| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 24041 |
| Drug | Sotatercept |
| Brand | Winrevair ® |
| Indication | Sotatercept, in combination with other pulmonary arterial hypertension (PAH) therapies, is indicated for the treatment of PAH in adult patients with WHO Functional Class II to III, to improve exercise capacity. |
| Assessment Process | |
| Rapid review commissioned | 09/09/2024 |
| Rapid review completed | 24/10/2024 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of sotatercept compared with the current standard of care. |
| Full HTA commissioned by the HSE | 29/11/2024 |
| Pre-submission consultation with Applicant | 28/01/2025 |
| Full submission received from Applicant | 15/05/2025 |
| Preliminary review sent to Applicant | 16/12/2025 |
| NCPE assessment re-commenced | 23/01/2026 |
| Factual accuracy sent to Applicant | 11/02/2026 |
| NCPE assessment re-commenced | 18/02/2026 |
| NCPE assessment completed | 03/03/2026 |
| NCPE assessment outcome | The NCPE recommends that sotatercept (when given in combination with other PAH therapies), for this indication, not be considered for reimbursement.* |
*Next steps: The NCPE Assessment Report and recommendation and Patient Organisation submission, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health Pricing and Supply of Medical Goods Act 2013.
Further information on this process may be found here.
Please see the HSE Pricing and Reimbursement Tracker for any updates on the reimbursement status of this drug.