ASSESSING RELATIVE CLINICAL VALUE WITHIN THREE METASTATIC DISEASES

Author(s)

Karweit J1, Wolfe S1, Kotapati S2, Lees M3, Abernethy AP41IMS Consulting Group, New York, NY, USA, 2Bristol-Myers Squibb Pharmaceuticals, Wallingford, CT, USA, 3Bristol-Myers Squibb, Rueil-Malmaison, France, 4Duke Clinical Research Institute and Duke Cancer Institute, Durham, NC, USA

OBJECTIVES: As more innovative oncology agents become available, budget limitations are necessitating deeper value assessments of products. Previous research demonstrated that examining a variety of key survival metrics is required to fully define the value of an anti-neoplastic intervention.  Here we examine how various survival metrics compare across 3 major metastatic tumor types, chosen because of the introduction of new therapeutics in the past year:  melanoma, prostate and lung cancer. METHODS: We conducted a literature-based review of pivotal clinical trial data supporting new therapeutics in these tumor types from 2006-2012 and selected all products with demonstrated overall survival benefit in the metastatic setting: vemurafinib, ipilimumab for melanoma; cabazitaxel, abiraterone, sipuleucel-T for prostate cancer; pemetrexed, erlotinib, and bevacizumab for lung cancer. Crizotinib was excluded having not reached median overall survival (OS) at approval. We compared products on four survival metrics: median OS, mean OS, 1-year survival, and number needed to treat to avoid one event (NNT). RESULTS: Despite variations in patient tumor types , the products showed a narrow range of median OS improvement.  However, greater variability was seen across other metrics: in lung cancer, pemetrexed presented the greater mean OS improvement, while erlotinib demonstrated greater 1-year survival and lower NNT. In melanoma, vemurafenib and ipilimumab demonstrated the same number of months of median OS improvement in their respective clinical trials; however, ipilimumab demonstrated greater mean OS, 1-year survival, and  lower NNT. In prostate cancer, sipuleucel-T demonstrated better mean OS improvement, whereas abiraterone had better 1-year survival and lower NNT. CONCLUSIONS: Drugs are being evaluated with remarkably similar median OS benefits for metastatic patient populations. Side-by-side comparisons that take multiple endpoints into account can assist decision-makers to better understand total clinical benefit in context and contribute to thoughtful resource management, especially when median OS benefit may be so similar.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PRM2

Topic

Methodological & Statistical Research

Topic Subcategory

Confounding, Selection Bias Correction, Causal Inference

Disease

Oncology

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