Trastuzumab emtansine Medicine 10 December 2019 Extended indication Trastuzumab entansine in combination with pertuzumab following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer. Therapeutic value No judgement Total cost € 178,500,000.00 Registration phase No registration expected Product Active substance Trastuzumab emtansine Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Breast cancer Extended indication Trastuzumab entansine in combination with pertuzumab following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer. Current proprietary name Already available biosimilars / generics Proprietary name Kadcyla Manufacturer Roche Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De fabrikant heeft aangegeven dat de behandeling van trastuzumab emtansine in combinatie met pertuzumab als adjuvante therapie voor patiënten met operabele HER2-positieve borst kanker niet zal worden geregistreerd, omdat de fase 3 studie KAITLIN haar primaire eindpunt niet heeft gehaald. Therapeutic value Current treatment options Chemotherapie - trastuzumab - pertuzumab Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 3,6 mg/kg References KAITLIN, NCT01966471 Additional remarks Expected patient volume per year Patient volume < 1,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR, NCT01966471 Additional remarks Inclusiecriterium fase III studie: "Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable (HER2-Positive)". Om die reden gaan wij uit van stadium I / II. Dit betreft zo'n 1.500 personen. Expected cost per patient per year Cost € 78,000.00 - 160,000.00 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 medicijnkosten.nl Additional remarks Trastuzumab emtansine poeder voor oplossing voor infusie 100mg fl. De behandelduur van 1 jaar betekent 17 toedieningen (elke 3 weken) wat resulteert in behandelkosten van €78.000 per jaar. Dit is in lijn met behandeling volgens de registratiestudie KAITLIN. Bij een dosering van 6mg/kg komt dit neer op zo'n €160.000 bij een patiënt van 70 jaar die een jaar lang behandeld wordt. Potential total cost per year Total cost € 178,500,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions Zie ander record in de horizonscan, geen andere fase III studies in de pijplijn van Roche. References adisinsight Additional remarks Buiten de indicaties in de Horizonscan geen nieuwe indicatie-uitbreidingen. Other information Additional remarks