NICE Consultation on Highly Specialised Technologies Routing Criteria

Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, highlights an open consultation on Highly Specialised Technologies.

The National Institute for Health and Care Excellence (NICE) has launched a public consultation on the refinement of its Highly Specialised Technologies (HST) assessment process. This consultation aims to enhance the transparency, consistency, and efficiency of routing decisions for highly specialised technologies, aligning with the broader vision of the UK Rare Diseases Framework.

Examples of technologies previously included in the HST process are Voretigene neparvovec (Luxturna), a gene therapy to treat inherited retinal dystrophies; Eculizumab (Soliris), a medication for treating atypical hemolytic uremic syndrome, a rare disease that causes abnormal blood clotting and can lead to kidney failure; and Elosulfase alfa (Vimizim), an enzyme replacement therapy to treat Morquio A syndrome, a rare metabolic disorder that affects bone development.

NICE is seeking to:

• Enhance the clarity and application of the criteria.
• Improve the transparency of routing decisions by publishing HST assessment checklists.
• Promote efficient decision-making and reduce the need for further clarification.
• Ensure timely access to effective technologies for people with ultra-rare conditions[1].

Professor Jonathan Benger, Chief Medical Officer at NICE, said: “We recognise that we can do more to help provide better clarity around how decisions are made. This is why we are proposing changes to the wording of the 4 criteria to ensure fairer and more predictable decisions. We’ve also included new qualifying statements to help with extra consistency and transparency.”

The consultation runs until 30^th January.

The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.