| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 23069 |
| Drug | Birch bark extract |
| Brand | Filsuvez® |
| Indication | Treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older. |
| Assessment Process | |
| Rapid review commissioned | 10/11/2023 |
| Rapid review completed | 08/12/2023 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of birch bark extract compared with the current standard of care. |
| Full pharmacoeconomic assessment commissioned by HSE | 18/12/2023 |
| Pre-submission consultation with Applicant | 23/04/2024 |
| Full submission received from Applicant | 15/10/2024 |
| Preliminary review sent to Applicant | 27/02/2025 |
| NCPE assessment re-commenced | 26/03/2025 |
| Factual accuracy sent to Applicant | 31/03/2025 |
| NCPE assessment re-commenced | 07/04/2025 |
| NCPE assessment completed | 14/04/2025 |
| NCPE assessment outcome | The NCPE recommends that birch bark extract (Filsuvez®) be considered for reimbursement if cost-effectiveness is improved*. |
*This recommendation should be considered while also having regards to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.