Extended indication

Women With Persistent, Recurrent, or Metastatic Cervical Cancer (1L).

Therapeutic value

No estimate possible yet

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

Other oncology

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

November 2022

Orphan drug

No

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht indiening in 2021 en registratie in het derde kwartaal van 2022.

Therapeutic value

Therapeutic value

No estimate possible yet

Frequency of administration

1 times every 3 weeks

Dosage per administration

200mg

References
SMPC Keytruda, NCT03635567.
Additional comments
- 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 comments
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 comments
AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 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 Geneesmiddelen.

References
Fabrikant.

Other information

There is currently no futher information available.