PICO scoping exercise in prostate cancer to prepare for a full JCA submission

Project background

The implementation of the HTA regulation (HTAR), and therefore the initiation of the JCA has brought manufacturers a lot of uncertainty and additional work. Our client was preparing for a future JCA submission in metastatic hormone-sensitive prostate cancer (mHSPC) and sought strategic guidance to anticipate potential evidence challenges. The goal was to simulate plausible PICOs across key European markets, assess how well their pivotal clinical trial would meet those expectations, and identify concrete actions to align evidence generation with evolving HTA demands.

Challenges faced

The project was set against a rapidly shifting treatment landscape, with emerging combinations regimens and increasing heterogeneity in national comparator requirements. Complicating matters, not prior JCAs existed for this indication, requiring a predictive approach to forecast country-level expectations. The client needed clarity not only on the likely PICO constructs, but also on how trial design and real-world patterns could influence national HTA responses.

Our solution

To tackle this, we applied a structured, three-phase PICO scoping framework:

1. Landscape Analysis

We conducted a comprehensive review of national and European guidelines, HTA reports, regulatory assessments (e.g., EPARs), and real-world treatment patterns across five major EU countries. This helped establish a detailed understanding of the mHSPC treatment ecosystem, including national variation in standard of care and comparator use.

2. PICO Simulation

Based on the landscape findings, we developed a broad set of plausible PICOs reflecting different country contexts. This included identifying relevant subpopulations, priority outcomes, and country-specific comparators — with a forward-looking view on how evolving standards might affect future assessments.

3. PICO Consolidation

We then consolidated these into a realistic and manageable set of expected PICOs, aligned with the latest JCA methodology. We also forecasted likely country-level reactions to specific PICO scenarios and provided tailored recommendations on how to bridge gaps between the trial evidence and HTA expectations.

Our impact

The project gave the client strategic clarity on how to optimize their evidence package well in advance of submission. By anticipating likely PICO structures and aligning internal functions around them, the client strengthened its preparedness for both JCA and national HTA reviews. Our recommendations directly informed clinical evidence planning, reduced the risk of downstream rework, and enabled faster, more informed decision-making across access and development teams.