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Approval says a drug works; reimbursement says who will pay. Health technology assessment bodies (NICE, G-BA, PBAC) judge whether the benefit is worth the price, often per quality-adjusted life year, and can delay access for years after approval.
A QALY is one year of life in perfect health; NICE's threshold is £25,000-35,000 per QALY, raised from £20,000-30,000 on 2 April 2026, with a severity modifier that weights QALYs by 1.2 or 1.7, and drugs above it are rejected or admitted via managed access schemes such as the Cancer Drugs Fund with confidential discounts. Germany assesses added benefit and negotiates price after a year of free pricing; France's HAS grades clinical benefit; the US has no national HTA and Medicare must cover approved cancer drugs, though ICER publishes non-binding assessments and the IRA now permits Medicare negotiation. The gap between approval and reimbursement (often 1-2 years in Europe, longer in middle-income countries) is a major access bottleneck.
Shares Jonathan Benger, Innovative Medicines Fund (England), Bundesinstitut für Arzneimittel und Medizinprodukte, National Healthcare Security Administration.
Shares Lionel Collet, France: early access (accès précoce), formerly ATU, EU HTA Regulation (EU) 2021/2282: joint clinical assessments, Real-world evidence.
Shares Bundesinstitut für Arzneimittel und Medizinprodukte, Deutsche Krebsgesellschaft, AMNOG (Germany, 2011), EU HTA Regulation (EU) 2021/2282: joint clinical assessments.
Shares Innovative Medicines Fund (England), France: early access (accès précoce), formerly ATU, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Cancer Drugs Fund (England).
Shares NICE technology appraisal methods (2022), ILAP (Innovative Licensing and Access Pathway), Real-world evidence.
Shares Robyn Ward, Real-world evidence.
Shares ILAP (Innovative Licensing and Access Pathway), Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA), Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation.
Shares France: early access (accès précoce), formerly ATU, EU HTA Regulation (EU) 2021/2282: joint clinical assessments, Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA).