Ofev (nintedanib) — Highmark
Chronic Fibrosing Interstitial Lung Disease (ILD) with Progressive Phenotype
Initial criteria
- Documented diagnosis of chronic fibrosing ILD with progressive phenotype (ICD-10: J84.170)
- High-resolution chest CT demonstrating > 10% pulmonary fibrosis
- Evidence of disease progression within the previous 24 months despite treatment meeting one of: relative decline in FVC ≥ 10% predicted, OR relative decline in FVC 5–<10% predicted with worsening respiratory symptoms, OR relative decline in FVC 5–<10% predicted with increasing fibrotic changes on HRCT, OR worsening respiratory symptoms and increasing fibrotic changes on HRCT
- Baseline forced vital capacity (FVC) ≥ 45%
- Percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 30%
- Member is a non-smoker OR is currently engaged in smoking cessation
Reauthorization criteria
- Prescriber attests member has experienced disease improvement OR delayed disease progression
- Member is a non-smoker OR has maintained smoking cessation
Approval duration
12 months