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Report findings suggest that the National Institute for Health and Care Excellence (NICE) “may be systematically undervaluing medicines for severe medical conditions”, according to the Association of the British Pharmaceutical Industry (ABPI).
Commissioned and funded by the ABPI and published by the Office of Health Economics (OHE), the report — ‘Understanding societal preferences for priority by disease severity in England and Wales’, published on 14 November 2024 — suggests that NICE’s ‘severity modifier’, which is used to assess if a medicine is clinically and cost-effective, may be blocking innovative treatments that the public would like to see benefit NHS patients.
In a statement published alongside the report, the ABPI said: “NICE may be systematically undervaluing medicines for severe medical conditions, including terminal cancer, compared to how the public expects the health system to treat these patients.”
The statement added that while NICE has committed to conducting further research into how the public would like medicines to be valued, this research could take more than two years, with no timetable set for action on the findings.
“In the meantime, the ABPI is urging the government and NICE to show greater flexibility when assessing medicines for severe conditions,” it said.
The report also found that the public is prepared to pay more for medicines that are used to treat patients with severe disease.
Paul Catchpole, director of value and access policy for the ABPI, said: “Something has got to change if the NHS is to meet the public’s expectation on how the UK treats those with severe illness. The government should step in to allow NICE the flexibility to apply the severity modifier more ambitiously so that patients can benefit.
“Specifically, we need to look at how NICE and the NHS can use the guarantees in the existing five-year cost control agreement with the pharmaceutical industry to reverse the UK’s decade-long under-investment in medicines that has seen the country fall to the bottom of international tables for some treatable and preventable diseases.
“Appropriate use of effective medicines has a vital role to play in fixing the broken NHS, and we want to work with NHS England and NICE to unlock the potential of medical innovation,” he said.
NICE introduced the severity modifier in February 2022, replacing the previous ‘end-of-life modifier’, to provide an additional weighting to the ‘value’ of some medicines that treat more severe conditions.
The OHE research found that if the severity modifier reflected public preferences, a much lower cut-offs for designating a disease as severe would be used than the ones it currently applies.
Chris Skedgel, director at OHE and lead author of the report, said: “The updated severity modifier was a welcome evolution of the previous end-of-life policy, meaning a broader definition that includes more long-term chronic conditions.
“However, our research finds a disconnect between the levels that NICE has set for its severity modifiers and the points at which the public considers a disease to be severe and very severe. Societal preference is to prioritise conditions at a much lower severity threshold than NICE’s existing policy.”
A spokesperson for NICE said: “Recent analysis shows the severity modifier is doing what it was designed to do. Treatments for cancers, including advanced cancers, are now more likely to get a positive recommendation than under our old methods.
“It has also allowed treatments for a broader range of severe diseases to be recommended for patients on the NHS, such as cystic fibrosis and hepatitis D, as well as a range of non-end-of-life cancers. This is in line with the higher value society gives to the important benefits such treatments provide.”
In September 2024, NICE reported that, up to the end of July 2024, 19 appraisals had used the updated severity weighting.
Of these, 16 appraisals (84%) resulted in a positive recommendation, including 14 appraisals for blood, bowel, breast, endometrial, gastric and lung cancers.
