| 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.* |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.