OnCo
ideasIdea

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

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.

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.

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.
What would test it
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
Who has to act
payer
Cost to try
Small (under $1M)
Years to first evidence
4
Bottlenecks it attacks
  • Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
  • Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.

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Prices and valueRegulatory divergence between regions