Giredestrant Medicine 03 June 2025 Extended indication Giredestrant in combination with palbociclib for first line treatment of locally advanced or metastatic ER-positive HER2-negative breast cancer in adults and elderly. Therapeutic value No estimate possible yet Total cost € 62,860,000.00 Registration phase Clinical trials Product Active substance Giredestrant Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Giredestrant in combination with palbociclib for first line treatment of locally advanced or metastatic ER-positive HER2-negative breast cancer in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Selectieve oestrogeenreceptor-degrader (SERD). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date February 2027 Expected Registration February 2028 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in april 2026 en registratie in maart 2027. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten gepubliceerd. Duration of treatment Frequency of administration Dosage per administration References NCT04546009 (persevERA) Additional remarks Expected patient volume per year Patient volume < 1,400 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata (1) Additional remarks In 2023 waren er ongeveer 1.400 mensen die palbociclib ontvingen in combinatie met fulvestrant (1). Dit aantal is mogelijk gelijk aan het volume dat in aanmerking komt voor giredestrant. Expected cost per patient per year Cost € < 44,900.00 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 Horizonscan Geneesmiddelen elacestrant. Additional remarks De kosten zijn mogelijk gelijk aan die van elacestrant. Potential total cost per year Total cost € 62,860,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks