Going forward, the BIA will continue to work with NICE as it implements these changes to its manual
The BioIndustry Association has published a response following the release of the National Institute for Health and Care Excellence (NICE) conclusions to its review of 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 concerns, the BIA says it 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 address some of the difficulties in rare disease medicine.
Despite the positive changes, rarity in and of itself is is not adequately addressed by the changes, the Association says. Furthermore, there are concerns 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.
Going forward, the BIA will continue to work with NICE as it implements these changes to its manual.