At its meeting today (25 September 2024) NICE's Board concluded
the new severity modifier is working as intended and is allowing
more medicines for severe, often life-long conditions to be
recommended on the NHS.
The new modifier was introduced in 2022 to allow extra weight to
be given to medicines that address severe diseases.
The review found:
- Where the new severity weighting has been used there has been
a higher proportion of positive recommendations (84.4%) compared
with the end-of-life modifier (82.7%) it replaced.
- The severity modifier has been applied to diseases including
non-end-of-life cancers as well as non-cancer conditions that
have dramatic and far-reaching impacts on patients, such as
cystic fibrosis, which would not have qualified for additional
weighting under the previous criteria.
- Medicines for late-stage cancers are being recommended
following the change, including for colorectal, lung and breast
cancers.
- The proportion of positive cancer recommendations is higher
(80%) than with the end-of-life modifier (75%) and the proportion
of positive recommendations for advanced cancer treatments is
also higher (81% compared to 69%).
NICE has been monitoring the use of the severity modifier and
presented an analysis to its Board.
Dr Sam Roberts, chief executive of NICE, said:
“The analysis shows the severity modifier is doing what it was
designed to do. It has 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.”
Up to the end of July 2024, 19 appraisals have involved the
updated severity weighting. 16 (84%) have resulted in a positive
recommendation, including 14 positive appraisals for blood,
bowel, breast, endometrial, gastric and lung cancers.
The introduction of the severity modifier has also seen positive
recommendations for treatments for cystic fibrosis and chronic
hepatitis – neither of which would have qualified for an
additional weighting under the old system.
The change to severity had to remain opportunity cost neutral.
This is important because a larger severity modifier would have
squeezed out more care, and therefore more health benefits, for
patients elsewhere in the NHS. This is a key constraint NICE
works under and any change to NICE methods that were cost
inflationary would have to be approved by the Department of
Health and Social Care.
The Board also agreed to continue to monitor the impact of the
change. As part of that work, it will commission additional
research into societal preferences in relation to severity.
The review also found:
- Almost a third of the decisions during the timeframe of the
review that were considered likely to have met the old
end-of-life criteria achieved the highest 1.7 weighting for
severity - showing that NICE committees still give precedence to
drugs that extend life in its decision making.
- Appraisal decisions published between January 2022 up until
the end of July 2024 received an average severity weight of
1.125. This compares to an average severity weight of 1.122 for
decisions published between January 2009 and March 2021 for which
severity weightings could be estimated.
- Since the introduction of the broader access to additional
weighting 98% of the decisions that did not attract any
additional weighting under the severity modifier would not have
been eligible for any additional weighting under the previous
end-of-life criteria either.
- Only 1 of the 22 decisions estimated to have met the-end-of
life criteria (5%) did not achieve an additional weighting under
the severity modifier. This topic was for a first line non-small
cell lung cancer treatment, dabrafenib with trametinib for
treating advanced BRAF V600 mutation-positive NSCLC (TA898). It
received a positive recommendation without a severity
weight.
11 of the 69 decisions estimated not to have met the old
end-of-life criteria (16%) achieved additional weighting under
the new severity modifier, 3 of which achieved a weight of 1.7.
- The Board paper ‘Review of the implementation of the severity
modifier' is available on the NICE website.
