Burosumab (Crysvita®) for the 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.
|NCPE Assessment Process||Complete|
|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 the HSE||08/01/2019|
|Pre-submission consultation with Applicant||12/02/2019|
|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|
|Current status||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 FAC 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.