Ribociclib Medicine 05 December 2023 Extended indication Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer 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 Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer Current proprietary name Already available biosimilars / generics Proprietary name 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 Exact indication not yet known Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date July 2023 Expected Registration May 2024 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Adjuvant endocrine therapy Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation RIB + ET liet een significant langere iDFS dan enkel ET zien (HR, 0.748; 95% CI, 0.618-0.906; P = .0014). Er is nog geen overlevingswinst aangetoond Duration of treatment Average 3 year / years Frequency of administration 1 times a day Dosage per administration 400 mg References https://clinicaltrials.gov/study/NCT03701334?term=NATALEE&intr=ribociclib&aggFilters=phase:3&rank=1 Additional remarks Awaiting publication of study results Expected patient volume per year Patient volume < 2,338 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL: Ned Kanker registratie 2018 en waar mogelijk is een gemiddelde genomen van de jaren 2018 + 2019. Additional remarks Incidentie invasief mammacarcinoom is 14.845. Totaal aantal invasieve HR+, HER2- vroeg stadium borstkankerpatiënten (na selectie op minstens 1 positieve lymfeklier, zonder micrometastasen. En exclusie van stadium 0 en 4 patiënten (en reeds chirurgie ondergaan) is 2.338. Expected cost per patient per year Cost References Additional remarks Er is een financieel arrangement van toepassing tot 1 januari 2025. Potential total cost per year Total cost Total cost for sluice Additional remarks Unknown, awaiting EMA label Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks