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Fast-track process and price cap limit for new drugs in the NHS set out by NICE

NHS patients in England are to get faster access to cost-effective new drugs under plans announced by the National Institute for Health and Care Excellence (NICE).20 Mar 2017

Changes have been agreed to the way NICE approves drugs which could see some medicines approved for use within a month of being licensed, it said. Drugs that deliver "a likely cost per extra year of quality-adjusted life of under £10,000" will be eligible for the fast-track process that NICE has approved.

The fast track process could be extended in future to other drugs and types of treatment too, NICE said, such as medical devices and diagnostics.

NICE has also set a £20 million limit on the cost of drugs in any of the first three years in use in the NHS. If the limit would be exceeded "commercial discussions" would take place between the drugs manufacturer and NHS England "to mitigate the impact on the rest of the NHS", NICE said. Where a dispute arises over the cost of drugs, NHS England would be able to apply to NICE to use the drugs "in a phased way", generally for up to three years maximum, NICE said.

Special rules will apply to drugs for very rare diseases. NICE said that the costlier those medicines are the "greater the health benefit it must provide" to win approval for "routine NHS use".

Sir Andrew Dillon, NICE chief executive, said: “We are taking forward the proposal for more flexibility in the adoption of technologies into the NHS which are cost effective but which have a predicted budget impact of £20 million or more during the first 3 years. Companies will have the opportunity of confidential negotiations with NHS England, to help avoid and minimise delays in patients having access to treatments recommended by NICE. We have agreed that we will review this in three years to see what impact it is having on allowing access to new drugs."

"We believe these and the other changes that have now been approved will enhance our ability to optimise access to innovative treatments in the light of the significant financial challenge facing the NHS," he said.

NICE also said that it had increased the cost limit up to which it would authorise the use of highly specialised treatments in the NHS in England. The limit of a likely cost per extra year of quality-adjusted life of £300,000 is triple that which NICE had first proposed.

NHS England’s acting director for specialised commissioning, John Stewart, said: “As well as significantly speeding up access for patients for the most cost effective new technologies, NICE’s new approach also shows that the NHS is prepared to pay far more for highly specialised treatments that can transform patients’ quality of life.

“These are not easy decisions, but we are committed to working closely with companies that are willing to price their products responsibly and this new flexibility will help us develop innovative win/win/win agreements – good for patients, good for taxpayers and good for those companies that are willing to price responsibly," Stewart said.