Optimizing Adoption of Advanced Technology to Achieve High Value Cancer Care: The Case of Proton Therapy ECRI NCI Conference November 17, 2015

Transcription

1 Optimizing Adoption of Advanced Technology to Achieve High Value Cancer Care: The Case of Proton Therapy ECRI NCI Conference November 17, 2015 Justin E. Bekelman, MD Associate Professor, Radiation Oncology and Medical Ethics & Health Policy Faculty, Center for Health Incentives and Behavioral Economics (CHIBE)

2 Adoption of Advanced Radiotherapy Technology: Rapid Proportion of Patients Treated Substitution of IMRT for 3DCRT In Prostate Cancer 100% 80% 60% 40% 20% 0% Intensity-Modulated Radiotherapy 3D Conformal Radiotherapy Adoption of Brachytherapy In Breast Cancer Source: SEER Medicare analyses: Yeboa DN (2009); Smith GL (2010), Nyugen P (2011)

3 Increasing Effectiveness The Intervention Ladder 8. Eliminate choice 7. Restrict choice 6. Guide choice through disincentives 5. Guide choice through incentives 4. Guide choice through changing the default 3. Enable Choice 2. Provide Information 1. Do nothing or monitor Decreasing Choice Source: The Intervention Ladder. Nuffield Council on Bioethics. Public Health: Ethical Issues Cambridge Publishers. p. 41

4 The Intervention Ladder 8. Eliminate choice Increasing Effectiveness 7. Restrict choice 6. Guide choice through disincentives 5. Guide choice through incentives 4. Guide choice through changing the default 3. Enable Choice 2. Provide Information 1. Do nothing or monitor Decreasing Choice Proton Therapy Distinguished by the immense capital investment to develop centers Source: The Intervention Ladder. Nuffield Council on Bioethics. Public Health: Ethical Issues Cambridge Publishers. p. 41

5 Proton Therapy: Evidence Generation Randomized trial (RCT) Prostate Breast Lung PARTIQOL RCT RADCOMP Pragmatic RCT RTOG 1308 RCT Funder Primary endpoint Patient reported bowel fxn Major CV events and relapse Survival Patient centric? Payer centric? Timeline > 5 years > 10 years > 5 years

6 The Key Issues: Breast Cancer Radiotherapy plays a major, curative role in the treatment of patients with breast cancer. Because of incidental radiation to the heart, radiotherapy carries increased risks of cardiovascular morbidity and mortality The real world effectiveness of proton therapy vs. photon therapy is unknown. Prior studies have been small, non randomized with short follow up. Only a large, prospective pragmatic randomized trial in patients requiring comprehensive radiation can answer this question. RADCOMP CONSORTIUM 6

7 RADCOMP Trial: Schema S T R A T I F Y Age (<65 vs 65) Cardiovascular risk (0-2 vs > 2 risk factors) Surgery (mastectomy vs lumpectomy) Laterality (right versus left) R A N D O M I Z E Both arms: Breast/chest wall and nodal radiation with internal mammary node treatment Arm 1: Photon Therapy* Arm 2: Proton Therapy* *Pragmatic dose specification: 45.0 Gy(RBE) to 50.4 Gy(RBE) in 1.8 to 2.0 Gy(RBE) fractions with or without a tumor bed boost RADCOMP CONSORTIUM 7

8 RADCOMP Trial: Essential Features Patient-centered, Pragmatic: Patients and patient advocates involved in design and conduct of study, highly pragmatic orientation Randomization: Randomization to proton beam therapy versus photon-based treatment is an defining element of the study. Important Outcomes: Primary superiority outcome is major cardiovascular events. Primary noninferiority outcome is local-regional recurrence Large, simple trial approaches: Passive and Active follow-up techniques using short CRFs and direct patient reported surveys. Radiorepository: Differences in effects mediated by differences in radiation dose. Suitable for range of studies across research spectrum. RADCOMP CONSORTIUM 8

9 RADCOMP Trial: Participating Sites 1 MGH-Massachusetts General Hospital (Boston, MA) 2. MDACC-University of Texas MD Anderson (Houston, TX) 3. UF-University of Florida 4. OKC-Oklahoma City Procure (Oklahoma City, OK) 5. PENN-University of Pennsylvania (Philadelphia, PA) 6. CH-Chicago/Cadence Health (Chicago, IL) 7. NJ Proton/NY Proton Consortium (Somerset, NJ) 8. UW-University of Washington (Seattle, WA) 9. WUSTL-Washington University (St. Louis, MO) 10. PROV-Provision (Knoxville, TN) 11. SCRIPPS (La Jolla, CA) 12. WK-Willis Knighton (Shreveport, LA) 13. CINJ-Cancer Institute of New Jersey (NewBrunswick, NJ) 14. MAYO Clinic (Rochester, MN) 15. UM-University of Maryland (Baltimore, MD) 16. UH-Case-Western (Cleveland, OH) 17. MCL-McLaren Proton Therapy (Flint, MI) 18. MAYO Clinic (Phoenix, AZ) 19. EU-Emory University (Atlanta, GA) 20. WB-William Beaumont (Royal Oak, MI) 20. HOPK-Johns Hopkins (Washington D.C.) 22. UTSW-UT Southwestern (Dallas, Tx) 23. TCPT Texas Center for Proton Therapy (Dallas, Tx) RADCOMP CONSORTIUM *Other sites pending 9

10 Who should pay for proton treatment during evidence generation? Federal government (taxpayers) Radiation device industry Medicare Commercial payers Providers Patients

11 Opportunity for Radiation Device Industry to Invest in Evidence Generation R&D Spend of Leading Companies as Proportion of Sales Varian: 6 7% Elekta: 8 9% IBA: 10 11% Accuray: 15 22% Source: Lin J (2010); Businesswire (2012); ycharts.com (2012)

12 Opportunity for Payers to Invest in Evidence Generation Medicare covers proton therapy Many commercial payers have restrictive policies Evocative of bone marrow transplant for breast cancer Some payers particularly interested in PCORIfunded or NCI Phase III trials Others considering providing access to proton responsibly outside of CED

13 Opportunity for Providers to Invest in Evidence Generation Common level of payment for different therapies; reset payment with evidence of value Preserves access, reduces financial barrier to evidence development Links to evidence generation to reimbursement Is a discount and may be under costs for delivery of proton therapy

14 Summary Evidence generation for proton therapy requires the will and partnership of patients, providers, payers, and funders If not now, when?