Suggested remit: To appraise the clinical and cost effectiveness of sugemalimab within its marketing authorisation for untreated metastatic non-small-cell lung cancer.
The company (EQRx) has advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
 
Status Suspended
Technology type Medicine
Decision Selected
Process STA Standard
ID number 4001

Project Team

Project lead Celia Mayers

Email enquiries

Stakeholders

Companies sponsors CStone Pharmaceuticals (sugemalimab)
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Black Health Agency for Equality
  Cancer Black Care
  Cancer Equality
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  Roy Castle Lung Cancer Foundation
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tenovus Cancer Care
  UK Lung Cancer Coalition
Professional groups Association of Anaesthetists
  Association of Cancer Physicians
  Association of Respiratory Nurse Specialists
  Association of Surgeons of Great Britain and Ireland
  Association for Cancer Surgery
  British Geriatrics Society
  British Institute of Radiology
  British Psychosocial Oncology Society
  British Thoracic Oncology Group
  British Thoracic Society
  Cancer Research UK
  Health Lumen
  Lung Cancer Nursing UK
  National Heart and Lung Institute
  Primary Care Respiratory Society
  Royal College of Anaesthetists
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  Royal College of Surgeons
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Clinical Pharmacy Association
  UK Oncology Nursing Society
Associated public health groups Public Health Wales
  UK Health Security Agency
Comparator companies Accord Healthcare (cisplatin, carboplatin, docetaxel, gemcitabine, paclitaxel, pemetrexed, vinorelbine)
  Aspire Pharma (pemetrexed)
  Celgene (paclitaxel)
  Eli Lilly (pemetrexed)
  Genus Pharmaceuticals (bevacizumab, pemetrexed)
  Hospira (cisplatin, carboplatin, docetaxel, gemcitabine, paclitaxel)
  Medac GmbH (vinorelbine)
  Merck, Sharp & Dohme (pembrolizumab)
  Organon Pharma (bevacizumab)
  Pfizer (bevacizumab)
  Pierre Fabre (vinorelbine)
  Roche (atezolizumab, bevacizumab)
  Sandoz (cisplatin, pemetrexed)
  Sanofi (cemiplimab)
  Seacross Pharmaceuticals (docetaxel, paclitaxel, pemetrexed)
  Sun Pharma (gemcitabine, pemetrexed)
  Teva UK (carboplatin, paclitaxel)
  Zentiva Pharma UK (bevacizumab, pemetrexed)
General commentators All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare Products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups British Association of Lung Research
  Cochrane Airways Group
  Cochrane Lung Cancer Group
  Cochrane UK
  Genomics England
  Institute of Cancer Research
  MRC Clinical Trials Unit
  National Cancer Research Institute
  National Institute for Health Research

Timeline

Key events during the development of the guidance:

Date Update
07 June 2023 Suspended. The company (EQRx) has advised that they are no longer pursuing a Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for this indication at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
20 March 2023 Due to changes in the regulatory review timeline, the timelines for this appraisal are now TBC.
23 November 2022 The timelines for this appraisal are now confirmed.
07 October 2022 Following conversations with the company, the timelines for this appraisal are now to be confirmed. New timelines will be shared in November 2022.
19 August 2022 Invitation to participate
26 July 2022 The timelines for this appraisal have been updated due to changes in the regulatory timelines for this technology. NICE will be reissuing the Invitation to Participate (ITP) in mid-August 2022 to ensure that all consultees and commentators participating in the appraisal submit evidence or comments in accordance with the NICE health technology evaluations: the manual (2022) and we will confirm the new timelines at this stage.
01 December 2021 Invitation to participate
01 December 2021 In progress. Invitation to participate issued.
06 October 2021 - 27 October 2021 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators

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