Ribociclib Medicine 05 December 2023 Extended indication Extension of indication to include the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, Stage II or Stage III early breast cancer, irrespective of nodal status, in combination with an AI for Kisqali. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Ribociclib Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Extension of indication to include the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, Stage II or Stage III early breast cancer, irrespective of nodal status, in combination with an AI for Kisqali. Current proprietary name Already available biosimilars / generics Proprietary name Kisqali Manufacturer Novartis Portfolio holder Novartis Mechanism of action CDK4 / 6 tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Ribociclib is een selectieve remmer van cycline-afhankelijke kinase (CDK) 4 en 6. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date September 2023 Expected Registration July 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03701334 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks