Trastuzumab

Extended indication	Early and metastatic breast cancer and metastatic gastric cancer.
Therapeutic value	No judgement
Total cost	90,000,000.00

Product

Active substance	Trastuzumab
Domain	Oncology and Hematology
Main indication	Breast cancer
Extended indication	Early and metastatic breast cancer and metastatic gastric cancer.
Proprietary name	Ontruzant
Manufacturer	samsung
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	Eerste biosimilar voor Trastuzumab die goedgekeurd is door de EMA.

Registration

Registration route	Centralised (EMA)
Expected Registration	November 2017
Orphan drug	No
Additional remarks	Geregistreerd in november 2017.

Therapeutic value

Therapeutic value	No judgement
Duration of treatment	Average 1 year / years
Frequency of administration	17 times a year
Dosage per administration	600 mg
Additional remarks	Toedieningsfrequentie is 1 maal per 3 weken. Behandelduur ingeschat op basis van huidige biological Herceptin.

Expected patient volume per year

Patient volume	2,000 - 4,000 Market share is generally not included unless otherwise stated.
References	NKR, GIPdatabank
Additional remarks	Schatting op basis van NKR data: Ongeveer 1500 patiënten in 2015 met borstkanker in 1e lijn kregen trastuzumab. Aantal Her+ is circa 2000. Volgens de GIPdatabank waren er in 2016 4292 gebruikers van Herceptin, Ontruzant zal op termijn een marktaandeel van rond de 50% halen.

Patient volume

2,000 - 4,000

Market share is generally not included unless otherwise stated.

References

NKR, GIPdatabank

Additional remarks

Schatting op basis van NKR data: Ongeveer 1500 patiënten in 2015 met borstkanker in 1e lijn kregen trastuzumab. Aantal Her+ is circa 2000. Volgens de GIPdatabank waren er in 2016 4292 gebruikers van Herceptin, Ontruzant zal op termijn een marktaandeel van rond de 50% halen.

Expected cost per patient per year

Cost	20,000.00 - 40,000.00
References	Medicijnkosten.nl
Additional remarks	Herceptin €1.750,49 per injectieflacon van 120 mg/ml flacon van 5 ml.

Potential total cost per year

Total cost	90,000,000.00 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

90,000,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.