Pembrolizumab

Active substance
Pembrolizumab
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Breast cancer
Extended indication
Breast cancer, metastatic, triple negative, 1L.

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
Anti-PD-1

2. Registration

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

3. Therapeutic value

Therapeutic value
No judgement yet
Duration of treatment
Not found
Frequency of administration
1 times every 3 weeks
Dosage per administration
200 mg
References
SmPC
Additional comments
Max 2 jaar behandeling

4. Expected patient volume per year

Patient volume

< 134

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
NKR 2016: 134 diagnoses mammacarcinoom HR-, HER-, stadium 4.

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 dat 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.

6. Potential total cost per year

Total cost

6,700,000

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

Off label use
No
References
Fabrikant

8. Indication extension

Indication extension
Yes
Indication extensions
Indicatie-uitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, etc.)
References
Fabrikant

9. Other information

There is currently no futher information available.