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
If you have any queries please email [email protected]
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