Pembrolizumab

Active substance
Pembrolizumab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Other oncology
Extended indication
1L Colorectaalcarcinoom, MSI-High

1. 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.

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
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

3. 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 400 mg per 6 weken mogelijk.

4. 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.

5. Expected cost per patient per year

Cost
40,000 - 60,000
References
G-standaard
Additional comments
Voor alle indicatie van pembrolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met juni 2020). AIP per nov 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Inschatting: in lijn met andere indicaties.

6. Potential total cost per year

Total cost

23,400,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
Yes
Indication extensions
Indicatieuitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, etc.)
References
Clinicaltrials.gov; SPS

9. Other information

There is currently no futher information available.