach To Pricing and Reimbursement As We Do To Fighting Cancer? Burden of illness and Complexity of Cancer Biology Reimbursement system complexity based on drug use and site of care Common Ground Maintaining R&D investment into new targets and health technologies in cancer Enhancing Value - Impact length and quality of cancer patient s lives Common Ground Maintaining reward for meaningful innovation Development of payment processes based on indication and clinical pathway adherence [.P4P?] Evolving insurance benefit design to protect patient financial risk August 14 38

39 ASCO s Value Initiative In spring 2013, ASCO Board of Directors engaged in a strategic discussion on value around the following statement: Increasingly, the desired care for oncology patients will be assessed on the VALUE of that care rather than the COST This is an opportune moment for ASCO to take the lead in defining VALUE and suggesting how VALUE should be integrated into treatment decisions Modified from a presentation by: Lowell Schnipper, M.D.

40 Case 2: Non-Small Cell Lung Cancer A 48-year-old man with a long history of tobacco use cough and right upper quadrant pain Non-small cell lung cancer with liver and bone metastases (PS=1) Standard first-line therapy for this patient is carboplatin and paclitaxel Predicted median PFS of 3 months, Median overall survival 8.2 months, Moderately well tolerated. Modified from a presentation by: Lowell Schnipper, M.D.

41 Case 2: Non-Small Cell Lung Cancer Clinical Benefit, Toxicity and Cost: Regimen Carboplatin + Paclitaxel OS (mos) 8.2 ( ) HR PFS (mos) 3.0 ( ) Palliation Data Time to Next Treatment Reported Toxicity n/a n/a Grades 3-5: Anemia 7%; Infection-5%; Peripheral Neuropathy (Gr.3)-9%; Arthralgia/myalgia-8%; Astenia-10%; Nausea/Vomiting-6%; Diarrhea-2%; Renal Toxicity (Gr.3)-1% Total Cost per Cycle $ Cisplatin + Pemetrexed (vs. CisGem control) 4.8 n/a n/a Grade3/4: Anemia-5.6%; Febrile neutropenia- 1.3%; Alopecia (any grade)-11.9%; Nausea- 7.2%; Vomiting-6.1%; Dehydration (any grade)-3.6%; Fatigue-6.7% $6, Bevacizumab + paclitaxel + carboplatin (vs. Carbo Taxol control) 6.2 n/a n/a Grade 3: Febrile neutropenia-4%; Headache- 3%; Rash/desquamation-2.3%; Epistaxis- 0.7%; Hemoptysis-0.5%; Melena/GI bleeding- 0.7%; Other hemorrhage-0.2% Grade 4: CNS hemorrhage-0.7%; Hemoptysis- 0.2%; Melena/GI bleeding-0.2%; Other hemorrhage-0.2% Grade 5: Febrile neutropenia-1.2%; Hematemesis-0.5%; Hemoptysis-1.2% $8, Modified from a presentation by: Lowell Schnipper, M.D.

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43 Useful aphorisms If something cannot go on forever, it will stop. (Herbert Stein, c 1984) Always do right. This will gratify some people & astonish the rest. (Samuel Clemmons, 1901) With personalized medicine, every tumor will be an orphan disease.

44 My synthesis (1) We are on a burning platform We need to lead change, or else others will do it for us Bedside rationing is unacceptable Providing Cancer Care is very different than selling shoes We are not selling the shoes We are advising patients how best to solve their problem Protecting their feet in a high quality method which meets their needs and goals

45 My synthesis (2) Reduce waste Lean methods have been applied to processes of care, but not widely applied to the design of care We can be stewards of precious resources, but in a transparent manner Antibiotics and antibiotic resistance Blood, organ donations Guidelines, Pathways Choosing Wisely can provide air cover ASCO s programs can help Annual Meeting presentations included direct cost estimates QOPI and eqopi CancerLinQ Value of cancer care

46 My synthesis (3) We must advocate and protect innovation Safe and effective Safe, about as effective, and cheaper(?) e.g. Orteronel cohort Preclini cal 63% Phase Phase Phase I Filing II III 42% 84% Laun 24% 61% ch Engage with payers in new payment models

47 Useful aphorisms If something cannot go on forever, it will stop. (Herbert Stein, c 1984) Always do right. This will gratify some people & astonish the rest. (Samuel Clemmons, 1901) With personalized medicine, every tumor will be an orphan disease.