Extended indication

Extension of indication to include treatment of chronic hepatitis C (CHC) in paediatric patients 12

Therapeutic value

No estimate possible yet

Registration phase

Positive CHMP opinion

Product

Active substance

Elbasvir / grazoprevir

Domain

Infectious diseases

Reason of inclusion

Indication extension

Main indication

Viral infections other

Extended indication

Extension of indication to include treatment of chronic hepatitis C (CHC) in paediatric patients 12 years of age and older who weigh at least 30kg for Zepatier.

Proprietary name

Zepatier

Manufacturer

MSD

Mechanism of action

Virus inhibitor

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Extramural (GVS)

Registration

Registration route

Centralised (EMA)

ATMP

No

Submission date

March 2021

Expected Registration

December 2021

Orphan drug

No

Registration phase

Positive CHMP opinion

Additional comments
Positieve CHMP-opinie (september 2021).

Therapeutic value

Therapeutic value

No estimate possible yet

Expected patient volume per year

Patient volume

5 - 10

Market share is generally not included unless otherwise stated.

Additional comments
Er wordt beperkt gebruik van 5 á 10 patiënten per jaar verwacht. Dit is voor bepaalde subtypes hepatitis C.

Expected cost per patient per year

References
Medicijnkosten
Additional comments
Pediatrische indicatie, kosten zijn afhankelijk van dosering. Voor volwassenen met dezelfde indicatie zijn de kosten €272,50 per stuk

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.