Palbociclib Medicine 08 December 2020 Extended indication Patients with HR+/HER2- invasive early breast cancer in combination with standard adjuvant endocrine therapy. Therapeutic value No estimate possible yet Total cost € 117,981,408.00 Registration phase No registration expected Product Active substance Palbociclib Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Patients with HR+/HER2- invasive early breast cancer in combination with standard adjuvant endocrine therapy. Current proprietary name Already available biosimilars / generics Proprietary name Ibrance Manufacturer Pfizer Portfolio holder Mechanism of action CDK4 / 6 tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Primaire eindpunten van de studie zijn niet gehaald. De fabrikant verwacht op dit moment geen indiening. Therapeutic value Current treatment options Endocriene therapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 2 year / years Frequency of administration 1 times a day Dosage per administration 125 mg References NCT02513394 https://investors.pfizer.com/investor-news/press-release-details/2020/Pfizer-Provides-Update-on-Phase-3-PALLAS-Trial-of-IBRANCE-palbociclib-Plus-Endocrine-Therapy-in-HR-HER2--Early-Breast-Cancer/default.aspx Additional remarks Addition of 2 years of palbociclib to standard adjuvant endocrine therapy. Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years. Expected patient volume per year Patient volume < 5,006 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Er waren in 2016 in totaal 5.006 patiënten met stadium II of III HR+/HER2- borstkanker in Nederland. Een gedeelte van deze patiënten komt mogelijk in aanmerking voor deze behandeling. Expected cost per patient per year Cost € 23,568.00 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 farmacotherapeutischkompas.nl; Additional remarks De gemiddelde prijs per 21 stuks: IBRANCE, CDe lijstprijs van Ibrance is €1.964,52 (exclusief BTW). Op jaarbasis komt dit uit op €23.568 exclusief btw. Potential total cost per year Total cost € 117,981,408.00 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 Non-small cell lung cancer References Adisinsight. Additional remarks Fase 2-3 Other information Additional remarks