Assessing the value of cardiac biomarkers: going beyond diagnostic accuracy?

Area of Science:

• Health Economics
• Clinical Diagnostics
• Health Technology Assessment

Background:

• Healthcare providers and payers increasingly scrutinize resource utilization and demand evidence of value for interventions.
• Cost-effectiveness evaluations are crucial for guiding healthcare budget allocation decisions.
• Historically, laboratory diagnostics have been methodologically excluded from cost-effectiveness evaluations.

Purpose of the Study:

• To explore current health technology agency requirements for including laboratory diagnostics in evaluations.
• To describe alternative methods for establishing the value of biomarkers and laboratory diagnostics beyond assay performance.
• To evaluate the use of a linked evidence approach in cost-effectiveness studies for cardiac laboratory tests over the past five years.

Main Methods:

• Literature review of health technology agency requirements.
• Exploration of alternative methods for valuing laboratory diagnostics.
• Analysis of cost-effectiveness studies focusing on cardiac laboratory tests using a linked evidence approach.

Main Results:

• Findings on current requirements of health technology agencies regarding laboratory diagnostics.
• Identification and description of alternative methods for assessing diagnostic test value.
• Data on the application of linked evidence approaches in cardiac laboratory test cost-effectiveness studies.

Conclusions:

• The study highlights the evolving landscape of cost-effectiveness evaluations to incorporate laboratory diagnostics.
• Alternative methods, such as linked evidence, offer a pathway to establish broader value.
• The findings inform future assessments of cardiac laboratory tests and other diagnostics.