Abemaciclib Medicine 10 June 2020 Extended indication Extension of indication to include Verzenios in combination with endocrine therapy for adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. Therapeutic value No estimate possible yet Total cost € 30,666,090.00 Registration phase Registration application pending Product Active substance Abemaciclib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Extension of indication to include Verzenios in combination with endocrine therapy for adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. Current proprietary name Already available biosimilars / generics Proprietary name Verzenios Manufacturer Eli Lilly Portfolio holder Mechanism of action CDK4 / 6 tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Cyclin-dependent kinase 4 inhibitors Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2020 Expected Registration July 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Endocriene behandeling (na chirurgie en radiotherapie en/of chemotherapie). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Abemaciclib plus endocriene therapie had een superieure IDFS versus enkel endocriene therapie (P = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93). De follow up tijd is op dit moment nog te kort voor een cieBOM-advies. Duration of treatment Maximal 2 year / years Frequency of administration 2 times a day Dosage per administration References NCT03155997 Additional remarks Expected patient volume per year Patient volume < 987 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; Ned. Kanker registratie 2018 Additional remarks In de studie worden alleen high risk patiënten geïncludeerd. Van het totale aantal patiënten (9.865) zal naar verwachting een klein deel (maximaal 10%) behandeld worden. Er zullen dus maximaal 987 patiënten in aanmerking komen voor abemaciclib. Expected cost per patient per year Cost € 31,070.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References G-standaard januari 2021 Additional remarks Berekent volgens behandelschema in klinische studie: de AIP-prijs voor een verpakking van 56 tabletten Verzenios is €2.390 Bij een behandelduur van een jaar (13 verpakkingen) zou dat €31.070 bedragen. De definitieve dosering is echter nog niet vastgesteld. Voor alle oncologische behandelingen is voor abemaciclib een financieel arrangement afgesloten tot en met eind 2024). Potential total cost per year Total cost € 30,666,090.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References AdisInsight Additional remarks Fase 2 studies naar veel verschillende indicaties. Other information Additional remarks