Suggested remit: To appraise the clinical and cost effectiveness of zolbetuximab with chemotherapy within its marketing authorisation for untreated claudin 18.2 positive HER2 negative unresectable advanced gastric or gastro-oesophageal junction adenocarcinoma.
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Status
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In progress
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Technology type
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Medicine
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Decision
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Selected
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Reason for decision
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Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
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Further information
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DHSC referral received
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| Process |
STA Standard
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| ID number |
5123
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Project Team
| Project lead |
Jennifer Upton |
Email enquiries
| External Assessment Group |
Kleijnen Systematic Reviews Ltd |
Stakeholders
| Companies sponsors |
Astellas Pharma Ltd |
| Others |
Department of Health and Social Care |
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NHS England |
| Patient carer groups |
OG Support |
| Professional groups |
Association of Cancer Physicians |
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Cancer Research UK |
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Royal College of Physicians |
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Royal College of Radiologists |
| Comparator companies |
Bristol-Myers Squibb |
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MSD |
| General commentators |
All Wales Therapeutics and Toxicology Centre |
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British National Formulary (BNF) |
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Department of Health - Northern Ireland |
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Healthcare Improvement Scotland |
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Medicines and Healthcare products Regulatory Agency |
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Scottish Medicines Consortium (SMC) |
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Welsh Government |
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Welsh Health Specialised Services Committee |
| Relevant research groups |
Institute of Cancer Research |
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Date
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Update
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10 December 2024
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Declaration of interests |
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07 October 2024
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Unfortunately, for operational reasons, NICE is unable to proceed with next week’s committee discussion of zolbetuximab with chemotherapy for untreated claudin 18.2-positive HER2 negative unresectable advanced gastric or gastro-oesophageal junction adenocarcinoma.We will update about rescheduling this discussion |
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02 September 2024 - 27 September 2024
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Draft guidance |
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13 August 2024
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Committee meeting: 1 |
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13 August 2024
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Declaration of interests |
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16 January 2024
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Invitation to participate |
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23 November 2023 - 21 December 2023
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Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 5123 |
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23 March 2023
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Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Zolbetuximab with chemotherapy for untreated CLDN 18.2-positive HER2 negative unresectable advanced gastric or gastro-oesophageal junction cancer have been revised. It is anticipated that the appraisal will begin in early-August 2023 when we will write to you about how you can get involved. |
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07 July 2022
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In progress |
For further information on our processes and methods, please see our CHTE processes and methods manual