Exclusive: NICE to remove approval from scores of drugs for first time

Such a move would end the NHS’s statutory mandate to supply the “retired” medicines, treatments, medical devices and procedures.

The government will also develop a “single national formulary” to replace local lists of approved medicines in an attempt to further encourage clinicians to prescribe in the most cost-effective way.

The plan, due to be published tomorrow, will also confirm that some digital technologies approved by NICE will be nationally reimbursed.

The idea of “retiring” approval for therapeutic interventions, including drugs, was first floated in NICE’s 2025-26 draft corporate business plan, which was published in May and is still awaiting approval from its board. It stated the organisation would “develop an aligned approach to retiring out-of-date guidance, starting by looking at options for retiring recommendations in our clinical guidelines”.

However, the 10YHP is explicit that the regulator will begin to “re-evaluate” its recommendations on a “rolling basis” to improve value for money and effectiveness, HSJ understands. It adds “compliance” with the revised guidelines will be incentivised and connected to new tariffs designed to drive best practice.

At present, NICE does not remove its approval for interventions which have successfully completed its appraisal process, even when they are no longer recommended in guidelines as being clinically and/or cost-effective. This new policy will see those interventions not recommended having their NICE approval withdrawn.

Hundreds of technologies have been approved by NICE since its formation in 1999. HSJ understands scores could be retired following re-evaluation over the next few years.

HSJ also understands that NICE has been asking to be allowed to withdraw its approvals for many years. However, consistent lobbying from the pharmaceutical and med tech sectors persuaded consecutive Conservative governments not to act. Industry is “incandescent” about the new proposal, HSJ was told.

However, the Labour government is said by sources to be very keen on the idea, seeing it as a powerful tool to remove less effective and sometimes costly medicines from the NHS’s budget.

The NICE business plan adds that technologies which remain recommended will be prioritised by ability to “maximise population health…expand access to treatments [and release] cost savings”.

Single national formulary

The 10YHP will also seek to address variation in prescribing practice across the country by proposing the creation of a “single national formulary” (SNF) by 2028. This is intended to replace the local formularies which the plan says “do not make sense” in the context of ensuring patients receive consistent, high-quality care across the country, HSJ understands.

The idea is being driven by NHS England, particularly its primary care directorate, which is in the process of being merged with the Department of Health and Social Care.

A formulary is a list of drugs clinicians are encouraged to prescribe by default for particular indications.

A central oversight group will be created to decide which medicines should appear on the SNF. In line with the “rolling compliance” approach to be adopted by NICE, those without approval will be dropped, and the remaining medicines sequenced in an order reflecting the oversight group’s view of their cost effectiveness.

The NHSE/DHSC will “encourage” prescribers to comply with the SNF. However, clinicians will retain autonomy over decisions for individual patients as long as they act in line with NICE guidance.

Senior sources told HSJ the SNF would have the most impact in three prescribing spheres.

The first would be where NICE’s recommendation is to simply use the cheapest approved intervention. At present the calculation to determine which one meets this criteria is done more than 100 times by local prescribing committees. This will now be done once at national level.

The second sphere is the use of cheaper biosimilar alternatives to branded medicines. The SNF will aim to make selecting the rapidly growing number of alternatives easier.

The final sphere will cover those therapeutic areas in which there are a large number of treatments and medicines with different levels of clinical and cost effectiveness, making it very difficult to determine the best choice. This choice will be made easier by the prioritisation within the SNF.

Mandated digital interventions

NICE chief executive Sam Roberts used an interview with HSJ in April to call for digital therapeutic interventions approved by her organisation to be nationally reimbursed, as is the case with recommended pharmaceutical products. The statutory mandate for funding would mean relevant patients had a legal right to access the technology and could take a commissioner to court if denied.

The 10YHP backs the idea and suggests that central funding may be made available in the areas of greatest need or where such a move would support the service’s financial sustainability. The most fertile areas are believed to include dermatology – where the Skin Analytics tool has recently been approved by NICE, physiotherapy and digital weight loss tools.

However, HSJ understands this approach will only apply to a “handful” of digital therapeutics in the remaining years of this parliament because of the cost implications.