Ofev (nintedanib) — Medica
Chronic fibrosing interstitial lung diseases with a progressive phenotype (not associated with idiopathic pulmonary fibrosis)
Initial criteria
- age ≥ 18 years
- forced vital capacity (FVC) ≥ 40% of the predicted value
- fibrosing lung disease impacting more than 10% of lung volume on high-resolution computed tomography as assessed by the prescriber
- clinical signs of progression as assessed by the prescriber (e.g., FVC decline ≥ 10% of predicted value OR FVC decline ≥ 5% to < 10% with worsening symptoms and/or worsening imaging)
- prescribed by or in consultation with a pulmonologist
Reauthorization criteria
- age ≥ 18 years
- patient is currently receiving Ofev and has experienced a beneficial response as determined by the prescriber (e.g., stabilization or improvement in pulmonary function or symptoms)
- prescribed by or in consultation with a pulmonologist
Approval duration
1 year