Pharmaceutical companies have long been dealing with negative press about the supposed “rise of prescription drug costs.” Now, several organizations are adding themselves to the drama, developing different ways to assess the value of new medicines, based on attributes such as cost, quality of life, and effectiveness. The tools, also known as “value frameworks,” are being developed by four groups: the American Society of Clinical Oncology, the Institute for Clinical and Economic Review, the National Comprehensive Cancer Network, and Memorial Sloan Kettering Cancer Center, detailed below.
American Society of Clinical Oncology
The American Society of Clinical Oncology (ASCO) formed the Task Force on the Cost of Cancer Care in 2007, focused on educating oncologists about the importance of discussing costs associated with recommended treatments and identifying the drivers of the rising costs of cancer care, among other things. In a statement released by ASCO, the Association believes that “health care will become less and less affordable for Americans unless steps are taken to curb current cost trends.” As such, the group renamed the Task Force to the Value in Cancer Care Task Force in 2013, and changed the focus to “developing a framework for comparing the relative clinical benefit, toxicity, and cost of treatment in the medical oncology setting.”
In the ASCO frameworks, “points are awarded (or subtracted) in the categories of clinical benefit and toxicity. In the advanced disease framework, bonus points can be earned if a regimen shows statistically significant improvement in palliation of symptoms and/or treatment-free interval compared with the control treatment in a clinical trial.” Clinical benefit and toxicity, along with any bonus points, are then combined to generate a net health benefit score, which is juxtaposed against the direct cost of the treatment.
Institute for Clinical and Economic Review
The Institute for Clinical and Economic Review (ICER) framework has been denounced by many, and ICER has put out a request for ways to improve it. The value assessment includes: comparative clinical effectiveness, incremental cost per clinical outcomes achieved, other benefits or disadvantages, contextual considerations, “care value,” potential short-term health system budget impact, provisional “health system value,” mechanisms to maximize health system value, and achieved “health system value.”
However, the actual “health system value” is not evaluated by ICER. As we recently wrote about, ICER has been found to overestimate drug price impacts, and the fact that they do not make attempts to evaluate health system value and the accuracy of their estimates, should be a concern to members of industry.
National Comprehensive Cancer Network
The National Comprehensive Cancer Network (NCCN) has created the Evidence Block, which follows a failed effort from seven or eight years ago to come up with ratings for drugs based on toxicity, effectiveness, and cost. That effort failed because stakeholders could not agree on what defined effectiveness across different forms of cancer.
The Evidence Block, however, was created roughly two to three years ago and uses five measures: effectiveness of treatment, its toxicity, the quality of evidence used to determine safety and effectiveness, the quantity of evidence used to determine safety and effectiveness, and affordability. The panels of experts who work to draft the Evidence Block do not make a decision to recommend a treatment or not based on affordability, but that information is provided as a supplement.
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center (MSKCC) came up with their own an interactive strategy, in an attempt to put the cost of a drug in context with its overall value. The strategy is created by Peter B. Bach, MD, director of the Center for Health Policy and Outcomes, who notes that “this is really a proof of principle that we could develop an approach – if we choose to – where price was based on the value of drugs.” The MSKCC approach incorporates measures of cost, toxicity, efficacy, novelty, research and development costs, rarity of the disease, and population health burden.
Dr. Bach recognizes, however, that it is hard to define value when it comes to drug pricing, “It seems that there was a fair amount of coalescence around the possible domains of value, but there has been little effort and certainly little consensus on how much each of those domains should matter in the determination of value, or if they should even be included.”
Conclusion
Interestingly, a survey conducted by Avalere Health found that out of eleven health plans surveyed, none of them rely on the new tools, and a majority do not expect to do so next year, either. According to the survey, the plans would like to see the provider community embrace the frameworks before formally adopting them into their decision-making process.
It is possible that these frameworks have the potential to be as dangerous to patients as Open Payments. As we have learned, more information is not always beneficial, and it can oftentimes add to the confusion many patients already feel about their health care treatment. We urge extreme caution when it comes to these frameworks, in part because it is hard to generalize and predict the value of medications to individual patients.