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Pembrolizumab

Keytruda

Extended indication 2/3L Triple negative metastatic breast cancer
Therapeutic value No judgement yet
Total cost 16,250,000.00
Registration phase Withdrawn

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Breast cancer
Extended indication 2/3L Triple negative metastatic breast cancer
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 Anti-PD-1

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Orphan drug No
Registration phase Withdrawn
Additional remarks Mogelijk met een PD-L1 expressie marker. KEYNOTE-119 heeft primaire eindpunt niet gehaald.

Therapeutic value

Therapeutic value No judgement yet
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References SmPC

Expected patient volume per year

Patient volume

250 - 400

Market share is generally not included unless otherwise stated.
References NKR 2016, expert opinie
Additional remarks In totaal 1.687 diagnoses mammacarcinoom HR-, HER-, waarvan 134 diagnoses stadium 4. Er komen in de loop van de ziekte veel meer patienten in stadium IV; de meest vrouwen ontvangen uiteindelijk een tweede (en ws ook wel derde) van behandeling. Schatting experts: 250-400.

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 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.

Potential total cost per year

Total cost

16,250,000.00

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

Off label use No
References Fabrikant

Indication extension

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

Other information

There is currently no futher information available.