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Pembrolizumab

Keytruda

Extended indication Treatment of recurrent locally advanced or metastatic oesophageal cancer in adults whose tumours exp
Therapeutic value No judgement yet
Total cost 11,250,000.00
Registration phase Registration application pending

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Oncology other
Extended indication Treatment of recurrent locally advanced or metastatic oesophageal cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have received prior systemic therapy.
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 February 2019
Expected Registration August 2019
Registration phase Registration application pending
Additional remarks Mogelijk met een PD-L1 expressie marker.

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

200 - 250

Market share is generally not included unless otherwise stated.
References NKR, expertopinie.
Additional remarks Aantal patiënten met slokdarmkanker stadium II/III/IV betrof 1.596. Gezien het een 2L behandeling voor patiënten met een plaveiselcelcarcinoom betreft schatting patiëntvolume: 200-250 patiënten voor deze indicatie. Mocht het in de toekomst breder ingezet gaat worden (in combinatie met brachytherapie), dan zal het patiëntaantal groter worden.

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: €2624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Inschatting: in lijn met andere indicaties.

Potential total cost per year

Total cost

11,250,000.00

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.