| Assessment Status | Assessment Process Complete |
| HTA ID | 21006 |
| Drug | Risdiplam |
| Brand | Evrysdi™ |
| Indication | For the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. |
| Assessment Process | |
| Rapid review commissioned | 15/03/2021 |
| Rapid review completed | 29/03/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of risdiplam compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 04/05/2021 |
| Pre-submission consultation with Applicant | 28/06/2021 |
| Full submission received from Applicant | 20/08/2021 |
| Preliminary review sent to Applicant | 01/10/2021 |
| NCPE assessment re-commenced | 29/10/2021 |
| Follow-up to preliminary review sent to Applicant | 26/11/2021 |
| NCPE assessment re-commenced | 20/12/2021 |
| Factual accuracy sent to Applicant | 18/02/2022 |
| NCPE assessment re-commenced | 25/02/2022 |
| NCPE assessment completed | 31/03/2022 |
| NCPE assessment outcome | The NCPE recommends that risdiplam not be considered for reimbursement until cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
