Suggested remit: To appraise the clinical and cost effectiveness of cemiplimab with chemotherapy within its marketing authorisation for untreated advanced or metastatic NSCLC.
- Status:
- In progress
- Technology type:
- Medicine
- Decision:
- Selected
- Process:
- STA Standard
- ID number:
- 3949
Provisional Schedule
- Appeal:
- 03 September 2025
Project Team
- Project lead
- Kate Moore
Email enquiries
If you have any queries please email [email protected]
- External Assessment Group:
- Newcastle NIHR TAR Team, Newcastle University
Stakeholders
- Companies sponsors
- Regeneron (cemiplimab)
- 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 (BTOG)
- Cancer Research UK
- Royal College of Physicians
- Royal College of Radiologists
- Associated public health groups
- None
- Comparator companies
- Bristol Myers Squibb (paclitaxel) – confidentiality agreement not signed, not participating
- Eli Lilly (pemetrexed) – confidentiality agreement not signed, not participating
- Hospira UK (carboplatin, paclitaxel) – confidentiality agreement not signed, not participating
- Medac (vinorelbine) – confidentiality agreement not signed, not participating
- MSD (pembrolizumab) – confidentiality agreement signed, participating
- Pierre Fabre (vinorelbine) – confidentiality agreement not signed, not participating
- Pfizer (pemetrexed, cisplatin, carboplatin, gemcitabine) – confidentiality agreement not signed, not participating
- Ranbaxy (gemcitabine, pemetrexed) – confidentiality agreement not signed, not participating
- Roche (atezolizumab, bevacizumab) – confidentiality agreement signed, participating
- Seacross Pharmaceuticals (paclitaxel) – confidentiality agreement not signed, not participating
- Sandoz (cisplatin) – confidentiality agreement not signed, not participating
- Synchrony Pharma (gemcitabine) – confidentiality agreement not signed, not participating
- Teva UK (paclitaxel) – confidentiality agreement not signed, not participating
- General commentators
- All Wales Therapeutics and Toxicology Centre
- British National Formulary
- Department of Health - Northern Ireland
- Healthcare Improvement Scotland
- Medicines and Healthcare products Regulatory Agency
- NHS Wales Joint Commissioning Committee
- Scottish Medicines Consortium
- Welsh Government
- Relevant research groups
- Institute of Cancer Research
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 23 May 2025 - 09 June 2025 | Final draft guidance |
| 05 March 2025 - 26 March 2025 | Draft guidance |
| 12 February 2025 | Committee meeting |
| 12 February 2025 | Declaration of interests |
| 10 July 2024 | Invitation to participate |
| 25 April 2024 | Please note that following on from conversation between NICE and the company, the timelines for this appraisal have been scheduled and the appraisal is now anticipated to begin in early July 2024 when we will write to you about how you can get involved. |
| 13 February 2024 - 12 March 2024 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 3949 |
| 13 February 2024 | In progress. Scoping commencing |
| 18 August 2022 | Suspended. As you will be aware, the Department for Health & Social Care has asked NICE to carry out a Single Technology Appraisal of Cemiplimab with chemotherapy for untreated advanced or metastatic non-small-cell lung cancer [ID3949]. For information the company have advised that they will not be making a submission. Therefore, in collaboration with the company, NICE has suspended this evaluation from its current work programme. As this evaluation has been referred NICE will continue to monitor any development and will update interested parties if the situation changes. |
For further information on our processes and methods, please see our CHTE processes and methods manual