Health Policy

Commentary

Choosing Wisely: Where’s the Beef? By Derek Raghavan, MD, PhD, FACP, FRACP, FASCO Levine Cancer Institute, Charlotte, NC See accompanying article on page 322

Copyright © 2015 by American Society of Clinical Oncology

J U L Y 2015

work of this committee is now being incorporated into our novel system of Cancer Management Pathways, an intranet accessible set of management dicta that have been formulated by tumor-specific teams based on the best available level 1 or level 2 data. However, the real conundrum is how to “sell” this new era of cost containment to the population at large. This will, in part, be facilitated by community concern when faced with rising costs for health care and health insurance and a concomitant desire to reduce these costs. However, learning from the experience in Oregon some years ago,6,7 when a rational approach to cost containment in health care was politicized and framed as “rationing” of treatment, it will be important for responsible clinicians and their representative societies to frame cost containment carefully and specifically—viz avoidance of unnecessary cost—with an increased focus on value, and little or no loss of safety/efficacy for the patient. This is actually a difficult task, as there is remarkably scanty structured information available in the oncology space that allows true benchmarking of value versus cost. Managers of health expenditure and the leaders of the pharmaceutical industry are anxiously awaiting (some with significant trepidation) the public distribution of the work product of the ASCO Value Task Force,8 which has attempted to structure a rational value algorithm. Exercises of this type will be crucial to allow those of us on the front lines of health care to produce valuable and valuedriven products that serve the needs of the community. Part of our responsibility will be to refocus our expression of the value algorithm so that the community can receive transparent and accurate information on what they gain for a specific expenditure of personal and fiscal resources. I continue to be concerned at our industry’s confusion about the difference between clinical relevance and statistical significance. Although this is not a new concern, I continue to be surprised at reports, particularly from the domains of treatment for some of the resistant tumors, such as pancreatic cancer,9,10 that continue to herald with great gusto the impact of novel agents that improve median survival or progression-free survival by a matter of weeks. This simply sets false expectations from the community at large and eventually leads to substantial expenditure by the community without great value for most patients. Those who would challenge this blunt assertion should be prepared to defend a set of survival curves with overall long-term survival of substantially less than 10% (hardly better than when I was a fellow) stage for stage. •

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The article by Reddy et al1 is a harbinger of things to come, and I congratulate them on the presence of mind to initiate their work early and in response to the rising need for optimal cost containment strategies. They noted a near doubling of cost when comparing denosumab with zoledronic acid in 2011,2 and this price differential increased when generic zoledronic acid became available. In addition, they cite unclear levels of benefit and potentially increased toxicity associated with denosumab. Reddy et al indicated that the Dana Farber Center for Drug Policy has set guidelines for the use of denosumab, and consequently reduced its prescribing by approximately 90%, leading to a cost avoidance of approximately $565,000 in 2012, with a greater differential after the introduction of generic zoledronic acid. This is meritorious work, and my only concern is that the savings are modest, and I am not sure that a single, one-line cost-saving exercise without a great deal of objectively gathered data necessarily befits a full peer-reviewed manuscript in a journal with a significant citation index. I suppose that one of the benefits of working in a relatively novel space is the ability to publish by crossing a lower editorial threshold than for established domains. This does not, in any way, detract from the fact that Reddy et al1 are doing important work that must be replicated nationally. Their emphasis is on rational restriction and control in the domain of therapeutics, which I applaud unreservedly. In parallel, ASCO has issued two sets of recommendations with a broader span, including diagnostic and therapeutic cost containment.3,4 These recommendations focus predominantly on avoiding the use of repeated diagnostic tests that do not influence treatment outcome, and on restricting the inappropriate use of aggressive and/or expensive treatments that are unlikely to improve survival or quality of life. The bracketing of these two major arms of clinical practice will allow even greater cost savings. At the Levine Cancer Institute, as part of our approach to value-driven cancer care,5 we have established an Oncology Pharmaceutical Oversight Committee, constituted of oncologists, oncology pharmacists, an ethicist, an expert in pharmacoeconomics and a biostatistician, which is charged with vigilance in the domain of cost-effective and safe use of oncology and related products. We have established an approach to prioritization that favors curative treatment or the delivery of sustained palliation or remission, and which balances toxicity and cost for equi-active agents or regimens. In our 17-site electronically integrated cancer institute, the

We should all begin to prepare ourselves and our patients for the reality of a diminishing budget for health care, and a good place to begin is by reporting our data transparently, minimizing hype and false claims, and focusing on real value so that the average member of the lay community can make good decisions relating to value, expenditure, and outcome. Author’s Disclosures of Potential Conflicts of Interest Disclosures provided by the authors are available with this article at jop.ascopubs.org.

DOI: 10.1200/JOP.2015.004663; published online ahead of print at jop.ascopubs.org on June 2, 2015.

References 1. Reddy P, Glouin GC, Yeh Y-C, et al: Choosing treatments on the basis of cost: Can clinicians opt for less expensive treatments? J Oncol Pract 11:322-324, 2015

6. Floyd EJ: Healthcare reform through rationing. J Healthc Manag, 48:233-241, 2003

2. Snedcor SJ, Carter JA, Kaura S, et al: Cost-effectiveness of denosumab versus zoledronic acid in in the management of skeletal metastases secondary to breast cancer. Clin Ther 34:1334-1349, 2012

7. Oberlander J, Marmor T, Jacobs L: Rationing medical care: Rhetoric and reality in the Oregon Health Plan. CMAJ 164:1583-1587, 2001

3. Schnipper LE, Smith TJ, Raghavan D, et al: American Society of Clinical Oncology identifies five key opportunities to improve clinical care and reduce costs: The top five list for oncology. J Clin Oncol 30:1715-1725, 2012 4. Schnipper LE, Lyman GH, Blayney DW, et al: American Society of Clinical Oncology 2013 top five list in oncology. J Clin Oncol 31:4362-4370, 2013 5. Raghavan D: Costs of cancer care: Rhetoric, value and steps forward. Semin Oncol 40:659-661, 2013

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8. Schnipper LE, Davidson NE, Wollins DS, et al: American Society of Clinical Oncology Statement: A framework to assess the value of cancer treatment options. J Clin Oncol doi: 10.1200/JCO.2015.61.6706 9. Von Hoff DD, Ervin T, Arena FP, et al: Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med, 369:1691-1703, 2013 10. Trouilloud I, Dupont-Gossard AC, Malka D, et al: Fixed-dose rate gemcitabine alone or alternating with FOLFIRI.2 (irinotecan, leucovorin and fluorouracil) in the first-line treatment of patients with metastatic pancreatic adenocarcinoma: An AGEO randomized phase II study (FIRGEM). Eur J Cancer 50:3116-124, 2014

V O L . 11, I S S U E 4

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Corresponding author: Derek Raghavan, MD, Levine Cancer Institute, 1021 Morehead Medical Plaza, Ste 3001, Charlotte, NC 28204; e-mail: [email protected].

Derek Raghavan is the Founding President of the Levine Cancer Institute, Charlotte, NC, and was formerly Director and Distinguished Chair of the Cleveland Clinic Taussig Cancer Institute, Cleveland, and Chair of Medical Oncology and Associate Director for Clinical Research of the USC Norris Comprehensive Cancer Center, Los Angeles. His research focuses on genitourinary oncology, preclinical models of novel anticancer agents, and geriatric oncology, and he also is developing clinical paradigms to improve the value proposition in delivery of cancer care.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST Choosing Wisely: Where’s the Beef? The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated. Relationships are self-held unless noted. I ⫽ Immediate Family Member, Inst ⫽ My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or jop.ascopubs.org/site/misc/ifc.xhtml.

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Derek Raghavan Consulting or Advisory Role: Sanofi, Gerson Lehrman Group, Astellas Travel, Accommodations, Expenses: Sanofi



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Choosing Wisely: Where's the Beef?

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