APPLICATION OF ASCO VALUE FRAMEWORK EVALUATIONS OF NET HEALTH BENEFIT FOR ONCOLOGY DRUGS LAUNCHED IN THE UNITED STATES BETWEEN 2013 AND 2015

Author(s)

Li J, Asabere A, Kelly S, Cho Y, Dua D, Bastian A
GfK, San Francisco, CA, USA

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: 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.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PCN333

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Oncology

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