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. 2024 Jan 11;29(2):105–135. doi: 10.1111/resp.14656

TABLE 2.

Australian pharmaceutical benefits scheme authority criteria for nintedanib in progressive fibrosing interstitial lung disease (PF‐ILD) and ATS/ERS/JRS/ALAT progressive pulmonary fibrosis criteria (PPF) as of May 2023.

Australian PBS PF‐ILD criteria ATS/ERS/JRS/ALAT PPF criteria
Diagnosis Diagnosis other than IPF through a multi‐disciplinary meeting Any fibrotic ILD other than IPF
Not due to reversible causes
Physiology FVC ≥45%
DLCO ≥30% and ≤ 80%
FEV1/FVC >0.7
HRCT HRCT within 12 months of application.
Affected area of ≥10% on HRCT.
Progression

In the 2 years prior to the application, one of the following:

  1. Relative decline of FVC% predicted of ≥10%
  2. Relative decline of FVC% predicted of ≥5% and < 10% with either worsening respiratory symptoms or increased fibrosis on HRCT
Two or more of the following within the past 12 months without an alternative explanation:
  1. Worsening respiratory symptoms

  2. Physiological deterioration:
    • Absolute decline in FVC% predicted ≥5%, or
    • Absolute decline in DLCO %predicted ≥10%
  3. Radiological progression:
    • Increased extent or severity of traction bronchiectasis/bronchiolectasis
    • New ground glass opacity with traction bronchiectasis
    • New fine reticulation
    • Increased extent or increased coarseness of reticulation
    • New or increased honeycombing
    • Increased lobar volume loss

Abbreviations: ATS/ERS/JRS/ALAT, American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society, and the Latin American Thoracic Association; DLCO, diffusing capacity for carbon monoxide; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; HRCT, high‐resolution computed tomography; IPF, idiopathic pulmonary fibrosis; PBS, pharmaceutical benefits scheme; PF‐ILD, progressive fibrosing interstitial lung disease; PPF, progressive pulmonary fibrosis.