PBS listing for nintedanib expanded for people with progressive fibrosing ILD


By Mardi Chapman

30 Mar 2022

The PBS listing of nintedanib (Ofev) will be expanded from 1 May to include progressive fibrosing interstitial lung diseases (PF-ILD).

Already listed on the PBS for the treatment of IPF since 2017, the expanded listing will cover other types of PF-ILD where there has been a high unmet clinical need for treatments.

They include idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonias (IIPs), connective tissue disease-related ILDs (CTD-ILDs), chronic sarcoidosis, chronic hypersensitivity pneumonitis (HP) and exposure-related diseases such as asbestosis and silicosis.

The PBAC finally recommended the listing of nintedanib for the treatment of patients with PF-ILD at its September 2021 intracycle meeting after a previous rejection in March 2021.

At the March meeting it acknowledged the “high clinical need for an effective treatment for PF-ILD, noting the disease has debilitating effects on quality of life and a progressive course similar to IPF.”

However the submission was rejected due to uncertainty around any overall survival benefit and incremental cost-effectiveness ratio (ICER).

It has since said it was satisfied that nintedanib provides “for some patients, a significant improvement in effectiveness compared with best supportive care”.

Evidence for nintedanib has come from the INBUILD study which found the drug slowed the annual rate of decline in FVC.

Boehringer Ingelheim said 18% to 32% of patients with non-IPF ILDs were estimated to be at risk for developing a progressive fibrosing disease.

Federal Health Minister Greg Hunt said the expanded PBS listing will benefit about 1,400 patients a year.

Without the PBS subsidy, treatment could cost patients more than $40,000 per year. With the listing, patients will pay a maximum of $42.50 per script, or $6.80 with a concession card.

A recent analysis of the INBUILD trial involving 170 subjects with autoimmune disease-related ILDs showed that the rate of decline in FVC over 52 weeks was -75.9 mL/year with nintedanib versus -178.6 mL/year with placebo (difference 102.7 mL/year [95% CI 23.2, 182.2]; nominal P=0.012).

No heterogeneity was detected in the effect of nintedanib versus placebo across subgroups by ILD diagnosis.  Adverse events (most frequently diarrhoea) led to discontinuation of the drug in 17% and 10% of subjects in the nintedanib and placebo groups, respectively.

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