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New thinking on clinical utility: hard lessons for molecular diagnostics
John W Peabody1, Riti Shimkhada, Kuo B Tong
1QURE Healthcare, 1000 Fourth St, Suite 300, San Rafael, CA 94901.
The American Journal of Managed Care
|November 4, 2014
Summary
Establishing clinical utility for diagnostic tests is crucial for reimbursement. Companies must invest early in rigorous studies to demonstrate net clinical benefits and secure coverage.
Area of Science:
- Clinical diagnostics
- Health economics
- Regulatory science
Background:
- Reimbursement decisions for diagnostic tests are increasingly evidence-based.
- Failure to demonstrate clinical utility is a common barrier to coverage.
Purpose of the Study:
- To outline five essential requirements for diagnostic test clinical utility studies.
- To inform test developers on navigating reimbursement landscapes.
Main Methods:
- Qualitative review of Palmetto GBA's MolDx program decisions.
- Analysis of industry experience and publicly available coverage data.
Main Results:
- Lack of clinical utility data frequently leads to unfavorable reimbursement decisions.
- Five strategies are proposed: capture outcomes via behavior change, initiate studies early, learn from experience, employ rigorous science, and involve payers/providers from the outset.
Conclusions:
- Higher, evidence-based barriers for coverage and reimbursement necessitate demonstrating net clinical benefits.
- Early investment in well-designed clinical utility studies is essential for diagnostic test developers.
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