Variation exists in the quality and quantity of data available to patients seeking financial assistance for cancer treatment via manufacturer Web sites and hotlines. Greater transparency among patient assistance programs would enhance utility for patients and help to determine the net impact on costs and adherence.
A489 Objectives: As the emphasis on value of oncology agents grows, ASCO has released a framework proposing to evaluate the net health benefit of such therapies. This study aims to evaluate the application of the ASCO framework for all recently approved oncology therapies, including barriers and challenges that may be encountered. MethOds: Oncology drugs approved from January 2013 to May 2015 (N= 19) were obtained from the FDA website. Palliative therapies were excluded. Registrational trials (N= 31) for the corresponding drugs were identified from peer-reviewed publications. The Net Health Benefit (NHB) score worksheet was completed for each clinical trial as outlined in the ASCO advanced disease framework using Overall Survival (OS), Progression-Free Survival (PFS), Response Rate (RR), Toxicity, Palliation, and Treatment-Free Interval. Issues encountered were catalogued for review. Results: 1 of 31 clinical trials was excluded due to lack of publication in peer-reviewed journals. An additional 9 trials were excluded due to non-randomized trial design, resulting in 22 trials corresponding to 16 drugs. OS data was used for scoring in 59% of the remaining trials. PFS was used in 27% of the trials, and RR in 14% of the trials. Toxicity data was scored in 95% of the trials, palliation data in 77% of trials, and treatment-free interval data in 95% of the trials. The most common scoring issues encountered included median OS or PFS not reached (8/22) and incomplete palliation or treatment-free interval data (5/22). cOnclusiOns: Lack of peer-reviewed publications, non-randomized trial designs, and requisite clinical data resulted in methodological challenges that deterred application of the ASCO framework for recent oncology drugs. Lack of appropriate data may result in lower scores than could be recognized from the available evidence at time of market authorization.
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