Against a background of exponential growth in the number of genuinely personalized medicines in development, an affordability crisis is looming. Based on robust science and promise from intermediate endpoints, regulators are accelerating approvals; payers are starting to consider changing their approaches but remain cautious and sensitive to uncertainty. Manufacturers must use all the tools at their disposal to optimize their opportunity for first-time reimbursement across all major markets.
Sharing new insight from developing trends, particularly in oncology, David Sykes, Founding Partner at PRMA Consulting, and members of the senior team, consider the interplay and impact of critical factors for a favorable product launch in an uncertain landscape.
The practical implications for evidence generation are examined, and actionable insights provided.
This webinar discusses:
- Evolution of regulatory and HTA approaches, and flexibility within traditional payer archetypes;
- Emergence of new stakeholders;
- Changing definitions of disease;
- Increased engagement with patients and impact of patient voice;
- New approaches to demonstrating value; and
- Strategic decision-making in a rapidly changing environment.