Suggested remit: To appraise the clinical and cost effectiveness of pembrolizumab within its marketing authorisation for adjuvant treatment of resected non-small-cell lung cancer.
 
Status In progress
Technology type Medicine
Decision Selected
Process STA Standard
ID number 3907

Provisional Schedule

Final draft guidance 20 December 2024 - 17 January 2025
Expected publication 05 February 2025

Project Team

Project lead Greg O'Toole

Email enquiries

External Assessment Group BMJ Technology Assessment Group (BMJ-TAG), BMJ

Stakeholders

Companies sponsors Merck Sharp & Dohme (pembrolizumab)
Others Department of Health and Social Care
  NHS England
Patient carer groups Roy Castle Lung Cancer Foundation
Professional groups Association of Cancer Physicians
  British Thoracic Oncology Group
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
Comparator companies Aspire Pharma (pemetrexed) – confidentiality agreement not signed, not participating
  AstraZeneca (durvalumab, osimertinib)
  Bristol Myers Squibb (paclitaxel)
  Eli Lilly (pemetrexed) – confidentiality agreement not signed, not participating
  Genus Pharmaceuticals (pemetrexed) – confidentiality agreement not signed, not participating
  Hospira UK (carboplatin, cisplatin, docetaxel, gemcitabine, paclitaxel) – confidentiality agreement not signed, not participating
  Medac (vinorelbine) – confidentiality agreement not signed, not participating
  Pfizer (pemetrexed) – confidentiality agreement not signed, not participating
  Pierre Fabre (vinorelbine) – confidentiality agreement not signed, not participating
  Roche (atezolizumab)
  Sandoz (cisplatin, pemetrexed) – confidentiality agreement not signed, not participating
  Seacross Pharmaceuticals (docetaxel, pemetrexed, paclitaxel) – confidentiality agreement not signed, not participating
  Sun Pharma (gemcitabine) – confidentiality agreement not signed, not participating
  Synchrony Pharma (gemcitabine) – confidentiality agreement not signed, not participating
  Teva UK (paclitaxel) – confidentiality agreement not signed, not participating
  Zentiva (pemetrexed) – confidentiality agreement not signed, 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 National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
03 October 2024 Committee meeting: 2
03 October 2024 Declaration of interests
29 August 2024 - 19 September 2024 Draft guidance
07 August 2024 Committee meeting
09 January 2024 Invitation to participate
25 August 2023 Please note that following on from a request received from the company, the timelines for this appraisal have been revised and the appraisal is now anticipated to begin in January 2024. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive submission.
18 July 2023 The scope of the first iteration of the NSCLC pathway will focus on development of the evidence synthesis of currently available data and the core model development. Therefore, ID3907, will be routed through a single technology appraisal route. More details about the NSCLC can be found on the webpage for ID6234.
27 February 2023 Please note that the evaluation of pembrolizumab for adjuvant treatment of resected non-small-cell lung cancer ID3907, will now be conducted via ID6234 considering multiple treatments for non-small-cell lung cancer.
16 December 2022 Please note that following on from a further regulatory update received from the company, the timelines for this appraisal have been revised.
14 September 2022 Please note that following on from a regulatory update received from the company, the timelines for this appraisal have been revised.
14 July 2022 Invitation to participate
13 April 2022 - 13 May 2022 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
28 January 2022 In progress. DHSC referral received

For further information on our processes and methods, please see our CHTE processes and methods manual