Extended indication

Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy.

Therapeutic value

No estimate possible yet

Total cost

48,600,000.00

Registration phase

Clinical trials

Product

Active substance

Pembrolizumab

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Kidney cancer

Extended indication

Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy.

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

February 2022

Orphan drug

No

Registration phase

Clinical trials

Therapeutic value

Therapeutic value

No estimate possible yet

Substantiation

Dit jaar te verwachten survival data in september.

Frequency of administration

1 times every 3 weeks

Dosage per administration

200mg

References
SMPC Keytruda, NCT03142334.
Additional comments
Bij monotherapie eenmaal in de 6 weken 400mg mogelijk; tot maximaal 1 jaar behandeling.

Expected patient volume per year

Patient volume

< 540

Market share is generally not included unless otherwise stated.

References
NKR
Additional comments
Op basis van de inclusiecriteria van de Keynote-564, komen er jaarlijks maximaal 540 patiënten voor deze behandeling in aanmerking.

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

48,600,000.00

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.