# One evidence plan agreed by regulator and payer before the pivotal trial

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

## TL;DR

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.

## Fields

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

## Sources

- EU HTA Regulation: https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en

## Connected records

- bottlenecks: [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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