Extended indication

Extension of indication for Keytruda to include in combination with chemotherapy, treatment of local

Therapeutic value

No estimate possible yet

Total cost

6,750,000.00

Registration phase

Registration application pending

Product

Active substance

Pembrolizumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Breast cancer

Extended indication

Extension of indication for Keytruda to include in combination with chemotherapy, treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease.

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

December 2020

Expected Registration

October 2021

Orphan drug

Yes

Registration phase

Registration application pending

Additional comments
De fabrikant verwacht registratie in het laatste kwartaal van 2021.

Therapeutic value

Therapeutic value

No estimate possible yet

Frequency of administration

1 times every 3 weeks

Dosage per administration

200 mg

References
SmPC
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
Het aantal patiënten wordt door de Dutch Gynaecological Oncology Group (DGOG) geschat op maximaal 70-80 patiënten.

Expected cost per patient per year

Cost

< 90,000.00

References
G-standaard; fabrikant
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

Off label use

No

References
Fabrikant

Indication extension

Indication extension

Yes

Indication extensions

Indicatieuitbreidingen worden weergegeven in de Horizonscan Geneesmiddelen (maagkanker, hoofd- en halskanker, huidkanker, Longkanker, Nierkanker, et cetera.)

References
Fabrikant

Other information

There is currently no futher information available.