Pembrolizumab

Extended indication	Head & Neck cancer, metastatic, 2L
Therapeutic value	No judgement
Total cost	5,000,000.00
Registration phase	Registration application pending

Product

Active substance	Pembrolizumab
Domain	Oncology and Hematology
Main indication	Head and neck cancer
Extended indication	Head & Neck cancer, metastatic, 2L
Proprietary name	Keytruda
Manufacturer	MSD
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)
Additional remarks	Anti-PD-1

Registration

Registration route	Centralised (EMA)
Particularity	Indication extension
Expected Registration	August 2018
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	Al geregistreerd door FDA. Pembrolizumab heeft in de sluis gezeten, de afspraken die gedurende die periode zijn gemaakt t.a.v. de vergoeding gelden ook voor deze indicatie-uitbreiding.

Therapeutic value

Current treatment options	Nivolumab, Durvalumab, Tremelimumab
Therapeutic value	No judgement
Frequency of administration	1 times every 3 weeks
Dosage per administration	200 mg
References	Fabrikant

Expected patient volume per year

Patient volume	> 100 Market share is generally not included unless otherwise stated.
Additional remarks	NKR 2015: totaal 3202, per stadia: 1) 970; 2) 300; 3) 427; 4) 1189. Gezien de huidige behandelopties / concurrentie zal het realistisch patiëntvolume lager liggen. Schatting 100 patiënten.

Patient volume

> 100

Market share is generally not included unless otherwise stated.

Additional remarks

NKR 2015: totaal 3202, per stadia: 1) 970; 2) 300; 3) 427; 4) 1189. Gezien de huidige behandelopties / concurrentie zal het realistisch patiëntvolume lager liggen. Schatting 100 patiënten.

Expected cost per patient per year

Cost	40,000.00 - 60,000.00
References	Medicijnkosten.nl, AIP fabrikant.
Additional remarks	AIP per nov 2017: €2624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). € 1312,19 per injectieflacon 50MG FL (poeder).

Potential total cost per year

Total cost	5,000,000.00 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

5,000,000.00

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.