ASCO’s position statement highlights that new cancer drugs routinely cost more than $100,000 per year, and prices on many existing treatments continue to rise causing serious financial hardship, even for many patients with insurance. Patients with cancer are more than twice as likely to declare bankruptcy as those without cancer,1 and nearly six in 10 report being distressed about their finances during treatment.2 As a result many patients forego or delay treatments, potentially compromising their effectiveness.
“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,” ASCO Chief Executive Officer Clifford A. Hudis, MD, FACP, FASCO, said. “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.”
Policymakers and the medical community have proposed a range of solutions to address rising prices, but none have been fully tested, and little agreement exists on what will increase affordability without stifling innovation and access. Developed by ASCO volunteer leaders and adopted by the Society’s Board of Directors, the position statement analyzes a wide range of cost-cutting proposals, from allowing Medicare to negotiate drug prices, to legalizing the importation of drugs, to adopting bundled payment programs.
Specifically, ASCO proposes that a diverse group of stakeholders from across the health care sector:
- Identify, prioritize, and test potential solutions to address the affordability of cancer drugs, and
- Help define a standard approach to assessing the value of drugs that could be applied broadly to inform drug pricing and reimbursement.
ASCO suggests that Congress and the current administration could play an important role in convening such a group. The Society stands ready to assist in efforts to arrive at solutions that ensure access, affordability, and innovation.
“Drug pricing is clearly too complex and political to tackle without evidence-based solutions,” Dr. Hudis said. “We’re focused on finding out what works and what the potential downsides and unintended consequences might be with each intervention. However, ASCO believes we must develop approaches that will protect patients from rising costs while improving care.”
Although new classes of drugs have achieved unprecedented success in a growing number of cancers, in some cases the price of a new drug bears no relation to its effectiveness. According to one study, only 19% of cancer drugs recently approved by the U.S. Food and Drug Administration (FDA) produced clinically meaningful outcomes for patients, despite their high prices.3 ASCO believes that regardless of the specific policy recommendations pursued, defining value must underpin the drug pricing debate, and therefore, suggests that:
- The FDA consider using meaningful clinical outcomes when assessing new and supplemental drug applications, rather than small benefits that achieve statistical significance in large trials. In 2014, ASCO published an article in the Journal of Clinical Oncology recommending a definition of clinically meaningful outcomes for cancer clinical trials, which the FDA could use when approving new cancer treatments and drug indications.4
- Medicare test the feasibility of a value-based pathway approach designed to incentivize providers to use higher-value drugs and the pharmaceutical industry to develop high-value treatments.
ASCO is firm in its position that any policy solutions to address the rising cost of cancer drugs must promote patient access to care, affordability of necessary drug treatments, and innovation in drug development. Furthermore, a single, reliable framework for comparing treatment options is also essential and will require more comparative effectiveness research to determine how well new drugs perform relative to existing alternatives, along with their impact on diverse populations. This framework will need a broader range of clinical trial endpoints that accurately reflect patients’ quality of life and big data projects such as ASCO’s CancerLinQ® to compare drug safety and effectiveness in real-world settings.