Suggested remit: To appraise the clinical and cost effectiveness of olezarsen within its marketing authorisation for treating familial chylomicronaemia syndrome.

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
Process:
STA Standard
ID number:
6585

Provisional Schedule

Committee meeting: 1:
25 June 2026
Expected publication:
19 August 2026

Project Team

Project lead
Thomas Feist

Email enquiries

If you have any queries please email TAteam3@nice.org.uk


External Assessment Group:
Peninsula Technology Assessment Group (PenTAG), University of Exeter

Stakeholders

Companies sponsors
Sobi
Others
All Wales Inherited Metabolic Disease Service
 
Central Manchester Foundation Trust, Willink Unit, Genetic Medicine
 
Department of Health and Social Care
 
Great Ormond Street Hospital Metabolic Unit
 
Guys and St Thomas’ NHS Trust, Adult Inherited Metabolic Diseases
 
Leeds Teaching Hospitals NHS Trust, St James’ Hospital, Diabetes
 
NHS England
 
NHS England National Programmes of Care, Internal Medicine: Hepatobiliary and Pancreas Clinical Reference Group (CRG)
 
NHS Genomic Medicine Service
 
Salford Royal NHS Foundation Trust Mark Holland Metabolic Unit
 
Specialised Endocrinology CRG
 
University Hospital Birmingham Foundation Trust, Department of Endocrinology
 
University Hospitals of Bristol NHS Foundation Trust, Clinical Biochemistry
Patient carer groups
Action FCS
 
Beacon
 
Gene People
 
Genetic Alliance UK
 
Metabolic Support UK
 
South Asian Health Foundation
 
Specialised Healthcare Alliance
Professional groups
Association of Genetic Nurses and Counsellors
 
British Dietetic Association
 
British Geriatrics Society
 
British Inherited Metabolic Disease Group
 
British Society for Gene and Cell Therapy
 
British Society for Genetic Medicine
 
HEART UK
 
National Metabolic Biochemistry Network
 
Royal College of General Practitioners
 
Royal College of Nursing
 
Royal College of Pathologists
 
Royal College of Physicians
 
Royal Pharmaceutical Society
 
Royal Society of Medicine
 
Society for Endocrinology
 
UK Clinical Pharmacy Association
Associated public health groups
Public Health Wales
 
UK Health Security Agency
Comparator companies
Akcea Therapeutics (volanesorsen)
 
Arrowhead Pharmaceuticals (plozasiran)
General commentators
All Wales Therapeutics and Toxicology Centre
 
Allied Health Professionals Federation
 
Board of Community Health Councils in Wales
 
British National Formulary
 
Care Quality Commission
 
Cell and Gene Therapy Catapult
 
Department of Health - Northern Ireland
 
Healthcare Improvement Scotland
 
Medicines and Healthcare products Regulatory Agency
 
National Association of Primary Care
 
National Pharmacy Association
 
National Services Division
 
NHS Confederation
 
NHS Wales Joint Commissioning Committee
 
Scottish Medicines Consortium
 
Welsh Government
Relevant research groups
Cochrane Cystic Fibrosis and Genetic Disorders Group
 
Cochrane Metabolic and Endocrine Disorders Group
 
Genomics England
 
MRC Clinical Trials Unit
 
National Institute for Health Research
 
Society for The Study of Inborn Errors of Metabolism

Timeline

Key events during the development of the guidance:

Date Update
12 November 2025 Invitation to participate
02 October 2025 To appraise the clinical and cost effectiveness of Olezarsen within its marketing authorisation for treating familial chylomicronaemia syndrome ID6585
23 July 2025 - 20 August 2025 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6585
23 July 2025 In progress. Scoping commenced.
30 January 2025 Awaiting development. Status change linked to Topic Selection Decision being set to Selected

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