Elbasvir / grazoprevir

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.
Therapeutic value	No estimate possible yet
Total cost	€ 127,635.00
Registration phase	Registered and reimbursed

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	October 2021
Orphan drug	No
Registration phase	Registered and reimbursed
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.

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

Cost	< € 17,018.00
References	GIPdatabank
Additional comments	Pediatrische indicatie, kosten zijn afhankelijk van dosering. Voor volwassenen met dezelfde indicatie zijn de kosten €17.018 per patiënt per jaar.

Potential total cost per year

Total cost	€ 127,635.00 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.

Total cost

€ 127,635.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.