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Pembrolizumab

Keytruda

Extended indication Women With Persistent, Recurrent, or Metastatic Cervical Cancer (1L).
Therapeutic value No judgement
Total cost 6,750,000.00
Registration phase Clinical trials

Product

Active substance Pembrolizumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Oncology other
Extended indication Women With Persistent, Recurrent, or Metastatic Cervical Cancer (1L).
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)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2021
Expected Registration April 2022
Orphan drug No
Registration phase Clinical trials
Additional remarks Fabrikant verwacht indiening in 2021 en registratie in het tweede kwartaal van 2022.

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times every 3 weeks
Dosage per administration 200mg
References SMPC Keytruda, NCT03635567.
Additional remarks - Bij mono therapie eenmaal in de 6 weken 400mg mogelijk; - tot maximaal 2 jaar behandeling.

Expected patient volume per year

Patient volume

70 - 80

Market share is generally not included unless otherwise stated.
References DGOG
Additional remarks Er wordt verwacht dat er 70-80 patiënten in aanmerking zullen komen voor deze behandeling. Deze inschatting is gedaan op basis van huidige getallen van bevacizumab bij cervixcarcinoom.

Expected cost per patient per year

Cost < 90,000.00
References G-standaard
Additional remarks Voor alle indicatie van pembrolizumab geldt een financieel arrangement dat is voortgekomen uit de onderhandelingen in de sluis. AIP per november 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Uitgaande van een behandeling van 1 x per 3 weken 200mg voor 12 maanden zou dat gaan om maximaal €90.000 per patiënt per jaar.

Potential total cost per year

Total cost

6,750,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Indicatie uitbreidingen worden weergegeven in de Horizonscan.
References Fabrikant.

Other information

There is currently no futher information available.