Extended indication

Triple Negative Breast Cancer - Neoadjuvant and adjuvant.

Therapeutic value

No estimate possible yet

Total cost

156,150,000.00

Registration phase

Clinical trials

Product

Active substance

Pembrolizumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Breast cancer

Extended indication

Triple Negative Breast Cancer - Neoadjuvant and adjuvant.

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

2021

Expected Registration

February 2022

Orphan drug

No

Registration phase

Clinical trials

Additional comments
De fabrikant verwacht registratie in het eerste kwartaal van 2022.

Therapeutic value

Therapeutic value

No estimate possible yet

Frequency of administration

1 times every 3 weeks

Dosage per administration

200 mg

References
NCT02819518
Additional comments
Maximaal 1 jaar behandeling. Nota bene: voor monotherapie ook 1 x 400mg per 6 weken mogelijk.

Expected patient volume per year

Patient volume

< 1,735

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
NKR 2018: 1.735 diagnoses mammacarcinoom HR-, HER- waarbij een chirurgische ingreep is gedaan.

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.
De behandelduur die voor deze indicatie onderzocht wordt is maximaal 12 maanden.

Potential total cost per year

Total cost

156,150,000.00

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 Geneesmiddelen (maagkanker, hoofd- en halskanker, huidkanker, longkanker, nierkanker, et cetera)

References
Fabrikant

Other information

There is currently no futher information available.