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 Possibly no place in the treatment regimen Total cost Registration phase Registered 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 Particularity ATMP No Submission date September 2023 Expected Registration January 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Broadly excluded Additional remarks Therapeutic value Current treatment options Adjuvant endocrine therapy Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Ribiciclib + 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. Disease free survival haalt de PASKWIL criteria voor adjuvante therapie niet. Het is naar verwachting meer toxisch dan huidige behandeloptie. Duration of treatment Average 3 year / years Frequency of administration 1 times a day Dosage per administration 400mg References NCT03701334 (NATALEE) Additional remarks 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 en 2019. Additional remarks Incidentie invasief mammacarcinoom is 14.845. Totaal aantal invasieve HR+, HER2- vroeg stadium borstkankerpatiënten (na selectie op minstens een 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 Er was een financieel arrangement van toepassing tot 1 januari 2025. Deze is afgelopen, waardoor Kisqali weer in de sluis is opgenomen. https://zoek.officielebekendmakingen.nl/stcrt-2024-21048.html Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks