PURPOSE: While innovative medicines, such as gene therapy, offer the potential for important health gains in many diseases, these innovations raise concerns about health care spending. As a result, health technology assessment (HTA) is gaining traction in countries where payers traditionally have not used HTAs for pricing negotiations. Because the need to adapt HTA processes and methods to overcome emerging challenges is likely similar across countries, discussion of the challenges and solutions surrounding how new technologies are appraised in different markets can provide valuable insights. This workshop will discuss how HTAs affect pricing and coverage decisions in the United Kingdom, the United States, and Japan and how pricing and market access are granted to drugs that may not be considered cost-effective using conventional methods. Recent case studies and application of novel HTA approaches can provide ideas on future directions in HTA methods and processes.
DESCRIPTION: The first section of this workshop will focus on understanding the relationship between HTAs and pricing and market access in each of the three markets (20 minutes). Next, speakers will discuss whether and how pricing and market access is granted to drugs that may not be considered cost-effective using conventional methods. The process and rationale for each of the three markets will be presented, illustrated by recent appraisals. Specifically, examples of patient access schemes, managed access schemes, and outcome-based contracts will be introduced (20 minutes). Speakers will discuss the feasibility and downstream implications of each scheme in addressing challenges faced in other markets. (10 minutes). There will be polling throughout the workshop for the audience to share their experiences and challenges in conveying the value of innovative medicines within their market’s HTA framework and to discuss the advantages and disadvantages of the approaches presented. Finally, there will be an opportunity for audience questions (10 minutes).
