| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 21058 |
| Drug | Odevixibat |
| Brand | Bylvay® |
| Indication | For the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older. |
| Assessment Process | |
| Rapid review commissioned | 24/11/2021 |
| Rapid review completed | 22/12/2021 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of odevixibat (Bylvay®) compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 31/01/2022 |
| Pre-submission consultation with Applicant | 07/03/2022 |
| Full submission received from Applicant | 16/08/2022 |
| Preliminary review sent to Applicant | 20/09/2022 |
| NCPE assessment re-commenced | 19/10/2022 |
| Factual accuracy sent to Applicant | 06/03/2023 |
| NCPE assessment re-commenced | 13/03/2023 |
| NCPE assessment completed | 14/03/2023 |
| NCPE assessment outcome | The NCPE recommends that odevixibat not be 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.
