The National Institute for Health and Care Excellence (NICE) has now begun formally consulting on its plans to introduce changes to the way it makes recommendations on new medicines and other treatments for use in the NHS.
The new proposals would incorporate two new “value elements” - burden of illness and wider societal impact - into NICE appraisals. The Institute is consulting on ways to take the concept of “burden of illness” into account “more explicitly and systematically,” and proposes that this would replace the current approach in which NICE’s appraisal committees consider life-extending treatments used at the end of life, while the “wider societal impact” element concerns the wider impact of a disease on people’s ability to be part of society.
However, NICE has again made it clear that its appraisal committees will not use the age of people with particular conditions as the basis for deciding whether or not the NHS should offer new treatments, nor will they use gender or any of the other “protected” characteristics under equalities legislation.
“Regardless of the way the proposals in this paper are incorporated into the appraisal process, we will ensure that age or any of the other protected characteristics will not tip the balance of a recommendation against the use of a treatment,” the consultation document emphasises.
Commenting, Paul Catchpole, director of value and access at the Association of the British Pharmaceutical Industry (ABPI), said that NICE’s current process denies too many patients the medicines they should be entitled to, and is now inappropriate for many of the new medicines now being developed by the industry. But value-based assessment has the potential to allow NICE to use a broader definition of value to reflect more fully the value that medicines bring to patients and society.
Also, the new Pharmaceutical Price Regulation Scheme (PPRS), under which the industry will make payments to underwrite all expenditure above agreed growth levels in the UK medicines bill for five years, presents an opportunity for NICE to look at value-based assessment differently, taking a more “pro-innovative” approach, he said.
“We need to see increased predictability in the system and clearer frameworks on how decisions are made so that pharmaceutical companies and the NHS can appropriately plan around patients’ needs. The vital role of patients should not be overlooked by NICE when assessing medicines, and we hope the opportunity will also be taken to allow greater contributions from patients and clinicians in the appraisal decision-making process,” said Mr Catchpole.
He also noted the ABPI's “particular concern” about the potential impact of incorporating NICE’s existing “end of life” criteria into the new system.
“We need to ensure that this does not lead to fewer medicines, for patients at their end of their life, being approved. There is currently an issue with NICE approving too few new cancer medicines, which the new agreement must address,” said Mr Catchpole.
The consultation will run until June 20, after which the NICE Board will consider the final changes and they will be introduced in the autumn.