Trastuzumab emtansine

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	Clinical trials

Product

Active substance	Trastuzumab emtansine
Domain	Oncology and Hematology
Reason of inclusion	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.
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
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 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.

Patient volume

< 1,500

Market share is generally not included unless otherwise stated.

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
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 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	178,500,000.00 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.

Total cost

178,500,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

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

Other information

There is currently no futher information available.