Suggested remit: To appraise the clinical and cost effectiveness of pembrolizumab with trastuzumab and chemotherapy within its marketing authorisation for treating untreated HER2-positive advanced gastric or gastro-oesophageal junction cancer.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 3742

Provisional Schedule

Expected publication 24 April 2024

Project Team

Project lead Leena Issa

Email enquiries

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
31 January 2024 Expected publication
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