Suggested remit: To appraise the clinical and cost effectiveness of cemiplimab within its marketing authorisation for untreated PD-L1 positive advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS-1 mutations.
The company has informed NICE that they will be withdrawing their evidence submission for this appraisal and NICE is therefore suspending the appraisal. As this appraisal has been referred, NICE will continue to monitor any developments and will provide an update as and when the situation changes.
 
Status Suspended
Decision Selected
Process STA 2018
ID number 3839

Project Team

Project lead Louise Jafferally

Email enquiries

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

Stakeholders

Companies sponsors Sanofi (cemiplimab)
Others Department of Health and Social care
  NHS England
  Welsh Government
Patient carer groups Roy Castle Lung Cancer Foundation
Professional groups British Thoracic Oncology Group
  British Thoracic Society
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
Associated guideline groups National Guideline Alliance
Associated public health groups None
Comparator companies Eli Lilly (pemetrexed) (confidentiality agreement signed, participating)
  Merck, Sharp & Dohme (pembrolizumab) (confidentiality agreement signed, participating)
  Roche (atezolizumab) (confidentiality agreement signed, participating)
  Accord Healthcare (cisplatin, carboplatin, docetaxel, gemcitabine, paclitaxel, vinorelbine) (confidentiality agreement not signed, not participating)
  Celgene (paclitaxel) (confidentiality agreement not signed, not participating)
  Consilient Health (carboplatin, gemcitabine, vinorelbine) (confidentiality agreement not signed, not participating)
  Hospira UK (carboplatin, cisplatin, docetaxel, gemcitabine, paclitaxel)
  Medac GmbH (vinorelbine) (confidentiality agreement not signed, not participating)
  Pierre Fabre (vinorelbine) (confidentiality agreement not signed, not participating)
  Sandoz (cisplatin) (confidentiality agreement not signed, not participating)
  Seacross Pharmaceuticals (docetaxel, pemetrexed, paclitaxel) (confidentiality agreement not signed, not participating)
  Sun Pharmaceuticals (gemcitabine) (confidentiality agreement not signed, not participating)
General commentators All Wales Therapeutic 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 Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
20 January 2022 Suspended. The company has informed NICE that they will be withdrawing their evidence submission for this appraisal and NICE is therefore suspending the appraisal. As this appraisal has been referred, NICE will continue to monitor any developments and will provide an update as and when the situation changes.
14 December 2021 Committee meeting: 1
23 April 2021 Invitation to participate
19 January 2021 - 16 February 2021 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
18 March 2019 In progress. DHSC referral received

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