A Conceptual Framework for Life-Cycle Health Technology Assessment

Area of Science:

• Health Economics
• Health Technology Assessment
• Decision Science

Background:

• Standard health technology assessment (HTA) processes face challenges in supporting decisions with significant uncertainty and adapting to new evidence.
• Existing HTA methods can be slow and may not adequately address the dynamic nature of innovative health technologies.

Purpose of the Study:

• To introduce the life-cycle (LC)-HTA framework, designed to address limitations in traditional HTA processes.
• To provide decision-makers with enhanced tools for managing uncertainty and incorporating evolving evidence.

Main Methods:

• Aligning HTA processes with life-cycle management principles.
• Implementing risk-based pricing and research-oriented managed access (ROMA) for uncertain technologies.
• Utilizing contractual agreements for reassessment and value-of-information methods to guide ROMA.

Main Results:

• The LC-HTA framework facilitates the adoption of high-value, high-risk innovations while ensuring health system sustainability.
• Risk-sharing mechanisms and ROMA enable conditional adoption, allowing for evidence generation under uncertainty.
• Improved responsiveness to evolving evidence through contractually embedded reassessment rules.

Conclusions:

• The LC-HTA framework offers a more adaptive and robust approach to HTA, improving outcomes for all stakeholders.
• Patients gain earlier access to beneficial technologies, payers optimize investments, and sponsors achieve greater market certainty.