Life Years Gained From the FDA Accelerated Approval Program in Oncology: A Portfolio Model.

Background: Although the FDA Accelerated Approval Program (AAP) has come under scrutiny, the population-level health benefit of the program has not been quantified. Therefore, the objective of this study was to estimate the number of life years gained among patients with cancer that can be attributable to the therapies receiving FDA accelerated approvals in oncology between 2006 and 2022 in the United States.

Methods: The data sources used were FDA listings, FDA approval letters and labels, published clinical trial data and other publications including relative effectiveness estimates, and the Ipsos Oncology Uptake Tool for product uptake.

Patient perceptions of copay card utilization and policies.

Background: Copay cards are intended to mitigate patient out-of-pocket (OOP) expenses. This qualitative, exploratory focus group study aimed to capture patient perceptions of copay cards and copay adjustment programs (CAPs; insurers' accumulator and maximizer policies), which redirect the copay card utilization benefits intended for patients' OOP expenses.

Methods: Patients with chronic conditions were recruited through Janssen's Patient Engagement Research Council program.