Limited coverage criteria – nintedanib

Last updated on March 19, 2025

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Generic name		nintedanib
Strength & form		100 mg and 150 mg oral capsule

Special Authority criteria	Approval period
Initial For the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adult patients: Whose diagnosis of IPF is confirmed by a respirologist with expertise in IPF and has had a high-resolution computed tomography (HRCT) scan within the previous 24 months¹ AND In whom all other causes of restrictive lung disease (e.g., collagen vascular disorder or hypersensitivity pneumonitis) are excluded AND Who have a predicted forced vital capacity (FVC) ≥ 50% AND Who are under the care of a physician with experience in IPF Exclusion: Combination use of nintedanib and pirfenidone will not be funded for IPF	Initial: 7 months (including a 4-week period for repeat pulmonary function tests (PFT), if needed)³
Initial For the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype also known as progressive fibrosing ILD (PF-ILD) or progressive pulmonary fibrosis (PPF) in adult patients: Whose diagnosis of PPF or PF-ILD is confirmed by a respirologist with expertise in ILDs and has had a HRCT scan² AND Who have a predicted FVC ≥ 45% AND Who are under the care of a physician with experience in ILDs Exclusion: Combination use of nintedanib and pirfenidone will not be funded for PPF/PF-ILD
Renewal for both IPF and PPF/PF-ILD: Prescribed by a respirologist with expertise in IPF or ILDs AND For initial renewal: Patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% from initiation of therapy until renewal. If a patient experienced progression as defined above, then the results should be validated with a confirmatory PFT conducted 4 weeks later OR For second and subsequent renewals: Patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% within the last 12-month period. If a patient experienced progression as defined above, then the results should be validated with a confirmatory PFT conducted 4 weeks later	Renewal: 12 months (including a 4-week period for repeat PFT, if needed)³

Special Authority criteria

Approval period

Initial

For the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adult patients:

Whose diagnosis of IPF is confirmed by a respirologist with expertise in IPF and has had a high-resolution computed tomography (HRCT) scan within the previous 24 months¹

AND

In whom all other causes of restrictive lung disease (e.g., collagen vascular disorder or hypersensitivity pneumonitis) are excluded

AND

Who have a predicted forced vital capacity (FVC) ≥ 50%

AND

Who are under the care of a physician with experience in IPF

Exclusion: Combination use of nintedanib and pirfenidone will not be funded for IPF

Initial: 7 months (including a 4-week period for repeat pulmonary function tests (PFT), if needed)³

Initial

For the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype also known as progressive fibrosing ILD (PF-ILD) or progressive pulmonary fibrosis (PPF) in adult patients:

Whose diagnosis of PPF or PF-ILD is confirmed by a respirologist with expertise in ILDs and has had a HRCT scan²

AND

Who have a predicted FVC ≥ 45%

AND

Who are under the care of a physician with experience in ILDs

Exclusion: Combination use of nintedanib and pirfenidone will not be funded for PPF/PF-ILD

Renewal for both IPF and PPF/PF-ILD:

Prescribed by a respirologist with expertise in IPF or ILDs

AND

For initial renewal: Patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% from initiation of therapy until renewal. If a patient experienced progression as defined above, then the results should be validated with a confirmatory PFT conducted 4 weeks later

For second and subsequent renewals: Patients must not demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥ 10% within the last 12-month period. If a patient experienced progression as defined above, then the results should be validated with a confirmatory PFT conducted 4 weeks later

Renewal: 12 months (including a 4-week period for repeat PFT, if needed)³

Practitioner exemptions

No practitioner exemptions.

Special notes

¹For initial coverage of nintedanib for the treatment of IPF, practitioners must submit a copy of the diagnostic report from a HRCT scan within the previous 24 months. If HRCT report is inconclusive (e.g., suggests probable or possible IPF), please submit additional supporting information such as the results from a multi-disciplinary discussion of case, and/or other details of clinical history that support IPF diagnosis
²For initial coverage of nintedanib for the treatment of PPF/PF-ILD, practitioners must submit a copy of the diagnostic report from a HRCT scan. If the HRCT scan report is inconclusive, additional supporting information such as the results from a Multi-Disciplinary Discussion of case, and/or other details of clinical history that support PPF or PF-ILD diagnosis may be required.
³For initial and renewal coverage of nintedanib for the treatment of IPF or PPF/PF-ILD, practitioners must submit a copy of the PFT report evaluated within the last 3 months
Special Authority request must be submitted by a respirologist

Special Authority request form(s)

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