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Limited coverage drugs – nintedanib

Last updated on October 6, 2022

Generic name

nintedanib

Strength

100 mg and 150 mg

Form

oral capsule

Special Authority criteria

Approval period

1. 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 approval:

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

2. 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.

Renewals 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.

Renewals:

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

Practitioner exemptions

  • No practitioner exemptions.

Special notes

  1. For 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.
  2. For 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.
  3. For 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 form(s)