UK missing opportunity to unlock medicines for severe conditions

A new report shows the public wants more support for patients with severe conditions and is prepared to value associated medicines more highly than the current levels used by NICE.

A new report from the Office of Health Economics (OHE) reveals how 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. [1]

The report, “Understanding societal preferences for priority by disease severity in England and Wales”, suggests that the public is prepared to pay more for medicines when they are used to treat patients with severe disease.

The preferences revealed in the research suggest NICE’s current ‘severity modifier’, which is used to decide if a medicine is clinically and cost-effective, may be blocking innovative treatments which the public would like to see benefit NHS patients.

While NICE has already committed to conducting further research into how the public wants medicines for severe conditions to be valued, it has set a timeline of more than two years for the research, with no timetable set for any 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.

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 underinvestment in medicines that has seen the country fall to the bottom of international tables for some treatable and preventable diseases. [2] 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.”

In February 2022, NICE introduced the severity modifier– replacing the previous end of life modifier – to provide an additional weighting to the ‘value’ of some medicines which treat more severe conditions. NICE uses an algorithm with cut-offs to determine the severity of a patient’s condition. Higher severity conditions receive a weighting which increases the chances of a positive recommendation, meaning these treatments can be used in the NHS.

The OHE research shows that if NICE’s severity modifier reflected public preferences, much lower cut-offs for designating a disease as severe would be used than those NICE currently applies. This disconnect between the public and NICE raises concerns about whether the current system adequately addresses patient needs.

When the severity modifier was introduced, NICE aimed for it to be ‘opportunity cost neutral’. This means that, all other things being equal, the total value derived from the severity modifier should be equal to that of the previous end-of-life modifier. The idea was for the severity modifier to cost the NHS no more, and no less, than the previous end of life modifier.

The ABPI argued strongly when this constraint was introduced that it would be seen to be unfair on those patients who would inevitably miss out - and miss out unnecessarily - due to other strong spending controls on the medicines budget agreed with the industry.

The Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) gives the government freedom to make ambitious changes to medicines policy, as the overall NHS branded medicines spend is capped for the next five years, with the industry directly paying back to government all expenditure over agreed levels in the form of rebates.

Chris Skedgel, Director at OHE and lead author of the report, said: “NICE is a world leader in tackling the significant challenge of getting the most health benefits for the most people out of the budget available for medicines. 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.

The challenge now is for NICE to find the right balance between maximising health and fairly distributing health. The latter is best informed by a clear understanding of the views of the population overall, and we see this study as an important contribution to that understanding.”

On the same day, the ABPI published its latest report reviewing the implementation of the NICE Health Technology Evaluation Manual. Since the introduction of the severity modifier in 2022, the ABPI has been monitoring the application of the severity modifier and publishing Continuous NICE Implementation Evaluation (CONNIE) reports. [3] 

The latest report has demonstrated that while there has been a recent increase in the use of the severity modifier, there are still treatments that would previously have been eligible for NICE’s ‘End of Life’ criteria which are now missing out on the same degree of weighting.

In September, the NICE Board decided not to change how it applies the severity modifier, meaning some patients may continue to miss out on treatments that would have been approved under the end-of-life modifier. At the same meeting NICE also re-committed to conducting further research into how the public wants medicines for severe conditions to be valued, but it set a timeline of more than two years before this work would be reported back. [4]