Ofev for PF-ILD Now Reimbursed in 7 regions of Canada

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by Steve Bryson, PhD |

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Ofev (nintedanib), a medicine approved to treat progressive fibrosing interstitial lung disease (PF-ILD), now is available for public reimbursement in Ontario, Quebec, New Brunswick, Newfoundland and Labrador, Alberta, and the Northwest Territories.

The therapy also will be reimbursed through the Non-Insured Health Benefits (NIHB) program, which provides eligible First Nations and Inuit individuals with coverage for health benefits not insured by other programs.

“This is welcome news for people living with a chronic fibrosing ILD, who rely on public reimbursement for their medications,” Sharon Lee, executive director of the Canadian Pulmonary Fibrosis Foundation, said in a press release. “We encourage other provinces and territories to follow suit and provide coverage swiftly, so all pulmonary fibrosis patients have access to treatment to manage their chronic disease.”

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ILDs include more than 200 conditions that can lead to pulmonary fibrosis (PF), or permanent scarring (fibrosis) of lung tissue. Chronic fibrosing ILDs, in which lung fibrosis worsens over time, are estimated to occur in up to a third of people with ILDs, according to Boehringer Ingelheim, the company that markets Ofev. It is estimated that, when all forms of PF are included, up to 30,000 Canadians live with the disease.

Ofev, an oral medication, is approved to treat people with PF-ILD in the U.S., Canada, and Europe. It also is approved to treat idiopathic pulmonary fibrosis (IPF) and ILD associated with scleroderma, an inflammatory connective tissue disorder.

“We are very proud of this tremendous milestone, reflecting our company’s ongoing commitment to improving the lives of people living with ILDs,” said Andrea Sambati, president and CEO of Boehringer Ingelheim (Canada). “At Boehringer Ingelheim, we stand by our purpose of transforming lives for generations.”

The medicine is designed to suppress specific signaling pathways that promote scarring, which are overly active in people with PF, and to slow the rate of lung function decline.

Approvals for the treatment of PF-ILDs were supported by positive findings from the Phase 3 INBUILD clinical trial (NCT02999178). The study included 663 adults with PF-ILDs who were assigned randomly to receive either 150 mg of Ofev or a placebo twice daily for one year.

After one year, Ofev slowed the rate of lung function decline by 57% compared with placebo, as measured by forced vital capacity (FVC) — the total amount of air a person can forcibly exhale after a deep breath. Ofev also lowered the proportion of participants with acute disease flares or who died during the study.

Symptoms, such as coughing and shortness of breath, were alleviated significantly in Ofev-treated patients, and the medicine was similarly effective in all patients, regardless of the cause of their underlying ILD.