Pembrolizumab

Keytruda
Active substance

Pembrolizumab
Domain

Oncology and Hematology
Reason of inclusion

Indication extension
Main indication

Other oncology
Extended indication 
Extension of indication to include first-line treatment of unresectable or metastatic microsatellite instability-high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults for Keytruda.

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)
Additional comments 
Humanised monoclonal IgG4 antibody against the programmed death-1 (PD-1) protein.

Registration
Registration route

Centralised (EMA)
Submission date

July 2020
Expected Registration

March 2021
Orphan drug

No
Registration phase

Registration application pending
Additional comments 
FDA grants Breakthrough Therapy Designation to pembrolizumab for treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. Mogelijk met een PD-L1 expressie marker. Fabrikant verwacht registratie in het eerste kwartaal van 2021.

Therapeutic value
Therapeutic value

No judgement
Duration of treatment

Not found
Frequency of administration

1 times every 3 weeks
Dosage per administration

200 mg
References 
SmPC; NCT02563002
Additional comments 
Toediening op dag 1 van iedere cyclus van 21 dagen. Maximaal 2 jaar behandeling. 
Nota Bene: voor monotherapie ook 1 x 400mg per 6 weken mogelijk.

Expected patient volume per year
Patient volume

312 - 624

Market share is generally not included unless otherwise stated.
References 
NKR; Poynter et al. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3208-15.
Additional comments 
NKR 2016: 3.120 colon en rectum carcinomen, stadium 4. Microsatellite instability (MSI) occurs in 10−20% of colorectal cancers.

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. 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 per patiënt per jaar.

Potential total cost per year
Total cost

€ 42,120,000

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

Indicatieuitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, et cetera).
References 
Clinicaltrials.gov; SPS.

Other information

There is currently no futher information available.