Extended indication Keytruda as monotherapy is indicated for the first‑line treatment of metastatic microsatellite insta
Therapeutic value No estimate possible yet
Total cost 11,430,000.00
Registration phase Registered and reimbursed

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Other oncology
Extended indication Keytruda as monotherapy is indicated for the first‑line treatment of metastatic microsatellite instability‑high (MSI‑H) or mismatch repair deficient (dMMR) colorectal cancer in adults.
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)
Type of trajectory Normal trajectory
Submission date July 2020
Expected Registration January 2021
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positief cieBOM advies in februari 2021. FDA grants Breakthrough Therapy Designation to pembrolizumab for treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer.

Therapeutic value

Therapeutic value No estimate possible yet
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

127

Market share is generally not included unless otherwise stated.

References NKR; Poynter et al. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3208-15. Zhaohui Jin. Prognostic and Predictive Values of Mismatch Repair Deficiency in Non-Metastatic Colorectal Cancer. Cancers 2021.
Additional comments In 2018 waren er 1.929 patiënten met een coloncarcinoom en 622 patiënten met een rectum carcinoom in stadium 4. Dit zijn in totaal 2.551 patiënten. Er wordt verwacht dat ongeveer 5% hiervan in aanmerking zal komen voor behandeling. Dit betekent dat er naar verwachting 127 patiënten per jaar behandeld zullen worden.

Expected cost per patient per year

Cost < 90,000.00
References G-standaard
Additional comments AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 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

11,430,000.00

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 Geneesmiddelen (maagkanker, hoofd- en halskanker, huidkanker, longkanker, nierkanker, et cetera).
References Clinicaltrials.gov; SPS.

Other information

There is currently no futher information available.