CMAC responded to the National Institute for Health and Care Excellence’s consultation on their proposed changes to the routing criteria for Highly Specialised Technology (HST) evaluations.
CMAC were pleased to see a focus on HST and ultra-rare diseases and a consultation to provide further clarity and transparency about HST routing; however, we felt the proposed criteria were too restrictive and were disappointed by the lack of ambition for this review and revision.
It felt like the amended criteria and definitions were developed primarily to reduce the risk of the HST route being used for commercial gain, rather than being developed to improve the process for patients by supporting the reimbursement of treatments for ultra-rare diseases.
We also had serious concerns about the proposed criteria to exclude any technology involved in clinical trials for other indications from HST evaluations. We believed this criterion could stall innovation for rare diseases and prevent a potential HST drug from being investigated for other highly beneficial indications.
