The company (EQRx) 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 |
| Process | TA |
| ID number | 4000 |
Project Team
| Project lead | Celia Mayers |
Email enquiries
- If you have any queries please email TATeam6@nice.org.uk
| External Assessment Group | Liverpool Reviews and Implementation Group, University of Liverpool |
Stakeholders
| Companies sponsors | CStone Pharmaceuticals (aumolertinib) |
| Others | Department of Health and Social Care |
| NHS England | |
| Welsh Government | |
| Patient carer groups | EGFR Positive UK |
| Roy Castle Lung Cancer Foundation | |
| Professional groups | Association of Cancer Physicians |
| British Thoracic Society | |
| Cancer Research UK | |
| Royal College of Physicians | |
| Royal College of Radiologists | |
| Comparator companies | • Accord Healthcare (gefitinib) (confidentiality agreement not signed, not participating) |
| • AstraZeneca (gefitinib, osimertinib) | |
| • Boehringer Ingelheim (afatinib) (confidentiality agreement not signed, not participating) | |
| • Cipla EU (gefitinib) (confidentiality agreement not signed, not participating) | |
| • Genus Pharmaceuticals (gefitinib) (confidentiality agreement not signed, not participating) | |
| • Glenmark Pharmaceuticals Europe (erlotinib, gefitinib) (confidentiality agreement not signed, not participating) | |
| • Mylan (erlotinib) (confidentiality agreement not signed, not participating) | |
| • Pfizer (dacomitinib) | |
| • Roche (erlotinib) (confidentiality agreement not signed, not participating) | |
| • Sandoz (erlotinib, gefitinib) (confidentiality agreement not signed, not participating) (confidentiality agreement not signed, not participating) | |
| • Tillomed Laboratories (erlotinib) (confidentiality agreement not signed, not participating) | |
| • Zentiva (erlotinib, gefitinib) (confidentiality agreement not signed, not participating) | |
| General commentators | All Wales Therapeutics and Toxicology Centre |
| British National Formulary | |
| Department of Health, Social Services and Public Safety for Northern Ireland | |
| Healthcare Improvement Scotland | |
| 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 |
|---|---|
| 14 August 2023 | Suspended. The company (EQRx) 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. |
| 20 March 2023 | Due to changes in the regulatory review timeline, the timelines for this appraisal are now TBC. |
| 07 July 2022 | Committee meeting |
| 20 June 2022 | Following the receipt of the evidence submission for this appraisal, NICE have considered this topic in line with the selection criteria for a Fast Track Appraisal (FTA). NICE can confirm that the selection criteria are met, and that the appraisal can proceed as a FTA. The final decision about the routing of the technology is the responsibility of NICE and is based on a review of the evidence by NICE supported by an external review group. If a positive recommendation is made through the FTA process, NHS England/commissioners have committed to providing funding for the technologies within 30 days of final guidance publication. For further information please refer to the process guide addendum. |
| 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