The American Society of Clinical Oncology (ASCO) has weighed in on rising cancer drug prices, calling for healthcare stakeholders, members of Congress, and the Trump administration to work toward addressing affordability—including the development of a framework for assessing the value of treatments.
The ASCO Position Statement On Addressing the Affordability of Cancer Drugs noted a 2016 Express Scripts forecast that oncology drug pricing is expected to increase at a rate of more than 20% per year for the next several years in issuing its recommendations. According to ASCO, new cancer drugs routinely cost more than $100,000 per year.
“As cancer doctors, we're accountable for ensuring our patients receive the right drug at the right time—but that alone isn't going to rein in costs. We need our nation's leaders to tackle the major drivers of patients' cost burdens, including rising prices,” ASCO CEO Clifford A. Hudis, MD, FACP, FASCO, said in the society’s position statement. “In what, undoubtedly, is one of the most difficult times in their lives, individuals with cancer should be focused on getting the best care possible, not worrying about financial strain on their families.”
Among ASCO’s recommendations is that a variety of healthcare stakeholders must actively participate in efforts to develop policy solutions to address cancer drug the affordability. Those stakeholders, the society said, should include “providers, patient advocates, payers, hospitals, experts in health economics and health outcomes, representatives from the pharmaceutical and biotechnology industries.”
Congress and the Trump administration should bring the stakeholders together to identify evaluate, and prioritize demonstration projects designed to test potential solutions. The stakeholders should also recommend adoption of solutions that prove to be successful, ASCO said.
“A high-priority effort of this group should be to propose a strategy for blending various value frameworks into a transparent and standardized approach to assessing value, and recommending drug pricing and reimbursement based on the value delivered,” ASCO stated.
Two years ago, ASCO was one of two key oncologist groups that offered potential frameworks for assigning value to cancer drugs; the other was the European Society for Medical Oncology (ESMO).
In a conceptual value framework published in 2015, ASCO conceived a six-step framework that assigned up to 80 points for clinical benefit based on overall survival (OS), progression-free survival (PFS), or response rate. Toxicity was graded from -20 to +20 points, while up to 30 more points were assigned for data showing palliation of symptoms and/or treatment-free interval.
The points—up to a maximum 130—were calculated into a “net health benefit” (NHB) representing the added benefit that patients can expect from the therapy, versus current standard of care.
When ASCO revised its value framework last year following comments from stakeholders, it addedthe awarding of bonus points for test regimens that yielded at least a 50% relative improvement in percentage of patients alive at a time point that is at twice the median OS or PFS point for the control regimen and if at least 20% of patients receiving the control regimen were alive at that time point.
The revised framework also included all adverse effects experienced by patients, rather than just high-0grade toxicities, and attributed different scores for the frequencies of toxicities depending on their grade.
ASCO also recommended that the FDA base decisions on new and supplemental drug applications on “meaningful” clinical outcomes rather than incremental benefits that achieve statistical significance in clinical trials.
ASCO’s position statement cautions Medicare on pursuing direct negotiations with drug developers. Without recommending against the idea, the society raised two concerns—that Washington may not grant such power to Medicare (“such power requires considerable thought and debate,” ASCO observed) and that part of the cost savings obtained by Medicare will likely go to private payers with less negotiating power.
Instead, ASCO recommended that Medicare require healthcare providers to use “value-based pathways” in which therapies would be assigned to hierarchical pathways based on their comparative value, and practices would be reimbursed based on their use of pathway recommendations. Practices that fall below a certain threshold would see reduced reimbursement.
“This has the advantage of incentivizing both provider use of higher value treatments and development of therapies by the pharmaceutical industry that achieve high value through a combination of maximizing efficacy and minimizing toxicity and costs,” ASCO concluded.
In addition to ASCO and ESMO, several other efforts to assess value of cancer drugs have been carried out in recent years—including by a team of doctors at Memorial Sloan Kettering Cancer Center, the Institute for Clinical and Economic Review (ICER), and the National Comprehensive Cancer Network (NCCN).