| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | - |
| Drug | Burosumab |
| Brand | Crysvita® |
| Indication | Treatment of X-linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons. |
| Assessment Process | |
| Rapid review commissioned | 22/11/2018 |
| Rapid review completed | 21/12/2018 |
| Rapid review outcome | A full HTA is recommended |
| Full pharmacoeconomic assessment commissioned by HSE | 08/01/2019 |
| Pre-submission consultation with Applicant | 12/02/2019 |
| Full submission received from Applicant | 03/07/2019 |
| Preliminary review sent to Applicant | 23/10/2019 |
| NCPE assessment re-commenced | 19/11/2019 |
| Factual accuracy sent to Applicant | 14/02/2020 |
| NCPE assessment re-commenced | 06/03/2020 |
| NCPE assessment completed | 12/03/2020 |
| NCPE assessment outcome | The NCPE recommends that burosumab (Crysvita®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments** |
*The NCPE have revised the timeline for burosumab due to new information received after the factual accuracy stage, which necessitated additional revisions to be made to the final appraisal document.
**This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations May 2021.
