Suggested remit: To appraise the clinical and cost effectiveness of nusinersen and risdiplam within their marketing authorisations for treating spinal muscular atrophy.

Status:
In progress
Technology type:
Medicine
Decision:
Selected
Reason for decision:
Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Rationale:
Scoping commenced.
Process:
MTA Standard
ID number:
6195

Project Team

Project lead
Kate Moore

Email enquiries

If you have any queries please email TACommD@nice.org.uk


External Assessment Group:
Newcastle NIHR TAR Team, Newcastle University

Stakeholders

Companies sponsors
Biogen (Nusinersen)
 
Roche (Risdiplam)
Others
Department of Health and Social Care
 
NHS England
Patient carer groups
Gene People
 
Muscular Dystrophy UK
 
Spinal Muscular Atrophy UK
 
TreatSMA
Professional groups
Adult SMA Reach
 
Association of British Neurologists
 
British Paediatric Respiratory Society
 
British Society of Physical and Rehabilitation Medicine
 
Royal College of Physicians
 
SMA Reach UK
 
UK National Screening Committee
Comparator companies
Novartis Gene Therapies, Inc. (onasemnogene abeparvovec) (confidentiality agreement signed, participating)
General commentators
All Wales Therapeutics and Toxicology Centre
 
British National Formulary
 
Department of Health, Social Services and Public Safety for Northern Ireland
 
Healthcare Improvement Scotland
 
Medicines and Healthcare products Regulatory Agency
 
NHS Wales Joint Commissioning Committee
 
Welsh Government

Timeline

Key events during the development of the guidance:

Date Update
21 April 2026 Further to the last update of 12 March 2026, we can now confirm that we anticipate sending the final draft guidance confidentially to stakeholders in the week commencing 4 May 2026 and publishing it on the NICE website 1 week later. - Note added to the project documents
12 March 2026 Final commercial discussions are still ongoing. The recommendations will be communicated in full once the commercial discussions are concluded and the guidance document is published on the website. We will give an indication of the anticipated guidance publication date when it is available. - Note added to the project documents
19 February 2026 Following the committee meeting on 3rd February 2026, NICE is working with the companies and NHS England to finalise the recommendations. The committee doesn’t need any further information or analysis, and we don’t anticipate any further committee meetings will be required. We anticipate being able to update stakeholders by w/c 9 March 2026. - Note added to the project documents
03 February 2026 Committee meeting: 2
03 February 2026 Declaration of interests
25 November 2025 Note added to the project documents
11 November 2025 Committee meeting: 1
29 July 2025 Assessment report sent for information
07 May 2025 Note added to the project documents
11 November 2024 Note added to the project documents
05 January 2024 Invitation to participate
28 July 2023 - 25 August 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
28 July 2023 In progress. Scoping commenced.

For further information on our processes and methods, please see our CHTE processes and methods manual