Extended indication Adjuvant melanoma stage III
Therapeutic value No judgement
Total cost 17,500,000.00

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Main indication Skin cancer
Extended indication Adjuvant melanoma stage III
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 2018
Orphan drug No
Additional remarks 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 Alle PD1 en PDL1 remmers worden verwacht voor deze indicatie
Therapeutic value No judgement
Frequency of administration 17 times a year
Dosage per administration 200 mg
References Fabrikant
Additional remarks Toedieningsfrequentie is 1 maal per 3 weken

Expected patient volume per year

Patient volume

350

Market share is generally not included unless otherwise stated.

References NKR; Oncoline
Additional remarks NKR 2015: 427 diagnoses melanoom stadium 3. Oncoline: momenteel wordt er niet geadviseerd om patiënten met melanoom buiten onderzoeksverband systemisch adjuvante behandeling te geven. Inschatting van de fabrikant bij Nivolumab is 350.

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

17,500,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.