As the launch of the European Union’s joint clinical assessment (JCA) in January 2025 approaches, pharmaceutical companies face an increasingly complex market. The JCA is poised to have a significant impact on oncology and advanced therapy medicinal product (ATMP) launches and development. At Putnam, we specialize in helping you navigate this new landscape with strategic insight and operational excellence.
As we help clients navigate the JCA, here are our top recommendations for success:
1. Embrace structure in protocol development
In the JCA framework, Population, Intervention, Comparator, Outcome (PICO) is central to clinical development. We guide companies to integrate PICO into their clinical development protocols, ensuring that it serves as a tool rather than a constraint. Our approach helps you define your value proposition and shape PICO to maximize the market potential of your products.
2. Have an evidence generation plan
A robust Evidence Generation Plan (EGP) is critical. We ensure your plan captures the necessary information to support key access pathways and relevant PICO elements. Using early indirect treatment comparisons (ITC) we can inform favorable market access scenarios and optimize clinical trial designs.
3. Create regulatory and market access synergy
Harmonizing regulatory and market access strategies is essential because labelling drives PICO. We foster closer integration between these functions, aligning strategies to ensure streamlined and successful market entry.
4. Anticipate and adapt to PICO variations
We employ early assessment models to understand PICO variations and their impact on drug value and positioning. Our policy and market access plans are designed to shape future PICO to support optimal market scenarios.
5. Develop comprehensive systematic literature reviews and indirect treatment comparison models
Our advanced systematic literature review (SLR) and indirect treatment comparison (ITC) methodologies are optimised for multiple PICO scenarios and ensure seamless updates and efficient processing. Our global cost-effectiveness models are flexible and responsive to different PICO requirements.
6. Cross-check anticipated PICO
We combine feedback from payers, patients, and key opinion leaders (KOLs) to validate anticipated PICO scenarios. Rapid assessments and engagements provide real-time insights, enhancing our strategic planning.
How we help
From early drug development through launch, Putnam offers a continuum of services:
- Early phase: Pivotal trial design, early phase clinical and economic SLR, and HTA report reviews and joint scientific consultation (JSC) or national early advice.
- Strategic planning: Developing strategic PICO scenarios, payer value propositions (PVPs), and core economic models.
- Market access road map: Including strength-weakness-opportunity-threat (SWOT) analysis and critical success factors (CSFs).
- JCA and national HTA dossiers: Preparing for submissions and meeting post-market authorization requirements from JCA to national advice.
- Patient Centred Outcome (PCO) development and implementation strategy: Putnam’s PCO specialists can support you throughout the product lifecycle in terms of strategic expertise in PCO selection, utilising best practices. PCO data are instrumental in demonstrating the value of treatments from the patients’ perspectives.
Your path to JCA readiness
Partner with Putnam to unlock the secrets of JCA success. Our tailored strategies and robust evidence‑based approaches are designed to help you achieve optimal market access and sustained success in the evolving healthcare landscape.
Contact us to learn more.
