NICE

Also known as: National Institute for Health and Care Excellence

The UK body that decides whether the NHS will reimburse a drug, based on cost-effectiveness.

Definition

The National Institute for Health and Care Excellence (NICE) is the UK body that issues guidance on whether the NHS in England (and largely in Wales/Northern Ireland) should reimburse a drug, primarily based on cost-effectiveness measured in cost per quality-adjusted life-year (QALY). The standard willingness-to-pay threshold is £20,000–£30,000 per QALY, rising to £100,000+ for end-of-life and orphan indications.

See also

• QALY — A measure combining length and quality of life used in cost-effectiveness analysis.
• HTA — The systematic evaluation of a medicine's clinical and cost-effectiveness for reimbursement decisions.

Other regulatory terms

• NDA
• BLA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Accelerated approval