Table 4.
Antifibrotic treatment availability in individual countries.
| Country | Year of joining EMPIRE | Number of patients receiving antifibrotic treatment, N (% all patients in the given country) | Reimbursement specifics |
|---|---|---|---|
| Czech Republic | 2015 (2012–2015 as National Czech Registry of IPF) | • nintedanib: 246 (25.3) ∘ pirfenidone: 364 (37.5) |
• 2015–2018 covered on individual request Reimbursed since 2018 in patients fulfilling predefined criteria covered by health insurance ∘ 2014–2017 covered on individual request Reimbursed since 2017 in patients fulfilling predefined criteria covered by health insurance |
| Turkey | 2016 | • nintedanib: 72 (14.3) ∘ pirfenidone: 201 (39.8) |
• September 23, 2017 Nintedanib received a refund. Free for those with FVC more than 50%, DLCO more than 30%, <10% FVC loss in 6 months ∘ October 11, 2016–267 mg capsules and 200 mg tablets received a refund 01 April 2020–600 mg tablets received a refund September 9, 2020–267 mg tablets and 801 mg tablets received a refund. Free for those with FVC more than 50%, DLCO more than 30%, <10% FVC loss in 6 months |
| Poland | 2015 | • nintedanib: 58 (20.4) ∘ pirfenidone: 73 (25.6) |
•2018 Therapeutic program (fully reimbursed in patients with: FVC ≥ 50% DLCO ≥ 30%). Stopping rule: decrease of 10% in FVC in first year of treatment and then in 6 months assessed every 6 months ∘ 2017 Therapeutic program (fully reimbursed in patients with: FVC ≥ 50% DLCO ≥ 30%) Stopping rule: decrease of 10% in FVC in first year of treatment and then in 6 months assessed every 6 months |
| Hungary | 2015 | • nintedanib: 121 (56.0) ∘ pirfenidone: 22 (10.2) |
• 2015–2017: individual request coverage by national insurance Since 2017 according label fully covered by national insurance ∘ 2017: According label fully covered by national insurance |
| Slovakia | 2015 | • nintedanib: 74 (49.7) ∘ pirfenidone: 11 (7.4) | • Available since 2015 based on individual reimbursement ∘ Available since 2015 based on individual reimbursement |
| Israel | 2018 | • nintedanib: 52 (43.3) ∘ pirfenidone: 20 (16.7) | • 2014–2016: Compassionate use program 2016: Fully covered ∘ 2016: Fully covered |
| Serbia | 2015 | • nintedanib: 19 (20.0) ∘ pirfenidone: 27 (28.4) |
• 2017: According label, not covered by national insurance, but at the cost of referral institutions (4 University hospitals of Pulmonology) based on decisions of their Consilia for Fibrosis ∘ 2016: For all cases of IPF, not covered by national insurance, but at the cost of referral institutions (4 University hospitals of Pulmonology) based on decisions of their Consilia for Fibrosis |
| Croatia | 2016 | • nintedanib: 11 (12.6) ∘ pirfenidone: 25 (28.7) |
• 2017: Fully covered by National Health insurance fund for patients with FVC between 50% and 80% Stopping rule: decrease of FVC >10% at any time during 12 months Reassessment: every 12 months ∘ 2017: Fully covered by National Health insurance fund for patients with FVC between 50 and 80% Stopping rule: decrease of FVC >10% at any time during 12 months Reassessment: every 12 months |
| Austria | 2018 | • nintedanib: 34 (61.8) ∘ pirfenidone: 6 (10.9) |
• Available since 2015, the access for patients is based on individual reimbursement. Full reimbursement for IPF no restrictions—systemic sclerosis/progressive fibrosing ILD individual reimbursement ∘ Available since 2011, only individual reimbursement for IPF with FVC ≥ 50 and ≤ 80 and stopping rule (10% in 6 months)—new indications still under discussion |
| Bulgaria | 2018 | • nintedanib: 2 (22.2) ∘ pirfenidone: 1 (11.1) |
• Since April 2018 Reimbursed by National Health insurance fund for patients over 50 year old and with FVC between 50 and 80% and DLCO between 79 and 30%. Stopping rule for patients reached DLCO or FVC bellow lower limit Reassessment every 6 month ∘ Since April 2018 Reimbursed by National Health insurance fund for patients over 50 year old and with FVC between 50–80% and DLCO between 79 and 30%. Stopping rule for patients reached DLCO or FVC bellow lower limit Reassessment every 6 month |