| Assessment Status | Full HTA submission received from Applicant |
| HTA ID | 23027 |
| Drug | Anifrolumab |
| Brand | Saphnelo® |
| Indication | Anifrolumab (Saphnelo®) is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy. |
| Assessment Process | |
| Rapid review commissioned | 19/05/2023 |
| Rapid review completed | 14/06/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of anifrolumab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
| Full pharmacoeconomic assessment commissioned by HSE | 05/07/2023 |
| Pre-submission consultation with Applicant | 14/08/2023 |
| Full submission received from Applicant | 30/05/2024 |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
