Extended indication

Extension of indication to include in combination with chemoradiotherapy (external beam radiation th

Therapeutic value

No estimate possible yet

Registration phase

Registration application pending

Product

Active substance

Pembrolizumab

Domain

Oncology

Reason of inclusion

Indication extension

Extended indication

Extension of indication to include in combination with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) the treatment of high-risk locally advanced cervical cancer in adults who have not received prior definitive therapy.

Proprietary name

Keytruda

Manufacturer

MSD

Mechanism of action

PD-1 / PD-L1 inhibitor

Route of administration

Intravenous

Therapeutical formulation

Infusion fluid

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Submission date

October 2023

Expected Registration

August 2024

Registration phase

Registration application pending

Therapeutic value

Therapeutic value

No estimate possible yet

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

References
G-standaard
Additional remarks
AIP per november 2017: €2.624,38 per injectieflacon 25mg/ml, flacon 4ml (oplossing). Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2027. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.