Methods / process manual consultation

This consultation aims to ensure that future routing decisions for highly specialised technologies (HST) are more transparent, consistent, efficient, and predictable and are aligned to the HST vision. 

HST context  

NICE inherited the 7 highly specialised technologies (HST) routing criteria from AGNSS (Advisory Group for National Specialised Services) in 2013. Following that, the NICE Highly Specialised Technologies (HST) Programme was established to provide guidance on suitable technologies.   

In January 2021, the UK Government published the UK Rare Diseases Framework, a national vision to improve the lives of the approximately 3.5 million people in the UK living with rare diseases. To support the UK Rare Diseases Framework in identifying clinically effective and cost-effective technologies for people with ultra-rare diseases, NICE updated the HST routing criteria (from 7 to 4 criteria) in 2021/22. To further enhance transparency, predictability and consistency in routing decisions, NICE is further refining the HST routing criteria in 2024/25.    

Why are we doing this – what is the aim of the HST criteria refresh?  

The purpose of the proposed refinement to the criteria is to:  

  • Enhance the criteria to be more explicit and objective without changing the essence or intent  
  • Provide additional guidance and clarity on the application of criteria to improve the transparency of routing decisions  
  • Neither increase nor decrease the number of medicines routed to the HST programme  
  • Promote efficient decision-making for HST routing decisions and reduce the need for further clarification.  

Process improvements 

If the aims of the work are met, then the routing process should be more timely and efficient.  This will mean that NICE can get effective technologies to people living with ultra rare conditions more quickly.   Additionally, we aim to enhance the transparency of routing decisions by publishing HST assessment checklists (see Appendix B) for all technologies considered.  We are also trying to enhance our horizon scanning work in the ultra-rare disease space to proactively ensure the validity of our approach to the consideration of highly specialised technologies.  Finally, will also promote our offering to manufacturers of ultra-rare technologies to clarify our processes and support evidence generation in advance of a NICE evaluation 

What do we want views on? 

We want to know what stakeholders think of the proposed refreshed HST criteria.  We would like to know if you think that the proposals will meet the aims of the work.  We are also keen to hear from stakeholders as to how we can further improve the proposals to improve the objectivity, transparency and predictability of our HST routing decisions. 

How will comments on the consultation be considered? 

We will publishing a thematic response to the consultation comments and will not be responding directly to individual stakeholders.  All comments will be reviewed by NICE and associated changes made to the proposals based on the feedback that we receive. 

How to comment 

Please read both the consultation document and the supporting information before making any comments. 

We have a new way of making comments on this consultation. You must make your comments directly onto the online version of the consultation document. When you go into the document you will find instructions on how to use the new commenting software. You can also review and edit your comments before you submit them.  

You can download a PDF version of the consultation document, but you can only make comments on the online version.  

If you wish to comment on this consultation, please create and activate a NICE Account first at https://accounts.nice.org.uk/register     

You can then sign into the Consultation area via the Draft Consultation Document (online commenting) link.  

Consultation document 

Supporting documents 

Closing date for comments: 5pm, 30 January 2025 

About the consultation  

We have asked some questions about the consultation that we would like you to answer. You will be able to see the questions when you go into the online consultation document.    

We would also like you to think about whether there are any aspects of the recommendations that need particular consideration to make sure we avoid unlawful discrimination against any group of people. For example, on the grounds of:  

  • race  
  • gender  
  • disability  
  • religion or belief  
  • sexual orientation  
  • age  
  • gender reassignment  
  • pregnancy and maternity  

After the consultation has closed, we will meet again to consider the responses received and prepare the final document.

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