Suggested remit: To appraise the clinical and cost effectiveness of ribociclib with endocrine therapy within its marketing authorisation for adjuvant treatment of hormone receptor-positive, HER2-negative early breast cancer
 
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 6153

Provisional Schedule

Committee meeting 01 April 2025
Expected publication 18 June 2025

Project Team

Project lead Leena Issa

Email enquiries

External Assessment Group Liverpool Reviews and Implementation Group, University of Liverpool

Stakeholders

Companies sponsors Novartis Pharmaceuticals (ribociclib)
Others Department of Health and Social Care
  NHS England
Patient carer groups Black Health Agency for Equality
  Breast Cancer Now
  Breast Cancer UK
  Cancer Black Care
  Cancer Equality
  Helen Rollason Cancer Charity
  Hereditary Breast Cancer Helpline
  Independent Cancer Patients Voice
  Inflammatory Breast Cancer Network UK
  Lobular Breast Cancer UK
  Macmillan Cancer Support
  Maggie’s Centres
  Marie Curie
  MET UP UK
  South Asian Health Foundation
  Specialised Healthcare Alliance
  Tenovus Cancer Care
  UK Charity for Triple Negative Breast Cancer
Professional groups Association of Breast Surgery
  Association of Cancer Physicians
  British Geriatrics Society
  British Institute of Radiology
  British Oncology Pharmacy Association
  British Psychosocial Oncology Society
  Cancer Research UK
  Royal College of General Practitioners
  Royal College of Nursing
  Royal College of Pathologists
  Royal College of Physicians
  Royal College of Radiologists
  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 Wales
  UK Health Security Agency
Comparator companies Eli Lily (abemaciclib)
  AstraZeneca (olaparib)
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 - Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare products Regulatory Agency
  National Association of Primary Care
  National Pharmacy Association
  NHS Alliance
  NHS Confederation
  Scottish Medicines Consortium
  Welsh Government
  Welsh Health Specialised Services Committee
Relevant research groups Against Breast Cancer
  Breast Cancer Hope
  Cochrane Breast Cancer Group
  Cochrane UK
  Genomics England
  Institute of Cancer Research
  MRC Clinical Trials Unit
  National Institute for Health Research
  Pro-Cancer Research Fund

Timeline

Key events during the development of the guidance:

Date Update
28 August 2024 Invitation to participate
16 April 2024 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 late August 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.
15 January 2024 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 July 2024. These timings are based on a request from the company to reschedule the initial date set by NICE, in order to better align with regulatory timelines and facilitate a suitably comprehensive and robust submission.
07 June 2023 - 05 July 2023 Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators
07 June 2023 In progress. Scoping commenced
27 March 2023 Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Ribociclib with an aromatase inhibitor for adjuvant treatment of hormone receptor-positive, HER2-negative early breast cancer at risk of relapse have been revised. It is anticipated that the appraisal will begin in early-August 2023 when we will write to you about how you can get involved.
11 July 2022 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