Suggested remit: To appraise the clinical and cost effectiveness of elacestrant within its marketing authorisation for treating postmenopausal hormone receptor-positive HER2-negative advanced or metastatic breast cancer after 1 or 2 endocrine treatments.
 
Status In progress
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 6225

Provisional Schedule

Final draft guidance 19 December 2024 - 16 January 2025
Expected publication 05 February 2025

Project Team

Project lead Jeremy Powell

Email enquiries

External Assessment Group Southampton Health Technology Assessment Centre (SHTAC), University of Southampton

Stakeholders

Companies sponsors Menarini Stemline (elacestrant)
Others Department of Health and Social Care
  NHS England
Patient carer groups Breast Cancer Now
  Make 2nds Count
  MET UP UK
Professional groups Association of Cancer Physicians
  Cancer Research UK
  Royal College of Physicians
  Royal College of Radiologists
  UK Breast Cancer Group
Associated public health groups None
Comparator companies Amarox (anastrozole, capecitabine, letrozole) (confidentiality agreement not signed, not participating)
  AstraZeneca (anastrozole, fulvestrant) (confidentiality agreement signed, participating)
  Aurobindo Pharma – Milpharm (tamoxifen) (confidentiality agreement not signed, not participating)
  Bristol Myers Squibb Pharmaceuticals (paclitaxel) (confidentiality agreement not signed, not participating)
  Cipla EU (fulvestrant, letrozole) (confidentiality agreement not signed, not participating)
  Dr. Reddy’s Laboratories (capecitabine, everolimus, fulvestrant) (confidentiality agreement not signed, not participating)
  Eisai (eribulin) (confidentiality agreement signed, participating)
  Ethypharm (everolimus) (confidentiality agreement not signed, not participating)
  Genus Pharmaceuticals (fulvestrant) (confidentiality agreement not signed, not participating)
  Glenmark Pharmaceuticals (capecitabine, exemestane, fulvestrant, letrozole) (confidentiality agreement not signed, not participating)
  Hospira UK (docetaxel, gemcitabine, paclitaxel) (confidentiality agreement not signed, not participating)
  Medac GmbH (vinorelbine) (confidentiality agreement not signed, not participating)
  Medical Valley (fulvestrant) (confidentiality agreement not signed, not participating)
  Mylan (anastrozole, exemestane, tamoxifen) (confidentiality agreement not signed, not participating)
  Novartis (alpelisib, everolimus, letrozole) (confidentiality agreement signed, participating)
  Pfizer (exemestane) (confidentiality agreement signed, participating)
  Pierre Fabre (vinorelbine) (confidentiality agreement not signed, not participating)
  Ranbaxy, a Sun Pharmaceuticals company (anastrozole, fulvestrant, gemcitabine, letrozole) (confidentiality agreement not signed, not participating)
  Rivopharm (exemestane) (confidentiality agreement not signed, not participating)
  Rosemont Pharmaceuticals (tamoxifen) (confidentiality agreement not signed, not participating)
  Sandoz (anastrozole, everolimus, fulvestrant) (confidentiality agreement not signed, not participating)
  Seacross Pharmaceuticals (docetaxel, paclitaxel) (confidentiality agreement not signed, not participating)
  Synchrony Pharma (gemcitabine) (confidentiality agreement not signed, not participating)
  Teva UK (fulvestrant, paclitaxel) (confidentiality agreement not signed, not participating)
  Tillomed Laboratories (tamoxifen) (confidentiality agreement not signed, not participating)
  Wockhardt UK (tamoxifen) (confidentiality agreement not signed, not participating)
  Zentiva (exemestane, fulvestrant) (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
  Medicines and Healthcare products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Institute of Cancer Research

Timeline

Key events during the development of the guidance:

Date Update
12 November 2024 Committee meeting: 2
01 October 2024 - 22 October 2024 Draft guidance
10 September 2024 Committee meeting
10 September 2024 Declaration of interests
09 February 2024 Invitation to participate
12 October 2023 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 in early February 2024. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to facilitate a suitably comprehensive and robust submission.
11 August 2023 - 11 September 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 6225
11 August 2023 In progress. DHSC referral received
26 January 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