Suggested remit: To appraise the clinical and cost effectiveness of datopotamab within its marketing authorisation for treating advanced non-small-cell lung cancer after platinum-based chemotherapy with or without immunotherapy or a targeted anti-cancer treatment.
For information, the company have 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
- 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
- Process:
- STA Standard
- ID number:
- 6241
Project Team
- Project lead
- Vonda Murray
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Kleijnen Systematic Reviews Ltd
Stakeholders
- Companies sponsors
- Daiichi Sankyo
- Others
- Department of Health and Social Care
- NHS England
- Patient carer groups
- Asthma and Lung UK
- 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
- British Geriatrics Society
- British Institute of Radiology
- British Oncology Pharmacy Association
- British Psychosocial Oncology Society
- British Society of Interventional Radiology
- British Thoracic Oncology Group
- British Thoracic Society
- British Transplantation Society
- Cancer Research UK
- Lung Cancer and Mesothelioma Clinical Expert Group
- Lung Cancer Nursing UK
- National Heart and Lung Institute
- NHS Blood and Transplant
- 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
- Assessment group
- National Institute for Health Research Health Technology Assessment Programme (NETSCC)
- Associated public health groups
- Public Health Wales
- UK Health Security Agency
- Comparator companies
- Boehringer Ingelheim (nintedanib)
- Hospira UK (docetaxel)
- Seacross pharmaceuticals (docetaxel)
- 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 - Northern Ireland
- Healthcare Improvement Scotland
- Medicines and Healthcare products Regulatory Agency
- National Association of Primary Care
- National Pharmacy Association
- NHS Confederation
- Scottish Medicines Consortium
- Welsh Government
- Welsh Health Specialised Services Committee
- Relevant research groups
- Cochrane Lung Cancer Group
- Cochrane UK
- Genomics England
- Institute of Cancer Research
- MRC Clinical Trials Unit
- National Institute for Health Research
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 13 January 2025 | Suspended. For information, the company have 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. |
| 22 October 2024 | Invitation to participate |
| 09 July 2024 - 06 August 2024 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6241 |
| 25 July 2024 | 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 late October 2024. The deadline for submissions is expected in approximately early January 2025. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to align with regulatory timelines. Although timelines have changed this does not affect the scoping consultation, the deadline for consultation comments will remain as is. |
| 09 July 2024 | In progress. Scoping commencing |
| 06 February 2023 | Awaiting development. Status change linked to Topic Selection Decision being set to Selected |
For further information on our processes and methods, please see our CHTE processes and methods manual