Extended indication Extension of the currently approved therapeutic indication for the treatment of relapsed or refracto
Therapeutic value No judgement
Total cost 3,150,000.00
Registration phase Registration application pending

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Hodgkin's lymphoma
Extended indication Extension of the currently approved therapeutic indication for the treatment of relapsed or refractory classical Hodgkin lymphoma (rrcHL) in adults to an earlier line of therapy and to include paediatric patients (2L).
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 June 2020
Expected Registration January 2021
Registration phase Registration application pending
Additional remarks De fabrikant verwacht registratie in januari 2021.

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 200mg
References SMPC KEYTRUDA, NCT02684292
Additional remarks Bij mono therapie eenmaal in de 6 weken 400mg mogelijk. Tot maximaal 2 jaar behandeling.

Expected patient volume per year

Patient volume

30 - 40

Market share is generally not included unless otherwise stated.

References NKR
Additional remarks Er zijn per jaar zo'n 400 patiënten met klassiek hodgkin lymfoom (incidentie NKR). Er zullen naar verwachting 30-40 patiënten in aanmerking komen voor deze tweedelijns behandeling.

Expected cost per patient per year

Cost < 90,000.00
References G-standaard
Additional remarks Voor alle indicatie van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met juni 2020). AIP per november 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Uitgaande van een behandeling van 1 x per 3 weken 200 mg voor 12 maanden zou dat gaan om maximaal €90.000.

Potential total cost per year

Total cost

3,150,000.00

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.
References Fabrikant

Other information

There is currently no futher information available.