Abemaciclib Medicine 10 June 2020 Extended indication Patients with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer. Therapeutic value No judgement Total cost € 30,666,090.00 Registration phase Clinical trials Product Active substance Abemaciclib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Patients with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer. 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 Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Estimated primary completion date van fase 3 studie in april 2021. Therapeutic value Current treatment options Endocriene behandeling (na chirurgie en radiotherapie en/of chemotherapie) Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation De studieresultaten zullen in 2021 bekend gemaakt worden. Duration of treatment 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 november 2020 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 2020). 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 Op dit moment geen nieuwe fase 3 studies. References AdisInsight Additional remarks Fase 2 studies naar veel verschillende indicaties. Other information Additional remarks