Value Tools at ASCO 2016: Building a Framework for Prime Time
By Lynne Lederman, PhD
The official theme of this year’s American Society of Clinical Oncology (ASCO) Annual Meeting was Collective Wisdom: The Future of Patient-Centered Care and Research; however, as it did last year, “value” emerged as a major topic of discussion and was the focus of a presentation during the Plenary Session.1
Value frameworks in oncology were discussed with Jon Roffman, Managing Principal, ZS Associates, a global firm focused on improving business performance, and oncologists Lee S. Schwartzberg MD, Clinical Professor of Medicine and Chief of the Division of Hematology and Oncology, University of Tennessee College of Medicine, Memphis, TN, Douglas Blayney, MD, Professor of Medicine, Stanford University Medical Center, Stanford, CA, and Debra Patt, MD, MPH, MBA, Vice President, Texas Oncology, Austin, TX, and Medical Director, US Oncology Network.
We report here on those discussions, as well as the results of a value survey conducted during and after ASCO by ZS in collaboration with WebMD that was completed by 93 medical or hematologic oncologists who practice in community or academic settings.
Most of the oncologists surveyed are somewhat (69%) or highly (16%) aware of value frameworks in oncology; about half say their clinical decisions are influenced by frameworks, and about half say value frameworks are not being considered at their practice.
Few reported that value frameworks were included in their electronic medical records (EMR). The 11% with value frameworks in their EMR are directed to value-driven decision making, so the majority of oncologists do not have this type of driver toward the use of value frameworks.
About one-fifth of survey responders consider value frameworks only as a reference to provide some guidance on cost, so taken together with those who do not consider value frameworks in any capacity, the majority of oncologists are not using value frameworks at all, despite increasing attention to them.
Which value frameworks are being considered?
In her plenary talk, Deborah Schrag, MD, MPH, Harvard Medical School, Dana-Farber Cancer Institute, Boston, MA, compared the core questions asked by 5 value frameworks that are currently available. These included the:
- ASCO value framework, which asks what is the clinical benefit, using a scoring algorithm for clinical benefit, toxicity, tail of the survival curve, palliation, quality of life, and treatment-free interval, for a net health benefit score to be considered in relation to cost2
- The National Comprehensive Cancer Network (NCCN) Evidence Blocks, which ask how expert clinicians rate a treatment’s value, taking into account efficacy, safety, the quality and quantity of evidence, consistency of evidence, and affordability. These are currently available for only for selected tumor types, although more are in development3
- The Institute for Clinical and Economic Review (ICER) value assessment framework asks what is the societal value of a therapeutic regimen4
- The DrugAbacus, developed at Memorial Sloan Kettering Cancer Center, asks what is the right price for a cancer drug5
- The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS), which asks what is the clinical value in relation to cost, and includes evaluation forms for therapies that are potentially curative as well as for those that are not likely to be curative6
Of these value frameworks, the ASCO value framework was the one most commonly considered for use by survey respondents, followed by the NCCN Evidence Blocks, excluding those who answered “I don’t know” (Figure 1).
Figure 1. The most commonly considered framework is the ASCO Value Framework.
The results of this survey suggest that the lack of consensus on a single value framework has probably hindered adoption. About one-fifth of oncologists are left to choose some kind of value framework to use in decision making.
Many oncologists say that they make decisions based on value, for example by choosing the least expensive drug among those with comparable efficacy. Whether this takes into account other components of value, is not clear.
There is a lack of agreement on the definition of what constitutes a value framework, as can be seen by the very different key questions that the 5 value frameworks listed try to answer.
Like Dr. Schrag, Dr. Blayney is a co-author of the ASCO value framework, which is now in its second iteration. He said that one of the first things the ASCO Value Task Force did was “articulate that it’s okay for doctors to talk to patients about the cost of care.” He noted that physicians are not trained to talk about the cost of treatment with patients who are facing a serious illness.
Dr. Schwartzberg, a member of the NCCN board of directors, said that the value frameworks being developed, although not perfect, are a “good first attempt to bring some rigor into the analysis of what value is.”
At his institution, NCCN treatment guidelines are used to guide treatment decisions, which are based first on efficacy, then on toxicity, and finally on cost.
Cost is a difficult entity to quantify, as cost can include the price of the drug and its administration, time in treatment, toxicities, quality of life, and potentially avoidable hospitalizations.
For some types of cancer, the treatment options are well defined. For others, the value framework may provide a guide, but the physician has to determine what is best for the patient e.g., after failure of multiple lines of treatment or where there is no good evidence.
Although clinical pathways play a small role for survey respondents, Dr. Blayney thinks pathways will be playing a larger role in the future. Then, rather than develop a regimen for each patient, physicians would have more time to discuss the specific side effects, benefits, and associated costs of the predetermined regimens with patients.
In contrast, Dr. Schwartzberg said, “It’s ironic in this era of personized medicine that we have formulas [guidelines] to treat people.” Pathways, formulas, or guidelines suggest an approach that is more one-size-fits-most than personalized treatment. Developing a specific approach for each patient can be expected to add to the cost of treatment. Only slightly more respondents are using clinical pathways rather than a patient-centered model as their value framework.
The lack of agreement on the definition of value framework presents a major challenge to adoption of value frameworks in oncology. Assuming that a consensus could be reached, it is difficult to imagine that all practices in all settings would agree to adopt a single value framework.
When will value frameworks be adopted?
The 46% of survey respondents who were not using value frameworks to influence their decision making gave a variety of reasons for why this was the case (Figure 2).
Figure 2. Physicians may choose not to adopt value frameworks until they are mandated by payers or their institution.
The top reason why value frameworks are not influencing prescribing decisions, according to respondents, is that value frameworks are not mandated either by their institution or by payers. Other reasons included that it is too early to adopt value frameworks or that they are too complicated.
Although cost is being brought more frequently into the conversation about clinical decision making, 11% of respondents said they “don’t worry about cost” when making prescribing decisions
Opinions differ on where value frameworks are being used today and where they will be used in the future. For example, Dr. Schwartzberg thinks that value frameworks are currently used more in academic settings than in community practices. He expects value will drive the way patients will be treated in the “very near future.”
Dr. Patt thinks that many academic centers have not incorporated value frameworks into their decision making, possibly because historically they were never discussed. However, academic institutions may eventually follow the lead of institutions like Memorial Sloan Kettering, where there are specific individuals leading value discussions and actively championing their DrugAbacus.
Where Dr. Patt practices, value frameworks are not routinely used to make value determinations. At Texas Oncology, they weigh value when making a decision about including a regimen in their Level 1 value pathways, which must be consistent with NCCN guidelines. Their value assessments include the same key components that formal value frameworks do, namely efficacy, toxicity, and cost.
Dr. Schwartzberg’s practice is enrolled in the Centers for Medicare and Medicaid Services (CMS) Oncology Care Model (OCM) pilot program.7 OCM is a new payment delivery system that links payments to quality of care, improvement in care delivery, and sharing information to support better decision making.
It will be several years before it’s known how effective the OCM payment system worked. Dr. Patt suggested that the interest CMS has in value-based prescribing may promote collaboration among organizations developing value frameworks independently, such as ASCO and NCCN.
Some critics of the OCM believe that it could cost practices money rather than result in savings because drugs are a major component of cost, cost continues to rise, and personalized approaches with targeted therapies, in particular, come at a high cost. In addition, as currently formulated, participation in the OCM is impossible for solo practitioners and difficult, at best, for small and even larger practices. Rather than drive care in community practices, mandatory participation in this model could result in further consolidation of practices.
Is there a role for manufacturers?
Physicians are divided in their thoughts about the role of manufacturers in value frameworks, with just about half seeing a role (Figure 3).
Figure 3. Physicians are split in their belief of whether or not manufacturers have a role in value frameworks.
Development of most value frameworks, including those from ASCO and NCCN, has not included input from manufacturers. Cost-effectiveness is incorporated into US Oncology’s value assessment framework and pathways—they offer manufacturers the opportunity to submit health economic data if they disagree with the value assessment.
Whether manufacturers will respond to wide-spread adoption of one or more value frameworks in oncology remains to be seen, as does any potential effect on innovation in this setting.
Currently there is no consensus on the definition of value in healthcare, which presents a difficult hurdle to overcome in the development of a value framework for oncology that will be used in practice.
The survey responses suggest that widespread adoption of value frameworks by oncologists is not likely to occur unless mandated by payers or their practices. It may take a mandate from payers or the government to drive alignment around a single value framework.
Although she applied one or more of the value frameworks she mentioned to therapeutic regimens presented at the ASCO plenary session, Dr. Schrag said that oncology value frameworks are not yet practical for clinical decision making at the bedside, in part because treatment costs vary enormously and exact figures are hard to obtain. She suggested that software tools may help, and ASCO is developing them.
One thing that has been overlooked in current value frameworks is the patient perspective. A value assessment that includes patient reported outcomes (PRO) would allow individuals to consider the specific side effect profiles of different treatments in relationship to their personal daily lives. PRO are supposed to be included in the next iteration of the ASCO value framework.
The role of manufacturers in value frameworks remains to be seen, although they could play a role in collecting PRO to be used in decision making.
Dr. Schwartzberg thinks that value frameworks are a first step. “I really do think five years from now we’ll be seeing a shift to a fundamentally different model. I can’t say what that’s going to be yet, but I think a lot of creative minds are working on this,” he concluded.
About the Contributors
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- Schrag D. Value frameworks in oncology. ASCO Annual Meeting Plenary Session, 2016.
- Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American Society of Clinical Oncology Value Framework: revisions and reflections in response to comments received. J Clin Oncol. Published online before print May 31, 2016, doi: 10.1200/JCO.2016.68.2518.
- National Comprehensive Cancer Network (NCCN) Evidence Blocks™. Available at: https://www.nccn.org/evidenceblocks/. Accessed June 15, 2016.
- Institute for Clinical and Economic Review (ICER). Available at: http://icer-review.org/methodology/icers-methods/icer-value-assessment-framework/ and at http://icer-review.org/wp-content/uploads/2016/02/Value-Assessment-Framework-One-Pager.pdf. Accessed June 15, 2016.
- Available at: http://www.drugabacus.org/drug-abacus-tool/. Accessed June 15, 2016.
- Cherny NI, Sullivan R, Dafni U, et al. A standardized, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Annals of Oncology. 2015;26:1547-1573.
- Lederman, L. ASCO, Payers, and COA React to CMMI’s New Oncology Care Model. OBRGreen, March 2015 Edition. Vol. 9, Issue 3 Available at: https://obroncology.com/obrgreen/print/ASCO-Payers-and-COA-React-to-CMMIs-New-Oncology-Care-Model. Accessed June 15, 2016.