Suggested remit: To appraise the clinical and cost effectiveness of nivolumab with temozolomide and radiotherapy within its marketing authorisation for newly diagnosed MGMT-methylated glioblastoma multiforme.
Following on from information provided to NICE by the company in February 2021, the appraisal of Nivolumab with temozolomide and radiotherapy for newly diagnosed glioblastoma with MGMT methylation [ID1582] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
 
Status Discontinued
Technology type Medicine
Decision Selected
Process TA
ID number 1582

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Timeline

Key events during the development of the guidance:

Date Update
21 November 2022 Following on from information provided to NICE by the company in February 2021, the appraisal of Nivolumab with temozolomide and radiotherapy for newly diagnosed glioblastoma with MGMT methylation [ID1582] 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 February 2021, the appraisal of Nivolumab with temozolomide and radiotherapy for newly diagnosed glioblastoma with MGMT methylation [ID1582] was suspended from NICE’s work programme. As no further information has been received from the company the topic has been discontinued.
18 August 2021 Expected publication
12 February 2021 The Department for Health and Social Care has asked NICE to carry out an appraisal of nivolumab with temozolomide and radiotherapy for newly diagnosed glioblastoma with MGMT methylation [ID1582]. For information, the company have announced that CheckMate -548 did not meet its primary endpoint and therefore they will no longer be pursuing a marketing authorisation application in 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 as and when the situation changes
12 February 2021 Suspended. Topic is suspended
21 August 2020 The Department for Health and Social Care has asked NICE to conduct an appraisal of nivolumab with temozolomide and radiotherapy for newly diagnosed glioblastoma with MGMT methylation. Please note that following on from advice received from the company the timelines for this appraisal have been revised and we now anticipate that the appraisal will begin during mid-June 2021 when we will write to you about how you can get involved.
12 May 2020 The Department for Health and Social Care has asked NICE to conduct an appraisal of nivolumab with temozolomide and radiotherapy for newly diagnosed glioblastoma with MGMT methylation. Please note that following on from advice received from the company the timelines for this appraisal have been revised and we now anticipate that the appraisal will begin during late September 2020 when we will write to you about how you can get involved.
11 December 2019 The Department for Health and Social Care has asked NICE to conduct an appraisal of nivolumab with temozolomide and radiotherapy for newly diagnosed glioblastoma with MGMT methylation. Please note that following on from advice received from the company this appraisal has been scheduled back into the work programme. We now anticipate that the appraisal will begin during late June 2020 when we will write to you about how you can get involved.
16 September 2019 The Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of nivolumab with temozolomide and radiotherapy for newly diagnosed glioblastoma with MGMT methylation. Please note that following on from advice received from the company the timelines for this appraisal are currently to be confirmed. As this appraisal has been referred, NICE will continue to monitor any development and will update interested parties as and when the situation changes.
28 June 2019 As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of nivolumab with temozolomide and radiotherapy for newly diagnosed glioblastoma with MGMT methylation. Please note that following on from advice received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during early October 2019 when we will write to you about how you can get involved.
08 May 2019 - 06 June 2019 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
18 April 2018 In progress. DHSC Referral received

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