Industry Responds to the Latest NICE Methods Review

The Association of the British Pharmaceutical Industry (ABPI) has issued a response, in an Aug. 19, 2021 press release, to the latest revisions being made to the National Institute for Health and Care Excellence (NICE) methods for assessment of drugs, devices, diagnostics, and digital technologies.

NICE, an executive non-departmental public body of the Department of Health in England, has proposed changes to its assessment approach in light of technological advances and to achieve faster and fairer access to healthcare solutions for the United Kingdom’s National Health Service (NHS). Essentially, the new approach is simplified so that only one panel of experts will decide upon what drugs and devices should be assessed, and also the criteria for very rare disease evaluations has been simplified.

“This [consultation] is a major milestone in an important review, and a significant opportunity to update the methods and processes NICE uses to support access to the life-changing medicines of today and tomorrow. The ABPI and our members will be working hard over the coming months to help make sure the proposals meet the ambition of the UK’s Life Sciences Vision and deliver meaningful change for patients, their families, and the NHS,” said Richard Torbett, chief executive of the ABPI, in a press release in response to the launch of NICE’s consultation period.

Adding to Torbett’s comments, Paul Catchpole, director of Value and Access Policy at the ABPI, stated in an opinion post, published on ABPI’s website on Aug. 19, 2021, that the consultation process for the proposed changes is affording an opportunity for industry to ensure NICE’s recommendations are cutting-edge. “A good balance has been struck in the process consultation proposals, retaining and building on NICE’s rigorous and inclusive technology appraisal processes, whilst providing opportunities to support faster access to the most promising new medicines,” Catchpole said in the post. “Early and better engagement with companies during appraisals remains essential, and industry will be seeking commitment to a set of changes which deliver real improvements, without compromising on the robustness of appraisals or on stakeholder engagement.”

However, Catchpole also iterated the need for more to be done in certain areas so that opportunities are not missed. “The wide-ranging proposals on NICE appraisal methods will be very helpful, but more should be done to deliver a more ambitious set of changes in specific areas, such as on the introduction of a new severity modifier so that more patients with challenging diseases benefit,” Catchpole asserted in the opinion post when discussing the proposed changes to NICE’s Highly Specialized Technologies (HST) evaluations.

On the proposed changes to NICE’s appraisal methods, Catchpole specified in the opinion post, “The wide-ranging proposals on NICE appraisal methods will be very helpful, but more should be done to deliver a more ambitious set of changes in specific areas, such as on the introduction of a new severity modifier so that more patients with challenging diseases benefit. We are disappointed that proposals to appropriately value the long-term benefits of potentially curative treatments such as cell and gene therapies has been missed. This will set the UK back in becoming a world leader in the development, manufacturing, evaluation and adoption of these and other ground-breaking treatments. The Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), which caps spend on medicines up until the end of 2023, means that a more ambitious set of changes than those proposed can be put in place from 2022 and at no additional cost to the system.”

The proposed changes to NICE’s approach to assessments are under public review until Oct. 13, 2021.

Sources: NICE, ABPI