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.