BIA response to changes to NICE regulations - cost-effectiveness threshold
The BIA has responded to Department for Health and Social Care's (DHSC) consultation on changes to NICE regulations: cost-effectiveness threshold. Summary of BIA response:
- The BIA welcomes the clarity this consultation provides in establishing a clear distinction between ministerial responsibility for setting NICE’s cost-effectiveness thresholds while maintaining NICE’s operational independence in the development of its guidance and recommendations.
- However, we believe that further reform is needed to extend ministerial powers beyond amending NICE thresholds to include future methods changes that require additional investment to implement.
- We are concerned that no commitment has been made to increase HST thresholds in line with the STA threshold and urge that a proportional increase is needed to ensure patients with ultra-rare conditions can benefit from the increased thresholds and the UK commercial environment is improved for all drug developers.
- The BIA opposes the proposal to remove NICE’s duty to consult on procedural changes resulting from ministerial decisions. A transparent review process is important to ensure decisions do not translate into implementation changes that unfairly disadvantage certain populations or products.
- We are concerned that increasing the threshold alone will not address the UK’s declining attractiveness as a launch market for innovative medicines, barriers within existing appraisal frameworks, or the limitations of NICE’s cost-neutral remit.
