BIA response to conclusion of NICE methods and processes review

The National Institute for Health and Care Excellence (NICE) has published its conclusions to its review of its methods and processes for Health Technology Assessments. 

Steve Bates OBE, Chief Executive of the BioIndustry Association (BIA) said: “While the review has brought some positive changes, its scope has failed to match the ambition set out at the start of the review and does not deliver on the promise of a “high ambition” methods review set out in the Government's Life Sciences Vision. By not being bolder in reform, this is a missed opportunity to ensure NICE retains its global leadership in the evaluation and appraisal of new medicines and technologies. Other countries are innovating and evolving their HTA systems faster.

“As we all seek to cement the UK's standing as a world leader for the access and uptake of new innovative treatments and technologies, we are concerned that NICE, by sticking so closely to a methodological process devised a generation ago, may struggle to keep pace with other UK system partners in delivering an ecosystem that enables innovative life science companies to grow.”

“It is particularly disappointing that the discount rate did not remain within the scope of the review given that NICE continues to recognise the evidence-based case for changing the reference-case discount rate to 1.5%. While we recognise that NICE has been limited by wider policy and fiscal constraints, we are concerned that failure to bring the discount rate in line with the HM Treasury Green Book will undermine the Government's ability to position the UK as a first-launch country for innovative new treatments. The BIA would welcome a broader conversation, involving other parts of government, to address these constraints.”

Despite these disappointments the BIA welcomes NICE's decision to allow its committees to accept a greater degree of uncertainty in their decision-making where evidence is difficult to obtain. Alongside plans to accept a more comprehensive evidence base, these changes will help to address some of the difficulties faced by rare disease medicines.

However, despite the positive changes, rarity in and of itself is a specific challenge that the BIA feels is not adequately resolved by these changes. Furthermore, there are concerns that the changes to the criteria for entry to the Highly Specialised Technologies (HST) programme could restrict the number of treatments for very rare diseases that are eligible, further limiting patient access to these treatments.

The BIA would like to thank NICE for all of the work that has gone into this review over the past two years, including for its continued engagement with industry and other stakeholders throughout the process. We would also like to thank the BIA members who have supported us in this engagement.

Going forward, the BIA will continue to work with NICE as it implements these changes to its manual, and in the longer term we look forward to engaging with NICE through its new "modular update" approach.