Suggested remit: To appraise the clinical and cost effectiveness of satralizumab (SA-237) within its marketing authorisation for preventing relapses in neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorders (NMOSD).
The company has informed NICE that it will not provide an evidence submission for this appraisal. Therefore, we are suspending the appraisal while we consider the next steps.
 
Status Suspended
Technology type Medicine
Decision Selected
Process TA
ID number 1319

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Timeline

Key events during the development of the guidance:

Date Update
15 March 2024 In progress. Topic to be suspended
15 March 2024 Suspended. The company has informed NICE that it will not provide an evidence submission for this appraisal. Therefore, we are suspending the appraisal while we consider the next steps.
21 November 2022 Following on from information provided to NICE by the company in July 2021, the appraisal of Satralizumab for preventing relapses in neuromyelitis optica spectrum disorders [ID1319] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
21 November 2022 Discontinued. Following on from information provided to NICE by the company in July 2021, the appraisal of Satralizumab for preventing relapses in neuromyelitis optica spectrum disorders [ID1319] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
25 August 2022 Suspended. As you will be aware, the Department for Health & Social Care has asked NICE to carry out a Single Technology Appraisal of Satralizumab for preventing relapses in neuromyelitis optica spectrum disorders [ID1319]. For information, the company have advised that they are no longer pursuing a Marketing Authorisation Application 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. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
07 May 2020 Schedule affected by COVID-19. Topic update: this appraisal has not been defined as therapeutically critical. The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide an update when this information is available.
17 April 2020 Topic update: this appraisal has not been defined as therapeutically critical (please follow the link titled rapid guidelines and evidence summaries within the yellow banner at the top of the page for information on recent changes to the way we work). The appraisal will therefore be paused. At this stage, we are unable to provide alternative timelines as to when the appraisal may be re-started but we will provide updates as and when this information becomes clear.
03 October 2019 - 31 October 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

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