In a recent pharmaphorum interview, EVERSANA’s Pamela Vo emphasized the importance of early strategic evidence planning under the EU’s new Health Technology Assessment Regulation (HTAR). With the Joint Clinical Assessment (JCA) streamlining clinical evaluations across member states, companies must align regulatory, clinical, and market access strategies from the start.
Key takeaways:
- Early PICO forecasting is essential to meet tight submission timelines.
- Indirect Treatment Comparisons (ITCs) are critical, especially in rare diseases.
- Joint Scientific Consultations (JSCs) offer valuable early guidance.
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