Proposal for value-based, tiered reimbursement for tumour biomarker tests to promote innovation and evidence generation

J Clin Oncol

25 September 2019 - Cancer precision medicine depends on high-quality tumour biomarker tests for treatment selection. 

Tumour biomarker tests (TBT) reimbursement within the United States in the current regulatory environment is not tied to premarket evidence of clinical utility, resulting in a vicious cycle wherein low-level evidence of utility leads to poor reimbursement, thereby impeding investment in developing new, clinically valuable TBTs supported by high-level evidence. Rational, value-based TBT pricing presents many practical challenges. 

We propose three use contexts of TBTs, each defined by its influence on treatment decisions relative to the current standard of care—Opt-Out, Opt-In, and the use of appropriate, alternative, effective therapies.

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Michael Wonder

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Michael Wonder