The UK National Institute for Health and Care Excellence (NICE) board has approved changes to the drug evaluation process.

The introduction of a new fast-track option for appraising treatments, a budget impact test and evaluating drugs for very rare diseases against a sliding scale are among the several changes made to the NICE processes.

These changes have been approved following a joint public consultation with NHS England, and aim to address the challenge of providing faster access to the most cost-effective treatments to patients.

In addition, they are designed to safeguard the NHS’ future financial sustainability.

NICE chief executive Sir Andrew Dillon said: “We’ve listened carefully to what stakeholders have been telling us throughout this consultation and made some important changes, as well as adding detail to our proposals.

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“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.”

The new fast-track appraisals offer exceptional value for money and will apply to drugs with a likely cost per extra year of quality-adjusted life of under £10,000. The upper limit of the standard NICE threshold range is £20-30,000 per QALY.

It will be rolled out to more treatments, including medical devices and diagnostics, over the next two years.

Under the new budget impact test measure, any new treatment costing the NHS more than £20m a year should trigger a negotiation over the way the treatment is funded.

Additionally, if these negotiations are not successful, NHS England will be able to apply to delay the introduction of the drug, which will usually be for no more than three years.

"We recognise the funding pressures that currently exist for the NHS, but we believe the budget impact test is not the right tool to fix this complex challenge."

Commenting on the test, charity organisation Alzheimer’s Research UK chief executive Hilary Evans said: “Alzheimer’s Research UK has significant concerns that this measure could mean delays for people with dementia accessing future treatments.

"There is a huge unmet need and with so many people likely to benefit from any new dementia drugs, it is very possible that such treatments may cost more than £20m a year.

"We recognise the funding pressures that currently exist for the NHS, but we believe the budget impact test is not the right tool to fix this complex challenge."

The changes will be introduced for topics for which a first evidence submission is received after 1 April.

Image: Different types of medicines. Photo: courtesy of jk1991/