Status | In progress |
Decision | Selected |
Process | STA 2018 |
ID number | 1500 |
Provisional Schedule
Committee meeting: 1 | 13 September 2022 |
Expected publication | 23 November 2022 |
Project Team
Project lead | Thomas Feist |
Email enquiries
- If you have any queries please email TAteam1@nice.org.uk
External Assessment Group | Kleijnen Systematic Reviews Ltd |
Stakeholders
Companies sponsors | Immunocore |
Others | Department for Health and Social Care |
NHS England | |
Welsh Government | |
Patient carer groups | Breast Cancer Now |
Professional groups | Association of Cancer Physicians |
Cancer Research UK | |
Royal College of Physicians | |
Royal College of Radiologists | |
General commentators | All Wales Therapeutic 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 |
---|---|
29 December 2021 | The appraisal of pembrolizumab with chemotherapy for neoadjuvant and adjuvant treatment of untreated locally advanced non-metastatic triple negative breast cancer has been paused following the submissions being received in late-November 2021. Due to the volume of topics within the NICE work programme, NICE is giving priority scheduling to new active substances so guidance can be published within 3 months of the topic receiving MA. This is a KPI which is set by the Department of Health. This KPI does not apply for licence extensions. Licence extensions where possible are being scheduled to allow first publication (FAD or ACD) to be published within 6 months of the GB marketing authorisation being received. It is acknowledged that this may not always be achievable. Therefore, we anticipate that the appraisal will restart in mid-March 2022 when the submissions are sent over to the Evidence Review Group (ERG) and will be discussed at committee in mid- September 2022. |
06 October 2021 | Invitation to participate |
26 August 2021 | Draft scope documents |
23 July 2021 | We recently contacted all stakeholders for the appraisal of pembrolizumab with chemotherapy for neoadjuvant and adjuvant treatment of untreated locally advanced non-metastatic triple negative breast cancer [ID1500] regarding a delay to this topic for operational reasons. Pembrolizumab with chemotherapy for neoadjuvant and adjuvant treatment of untreated locally advanced non-metastatic triple negative breast cancer has now been rescheduled into the work programme and the appraisal is due to start late September 2021 and will be discussed at committee in early June 2022. The new timelines are subject to the work programme capacity and we will continue to review our plans and update our stakeholders accordingly. |
17 June 2021 | Timelines for this appraisal are to be confirmed. Further information regarding the scheduling of this appraisal will be available in due course. |
15 June 2020 | The Department for Health and Social Care has asked NICE to conduct an appraisal of Pembrolizumab in combination with chemotherapy for neoadjuvant treatment of triple negative breast cancer. Following on from advice received from the company the timelines for this appraisal are to be aligned with the latest regulatory expectations and further information regarding the scheduling of this appraisal will be available in due course. |
08 August 2019 | As you will be aware, the Department for Health and Social Care has asked NICE to conduct an appraisal of pembrolizumab in combination with chemotherapy for neoadjuvant treatment of triple negative breast cancer. Please note that following on from advice received from the company, further information regarding the timelines for this appraisal will be available in due course. |
04 January 2019 | As you will be aware the Department for Health and Social Care has asked NICE to carry out a Single Technology Appraisal of pembrolizumab plus chemotherapy as a neo-adjuvant therapy in patients with previously untreated locally advanced non-metastatic triple negative breast cancer. I am writing to advise that following an update from the company, NICE has rescheduled the appraisal and it is expected to begin in mid-July 2019. |
15 October 2018 - 12 November 2018 | Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators |
26 June 2018 | In progress. Topic referred |
For further information on our processes and methods, please see our CHTE processes and methods manual