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
- Committee meeting: 2:
- 04 November 2025
- Expected publication:
- 28 January 2026
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
- Pulmonary Hypertension Association UK
- Professional groups
- Royal College of Pathologists
- Royal College of Physicians
- UK Clinical Pharmacy Association
- Associated public health groups
- Public Health Wales
- UK Health Security Agency
- Comparator companies
- ADVANZ Pharma (epoprostenol) (not participating)
- Amarox (sildenafil) (not participating)
- AOP Orphan (treprostinil)
- Aspire Pharma (tadalafil) (not participating)
- Aurobindo Pharma (bosentan, sildenafil, tadalafil) (not participating)
- Bayer (iloprost)
- Chiesi
- Cipla EU (ambrisentan, bosentan, tadalafil) (not participating)
- Colonis Pharma (iloprost) (not participating)
- Crescent Pharma (sildenafil) (not participating)
- Dr. Reddy’s Laboratories (ambrisentan, (not participating)
- bosentan, sildenafil, treprostinil) (not participating)
- Eli Lilly and Company (tadalafil) (not participating)
- GlaxoSmithKline (ambrisentan, epoprostenol)
- Janssen-Cilag (macitentan, epoprostenol, selexipag)
- Merck Sharp & Dohme (riociguat) (not participating)
- Mylan (ambrisentan, bosentan, sildenafil, tadalafil) (not participating)
- Ranbaxy (tadalafil, epoprostenol) (not participating)
- Rosemont Pharmaceutical (bumetanide, sildenafil) (not participating)
- Sandoz (sildenafil) (not participating)
- Sanofi (tadalafil) (not participating)
- Sigma Pharmaceuticals (sildenafil) (not participating)
- Sovereign Medical (tadalafil) (not participating)
- Teva Pharma (sildenafil) (not participating)
- The Boots Company (sildenafil) (not participating)
- Tillomed Laboratories (treprostinil) (not participating)
- Upjohn UK (sildenafil) (not participating)
- Zentiva (ambrisentan) (not participating)
- General commentators
- All Wales Therapeutics and Toxicology Centre
- British National Formulary
- Department of Health - Northern Ireland
- Healthcare Improvement Scotland
- Health Technology Wales
- Medicines and Healthcare products Regulatory Agency
- Scottish Medicines Consortium
- Welsh Government
- Welsh Health Specialised Services Committee
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 27 August 2025 - 17 September 2025 | Draft guidance: 1 |
| 05 August 2025 | Committee meeting: 1 |
| 05 August 2025 | Declaration of interests |
| 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