Status | In progress |
Technology type | Medicine |
Decision | Selected |
Process | STA Standard |
ID number | 3742 |
Project Team
Project lead | Leena Issa |
Email enquiries
- If you have any queries please email TATeam7@nice.org.uk
External Assessment Group | School of Health and Related Research (ScHARR), University of Sheffield |
Stakeholders
Companies sponsors | Merck Sharpe & Dohme (pembrolizumab) |
Others | Department of Health and Social Care |
NHS England | |
Professional groups | Association of Cancer Physicians |
Cancer Research UK | |
Royal College of Pathologists | |
Royal College of Physicians | |
Royal College of Radiologists | |
Comparator companies | Accord Healthcare (capecitabine, cisplatin, epirubicin, fluorouracil, oxaliplatin, trastuzumab)- no signed CAU- Not Participating |
Amgen (trastuzumab) - no signed CAU- Not Participating | |
Celltrion Healthcare (trastuzumab) | |
Dr. Reddy’s Laboratories (capecitabine) - no signed CAU- Not Participating | |
Glenmark Pharmaceuticals (capecitabine) - no signed CAU- Not Participating | |
Hospira UK (cisplatin, fluorouracil, oxaliplatin) - no signed CAU- Not Participating | |
medac (epirubicin, fluorouracil, oxaliplatin) - no signed CAU- Not Participating | |
Morningside Healthcare (capecitabine) - no signed CAU- Not Participating | |
Organon Pharma (trastuzumab) - no signed CAU- Not Participating | |
Pfizer (epirubicin, trastuzumab) - no signed CAU- Not Participating | |
Ranbaxy (oxaliplatin) - no signed CAU- Not Participating | |
Roche (trastuzumab) - no signed CAU- Not Participating | |
Sandoz (cisplatin) - no signed CAU- Not Participating | |
Seacross Pharmaceuticals (epirubicin, oxaliplatin) - no signed CAU- Not Participating | |
General commentators | All Wales Therapeutics and Toxicology Centre |
British National Formulary | |
Department of Health, Social Services and Public Safety for Northern Ireland | |
Healthcare Improvement Scotland | |
Medicines and Healthcare products Regulatory Agency | |
Scottish Medicines Consortium | |
Welsh Government Welsh Health Specialised Services Committee | |
Relevant research groups | Institute of Cancer Research |
National Institute for Health Research |
Timeline
Key events during the development of the guidance:
Date | Update |
---|---|
13 February 2024 | Committee meeting: 2 |
24 November 2023 - 03 January 2024 | Draft guidance |
07 November 2023 | Committee meeting: 1 |
15 March 2023 | Invitation to participate |
09 March 2023 | Please note that following on from a request received from the company the timelines for this appraisal have been revised. We now anticipate that the appraisal will begin during mid-March 2023. |
05 December 2022 | As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of Pembrolizumab with trastuzumab and chemotherapy for untreated HER2-positive advanced gastric or gastro-oesophageal junction cancer. 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 August 2023. |
12 September 2022 - 10 October 2022 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 3742 |
24 April 2020 | Following on from advice received from the company the timelines for this appraisal are to be aligned with the latest regulatory expectations and further information regarding the scheduling of this appraisal will be available in due course. |
29 January 2020 | In progress. Topic is in progress |
For further information on our processes and methods, please see our CHTE processes and methods manual