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

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

“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/FreeDigitalPhotos.net.

Pharmaceutical Technology Excellence Awards - Nominations Closed

Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact.

Excellence in Action
Imagene’s Oncology Intelligence (OI) Suite has won the Innovation Award for Precision Oncology, for transforming how pharma designs and runs oncology trials. From AI-driven biomarker discovery to smarter patient stratification, see how Imagene is cutting time, cost and risk in cancer drug development.

Discover the Impact