Expand all sections

Pembrolizumab

Keytruda

Extended indication

Extension of indication to include first-line treatment of unresectable or metastatic microsatellite

Therapeutic value

No judgement
Total cost

€ 42,120,000.00
Registration phase

Registration application pending

Product

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.
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
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

€ 42,120,000.00

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

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.