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.

1. Product

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

2. 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

3. 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

4. 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.

5. 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.

6. 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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.