Session (CTI)

Separate registration required.

Explore the value assessment of innovative drugs from the perspectives of relevant stakeholders, their respective data requirements, and their methods and processes. Gain a better understanding of the value assessment from the investor perspective, with a focus on orphan drugs and advanced therapy medical products (ATMPs).

The value of medical innovation depends on a stakeholder's perspective in different decision contexts. Regulatory authorities (EMA, FDA) mainly consider the clinical value of medical innovation. In the context of coverage decisions, national health authorities may adopt a broader perspective by including clinical, economic criteria, and sometimes even other criteria such as equity and social values. For pricing and reimbursement, "value-based pricing" is the most widely accepted approach across countries, but it can vary from a narrow concept based on the incremental cost-effectiveness ratio (ICER) threshold to broader societal or holistic approaches. 

Value-based pricing determines the maximum price from the national payer perspective. In the context of the investment decision, this price should exceed the minimum price for the investor acting in the international financial market to make a financial valuation. Furthermore, there are numerous other stakeholders, eg, patients, physicians, healthcare insurers, and employers--with their specific assessment of the value of medical innovation including, for example, patient and family quality of life, real-world effectiveness, budget impact, and the costs of lost productivity. Familiarity with health economic evaluation is desirable, but the course assumes little or no familiarity with economic valuation theory.