Analysis conducted using the set of preferred methods most appropriate for the decision-maker
B
Bayesian Method
A branch of statistics that uses prior information based on subjective opinion and objective evidence, such as the results of previous research, for estimation and inference
Bias
Bias is any distorting influence that makes the results of a study an inaccurate reflection of the true situation
Birch bark extract (Filsuvez®). HTA ID: 23069
| 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.
Blinding
When patients, investigators, researchers and/or assessors are kept unaware of the allocation of treatments (investigational agent or control) to participants in a study
Budget Impact Analysis
Estimates the financial consequences of adoption and diffusion of a new health-care intervention within a specific health-care setting or system context given inevitable resource constraints.