PBS Listing Expanded for Nintedanib

The Pharmaceutical Benefits Scheme (PBS) listing has recently been expanded for nintedanib. Nintedanib was previously subsidised for the treatment of idiopathic pulmonary fibrosis; it is now covered for other types of progressive fibrosing interstitial lung disease (PFILD). PFILD is an umbrella term for a diverse range of interstitial lung diseases characterised by accelerated respiratory failure, frequent exacerbations, and early mortality.

Nintedanib is a tyrosine kinase inhibitor that can slow disease progression in PFILD. It blocks vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR α and β) and fibroblast growth factor receptors (FGFR 1-3). This produces antifibrotic and anti-inflammatory effects that lead to inhibition of key processes involved in pulmonary fibrosis.

The INBUILD trial investigated the safety and efficacy of nintedanib in PFILD. The annual rate of decline in forced vital capacity (a measure of disease progression) was significantly lower in the nintedanib group compared to placebo (-80.8mL vs -187.8mL). However, changes in health-related quality of life (measured by the K-BILD questionnaire) were low over the 52-week study period. Some of the more commonly reported adverse effects included diarrhoea (66.9%), nausea (28.9%), vomiting (18.4%), and reduced appetite (14.5%).

Nintedanib is a substrate of P-glycoprotein. Co-administration with potent inhibitors of P-glycoprotein (e.g. ketoconazole, erythromycin) may increase nintedanib exposure, while potent inducers (e.g. rifampicin, carbamazepine, phenytoin, St. John’s Wort) may reduce exposure. Nintedanib capsules should be swallowed whole, preferably with food.