Version 2

Pembrolizumab

Medicine

Extended indication Unresectable or metastatic solid tumours with a microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) biomarker.
Therapeutic value No judgement
Total cost € 23,400,000.00
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension IND
Main indication Oncology other
Extended indication Unresectable or metastatic solid tumours with a microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) biomarker.
Proprietary name Keytruda
Manufacturer MSD
Mechanism of action Unknown
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Humanised monoclonal IgG4 antibody against the programmed death-1 (PD-1) protein.

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks FDA grants Breakthrough Therapy Designation to pembrolizumab for treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. MSD geeft aan dat de aanvraag niet op basis van fase 2 studies zal worden ingediend bij de EMA. De aanvraag voor Nivolumab voor een vergelijkbare indicatie is eerder teruggetrokken.

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References NCT02563002
Additional remarks Toediening op dag 1 van iedere cyclus van 21 dagen.

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 remarks 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 € 40,000.00 - 60,000.00

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.
References Medicijnkosten.nl, AIP fabrikant.
Additional remarks Voor alle indicatie van pembrolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019). AIP per nov 2017: €2624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). € 1312,19 per injectieflacon 50MG FL (poeder).

Potential total cost per year

Total cost € 23,400,000.00

Off label use

Off label use Unknown

Indication extension

Indication extensions Yes
Indication extensions Er lopen meerdere PhIII studies, o.a. Metastatic triple negative breast cancer, Malignant melanoma - post-resection adjuvant therapy in high-risk patients, Locally advanced or metastatic, PD-L1 positive gastric and gastro-oesophageal junction adenocarcinoma - third-line after ≥2 prior lines of therapy, Advanced non-small cell lung cancer (NSCLC), previously untreated with PD-L1 expression (>=1%) - monotherapy.
References Clinicaltrials.gov; SPS

Other information