# Provisional prices for surrogate-endpoint approvals, reset when survival data arrive

Source: https://onco.cc/ideas/idea-reg-provisional-price-until-os/  
OnCo record `idea-reg-provisional-price-until-os` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- Bottleneck evidence (Prices and value): Prasad, De Jesús & Mailankody, The high price of anticancer drugs: origins, implications, barriers, solutions (Nat Rev Clin Oncol 2017): https://doi.org/10.1038/nrclinonc.2017.31

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [Overall survival (OS)](https://onco.cc/terms/os/), [Progression-free survival (PFS)](https://onco.cc/terms/pfs/)
- bottlenecks: [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- key papers: [The high price of anticancer drugs: origins, implications, barriers, solutions](https://onco.cc/key-papers/paper-prasad-nat-rev-clin-oncol/)

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