Pembrolizumab

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).

Product

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 comments
De fabrikant verwacht registratie in januari 2021.

Therapeutic value

Therapeutic value

No judgement

Duration of treatment

Not found

Frequency of administration

1 times every 3 weeks

Dosage per administration

200mg

References
SMPC KEYTRUDA, NCT02684292
Additional comments
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 comments
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 comments
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

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.