Ofev Negotiations Complete in Canada, Paving Way for Availability

Marisa Wexler MS avatar

by Marisa Wexler MS |

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Boehringer Ingelheim Canada has finished negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) — a partnership between the country’s provincial, territorial and federal governments — for Ofev (nintedanib), the company’s approved oral medication for progressive fibrosing interstitial lung diseases (PF-ILD).

The pCPA conducts negotiations with drug manufacturers for treatments in Canada. Individual public plans can then decide whether or not to cover a given medication.

“The successful conclusion of our negotiations with pCPA means that patients living with PF-ILD, which is a very debilitating condition, are one step closer to receiving treatment, to slow the progression of lung scarring,” Andrea Sambati, president and CEO of Boehringer Ingelheim Canada, said in a press release.

“We look forward to working with jurisdictions across Canada to secure coverage from publicly funded drug plans, as there is no time to waste for these patients,” Sambati said.

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Sharon Lee, executive director of the Canadian Pulmonary Fibrosis Foundation (CPFF), said that the conclusion of negotiations “is encouraging news for the CPFF community across Canada.”

“We hope that provinces move swiftly to add Ofev to their drug plans to improve access to much-needed care and treatment for PF-ILD patients, care that enables them to preserve lung function and spend more time with their loved ones,” Lee said.

PF-ILD refers to a diverse group of conditions that all share a common progressive, fibrotic phenotype — in other words, patients develop pulmonary fibrosis (scarring in the lungs) that gradually worsens as time goes on. Scar tissue in the lungs interferes with their ability to take in oxygen and makes them stiffer, resulting in symptoms like shortness of breath.

Ofev is an oral therapy that works by blocking proteins called tyrosine kinases, effectively inhibiting signaling pathways that are known to drive fibrosis and ultimately lessening scarring. In addition to PF-ILD, Ofev is approved to treat idiopathic pulmonary fibrosis (IPF) and scleroderma-associated ILD.

The therapy was approved for PF-ILD in both the U.S. and Canada in 2020. These approvals were supported by data from a Phase 3 trial called INBUILD (NCT02999178), which enrolled 663 patients with fibrotic lung diseases. Results from INBUILD showed that treatment with Ofev slowed lung function decline by more than 50% compared with a placebo in a range of PF-ILD patients.

The pCPA is a government alliance that “collaborates on a range of public drug plan initiatives to increase and manage access to clinically effective and affordable drug treatments,” according to its website. It works to keep medication costs low and consistent across participating jurisdictions.