Palbociclib Medicine 08 December 2020 Extended indication Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery. Therapeutic value No estimate possible yet Total cost € 23,261,616.00 Registration phase No registration expected Product Active substance Palbociclib Domain Oncology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery. 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 De PENELOPE-B Trial heeft de primaire eindpunten niet gehaald. 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 Frequency of administration 1 times a day Dosage per administration 125 mg References NCT01864746 https://investors.pfizer.com/investor-news/press-release-details/2020/PENELOPE-B-Trial-of-IBRANCE-palbociclib-in-Early-Breast-Cancer-Did-Not-Meet-Primary-Endpoint/default.aspx Additional remarks Palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle Other Name: Ibrance Expected patient volume per year Patient volume < 987 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Ned. Kanker registratie 2018; Record abemaciclib. Additional remarks 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 palbociclib. 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: De 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 € 23,261,616.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks