MODELING LIFETIME EFFECTIVENESS OF DENOSUMAB VERSUS PLACEBO IN MEN WITH CASTRATION RESISTANT PROSTATE CANCER (CRPC) AT HIGH RISK OF DEVELOPING BONE METASTASIS (BM)

Author(s)

Lothgren M1, Hechmati G1, Jacobs I2, Qian Y2, Arellano J21Amgen (Europe) GmbH, Zug, Switzerland, 2Amgen Inc., Thousand Oaks, CA, USA

OBJECTIVES: With increasing healthcare resource constraints, it is important to understand the incremental cost-effectiveness (ICER) of new medicines, and an integral effort is to predict key clinical and economic outcomes over the patients’ lifetime. Our objective was to predict the lifetime mean overall survival (OS) and bone metastasis-free survival (BMFS) for denosumab (120mg subcutaneous every 4 weeks) vs. placebo in men with CRPC based on a recent phase III trial (ClinicalTrials.gov NCT00286091). METHODS: A three-state health state model (BMFS, BM progression, and Death) was developed. Parametric survival functions for OS and BMFS were estimated using trial data and extrapolated for lifetime. Model selection was based on the best fit within trial duration (AIC criteria), and overall shape of the lifetime predictions. For the parametric estimation, consistent with trial results, pooled data from both study arms were used for OS; the placebo arm was used for the baseline BMFS and the trial reported treatment effect (HR) was applied to derive the BMFS curve for denosumab. RESULTS: A Weibull function was identified as the best fit for both OS and BMFS. The pooled mean estimate was 4.02 years for OS, and 2.75 and 3.16 years for BMFS in placebo and denosumab respectively, resulting in an incremental BMFS of 0.41 year for denosumab vs placebo. CONCLUSIONS: Denosumab treatment is predicted to prolong time in BMFS, which will reduce time in BM progression state with potentially lower costs and costs offsets for denosumab from reduced need of routine care in the metastatic health state. This finding will facilitate our understanding of the ICER of denosumab in men with CRPC at high risk of developing BM.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

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

Code

PCN9

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Oncology

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