Suggested remit: To appraise the clinical and cost effectiveness of abemaciclib within its marketing authorisation for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer.
 
Status In progress
Decision Selected
Process STA 2018
ID number 3857

Provisional Schedule

Final draft guidance 17 June 2022 - 01 July 2022
Expected publication 20 July 2022

Project Team

Project lead Shonagh D'Sylva

Email enquiries

Stakeholders

Companies sponsors Eli Lilly (abemaciclib)
Others Department of Health and Social Care
  NHS England
  NHS Vale of York CCG
  NHS Hambleton, Richmondshire and Whitby CCG
  Welsh Government
Patient carer groups Black Health Agency
  Breast Cancer Now
  Breast Cancer Haven
  Breast Cancer UK
  Cancer Black Care
  Cancer Equality
  Helen Rollason Cancer Charity
  Independent Cancer Patients Voice
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tenovus Cancer Care
Professional groups Association of Anaesthetists
  Association of Breast Surgery
  Association of Cancer Physicians
  Association of Surgeons of Great Britain & Ireland
  British Association of Surgical Oncology
  British Geriatrics Society
  British Institute of Radiology
  British Psychosocial Oncology Society
  Cancer Research UK
  Royal College of Anaesthetists
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  Royal College of Surgeons
  Royal Pharmaceutical Society
  Royal Society of Medicine
  Society and College of Radiographers
  UK Breast Cancer Group
  UK Clinical Pharmacy Association
  UK Oncology Nursing Society
Associated public health groups Public Health England
  Public Health Wales
Comparator companies Accord Healthcare Limited (anastrozole, exemestane, letrozole)
  Aurobindo Pharma (tamoxifen)
  AstraZeneca UK Limited (anastrozole)
  Cipla EU Ltd (letrozole)
  Dr. Reddy’s Laboratories (UK) Ltd (letrozole)
  Glenmark Pharmaceuticals Europe Ltd (exemestane, letrozole)
  Mylan (anastrozole, exemestane, tamoxifen)
  Novartis Pharmaceuticals UK Ltd (letrozole)
  Pfizer Limited (exemestane)
  Ranbaxy (UK) Limited a Sun Pharmaceutical Company (anastrozole, letrozole)
  Rosemont Pharmaceuticals Limited (tamoxifen)
  Sandoz Limited (anastrozole)
  Tillomed Laboratories Ltd (tamoxifen)
  Wockhardt UK Ltd (anastrozole, tamoxifen)
  Zentiva (exemestane)
General commentators All Wales Therapeutics and Toxicology Centre
  Allied Health Professionals Federation
  Board of Community Health Councils in Wales
  British National Formulary
  Care Quality Commission
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association for Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Commercial Medicines Unit
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee
Relevant research groups Against Breast Cancer
  Breast Cancer Hope
  Breast Cancer Research Trust
  Cochrane Breast Cancer Group
  Genomics England
  Institute of Cancer Research
  MRC Clinical Trials Unit
  National Cancer Research Institute
  National Cancer Research Network
  National Institute for Health Research
  Pro-Cancer Research Fund

Timeline

Key events during the development of the guidance:

Date Update
10 May 2022 Committee meeting: 1
31 August 2021 Invitation to participate
21 May 2021 In progress. In progress
17 February 2021 - 17 March 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