Extended indication 1L Colorectaalcarcinoom, MSI-High
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
Main indication Oncology other
Extended indication 1L Colorectaalcarcinoom, MSI-High
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 remarks Humanised monoclonal IgG4 antibody against the programmed death-1 (PD-1) protein.

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
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. Mogelijk met een PD-L1 expressie marker

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References SmPC; NCT02563002
Additional remarks Toediening op dag 1 van iedere cyclus van 21 dagen. Max 2 jaar behandeling. Nota Bene: voor monotherapie ook 1 x 400 mg 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 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
References G-standaard
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: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Inschatting: in lijn met andere indicaties.

Potential total cost per year

Total cost

23,400,000.00

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 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

There is currently no futher information available.