BIA response to NICE consultation on refinements to its Highly Specialised Technologies (HST) routing criteria

The BIA has responded to the National Institute for Health and Care Excellence (NICE)’s consultation on proposed changes to its Highly Specialised Technologies (HST) routing criteria. The consultation closed on 30 January 2025. For further details about the consultation, please visit the consultation page on the NICE website.

Summary of BIA response and key recommendations:

• The BIA welcomes NICE’s intention to increase the clarity, predictability and transparency of the HST routing criteria. We also support the aims of NICE’s HST vision to encourage research and innovation in ultra-rare diseases and to secure equitable access to treatments for these conditions.
• However, the proposed changes would make the criteria significantly more restrictive, which contradicts the intention of the consultation and will reduce the number of products routed to HST.
• Greater clarity is needed around the definition of a disease in criterion 1 which excludes genetic subtypes when these are not ‘clinically meaningful’.
• We strongly recommend NICE removes criterion 2 as it directly contradicts the HST vision and could act as a significant barrier to patient access to treatments.
• The BIA recommends that a more pro-innovation approach should be applied to the HST criteria to ensure alignment with the HST vision, the UK Rare Disease Framework and wider Government ambitions related to growing the UK life science sector.