| 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 HTA commissioned by the 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.
The HSE has approved reimbursement following confidential price negotiations; April 2026