Ribociclib Medicine 09 January 2018 Extended indication Breast cancer, advanced metastatic, HR+ and HER2-, in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin, premenopausal women. Therapeutic value No judgement Total cost € 7,650,000.00 Registration phase Unknown Product Active substance Ribociclib Domain Oncology and Hematology Reason of inclusion Main indication Breast cancer Extended indication Breast cancer, advanced metastatic, HR+ and HER2-, in combination with tamoxifen and goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin, premenopausal women. Current proprietary name Already available biosimilars / generics Proprietary name Kisqali Manufacturer Novartis Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Eerstelijnsbehandeling i.c.m. een aromataseremmer. ibociclib is een selectieve remmer van cycline-afhankelijke kinase (CDK) 4 en 6. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date Expected Registration February 2019 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Patiënten worden grotendeels behandeld als zijnde postmenopauzaal: Palbociclib + Fulvestrant; Aromataseremmer monotherapie; Fulvestrant monotherapie; Everolimus + Exemestaan; Tamoxifen. In de toekomst komt Ademaciclib er nog bij. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 6 month / months Frequency of administration 1 times a day Dosage per administration 600 mg References Additional remarks Gemiddelde behandelduur is 3-6 maanden. Fabrikant: De gemiddelde behandelduur zal volgen uit de MONALEESA-7 studie. Expected patient volume per year Patient volume 50 - 630 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; Klijn et al, J Clin Oncol 2001;19: 343-53. Additional remarks Fabrikant: Max. patiënten: assumptie incidentie gediagnosticeerd mBC = 3674, 30% pre- of perimenopausaal, 75% is ER+, 15% is ook HER2+, 10% van de patiënten komt niet in aanmerking voor behandeling omdat hun conditie te zwak is of omdat zij vanwege aggresiviteit van de ziekte behandeld moeten worden met chemotherapie. 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 € 15,000.00 - 30,000.00 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 Additional remarks Sluis medicament (€ 60,57 per tablet van 200 mg). Fabrikant geeft aan de de Nederlandse lijstprijs voor 600 mg per dag €3.471 bedraagt per 30 dagen. Potential total cost per year Total cost € 7,650,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Post-menopauzale patiënten. References Additional remarks Other information Additional remarks