Our key learnings from ISPOR Europe 2022 were:
- Real-World Evidence (RWE) is increasingly being used to enhance and support the value proposition of assets in healthcare decision-making, acting as a supplement to randomized clinical trials data at a reasonable cost, and by demonstrating economic benefits for optimized and/or early access. Moreover, as a result of the large sample size, RWE can enable further data analysis (e.g., subpopulation analysis, investigation of uncommon effects).
- The new EU-wide HTA assessment (HTAR) will come into effect as of January 2025 providing a joint assessment framework for more efficient use of resources and to strengthen the quality of HTA across the European Union. Unified legislation across these member states and close collaboration between regulatory and HTA assessment bodies are key for the success of this historic milestone.
- Patient engagement is crucial for understanding the patients’ burden and unmet need across therapeutic areas. The perspectives of clinicians are not always the best way to understand how a disease is impacting patients’ lives and therefore pharma needs to start integrating the patient voice into clinical development programs.
- The use of artificial intelligence (AI) and advanced analytics is anticipated to transform the development process of drugs and devices and is steadily growing thanks to the increasingly available variety of real-word data (RWD). Machine learning and AI offer ways to analyse this RWD so that valid clinical assertions can be made (e.g., identification of clinically relevant data points critical to the approval process).
