Suggested remit: To appraise the clinical and cost effectiveness of pembrolizumab with chemotherapy and then pembrolizumab monotherapy within its marketing authorisation for neoadjuvant and adjuvant treatment of resectable stage 2 to 3B non-small cell lung cancer (NSCLC).
 
Status In progress
Technology type Medicine
Decision Selected
Reason for decision 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
Further information As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal Pembrolizumab with chemotherapy for neoadjuvant and adjuvant treatment of resectable non-small-cell lung 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 March 2024.
Process STA Standard
ID number 5094

Provisional Schedule

Expected publication 20 November 2024

Project Team

Project lead Celia Mayers

Email enquiries

External Assessment Group Liverpool Reviews and Implementation Group, University of Liverpool

Stakeholders

Companies sponsors Merck Sharp & Dohme
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 (nivolumab, paclitaxel)
  Dr Reddy’s Laboratories (pemetrexed) – confidentiality agreement not signed, not participating
  Eli Lilly (pemetrexed) – confidentiality agreement not signed, not participating
  Genus Pharmaceuticals (pemetrexed) – confidentiality agreement not signed, not participating
  Medac (oxaliplatin) – confidentiality agreement not signed, not participating
  Pfizer (cisplatin, carboplatin, docetaxel oxaliplatin, paclitaxel, pemetrexed) – confidentiality agreement not signed, not participating
  Roche (atezolizumab)
  Sandoz (cisplatin, pemetrexed) – confidentiality agreement not signed, not participating
  Seacross Pharmaceuticals (paclitaxel, oxaliplatin, docetaxel) – confidentiality agreement not signed, not participating
  Sun Pharmaceuticals (oxaliplatin) – 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
16 October 2024 - 30 October 2024 Final draft guidance
18 September 2024 NICE has agreed to pause publication of the guidance document to allow the company and NHS England to enter into a commercial discussion. Once these discussions have concluded, NICE will update stakeholders with the next steps. We expect this to be late September or early October 2024.
07 August 2024 Committee meeting
07 August 2024 Declaration of interests
09 January 2024 Invitation to participate
13 November 2023 - 27 November 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 5094
13 November 2023 In progress. Commenced to scoping
30 March 2023 Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Pembrolizumab with chemotherapy for neoadjuvant and adjuvant treatment of resectable non-small-cell lung cancer have been revised. It is anticipated that the appraisal will begin in early-January 2024 when we will write to you about how you can get involved.
07 July 2022 Awaiting development. DHSC referral received

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