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: 1 05 August 2025
Expected publication 15 October 2025

Project Team

Project lead Jeremy Powell

Email enquiries

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
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