ideasIdea

Pay for new biomarker tests only while evidence of clinical utility is being collected

Insurers pay for many cancer tests that have never been shown to improve outcomes. Paying only inside studies that measure whether the test helps would sort the useful from the useless.

Most genomic and liquid biopsy tests are reimbursed on analytical validity and association with outcome, not on demonstrated clinical utility. Coverage with evidence development, used by Medicare for PET and for some genomic tests, ties payment to enrolment in a registry or randomised study. Applying it systematically to new oncology biomarker tests would generate utility evidence at the scale of routine practice and remove payment for tests that fail.

Hypothesis

Tests entered into coverage-with-evidence programmes will reach a definitive utility answer within four years in at least half of cases, and at least a quarter will lose coverage on the evidence.

Rationale

The National Oncologic PET Registry produced evidence that changed coverage for FDG PET; the model has been under-used for molecular tests.

What would test it

Apply the programme to three new tests in one payer; measure time to evidence and coverage decisions.

Maturity

early clinical

Who has to act

payer

Cost to try

Medium ($1M to $50M)

Years to first evidence

Bottlenecks it attacks

Biomarkers are not validated or standardised · Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab.
Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.

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Pay for new biomarker tests only while evidence of clinical utility is being collected

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bottlenecks