Health technology assessment (HTA), reimbursement and QALYs
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 about £20,000-30,000 per QALY (higher for end-of-life treatments), 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.
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