Abemaciclib Medicine 09 January 2018 Extended indication Breast cancer, advanced, HR+ en HER2-, 1L or 2L. Therapeutic value No judgement Total cost € 11,857,500.00 Registration phase Registration application pending Product Active substance Abemaciclib Domain Oncology and Hematology Reason of inclusion Main indication Breast cancer Extended indication Breast cancer, advanced, HR+ en HER2-, 1L or 2L. Current proprietary name Already available biosimilars / generics Proprietary name Verzenio Manufacturer Eli Lilly Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CDK4/6 remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New medicine ATMP Unknown Submission date July 2017 Expected Registration November 2018 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 50 - 507 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2015: Mammacarcinoom HR+, HER-, stadium 4: 507 diagnoses. Van max. naar realistisch patiëntenaantal: waarschijnlijk zeer klein aantal patiënten ivm standaard inductie postmenopausale status (met LHRH of via ovariële ablatie). Expected cost per patient per year Cost € 35,000.00 - 50,000.00 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 Medicijnkosten.nl; FiercePharma Additional remarks Prijsrange geschat nav prijs en behandelschema Ibrance en Kisqaly bij borstkanker. Kisqali (ribociclib) kost €60,70 per tablet van 200 mg; Ibrance (palbociclib) is €163,54 voor een capsule van 100 mg. Prijs range pppj anders dan de kosten per behandeling gezien deze langer dan een jaar duurt. prijs per behandeling geschat op €63.000-76.000. Potential total cost per year Total cost € 11,857,500.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions neoMONARCH: postmenopausal women with previously untreated early stage HR+, HER2- breast cancer; MonarchE: abemaciclib in the adjuvant setting in patients with high-risk, early breast cancer. References NCT02441946; NCT03155997 Additional remarks Other information Additional remarks