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
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Status
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In progress
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Technology type
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Medicine
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Decision
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Selected
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Reason for decision
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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
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| Process |
STA Standard
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| ID number |
6153
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Provisional Schedule
| Committee meeting |
01 April 2025 |
| Expected publication |
18 June 2025 |
Project Team
| Project lead |
Greg O'Toole |
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 |
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NHS England |
| Patient carer groups |
Breast Cancer Now |
| Professional groups |
Association of Cancer Physicians |
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British Oncology Pharmacy Association |
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Cancer Research UK |
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Royal College of Physicians |
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Royal College of Radiologists |
| Associated public health groups |
None |
| Comparator companies |
AstraZeneca (olaparib) (confidentiality agreement signed, participating) |
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Eli Lily (abemaciclib) (confidentiality agreement not signed, not participating) |
| General commentators |
All Wales Therapeutics and Toxicology Centre |
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British National Formulary |
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Department of Health - Northern Ireland |
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Healthcare Improvement Scotland |
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Medicines and Healthcare products Regulatory Agency |
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Scottish Medicines Consortium |
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Welsh Government |
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Welsh Health Specialised Services Committee |
| Relevant research groups |
Institute of Cancer Research |
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Date
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Update
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28 August 2024
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Invitation to participate |
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16 April 2024
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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. |
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15 January 2024
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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. |
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07 June 2023 - 05 July 2023
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Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators |
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07 June 2023
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In progress. Scoping commenced |
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27 March 2023
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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. |
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11 July 2022
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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