Paclitaxel Medicine 03 June 2025 Extended indication Paclitaxel monotherapy for first line treatment of recurrent or metastatic HER2 negative breast cancer in adults over 19 years of age and elderly. Therapeutic value No estimate possible yet Total cost € 300,000.00 Registration phase Clinical trials Product Active substance Paclitaxel Domain Oncology Reason of inclusion New medicine (specialité) Main indication Breast cancer Extended indication Paclitaxel monotherapy for first line treatment of recurrent or metastatic HER2 negative breast cancer in adults over 19 years of age and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Liporaxel Manufacturer Daehwa Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: tubuline beta klasse 1 inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date July 2026 Expected Registration August 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 Er zijn nog geen studieresultaten bekend. Het betreft een oraal middel ter vervanging van intraveneus middel. Duration of treatment Median 6.3 month / months Frequency of administration 2 times a day Dosage per administration 200mg/m2 References NCT03315364 (OPTIMAL); Kim et al. Ther Adv Med Oncol. 2021 Additional remarks Expected patient volume per year Patient volume < 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiegegevens Additional remarks Volgens declaratiegegevens krijgen jaarlijks ongeveer 600 patiënten paclitaxel voorgeschreven als monotherapie voor gemetastaseerde borstkanker in de eerste lijn. Expected cost per patient per year Cost € 500.00 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 GIPdatabank Additional remarks In 2021 was de gemiddelde vergoeding per gebruiker van paclitaxel €442,78. Deze nieuwe toedieningsvorm kan echter duurder zijn dan generieke varianten. Potential total cost per year Total cost € 300,000.00 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