UK's NICE to takeover role of assessing high-cost rare disease drugs

In the UK, the role of assessing very high cost drugs for people who suffer with rare conditions, under the Health and Social Care Act 2012, currently managed by the Advisory Group for National Specialised Services (AGNSS), will pass to the country’s main drugs watchdog, the National Institute for Health and Clinical Excellence (NICE), which has long been criticized by pharmaceutical companies for keeping expensive medicines out of the reach of National Health Service patients.

Giving this role to the NICE, from April 2013, will create an impartial and robust mechanism for providing independent recommendations on which drugs the NHS Commissioning Board should commission as part of its new role of national commissioner for specialised services. The NICE will develop interim methods for the first few drug assessments and will take forward a consultation exercise in 2013/14 to ensure the process put in place is robust, transparent and consistent.

Health Minister Lord Howe said: “The assessment of very high cost drugs for patients with rare conditions is an important strand of work of AGNSS which needs to be properly secured for the future. Our decision to give this work to NICE from April 2013 means that there will be a robust, independent and transparent assessment of these drugs. NICE has built up a richly deserved international reputation for its work. In taking this work over from AGNSS, NICE will wish to build on the decision-making framework that AGNSS has developed to ensure that the needs of people with rare and very rare conditions are properly considered.”