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 Oncology other
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.