The American Society of Clinical Oncology (ASCO) published an updated framework for assessing the relative value of cancer therapies that have been compared in clinical trials. The framework, published in the Journal of Clinical Oncology, defines value as a combination of clinical benefit, side effects, and improvement in patient symptoms or quality of life in the context of cost. The updated framework will be the basis for a software tool that doctors can use to assist shared decision-making with their patients.
After publishing the initial version of the framework last year, ASCO invited public feedback during a 60-day comment period. More than 400 comments were received from patients, patient advocates, physicians, representatives of the pharmaceutical industry, and other members of the cancer community. "We are grateful for the extensive and thoughtful feedback, which has helped us strengthen key elements of the framework to improve its utility. We are pleased that a majority of respondents supported the framework's goals and overall approach," noted Julie M. Vose, MD, MBA, FASCO, ASCO President.
Based on the feedback received, ASCO has made several changes to the framework:
* Most notably, ASCO modified the Net Health Benefit score-a weighted measure of a treatment's benefits and side effects-to better reflect true differences between treatments. For example, to calculate the efficacy of a treatment, the framework now uses hazard ratios, when available, rather than absolute survival measures. Hazard ratios provide a more complete assessment of the relative differences between therapies. The framework also recognizes treatments that improve long-term disease control for a significant portion of patients.
* Additionally, the framework now considers all side effects in the Net Health Benefit score, not just the most severe, high-grade toxicities. This change reflects feedback from patients who emphasized that even mild side effects can have a major impact on quality of life. Therefore, in addition to awarding bonus points for symptom palliation, additional points are given for improvement in quality of life.
* The revised framework will continue to only evaluate treatments that were studied head-to-head in prospective randomized clinical trials. Some commenters expressed interest in making cross-trial comparisons, and ASCO agrees such comparisons would be valuable. However, head-to-head trials remain the only scientifically valid way to compare two treatments, given differences in trial designs, patient populations, cancer stages, and other factors.
* In addition, the framework will continue to focus on cancer drugs, rather than other interventions. As some commenters noted, the cost of drugs is only one component of overall cancer care costs. But evidence shows that drug costs are the most rapidly rising component of cancer care and among patients' biggest concerns-in large part because they pay a significant share of these costs through co-pays.
* Some commenters suggested adding patient-reported outcomes (PROs) to the framework. PROs are important, and may be included in future versions of the framework. Unfortunately, to date, clinical trials haven't adequately measured or reported PROs. ASCO hopes to be able to consider these data as they are more rigorously collected and reported in future trials.
In the coming months, ASCO will work to translate the framework into a user-friendly software tool for physicians to use with patients as part of broader discussions about treatment options. ASCO also will collaborate with stakeholders, particularly patient advocates, to help ensure that the tool fully considers the needs and preferences of patients. Once it is developed, the organization will provide physicians with educational resources so they can best apply the tool in their discussions with patients. ASCO anticipates the tool will undergo changes as it is tested, receive feedback from physicians and patients, and adapt it to multiple clinical scenarios and new clinical evidence.