Trastuzumab emtansine

Active substance Trastuzumab emtansine
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen Indication extension
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.

Product

Proprietary name Kadcyla
Manufacturer Roche
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2020
Expected Registration December 2021
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Chemotherapie - trastuzumab - pertuzumab
Therapeutic value No judgement
Duration of treatment Not found
Frequency of administration 1 times every 3 weeks
Dosage per administration 3,6 mg/kg
References KAITLIN, NCT01966471

Expected patient volume per year

Patient volume

< 1,500

Market share is generally not included unless otherwise stated.

References NKR, NCT01966471
Additional comments 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 - 160,000
References medicijnkosten.nl
Additional comments 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 6 mg / 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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References adisinsight
Additional comments Buiten de indicaties in de horizonscan geen nieuwe indicatie-uitbreidingen.

Other information

There is currently no futher information available.