Module 6

02/10/2024

Fundamental Questions to Assess the Value Proposition: Think like a payer

• What is the new drug, and which patients will use it? o Where does it fit into the care pathway? o What is current standard of care (if any)?

Efficacy

Is the drug safe and effective? o

•

Does it work in clinical practice?

• Is investing in this drug an efficient use of resources? o

Cost effectiveness, budget impact compared to which alternative?

How confident am I in this assessment? o Is more information / data needed?

•

Effectiveness

• What is the full range of impacts to the healthcare system? o What are the other requirements? Capital, training …

• Can I control use once market access is granted? o

Efficiency

Comparison diagnostic, stopping rules, further indications?

Demonstrating Value and Market Access

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

13

Regulatory-HTA Interface Shifting the paradigm

Reference: “How Regulatory Agencies could interact with Health Technology Bodies”, Source: Lonngren et al DIA, Berlin, March 2009.

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

14

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