Suggested remit: To appraise the clinical and cost effectiveness of omburtamab I-131 within its marketing authorisation for treating relapsed neuroblastoma with central nervous system or leptomeningeal metastasis in children and young people.
For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
 
Status Suspended
Technology type Medicine
Decision Awaiting decision
Process TA
ID number 1664

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Timeline

Key events during the development of the guidance:

Date Update
25 January 2023 Suspended. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
03 November 2022 As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of omburtamab I-131 for treating relapsed neuroblastoma. Please note that following on from information received from the company, the timelines for this appraisal will be aligned with the latest regulatory and UK launch expectations and further information regarding the scheduling of this appraisal will be available in due course. NICE will continue to monitor any developments and will update interested parties as and when the situation changes.
08 August 2022 Topic selection
06 September 2021 (10:00) Scoping workshop
12 July 2021 - 09 August 2021 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
24 August 2020 The National Institute for Health and Care Excellence (NICE) has been asked to conduct an appraisal of omburtamab for treating relapsed neuroblastoma ID1664. We have recently invited stakeholders to respond to a written consultation on the draft scope and to attend a scoping workshop for this appraisal. On receiving updated regulatory timing information from the company that is developing omburtamab, NICE has agreed that holding the scoping exercise at this time would not be appropriate. Consequently, NICE will not be progressing with the scoping exercise at this time, and the workshop arranged for Friday 28 August 2020 has been cancelled. Please accept our apologies for any inconvenience. The scoping exercise will be rescheduled to take place in line with anticipated regulatory approval timings. We apologise for any inconvenience this may cause. If you have any comments or concerns please contact the project manager for this proposed appraisal Emily Richards on (44 (0)161 413 4070 or via email on emily.richards@nice.org.uk).
21 January 2020 In progress. Topic is proposed

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