Pembrolizumab

Active substance

Pembrolizumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Breast cancer

Extended indication
Breast cancer, metastatic, triple negative, 1L.

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

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Submission date

2020

Expected Registration

2021

Orphan drug

No

Registration phase

Clinical trials

Additional comments
De fabrikant verwacht registratie in Q1 2021. Voor alle indicaties van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met juni 2020.

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
Maximaal 2 jaar behandeling

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.

Expected cost per patient per year

Cost

40,000.00 - 60,000.00

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

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.

Off label use

Off label use

No

References
Fabrikant

Indication extension

Indication extension

Yes

Indication extensions

Indicatieuitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, etc.)

References
Fabrikant

Other information

There is currently no futher information available.