Coverage with evidence development, only in research, risk sharing, or patient access scheme? A framework for...

Area of Science:

• Health economics
• Health policy
• Medical technology assessment

Background:

• Traditional medical technology purchasing decisions were binary (covered or not covered).
• Emerging policies allow for expanded decision options, such as coverage linked to evidence development for treatments with uncertain evidence.
• Limited efforts have reconciled technology features with available decision-making options.

Purpose of the Study:

• To describe a framework for evaluating diverse medical technology decision options.
• To distinguish between the value of a technology itself and the value of reducing decision uncertainty.
• To incorporate the costs associated with reversing coverage decisions.

Main Methods:

• Development of a framework for evaluating different decision options for medical technologies.
• Identification of two key sources of health value: technology value and value of reduced uncertainty.
• Inclusion of decision reversal costs in the evaluation framework.

Main Results:

• Purchasers must balance expected coverage benefits against potential decision reversal costs and impacts on evidence generation.
• Appropriate decisions depend on purchaser authority (access, research, price) and technology characteristics (reversibility, evidence).
• A taxonomy of coverage decisions was proposed, clarifying necessary assessments.

Conclusions:

• Expanded decision options can facilitate payment for promising but uncertain medical technologies.
• Decision-making should consider technology value, research value, coverage's impact on research, and reversal costs.