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Pembrolizumab

Keytruda

Extended indication 1L advanced gastric cancer
Therapeutic value No judgement yet
Total cost 6,850,000.00
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Stomach cancer
Extended indication 1L advanced gastric 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
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Mogelijk met een PD-L1 expressie marker. Scrip pipeline watch 22 dec 2017: Phase III Interim/Top-line Results KEYNOTE-061: missed primary endpoint.

Therapeutic value

Therapeutic value No judgement yet
Frequency of administration 1 times every 3 weeks
Dosage per administration 200 mg
References SmPC
Additional remarks Toedieningsfrequentie is 1 maal per 3 weken

Expected patient volume per year

Patient volume

< 137

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks In 2016 waren er gemiddeld 555 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom stadium IV. Ongeveer twee derde van deze patiënten werd behandeld in de 1e lijn (370 patiënten). Daarnaast werden 350 patiënten per jaar behandeld met palliatieve chemotherapie. Schatting voor percentage patiënten dat na progressie op 1e lijns systemische therapie start met 2e lijns systemische therapie is 37% (137 patiënten).

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References G-Standaard
Additional remarks Voor alle indicaties 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). Inschatting: in lijn met andere indicaties.

Potential total cost per year

Total cost

6,850,000.00

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 (Hoofd- en halskanker, Huidkanker, Borstkanker, Longkanker, Nierkanker, etc.)
References Fabrikant

Other information

There is currently no futher information available.