| Assessment Status | Assessment process complete |
| HTA ID | – |
| Drug | Patisiran |
| Brand | Onpattro® |
| Indication | For the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. |
| Assessment Process | |
| Rapid review commissioned | 07/12/2018 |
| Rapid review completed | 03/01/2019 |
| Rapid review outcome | Full Pharmacoeconomic Assessment Recommended. |
| Full pharmacoeconomic assessment commissioned by HSE | 09/01/2019 |
| Pre-submission consultation with Applicant | 26/02/2019 |
| Full submission received from Applicant | 28/06/2019 |
| Preliminary review sent to Applicant | 18/10/2019 |
| NCPE assessment re-commenced | 15/11/2019 |
| Follow-up to preliminary review sent to Applicant | 22/11/2019 |
| NCPE assessment re-commenced | 06/12/2019 |
| Factual accuracy sent to applicant | 31/01/2020 |
| NCPE assessment re-commenced | 13/02/2020 |
| Factual Accuracy #2 sent to Applicant | 18/02/2020 |
| NCPE assessment re-commenced | 19/02/2020 |
| NCPE assessment completed | 20/02/2020 |
| NCPE assessment outcome | The NCPE recommends that patisiran (Onpattro®) is not considered for reimbursement unless 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.
The HSE has approved reimbursement following confidential price negotiations October 2021
