Capivasertib Medicine 03 December 2024 Extended indication Capivasertib is indicated in combination with abiraterone as treatment for patients with de novo metastatic hormone-sensitive prostate cancer characterized by PTEN deficiency. Therapeutic value No estimate possible yet Total cost € 9,198,000.00 Registration phase Clinical trials Product Active substance Capivasertib Domain Oncology Reason of inclusion Indication extension IND Main indication Prostate cancer Extended indication Capivasertib is indicated in combination with abiraterone as treatment for patients with de novo metastatic hormone-sensitive prostate cancer characterized by PTEN deficiency. Current proprietary name Already available biosimilars / generics Proprietary name Truqap Manufacturer AstraZeneca Portfolio holder AstraZeneca Mechanism of action Unknown Route of administration Oral Therapeutical formulation Unknown 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 2025 Expected Registration December 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks In mei 2024 is het advies gegeven aan VWS om capivasertib in de sluis te plaatsen, voor zover verstrekt in het kader van geneeskundige behandelingen. Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog geen effectiviteitsdata bekend. CAPItello-281 is op dit moment bezig. Duration of treatment Maximal 12 month / months Frequency of administration 2 times a day Dosage per administration References NCT04493853 (CAPItello-281) Additional remarks Twee maal daags, 400mg (2 tablets of 200mg), iedere week op dag 1 tot 4 in een 28 daagse behandel cyclus. In combinatie met abiraterone. Expected patient volume per year Patient volume 146 - 291 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2024 (1); Piombino et al. Cancers (Basel). 2023 (2); Van der Eecken et al. Eur. Urol. Oncol. 2021 (3). Additional remarks In 2023 werden er in Nederland 14.561 mensen met prostaatkanker gediagnosticeerd (1). Gemetastaseerde hormoon sensitieve prostaatkanker (mHSPC) komt voor bij 5% tot10% van alle prostaatkankerdiagnoses (2). Bij 20% van de gevallen komt de PTEN-alteratie voor (3). Expected cost per patient per year Cost € 42,000.00 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 IHSI Additional remarks In Denemarken kost een verpakking van 64 tabletten 200mg Truqap ongeveer €6,911.07. Uitgaande van een mediane duur van 6 cycli zal dit omgerekend ongeveer €41.466 zijn. Potential total cost per year Total cost € 9,198,000.00 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