People should be reimbursed for costs of using Ofev (nintedanib) to treat progressive fibrosing interstitial lung diseases (PF-ILD), two agencies that help to guide health policy in Canada — the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d’excellence en santé et services sociaux (INESSS) — recommend.
These agencies work to provide evidence-based guidance to healthcare decision-makers, and their recommendation applies to patients meeting certain criteria. For example, the CADTH recommends reimbursement be initiated in patients whose PF-ILD diagnosis has been confirmed by a specialist, and who have a forced vital capacity — a measure of lung function — greater than or equal to 45% of predicted.
“With this recommendation from CADTH and INESSS, patients are one step closer to receiving this much needed treatment sooner, to help slow the decline in lung function, giving them the opportunity to continue to do the things that matter most to them,” Shane Shapera, MD, director of the Interstitial Lung Disease Program at the Toronto General Hospital Division of the University Health Network, said in a press release.
ILDs encompass over 200 conditions that can cause pulmonary fibrosis (PF), or permanent lung tissue scarring (fibrosis). Chronic fibrosing ILDs — conditions in which lung fibrosis continues to worsen over time — are estimated to occur in up to a third of people with ILDs, according to Boehringer Ingelheim, which developed and market Ofev.
Ofev is an oral medication approved to treat people with PF-ILD in Canada and the U.S., as well as in Europe. It is also approved to treat idiopathic pulmonary fibrosis (IPF), and scleroderma-associated ILD.
Ofev works by interfering with certain scar-promoting signaling pathways that are overly active in people with PF.
“As the first treatment available to manage PF-ILD, Ofev has the potential to fundamentally change the future outlook for patients who would otherwise expect their breathing to become progressively more difficult,” Shapera said.
These recommendations were supported by data from the Phase 3 INBUILD trial (NCT02999178), in which Ofev’s use for one year slowed the rate of lung function decline by 57% across a range of patients with PF-ILD compared with a placebo.
Data from INBUILD also found Ofev superior to a placebo at lowering the proportion of patients with acute disease flares or who died during the study (7.8% vs. 9.7%).
The most common side effect reported in the trial was diarrhea. It was more frequently seen in patients treated with Ofev than in those given a placebo (66.9% vs. 23.9%), which was in agreement with data from previous studies and with the known safety profile of the medication.
Other side effects, such as nausea, vomiting, and abdominal pain, were also more common in patients treated with Ofev than in those given a placebo.
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