Extended indication Advanced Hepatocellular Carcinoma in combination with lenvatinib (1L).
Therapeutic value No estimate possible yet
Total cost 14,220,000.00
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Liver cancer
Extended indication Advanced Hepatocellular Carcinoma in combination with lenvatinib (1L).
Proprietary name Keytruda
Manufacturer MSD
Mechanism of action PD-1 / PD-L1 inhibitor
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2021
Expected Registration May 2022
Orphan drug No
Registration phase Clinical trials
Additional comments De fabrikant verwacht registratie in het tweede kwartaal van 2022.

Therapeutic value

Current treatment options Sorafenib, lenvatinib.
Therapeutic value No estimate possible yet
Substantiation De LEAP-002 studie (fase 3 pembro/lenva versus lenva mono) loopt nog. Er zal mogelijk substitutie ten opzichte van sorafenib en lenvatinib plaatsvinden.
Frequency of administration 1 times every 3 weeks
Dosage per administration 200mg
References SMPC KEYTRUDA
Additional comments - tot maximaal 2 jaar behandeling.

Expected patient volume per year

Patient volume

< 158

Market share is generally not included unless otherwise stated.

References NKR
Additional comments Patiënten die op dit moment sorafenib/lenvatinib ontvangen zullen mogelijk overstappen. Het totaal aantal patiënten in 2016 met hepatocellulair carcinoom stadium 4 betreft 158. Een gedeelte van deze patiënten zal mogelijk in aanmerking komen voor deze behandeling.

Expected cost per patient per year

Cost < 90,000.00
References G-standaard
Additional comments AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 4ml (oplossing). Uitgaande van een behandeling van 1 x per 3 weken 200mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar. .

Potential total cost per year

Total cost

14,220,000.00

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 Yes
Indication extensions Indicatie uitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen.
References Fabrikant

Other information

There is currently no futher information available.