A drug that adds years of life would earn extra years of market protection; one that adds a few weeks would earn none. Extensions would be lost if the promised benefit is not confirmed.
Supplementary protection or regulatory exclusivity would be granted in proportion to demonstrated overall survival or cure-rate gain over the best prior standard in a randomised trial (for example one additional year of exclusivity per six months of median overall survival gain, capped at five years, with bonuses for curative-intent settings). Approvals on surrogate endpoints receive provisional extension that is confirmed or revoked when survival data mature. Regulators already collect the necessary data; the change is to the reward, not the evidence standard.
Shares Shorter exclusivity for later-in-class drugs without added benefit, Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains, Trial design, endpoints and cost.
Shares Shorter exclusivity for later-in-class drugs without added benefit, Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains, Trial design, endpoints and cost.
Shares A billion-dollar prize for the first durable cure of a lethal metastatic cancer, Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains.
Shares Launch prices indexed to the ESMO benefit scale, revisited when survival matures, Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape, Incentives reward me-too drugs and marginal gains.
Shares Accelerated approval, Overall survival (OS), Trial design, endpoints and cost.
Shares Progression-free survival (PFS), Overall survival (OS), Trial design, endpoints and cost.
Shares Progression-free survival (PFS), Overall survival (OS), Trial design, endpoints and cost.
Shares Transferable priority vouchers for first-in-class drugs, with price conditions, Incentives reward me-too drugs and marginal gains.