| Assessment Status | NCPE Assessment process complete |
| HTA ID | - |
| Drug | Cerliponase alfa |
| Brand | Brineura® |
| Indication | For the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency. |
| Assessment Process | |
| Rapid review commissioned | 11/10/2017 |
| Rapid review completed | 27/11/2017 |
| Rapid review outcome | Full Pharmacoeconomic Evaluation Recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 29/11/2017 |
| Pre-submission consultation with Applicant | 13/03/2018 |
| Full submission received from Applicant | 02/08/2018 |
| Preliminary review sent to Applicant | 30/11/2018 |
| NCPE assessment re-commenced | 25/01/2019 |
| Factual accuracy sent to Applicant | 25/02/2019 |
| NCPE assessment re-commenced | 08/03/2019 |
| NCPE assessment completed | 25/03/2019 |
| NCPE assessment outcome | The NCPE recommends that cerliponase alfa (Brineura®) 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. |
The HSE has approved reimbursement following confidential price negotiations; November 2020.