{"entity":{"id":"idea-bio2-mrd-coverage-with-evidence","kind":"idea","name":"Pay for residual disease tests only inside a trial or registry","aka":[],"tldr":"Leftover-cancer blood tests are being sold faster than evidence that acting on them helps. Paying for them only when the result is recorded would generate the missing evidence.","summary":"MRD testing is spreading through routine care ahead of randomised evidence that intervention on a positive result improves survival. Coverage with evidence development (reimbursement conditional on enrolment in a registry or trial with mandatory outcome submission) turns uncontrolled adoption into a data-generating engine, as it has for some devices and PET indications.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Dormant cells and minimal residual disease): Tie et al., ctDNA analysis guiding adjuvant therapy in stage II colon cancer (NEJM 2022)","url":"https://doi.org/10.1056/NEJMoa2200075"}],"tags":[],"related":["seer","clinicaltrials-gov"],"cancers":[],"sections":[],"technologies":["mrd-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["real-world-evidence"],"trials":[],"people":[],"bottlenecks":["b-dormancy-mrd","b-real-world-evidence","b-incentive-misalignment"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Conditional coverage produces an analysable dataset of over 50,000 tested patients with linked outcomes within three years, and identifies at least one tumour setting where MRD-guided intervention does not help.","rationale":"The National Oncologic PET Registry showed that conditional coverage can produce practice-changing evidence quickly at low cost. The alternative, unconditional payment, has repeatedly left the field with widespread use and no answer.","test":"One national payer or insurer pilots conditional coverage for one tumour type, publishing enrolment, completeness of outcome capture and cost per patient after 18 months.","maturity":"speculative","actor":"payer","cost":"small","horizonYears":3},"route":"/ideas/idea-bio2-mrd-coverage-with-evidence/","neighbours":{"collection":[{"id":"clinicaltrials-gov","kind":"collection","name":"ClinicalTrials.gov","route":"/collections/clinicaltrials-gov/"},{"id":"seer","kind":"collection","name":"SEER (Surveillance, Epidemiology, and End Results)","route":"/collections/seer/"}],"technology":[{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"}],"term":[{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-dormancy-mrd","kind":"bottleneck","name":"Dormant cells and minimal residual disease","route":"/bottlenecks/b-dormancy-mrd/"},{"id":"b-incentive-misalignment","kind":"bottleneck","name":"Incentives reward me-too drugs and marginal gains","route":"/bottlenecks/b-incentive-misalignment/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}],"paper":[{"id":"paper-imvigor011-nejm-2025","kind":"paper","name":"IMvigor011: using a blood test for leftover cancer to decide who gets immunotherapy after bladder surgery","route":"/key-papers/paper-imvigor011-nejm-2025/"}],"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}