Planning Post-Launch Evidence Generation: Lessons From France, England and Spain

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Real-World Evidence

Background:

• Medicinal products face increasing clinical and economic uncertainties at launch due to technological advancements and regulatory changes.
• Continuous evidence generation post-launch is vital for assessing the real-world value of new medicines.
• Existing Post-Launch Evidence Generation (PLEG) systems require examination to identify areas for improvement.

Purpose of the Study:

• To compare national approaches to PLEG planning and operationalization in France, Spain, and England.
• To identify common challenges and best practices in PLEG across different healthcare systems.
• To provide recommendations for optimizing PLEG processes and decision-making.

Main Methods:

• Analysis of Post-Launch Evidence Generation (PLEG) systems in France, Spain, and England.
• Insights gathered from multistakeholder roundtables hosted by RWE4Decisions.
• Presentations and discussions involving representatives from HTA bodies, payers, and industry.

Main Results:

• Despite national differences in PLEG application and operationalization, common challenges exist across systems and stakeholders.
• Recognition of the need for earlier anticipation of evidentiary requirements to either avoid or better plan PLEG.
• Identified need for streamlining data collection through greater use of existing data, prioritizing key outcomes, and enhancing international collaboration.

Conclusions:

• Improving scientific advice processes and fostering international collaboration are essential for early discussion of data gaps.
• Efficient and effective evidence collection can accelerate and enhance the quality of reimbursement and pricing decisions.
• Optimizing PLEG is critical for managing clinical and economic uncertainties associated with new medicines.