Managing Oncology Drug Costs in a Constrained Environment

摘要

PC Nearly all countries have an organization that assesses and approves drugs for clinical practice based on 3 regulatory hurdles: efficacy, safety, and quality. The US Food and Drug Administration serves this role in the United States, and the European Medicines Agency does so in Europe. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) adds a fourth hurdle for drug approval: cost-effectiveness. NICE evaluates how the cost of the drug and its effect on the treatment pathway balance with the improvements in quality of life and prolonged survival. In other words, for each intervention, NICE determines how much extra money the National Health Service (NHS) has to pay for the additional gains in health its patients receive. Drugs these days are licensed based on relatively early data, often with surrogate endpoints and short follow-up. NICE must therefore evaluate the modeling of longer-term outcomes of clinical benefit and economic consequences for all licensed drugs. NICE considers the most reasonable assumptions concerning clinical benefit and economic cost, and then decides whether or not to recommend the drug to the NHS in England. The standard threshold for all drugs is between ￡20,000 and ￡30,000 per quality-adjusted life-year (QALY). The amount varies based on the certainty of the committee's conclusion. If the committee is very confident about the results of its analyses, the cost can increase up to ￡30,000 per QALY. If it is less certain, it will use the lower limit of ￡20,000 per QALY.