How Value Frameworks Define Durable Survival of New Immuno-Oncology Agents

New immuno-oncology agents are providing durable survival for some patients, but the cost of these treatments is very high, which is a cause for concern. In a new study in JAMA Oncology, researchers sought to assess how value frameworks defined the efficacy of new immuno-oncology agents.

They reviewed 6 immuno-oncology agents approved by the FDA between March 2011 and August 2017: ipilimumab, pembrolizumab, nivolumab, atezolizumab, avelumab, and durvalumab. These 6 agents were approved for 23 indications.

They also assessed frameworks from the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), the National Comprehensive Cancer Network (NCCN), the Institute for Clinical and Economic Review (ICER), and the National Institute for Health and Care Excellence (NICE) in the United Kingdom, as well as the DrugAbacus tool from Memorial Sloan Kettering Cancer Center.

“These frameworks use various methods to assess value,” the authors explained. “With the arrival of modern immuno-oncology agents, it is important to evaluate each framework’s ability to account for durable survival as demonstrated by plateaus in the tails of survival curves.”

The updated ASCO framework has developed a structured weighting system on the benefit side, meaning it emphasizes the importance of achieving improved survival or progression-free survival. The study awarded bonus points based on the ASCO criteria.

The researchers determined that only 3 of the indications fulfilled the criteria of a minimum 20% survival rate compared with standard care: ipilimumab for second-line treatment of melanoma; nivolumab for first-line treatment of melanoma; and nivolumab for second-line treatment of squamous non—small cell lung cancer.

The authors noted that long-term follow-up data on immuno-oncology agents are needed to better understand the clinical benefit they provide.

“Our ability to assess the value of a medical intervention is crucial in a global health system in need of strategies for improving outcomes with the resources available,” the authors concluded. “Modern immuno-oncology agents have generated great excitement because of their potential to provide durable survival for some patients. However, if the frameworks are to be used to make coverage decisions, they will require additional refinement.”