Suggested remit: To appraise the clinical and cost effectiveness of sotatercept within its marketing authorisation for treating pulmonary arterial hypertension.
- 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:
- 6163
Provisional Schedule
- Expected publication:
- 15 October 2025
Project Team
- Project lead
- Jeremy Powell
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Health Economics Research Unit and Health Services Research Unit, University of Aberdeen
Stakeholders
- Companies sponsors
- Merck Sharp & Dohme (sotatercept)
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- Blood Pressure UK
- British Cardiovascular Society
- Asthma and Lung UK
- Cardiovascular Care Partnership
- Circulation Foundation
- Heart UK
- Network of Sikh Organisations
- Pulmonary Hypertension Association UK
- Pumping Marvellous Foundation
- South Asian Health Foundation
- Specialised Healthcare Alliance
- Professional groups
- British and Irish Hypertension Society
- British Association for Nursing in Cardiovascular Care
- British Geriatrics Society
- British Heart Foundation
- British Nuclear Cardiology Society
- British Society for Haematology
- British Society for Heart Failure
- British Society of Cardiovascular Imaging
- British Thoracic Society
- National Heart and Lung Institute
- Primary Care Cardiovascular Society
- Royal College of Emergency Medicine
- Royal College of General Practitioners
- Royal College of Nursing
- Royal College of Pathologists
- Royal College of Physicians
- Royal College of Surgeons
- Royal Pharmaceutical Society
- Royal Society of Medicine
- Society for Cardiological Science and Technology
- Society for Vascular Nurses
- Society for Vascular Technology
- UK Clinical Pharmacy Association
- Vascular Society of Great Britain and Ireland
- Associated public health groups
- Public Health Wales
- UK Health Security Agency
- Comparator companies
- ADVANZ Pharma (epoprostenol)
- Amarox (sildenafil)
- AOP Orphan (treprostinil)
- Aspire Pharma (tadalafil)
- Aurobindo Pharma (bosentan, sildenafil, tadalafil)
- Bayer (iloprost)
- Cipla EU (ambrisentan, bosentan, tadalafil)
- Colonis Pharma (iloprost)
- Crescent Pharma (sildenafil)
- Dr. Reddy’s Laboratories (ambrisentan, bosentan, sildenafil, treprostinil)
- Eli Lilly and Company (tadalafil)
- GlaxoSmithKline (ambrisentan, epoprostenol)
- Janssen-Cilag (macitentan, epoprostenol, selexipag)
- Merck Sharp & Dohme (riociguat)
- Mylan (ambrisentan, bosentan, sildenafil, tadalafil)
- Ranbaxy (tadalafil, epoprostenol)
- Rosemont Pharmaceutical (bumetanide, sildenafil)
- Sandoz (sildenafil)
- Sanofi (tadalafil)
- Sigma Pharmaceuticals (sildenafil)
- Sovereign Medical (tadalafil)
- Teva Pharma (sildenafil)
- The Boots Company (sildenafil)
- Tillomed Laboratories (treprostinil)
- Upjohn UK (sildenafil)
- Zentiva (ambrisentan)
- 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
- Department of Health - Northern Ireland
- Healthcare Improvement Scotland
- Medicines and Healthcare products Regulatory Agency
- National Association of Primary Care
- National Pharmacy Association
- NHS Confederation
- Scottish Medicines Consortium
- Welsh Government
- Welsh Health Specialised Services Committee
- Relevant research groups
- British Society for Cardiovascular Research
- Cardiac and Cardiology Research Dept, Barts
- Circulation Foundation
- Cochrane Hypertension Group
- European Council for Cardiovascular Research
- Genomics England
- Heart Research UK
- MRC Clinical Trials Unit
- National Centre for Cardiovascular Preventions and Outcomes
- National Institute for Health Research
- Wellcome Trust
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 05 August 2025 | Committee meeting: 1 |
| 10 January 2025 | Invitation to participate |
| 08 August 2024 | Please note that following a call between NICE and the company, the timelines for ID6163 - Sotatercept for treating pulmonary arterial hypertension, have been revised. A new invitation to participate will be sent out in January 2025. |
| 06 June 2024 | Invitation to participate |
| 12 March 2024 | Please note that following a call between NICE and the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin during early June 2024 when we will write to you about how you can get involved. |
| 27 October 2023 | Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations, and further details regarding timings and how you can get involved will be available in due course. |
| 19 September 2023 (10:00) | Scoping workshop |
| 27 July 2023 - 24 August 2023 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6163 |
| 13 October 2022 | In progress. DHSC referral received |
| 03 August 2022 | 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