NICE Agrees to Allow Ofev Therapy for Non-IPF Patients in UK

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by Steve Bryson PhD |

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Clinicians in the U.K. will now be able to prescribe the antifibrotic medicine Ofev (nintedanib) to people with non-idiopathic pulmonary fibrosis (PF) under a new decision by the National Institute for Health and Care Excellence (NICE).

That decision came following a five-year campaign led by the U.K. charity Action for Pulmonary Fibrosis — and supported by patients, families, and pulmonary disease specialists.

“This is a game changer for patients with progressive fibrosis,” Nazia Chaudhuri, PhD, a consultant respiratory physician at Manchester University National Health Service (NHS) Foundation Trust, said in a press release. “I am absolutely delighted with the NICE decision to be able to give life-changing antifibrotic therapy to all patients with progressive lung fibrosis.”

The NICE decision was welcomed by both patients and clinicians.

“This news means everything to me,” said Carol Fielding, a PF patient from Bolton,  “It’s about seeing my young grandchildren reach more of their milestones and making some more memories for them. It’s about maybe living long enough that even the younger ones might remember me.”

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PF is a disease characterized by scarring — or fibrosis — of lung tissue, leading to shortness of breath, also known as dyspnea, and a dry cough. Some patients also may experience fast, shallow breathing, fatigue, unexplained weight loss, and loss of appetite. PF is one of the more than 200 lung disorders collectively known as interstitial lung diseases (ILDs).

Marketed by Boehringer Ingelheim, Ofev is a therapy designed to block pro-fibrotic signaling mechanisms, which has been shown to slow the progression of PF and extend life expectancy. The therapy is approved in the U.S., Europe, and elsewhere for treating people with idiopathic PF (IPF), the most common form of the disease; idiopathic means this form of PF has no apparent cause. It also is available to treat those with progressive fibrosing ILDs.

Until now, however, Ofev could not be prescribed to people with PF associated with autoimmune diseases, such as rheumatoid arthritis, or triggered by exposure to certain toxic substances, including asbestos fibers, silica or coal dust, or animal droppings.

From now on, Action for Pulmonary Fibrosis says, Ofev will be available to treat the 15,000 people in the U.K. who are thought to be living with these forms of the disease.

“This is a landmark moment for patients and their loved ones with pulmonary fibrosis,” said Steve Jones, chair of trustees at Action for Pulmonary Fibrosis.

“[We] couldn’t have achieved this without the support of patients, families, MP’s and clinicians who understood the injustice of this rule,” Jones said. “[Ofev] has been proved in a clinical trial and offers doctors another treatment they can use to slow down disease progression and hopefully extend life.”

“We are delighted this will now be available to patients,” Jones added.