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 comments 
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 comments 
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 comments 
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 comments 
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.