{"entity":{"id":"idea-reg-joint-regulator-hta-plan","kind":"idea","name":"One evidence plan agreed by regulator and payer before the pivotal trial","aka":[],"tldr":"Regulators want proof a drug works; payers want proof it is worth the price. Agreeing both requirements at once would stop drugs being approved but then not paid for.","summary":"The EU HTA Regulation (applying to oncology from January 2025) introduces joint clinical assessments and joint scientific consultations alongside EMA advice. The proposal is to extend this to a single pre-pivotal evidence plan involving the regulator, national HTA bodies (NICE, G-BA, HAS, CADTH, PBAC) and ideally large payers, agreeing comparator, endpoints, patient-reported outcomes and real-world evidence commitments so that one trial serves both approval and reimbursement.","asOf":"2026-09-08","links":[{"label":"EU HTA Regulation","url":"https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-drug-pricing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Products developed under a joint regulator-HTA plan reach reimbursement a median of nine months sooner after approval and receive fewer HTA requests for additional comparative evidence.","rationale":"The approval-to-reimbursement gap in Europe averages well over a year and is driven largely by comparator and endpoint mismatches that were avoidable at design. Aligning demands upstream is cheaper than indirect comparisons downstream.","test":"Track reimbursement timelines for oncology products that used joint scientific consultations against contemporaneous products that did not; extend joint plans to include NICE and CADTH for a pilot of ten products.","maturity":"early-clinical","actor":"payer","cost":"small","horizonYears":4},"route":"/ideas/idea-reg-joint-regulator-hta-plan/","neighbours":{"bottleneck":[{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}