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Proton Therapy and the Risks of Irrational Exuberance David Shepard AAMD Annual Meeting - Seattle June 1, 2014 Acknowledgments • • • • • • Thomas Bortfeld Martijn Engelsman Alexei Trofimov Lei Dong Daniel Ollendorf Daniel Lessler 4/22/14 Questions • Is this rapid growth based on good fundamentals or irrational exuberance? • What does the future hold for proton therapy? • Is the proton bubble about to burst? “I’m fascinated and horrified by the way it’s developing. This is the dark side of American medicine.” Anthony Zietman – Endowed professor of radiation oncology @ Harvard, Editor of the Red Journal, Chair and Past President of ASTRO NYT – 12/26/07 “Proton-beam therapy is like the death star of American medical technology; nothing so big and complicated has ever been confronted by the system. It’s a metaphor for all the problems that we have in American medicine.” Amitabh Chandra – Health Economist – John F. Kennedy School of Government @ Harvard Business Week 3/26/12 Key Questions 1. Are protons better dosimetrically? 2. Are protons better clinically? 3. What are the financial implications? Key Questions 1. Are protons better dosimetrically? 2. Are protons better clinically? 3. What are the financial implications? GoodThe News is that good newsprotons is that stop. protons stop. The bad news is that we often do not know exactly where they will stop. Proton dose distributions are highly sensitive to changes in anatomy or tissue densities such as bowel filling or a clogged up sinus. Courtesy of Martijn Engelsman Proton Uncertainties Proton beams are much more sensitive to • • • • Anatomy changes in the beam path Organ Motion CT number accuracy Treatment devices in the beam path Issues 1: Range uncertainties due to setup Jan 08 Chen, Rosenthal, et al., IJROBP 48(3):339, 2000 Courtesy of Thomas Bortfeld Issues 1: Range uncertainties due to setup Jan 11 Chen, Rosenthal, et al., IJROBP 48(3):339, 2000 Courtesy of Thomas Bortfeld Distal Variations Due to Femur Rotation Alexei Trofimov and Lei Dong Photon IMRT Protons “To minimize the effects of the range uncertainties, prostate patients are typically irradiated using opposed lateral proton beams which generally forces at least a portion of the dose limiting anterior rectal wall into the high dose region.” Alexei Trofimov Issues 2: Range effects of breathing, 4D CT exhale inhale 95% 95% Engelsman et al., IJROBP 64(5):1589-1595, 2006 Courtesy of Thomas Bortfeld Tumor Shrinkage Initial Planning CT GTV 115 cc 5 weeks later GTV 39 cc S. Mori, G. Chen Courtesy of Thomas Bortfeld Tumor shrinkage results in proton overshoot Planning CT (T40%) Beam stops at distal edge CT after 5 weeks (T40%) Beam overshoot S. Mori, G. Chen Courtesy of Thomas Bortfeld Spherical tumor in lung The “static dose cloud” approximation Paralell opposed photons Single field photons Single field protons Displayed isodose levels: 50%, 80%, 95% and 100% Courtesy of Thomas Bortfeld Spherical tumor in lung The “static dose cloud” approximation Paralell opposed photons Single field photons Single field protons Displayed isodose levels: 50%, 80%, 95% and 100% Courtesy of Thomas Bortfeld Spherical tumor in lung The “static dose cloud” approximation Paralell opposed photons Single field photons Single field protons Displayed isodose levels: 50%, 80%, 95% and 100% Courtesy of Thomas Bortfeld CT artifacts High-density streak artifacts Density override Contrast / Onyx glue Multiple CT-scans Density override Proton Reality Check • • • Protons plans are kept simple using 1, 2, or 3 fields. Patient alignment with proton therapy is typically achieved using orthogonal 2D images rather than IGRT despite the fact that proton treatments are much more sensitive to organ motion. While there is great interest in pencil beam scanning, the actual utilization of pencil beam scanning and IMPT is quite low. Are protons better dosimetrically? • • • In many cases, the answer is NO. Because proton plans are highly sensitive to organ motion, changes in anatomy, and errors in CT number accuracy, the quality of the delivered dose distribution can be seriously compromised. Using photons makes it possible to use tighter margins and take advantage of techniques such as intensity modulation, VMAT, and IGRT. Key Questions 1. Are protons better dosimetrically? 2. Are protons better clinically? 3. What are the financial implications? History of Proton Therapy • Proton treatments were first delivered in the 1950s. • First hospital based program in the U.S. was built in 1990 in Loma Linda, CA. • Despite the fact that over 100,000 patients have been treated with proton therapy, there is very little clinical evidence to support their use. “The evidence that proton therapy has helped any cancer patient either live longer or with a better quality of life, in comparison with 3D-CRT, is almost nonexistent. Furthermore, there is substantial risk that the outcome may be worse after proton therapy.” Bhadrasain Vikram, MD - Chief of the Clinical Radiation Oncology Branch at the NCI Perils of Proton Therapy - 2009 “There is no solid clinical evidence to date that protons are better. If you are going to spend a lot more money, you want to make sure the patient can detect an improvement, not just a theoretical improvement.” Dr. Theodore Lawrence – Chairman of Radiation Oncology @ University of Michigan, ASTRO Gold Medal Winner, and ASTRO past president NYT – 12/26/07 “Statements about their superiority are just unjustified. They are unsupportable. The bottom line is that it hasn’t been proven to be better.” W. Robert Lee – Professor of Radiation Oncology @ Duke University Medical School, Editor of Practical Radiation Oncology (PRO) Business Week – 3/26/12 Proton Beam Therapy An Assessment of Comparative Clinical Effectiveness & Comparative Value Presented to the Washington State Health Care Authority by Daniel A. Ollendorf, MPH May 16, 2014 Condition Cancer Bone Brain/spinal Breast Esophageal GI Gynecologic Head/neck Liver Lung Lymphomas Ocular Pediatric Prostate Sarcomas Seminoma Thymoma Noncancerous AVMs Hemangiomas Other Incidence (per 100,000) Net Health Benefit vs. Comparators Type of Net Health Benefit Strength of Evidence Guideline Recommendations Coverage Policies 1.3 9.6 97.7 7.5 100.6 38.2 17.2 12.8 95.0 32.9 1.2 9.1 99.4 4.8 4.0 0.2 Insufficient Incremental Insufficient Insufficient Insufficient Insufficient Insufficient Comparable Comparable Insufficient Superior Incremental Comparable Insufficient Insufficient Insufficient --B: = H: ↓ ----------B: = H: = B: = H: = --B: ↑ H: ↓ B: = H: ↓ B: = H: = ------- + + o o o o + + ++ o ++ o* ++ o o o M U NM NM NM NM NM NM M NR/NC U U M NM NM NM M U NR/NC NR/NC NR/NC NR/NC M M M NR/NC U U M M NM NM 1.0 2.0 2.0 Insufficient Comparable Insufficient --B: = H: = --- o + o NM NM NM M NM M *Rating based on widespread acceptance rather than evidence base B: Benefits; H: Harms Strength of Evidence: Low=+; Moderate=++; High=+++; No evidence=o Legend: U=Universally recommended or covered; M=Mixed recommendations or coverage policies; NM=Not mentioned in guidelines or coverage policies; NR/NC=Not recommended or not covered 33 Summary & Conclusions Comparative evidence generated to date for PBT is sparse and of generally lower quality: > Moderate evidence of superior net health benefit only available for ocular cancers > Judgment of incremental benefit for brain and spinal tumors, but with low strength of evidence > Acceptance of PBT for pediatric cancers based on assumption of benefit from dosimetry and simulation, not clinical study > Even situations with evidence suggesting “comparable” performance to alternatives (liver, lung, and prostate cancer, hemangiomas), strength of evidence was low or moderate Ongoing RCTs and registries will provide opportunity to revisit evidence base as it emerges 34 Key Questions 1. Is it better dosimetrically? 2. Is it better clinically? 3. What are the financial implications? Costs of a Proton Center • • • • • Mayo Clinic - $370 million for 2 (MN & AZ) Scripps Health - $220 million (San Diego) MSKCC - $250 million (NYC) Hampton University - $225 million (Virginia) Univ. Maryland - $200 million (Baltimore) The operational costs of a proton therapy are also very high due to the substantial number of clinical and technical staff needed as well as the specialized staff for maintaining the particle accelerator. Who is paying for all of these new proton centers? Forbes Magazine: “Most of the $1.5 billion that has been sunk into or committed to building proton therapy centers has come from investors hoping to make a profit.” Forbes – 3/25/09 Forbes Magazine article featuring ProCure CEO Hadley Ford: “A fully operational proton center with four treatment rooms running 6 days a week, 16 hours a day - a typical usage - can dispense 40,000 treatments a year, generating $50 million in revenue and $18 million in pretax profits, says Ford. Ford aims to deliver a 15% to 20% annual return for his equity investors, more or less what they could get on a leveraged buyout pool, if not for the recession.” Forbes – 3/25/09 “One hazard of procuring third party investors, however, is that the business plans and pro form analyses generated by these parties may appear highly attractive at first glance but create outsized expectations. Institutions attempting to fulfill these expectations may struggle with balancing the need to generate revenue with the imperative to use proton therapy only when clinicians deem it appropriate” The Advisory Board The Path to Economic Viability • • • High patient volumes (> 100 per day). High patient throughput. High reimbursement rates. Economics of Proton Therapy • • • The per fraction reimbursement for protons is currently 60% higher than the reimbursement for IMRT. The cost per vault, however, is approximately a factor of 10 higher for the big-box solutions. Typically, profitability requires extended treatment days and high work loads on each gantry. Journal of the American College of Radiology, August 2012 • Financial analysis showed that a 4 room proton therapy clinic focusing on complex and pediatric cases would not have enough time slots to cover even 60% of their debt service. • “Debt service for a modern proton center requires a considerable number of simple or prostate cancer cases… centers without considerable workload devoted to these patients should not be expected to survive.” “Radiation oncologists have gotten themselves into a trap. They’ve built very expensive centers, and the only way they can recoup the costs is to treat lots of prostate cancers. A lot of men are going to be channeled into proton therapy, not necessarily to their advantage at a very great cost.” Anthony Zietman – Endowed professor of radiation oncology @ Harvard, Editor of the Red Journal, Chair and Past President of ASTRO Business Week – 3/26/12 “There is definitely pressure from a few of the investors to treat only prostate cancer.” Dr. Jim Cox – Division Head, Dept. of Radiation Oncology MD Anderson, Former Editor of the Red Journal “I’ve got people breathing down my neck who want to make money on this place. Dr. Allan Thorton – Medical Director @ the Midwest Proton Radiotherapy Institute US News – 4/16/08 Proton Center Reality Check • Many proton therapy centers are struggling to meet their projected patient volumes. • As more centers come on line fewer patients are taking a “radiation vacation”. Crain’s Chicago Business – 7/11/13 Proton Therapy Reimbursement • Proton reimbursement has a very uncertain future. • In many cases insurers are putting in place very significant restrictions on what cases they will reimburse. LA Times – 8/29/13 “Washington State and other payers face an unenviable choice: pay for an expensive therapy that has not been shown to be better than less expensive alternatives for prevalent malignancies or restrict coverage to rare tumors in which clinical benefit appears compelling. We propose a better way forward: reference pricing with evidence development.” “Reference pricing establishes a common level of payment for different therapies with similar outcomes. Under reference pricing, payers pay a set price for whichever therapy is selected from various alternatives. For proton therapy, the reference price should be set at the rate currently paid for IMRT. Patients should have no additional out-of-pocket expenses, and providers should be paid the same irrespective of treatment type.” Proton therapy centers are choosing this: In order to avoid this: Financial Concerns & Risks (1) • • • Budgets are highly sensitive to patient volumes. Many proton therapy centers have fallen well short of their projected patient volumes. This is due in part to poorer than expected throughput and difficulty in attracting patients regionally and nationally. Financial Concerns & Risks (2) • • Institutions risk cannibalizing their existing their existing radiation therapy business Changes in reimbursement are highly likely: CMS and private insurers may limit payment to only those indications where proton therapy has demonstrated superiority Capitation vs. fee-for-service Summary • • Current clinical evidence does not justify the conclusion that proton therapy will supplant photon radiation therapy and current enthusiasm for proton therapy is well ahead of the research. We need to reign in our irrational exuberance and take a more measured approach to the use of protons in radiation therapy. Photo credit goes here. ©2014 Photographer Name FOOTER 60