Understanding medicines access: a look at the severity modifier and its impact

Deciding which medicines the NHS should fund is one of the most difficult jobs in public life, and the UK has a fairly unique approach compared to other countries.

As in all countries, medicines need to be proven safe and effective for use in patients, a rigorous assessment done by the medicines regulator.

Next medicines then go through a complex health technology assessment (HTA) to ensure they represent a good use of NHS funding. In England, this is done by the National Institute for Health and Care Excellence (NICE), which uses various statistical and economic methods to calculate how much additional value a medicine provides, regardless of what disease the medicine is used to treat, this work also impacts the systems used in Wales and Northern Ireland.

In recent years, NICE has introduced a new way of deciding how much value to assign to some treatments, which is called the severity modifier. But what exactly is the severity modifier, and why is it important?

What is the severity modifier?

In February 2022, the severity modifier was introduced to provide an additional weighting to the ‘value’ of some medicines which treat more severe conditions. Previously, NICE applied an “end-of-life” modifier to support access to some treatments for cancer patients with short life expectancies. The severity modifier has replaced this, offering a broader approach and potentially benefitting patients with a wider range of conditions than was the case with the end-of-life modifier.

NICE uses an algorithm to determine the severity of a patient’s condition—classifying it as high, medium, or none. High severity conditions receive a 1.7 times weighting, and medium severity conditions receive a 1.2 times weighting. Obtaining a weighting increases the chances of a positive recommendation, meaning these treatments can be used in the NHS and patients with severe conditions are more likely to access the medicines they need.

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, or no, less than the previous end of life modifier.

Why opportunity cost neutrality does not have to be a goal?

Sticking to this strict rule of being opportunity cost neutral is not necessary because the pharmaceutical industry capped the NHS medicines bill as set out in the medicines pricing scheme agreed between government and the pharmaceutical industry, called the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG). Through VPAG, the overall branded medicines spend is capped for the next 5-years between government and industry with the industry paying back all expenditure over agreed levels in the form of rebates.

Given this context, there is room for much more flexibility in how the severity modifier is applied. By allowing for deviation from opportunity cost neutrality, the NHS could potentially deliver broader access to newer, more effective treatments for severe conditions, better reflecting the value that patients place on these treatments.

What does this mean for patient access?

While the concept of the severity modifier was generally welcomed as a positive development, its implementation has raised some concerns about patient access to medicines. One key issue is that the opportunity cost neutral approach could inadvertently limit access to late-stage treatments for some patients with severe diseases. Essentially, if NICE sticks too rigidly to this opportunity cost neutral approach, it might mean that some high-value treatments are not funded, leaving patients without potentially life-extending  options.

The ABPI regularly gathers data from companies on their NICE appraisals and publishes Continuous NICE Implementation Evaluation (CONNIE) reports. The latest report can be found here.

The recent analysis suggests that the way in which the severity modifier has been applied so far is on a more conservative basis than is needed, even to deliver opportunity cost neutrality. Some medicines previously eligible for the end-of-life modifier are now ineligible for the highest severity weighting under the new system, resulting in some cancer medicines not being recommended by NICE with patients missing out on access.

What needs to change to improve patient access?

The severity modifier represents a step forward in how the NHS evaluates medicines for severe conditions. However, it remains critical to balance its application in practice with the need for flexibility to ensure that patients can access the widest range of innovative treatments possible.

The ABPI believes that NICE should immediately review the severity modifier to adjust downwards the cut-off levels used to determine the degree of severity so that more medicines can benefit. Any changes necessary should be made quickly to ensure that the NHS does not go backwards in serving patients suffering from severe diseases.

The ABPI would like to see NICE replace the opportunity cost-neutral approach to implementing the modifier. Instead, NICE should use an approach that is evidence-based and better reflects societal preferences for helping people with severe disease to access innovative treatments.