May 13, 2025
Explore how different stakeholders assess the value of medical innovation and how value-based pricing influences the pricing and reimbursement process.
This course examines how perspectives differ across regulatory authorities (EMA, FDA), national health authorities, payers, physicians, patients, and investors, shaping value assessment frameworks for innovative drugs, orphan drugs, and advanced therapy medicinal products (ATMPs).
Technical Topics Include:
Stakeholder Perspectives on Value Assessment:
- Regulatory authorities (EMA, FDA): Clinical value focus in registration decisions
- National health authorities: Broader evaluation incorporating clinical, economic, and societal criteria
- Investors: Economic valuation in an international financial market, ensuring financial viability
- Patients, physicians, insurers, and employers: Considerations such as quality of life, real-world effectiveness, budget impact, and productivity costs
Value-Based Pricing (VBP) Methods:
- Incremental cost-effectiveness ratio (ICER): Narrow vs. broad interpretations of cost-effectiveness thresholds
- Multicriteria decision analysis (MCDA): Weighing multiple factors in value assessments
- Comparative effectiveness research (CER): Evidence-based comparisons of treatment benefits
- Relative effectiveness (RE): Evaluating the impact of innovations in real-world settings
Case Studies:
- Application of value assessment frameworks to orphan drugs, ATMPs, and traditional innovative drugs
- Balancing pricing perspectives: Aligning national payer expectations with investor-driven minimum pricing
This Course Includes Tools and Concepts That Can Be Immediately Applied, Including:
- Comprehensive frameworks for value assessment across multiple stakeholders
- Practical applications of value-based pricing in different healthcare settings
- Case studies on pricing and reimbursement challenges for high-cost innovative therapies
- Strategies for integrating broader value considerations into pricing and reimbursement decisions
This course is designed for professionals involved in health economic evaluation, pricing and reimbursement, and market access who seek to understand stakeholder-driven value assessments and pricing strategies for medical innovations. Familiarity with health economic evaluation is desirable, but the course assumes little or no familiarity with economic valuation theory.
LEVEL: Intermediate
TRACK: Health Policy & Regulatory
This short course is offered in-person at the ISPOR 2025 conference. Separate registration is required. Visit the ISPOR 2025 Program page to register and learn more.
FACULTY MEMBERS
Schedule:
LENGTH: 4 Hours | Course runs 1 day
Sunday, 13 May 2025 | Course runs 1 Day
1:00pm-5:00pm Eastern Daylight Time (EDT)
ISPOR short courses are designed to enhance knowledge and techniques in core health economics and outcomes research (HEOR) topics as well as emerging trends in the field. Short courses offer 4 or 8 hours of premium scientific education and an electronic course book. Active attendee participation combined with our expert faculty creates an immersive and impactful learning experience. Short courses are not recorded and are only available during the live course presentation.