Extended indication 1L bladder carcinoma stage III/IV, including cisplatin-eligible.
Therapeutic value No judgement
Total cost 12,200,000.00
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Bladder cancer
Extended indication 1L bladder carcinoma stage III/IV, including cisplatin-eligible.
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 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional comments Mogelijk met een PD-L1 expressie marker.

Therapeutic value

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

Expected patient volume per year

Patient volume

< 244

Market share is generally not included unless otherwise stated.

References NKR; expertopinie
Additional comments In 2016 waren er in totaal 3.337 patiënten met blaascarcinoom, hiervan waren 975 patiënten gediagnosticeerd met stadium III/IV. Maximaal 50% van de patienten is cisplatin eligible (488). Op basis van PD-L1 expressie > 1% is de verwachting dat maximaal de helft van deze patiënten voor dit geneesmiddelen in aanmerking kunnen komen (244).

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References Fabrikant (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.

Potential total cost per year

Total cost

12,200,000.00

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, Longkanker, huidkanker, Borstkanker, etc.)
References Fabrikant

Other information

There is currently no futher information available.