Loading
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.
Shares Regulatory divergence between regions, Prices and value.
Shares Regulatory divergence between regions, Prices and value.
Shares Regulatory divergence between regions, Prices and value.
Shares Regulatory divergence between regions, Prices and value.
Shares Regulatory divergence between regions, Prices and value.
Shares Regulatory divergence between regions, Prices and value.
Shares Regulatory divergence between regions, Prices and value.
Shares Regulatory divergence between regions, Prices and value.