Background

Metastatic castration-resistant prostate cancer (mCRPC) is a late-stage, hormone-refractory condition associated with significant clinical and economic burden. While initial surgical and hormone therapies are effective in controlling early-stage disease, many patients progress to mCRPC, which is resistant to further hormonal interventions. Approximately 3%–8% of newly diagnosed prostate cancer cases are metastatic, with 1%–4% of men with prostate cancer in mCRPC stage.​

 

Challenge

The client's primary challenge was to refine the approach for comparative efficacy assessment and cost-effectiveness modelling (CEM) for a novel combination therapy for mCRPC. Specific issues included accounting for variability in prognostic covariates across study populations, integrating real-world evidence (RWE) in survival modelling, defining patient subgroups for the CEM, modelling subsequent treatment costs, and incorporating companion diagnostic costs while addressing geographic variability in testing practices.

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Approach

A panel of 9 globally renowned experts was convened for a two-day virtual advisory board. To ensure alignment and provide comprehensive context, participants attended a pre-advisory board webinar. This session outlined the client’s clinical development programme, detailed the objectives of the advisory board, and introduced key discussion topics. A Q&A session at the end allowed participants to address any preliminary questions. 

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Outcomes

• ​The panel made actionable recommendations for improving the survival analyses vs both in-trial and external comparators, taking into consideration market-specific differences in first-line and subsequent treatments.

• Experts validated the CEM and offered practical advice for modelling treatment costs and addressing regional testing variability.  

• These recommendations enabled the client to refine their indirect treatment comparison approach and the cost-effectiveness model to meet HTA requirements and strengthen the market access strategy.