| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 22067 |
| Drug | Bulevirtide |
| Brand | Hepcludex® |
| Indication | Chronic hepatitis delta (CHD) infection in plasma (or serum) HDV RNA-positive adult patients with compensated liver disease. |
| Assessment Process | |
| Rapid review commissioned | 06/10/2022 |
| Rapid review completed | 10/11/2022 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of bulevirtide compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 30/11/2022 |
| Pre-submission consultation with Applicant | 10/01/2023 |
| Full submission received from Applicant | 06/09/2023 |
| Preliminary review sent to Applicant | 06/10/2023 |
| NCPE assessment re-commenced | 09/11/2023 |
| Factual accuracy sent to Applicant | 19/01/2024 |
| NCPE assessment re-commenced | 26/01/2024 |
| NCPE assessment completed | 22/02/2024 |
| NCPE assessment outcome | The NCPE recommends that bulevirtide 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.