In “What’s Next for Value-Frameworks in the U.S.?” a key session at ISPOR 2016, Lowell E Schnipper, MD, chair of the American Society of Clinical Oncology (ASCO), began by discussing why ASCO made the decision to develop and release its value framework in June 2015.
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Advances in the field of cancer research over the last decade have produced phenomenal results, said Dr Schnipper, leading to improved outcomes and a greater quality of life for patients. In particular, he referenced the rise of precision medicine therapies as a novel area of blockbuster potential.
However, as these new drugs have rapidly entered the market, they have also brought with them a substantial rise in drug costs. Citing a graph developed by Peter Bach, at Memorial Sloan Kettering (New York City, NY), Dr Schnipper explained that, since the mid-1960s, the number of drugs and the average cost of those drugs have both increased significantly.
To address this, providers and organizations similar to ASCO have had to find new ways to assess the value of different treatment regimens and ensure that patients receive the most appropriate care at manageable costs.
With this notion in mind, ASCO developed their Value Framework, which aimed to balance the costs, potential for adverse reactions, and clinical benefit of different treatments. Using the framework as a guideline for clinical decision-making can help providers and patients communicate about what they want and expect out of treatment.
Dr Schnipper hopes that the framework, in combination with new payment models, will help to create a health care system that incentivizes high-value care by prioritizing clinical benefit, patient-reported outcomes, toxicities, multidisciplinary care, and the deliverance of optimal treatment modalities. One key way in which Dr Schnipper believes this could be accomplished is by integrating value frameworks into clinical pathways in order to ensure physicians follow optimal treatment plans.
The Institute for Clinical and Economic Review (ICER) developed a value framework to address similar needs in the industry, explained Dan Ollendorf, PhD, chief scientific officer at ICER, in a follow-up presentation. The problems, he continued, are the poor reliability and consistency of value determinations by payers; the need for a more explicit and transparent way for health technology assessment groups and payers to analyze and judge value; and tension among stakeholders between the importance of long- and short-term perspectives.
For their framework, ICER first obtains the “core value” of a drug, which represents the long-term perspective at the patient level and is obtained by looking at its comparative clinical effectiveness, incremental cost per clinical outcomes achieved ($100-$150,000 per quality adjusted year), other benefits or disadvantages, and, finally, other contextual considerations (ethical, legal, etc) that influence the relative priority of illnesses and interventions.
Based on these factors, drugs are awarded a high, intermediate, or low value and are then analyzed again based on their potential budgetary impact, provisional “health system value” (the potential short-term budgetary impact of a drug if utilization is unmanaged), and then their achieved “health system value.”
In a trial utilizing the framework in a clinical setting in 2015-2016, the threshold was $904 million per year for each new innovative drug. Thus far, 5 topic reports have been completed (PCSK9s, sacubitril/valsartan, mepolizumab, insulin degludec, newer drug regimens for multiple myeloma) and the threshold was exceeded only 1 of 5 times. However, the list price only aligned with commonly-cited cost-effectiveness thresholds 1 of 5 times, leading the organizers to believe that this may be a critical measure for value in patient and clinician decision-making.
Still, Dr Ollendorf stressed that the framework has been a success in numerous other ways, such as helping to build patient-clinician communication and demonstrating the fundamental reasoning behind drug costs to insurers. Future steps will be to obtain unpublished data from manufactures to better inform decision makers and discuss the success and shortcomings of the framework in a fall 2016 multi-stakeholder meeting.
