{"entity":{"id":"idea-tr2-biomarker-cwe","kind":"idea","name":"Pay for new biomarker tests only while evidence of clinical utility is being collected","aka":[],"tldr":"Most genomic and liquid biopsy tests are reimbursed on analytical validity and association with outcome, not on proof that they improve care. Paying for new oncology biomarker tests only inside registries or randomised studies, as Medicare did for PET, would sort the useful from the useless.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Biomarkers are not validated or standardised): Fernandez et al., Examination of low ERBB2 protein expression in breast cancer tissue (JAMA Oncology 2022)","url":"https://doi.org/10.1001/jamaoncol.2021.7239"}],"tags":[],"related":["idea-tr2-payer-combo-cwe"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["real-world-evidence","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":["b-biomarker-validation","b-drug-pricing"],"keyPapers":["paper-fernandez-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"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.","test":"Apply the programme to three new tests in one payer; measure time to evidence and coverage decisions.","maturity":"early-clinical","actor":"payer","cost":"medium","horizonYears":3},"route":"/ideas/idea-tr2-biomarker-cwe/","neighbours":{"idea":[{"id":"idea-tr2-payer-combo-cwe","kind":"idea","name":"Payers cover off-label combinations only inside registry-randomised trials","route":"/ideas/idea-tr2-payer-combo-cwe/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"}],"paper":[{"id":"paper-fernandez-jama-oncol","kind":"paper","name":"Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue","route":"/key-papers/paper-fernandez-jama-oncol/"}]}}