Burosumab (Crysvita®)

Assessment Status NCPE Assessment Process Complete
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.

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