Capivasertib Medicine 06 June 2023 Extended indication Locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following recurrence or progression on or after endocrine therapy. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Capivasertib Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Locally advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following recurrence or progression on or after endocrine therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Other Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date May 2023 Expected Registration June 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is onduidelijk of er wel of geen CDK4/6 remmer werd gegeven. In de overall populatie werd weinig winst gezien, maar wel in de lijn waarin een CDK4/6remmer gegeven is. De plaatsbepaling hangt af van de SONIA studie. Duration of treatment Frequency of administration 2 times a day Dosage per administration 400 mg (2 tabletten van 200 mg twee keer per dag = totale dosering per dag is 800 mg) op dag 1 tot 4 van elke week tot aan progressie. In combinatie met fulvestrant in lijn met label. References CAPItello-291 (NCT04305496) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2020 (1) Pakketadvies palbociclib (2) Additional remarks Invasief mammacarcinoom: HR+HER- stadium 1; 5.026 patiënten, stadium 2; 3.938 patiënten, stadium 3; 994 patiënten en stadium 4; 597 patiënten (1) Het betreft locally advanced / metastatic om die reden gaan wij uit van stadium 3 en 4 (994+597=1.591 patiënten). In ongeveer 20% van de patiënten met vroege borstkanker zal de ziekte terugkeren als gemetastaseerde ziekte (5.026+3.938)*20%=1.793 patiënten. (2) In totaal komen er dan ook voor deze indicatie 1.793+1591=3.384 maximaal in aanmerking Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost 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 Prostaatkanker (fase III) References Adis Insight Additional remarks Other information Additional remarks