Expand all sections

Pirfenidone

Esbriet

Extended indication Extension of indication to include the treatment of advanced Idiopathic Pulmonary Fibrosis (IPF) for
Therapeutic value No estimate possible yet
Total cost 1,050,000.00
Registration phase Registration application pending

Product

Active substance Pirfenidone
Domain Lung diseases
Reason of inclusion Indication extension
Main indication Lung diseases other
Extended indication Extension of indication to include the treatment of advanced Idiopathic Pulmonary Fibrosis (IPF) for Esbriet.
Proprietary name Esbriet
Manufacturer Roche
Portfolio holder Roche
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Collagen inhibitor; Cytokine inhibitor

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2022
Expected Registration February 2023
Orphan drug No
Registration phase Registration application pending
Additional remarks M.T. Durheim. Outcomes of patients with advanced idiopathic pulmonary fibrosis treated with nintedanib or pirfenidone in a real-world multicentre cohort. Respirology. 2021; weesstatus is verlopen.

Therapeutic value

Current treatment options Nintedanib
Therapeutic value No estimate possible yet
Substantiation Van de 502 patiënten in het onderzoek hadden er 66 (13%) geavanceerd IPF. Jaarlijkse verandering in FVC was125ml (95% CI 163, 87) bij patiënten met een milde vorm van IPF en +28ml (95% CI 96, +152) onder patiënten met geavanceerde IPF. De therapeutische waarde c.q. remmend effect of achteruitgang longfunctie lijkt daarmee niet minder dan in niet-advanced patiënten.
References Durheim et al., (2021) Outcomes of patients with advanced idiopathic pulmonary fibrosis treated with nintedanib or pirfenidone in a real-world multicentre cohort. Respirology. 2021 Oct;26(10):982-988 (1)

Expected patient volume per year

Patient volume

60

Market share is generally not included unless otherwise stated.
References Jaarverslag Longfibrosepatiëntenvereniging 2017 (1); Expert opinie (2); GIP-databank (3);
Additional remarks Er zijn ongeveer 3.400 longfibrose patiënten in Nederland 60% daarvan heeft IPF. Dit komt neer op 2.040 IPF patiënten. Ongeveer 10% heeft de classificatie 'advanced IPF', dit zijn 200 patiënten(2). Voor licht tot matige ipf zijn er 611 gebruikers van pirfenidon in 2020 bekend (3). Naar schatting zullen ongeveer 60 patiënten per jaar in aanmerking komen voor pirfenidon (2).

Expected cost per patient per year

Cost 17,000.00 - 18,000.00
References GIPdatabank
Additional remarks In 2020 werd er per patiënt €17.327 vergoed aan pirfenidon.

Potential total cost per year

Total cost

1,050,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.