{"entity":{"id":"idea-reg-provisional-price-until-os","kind":"idea","name":"Provisional prices for surrogate-endpoint approvals, reset when survival data arrive","aka":[],"tldr":"Drugs approved on early signs of benefit are paid for as if they had proved they extend life. Pay a provisional price and adjust it, up or down, when the survival data come in.","summary":"Most accelerated oncology approvals rest on response rate or progression-free survival, and a substantial share later fail to show survival benefit, yet prices are set at launch and rarely fall. Coverage-with-evidence-development schemes exist (the UK Cancer Drugs Fund, Germany's post-launch benefit reassessment) but price adjustment is negotiated rather than automatic. The proposal is a contractual price schedule fixed at launch: a provisional price, a higher price if the confirmatory trial shows survival benefit above a threshold, a sharply lower price or rebate if it does not, with the payer co-funding registry follow-up.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Prices and value): Prasad, De Jesús & Mailankody, The high price of anticancer drugs: origins, implications, barriers, solutions (Nat Rev Clin Oncol 2017)","url":"https://doi.org/10.1038/nrclinonc.2017.31"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["accelerated-approval","pfs","os"],"trials":[],"people":[],"bottlenecks":["b-drug-pricing","b-regulatory-fragmentation"],"keyPapers":["paper-prasad-nat-rev-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Automatic reset contracts reduce payer spend on drugs that fail confirmatory trials by at least half and do not reduce the speed of uptake of drugs that later confirm benefit.","rationale":"Aligning price to eventual evidence rewards drugs that work and shares the uncertainty that accelerated approval creates, instead of placing it entirely on payers and patients.","test":"Model the scheme retrospectively on the last decade of accelerated oncology approvals in one market; then apply prospectively to all new conditional approvals for five years.","maturity":"early-clinical","actor":"payer","cost":"small","horizonYears":5},"route":"/ideas/idea-reg-provisional-price-until-os/","neighbours":{"term":[{"id":"accelerated-approval","kind":"term","name":"Accelerated approval","route":"/terms/accelerated-approval/"},{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"pfs","kind":"term","name":"Progression-free survival (PFS)","route":"/terms/pfs/"}],"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/"}],"paper":[{"id":"paper-prasad-nat-rev-clin-oncol","kind":"paper","name":"The high price of anticancer drugs: origins, implications, barriers, solutions","route":"/key-papers/paper-prasad-nat-rev-clin-oncol/"}]}}