Suggested remit: To appraise the clinical and cost effectiveness of burosumab within its marketing authorisation for treating FGF23-related hypophosphataemia in tumour-induced osteomalacia.
As you will be aware, the Department for Health & Social Care has asked NICE to carry out a Single Technology Appraisal of Burosumab for treating FGF23-related hypophosphataemia in tumour-induced osteomalacia ID3924]. For information, the company has advised that they are not in a position to apply for a Marketing Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme until further notice from the company. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes.
 
Status Suspended
Technology type Medicine
Decision Awaiting decision
Process TA
ID number 3924

Project Team

Project lead Michelle Adhemar

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
08 September 2022 Suspended. As you will be aware, the Department for Health & Social Care has asked NICE to carry out a Single Technology Appraisal of Burosumab for treating FGF23-related hypophosphataemia in tumour-induced osteomalacia ID3924]. For information, the company has advised that they are not in a position to apply for a Marketing Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme until further notice from the company. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes.
05 September 2022 Topic selection
06 May 2022 (14:00) Scoping workshop
17 March 2022 - 14 April 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
18 February 2021 In progress. DHSC referral received

For further information on our processes and methods, please see our CHTE processes and methods manual