Suggested remit - To appraise the clinical and cost effectiveness of pembrolizumab within its marketing authorisation for the neoadjuvant treatment of triple negative breast cancer
 
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

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

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