Trastuzumab pamirtecan Medicine 03 June 2025 Extended indication Trastuzumab pamirtecan monotherapy for second line or later treatment of recurrent HER2-expressing endometrial cancer in adults and elderly previously treated with platinum-based therapy and ICI treatment. Therapeutic value No estimate possible yet Total cost € 39,375,000.00 Registration phase Clinical trials Product Active substance Trastuzumab pamirtecan Domain Oncology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Trastuzumab pamirtecan monotherapy for second line or later treatment of recurrent HER2-expressing endometrial cancer in adults and elderly previously treated with platinum-based therapy and ICI treatment. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Biontech Portfolio holder Mechanism of action Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks DNA topoisomerase I remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks 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 Eerste resultaten fase 2 zouden op ESGO 2025 gepresenteerd worden, maar abstract teruggetrokken. Er wordt wel een fase 3 studie gepland (NCT06340568) Duration of treatment Frequency of administration Dosage per administration References NCT05150691 Additional remarks Expected patient volume per year Patient volume < 350 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks Volgens declaratiedata worden per jaar ongeveer 350 patiënten behandeld met medicijnen voor baarmoederkanker. Expected cost per patient per year Cost € 100,000.00 - 125,000.00 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 Additional remarks Er is nog niks bekend over de kosten van trastuzumab pamirtecan. Andere trastuzumab-bevattende regimes kunnen tussen de €100.000 en €125.000 per patiënt per jaar kosten. Potential total cost per year Total cost € 39,375,000.00 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