NICE backs use of Boehringer's Ofev in IPF from diagnosis


Thousands more UK patients with idiopathic pulmonary fibrosis (IPF) will now be eligible for treatment with Boehringer Ingelheim's Ofev, following new guidance from health technology assessment agency NICE.

Ofev (nintedanib) has been recommended since 2015 for NHS use in IPF patients who have a forced vital capacity (FVC) value of 50% to 80% of normal, but will now be an option for people with less severe disease, i.e. an FVC of more than 80%.

NICE said in an update that around 5,200 more people could be in line for treatment with the twice-daily, oral drug as a result of the new final draft guidance (PDF), which is scheduled to be implemented in February next year.

Currently, the only treatment option for people with IPF fibrosis who have an FVC above 80% predicted is supportive care, so the new guidance takes Ofev into new territory for pharmacological treatment of the progressive lung disease, characterised by damage and scarring to the tissue surrounding the small airways in the lungs.

It's main rival in the market – Roche's Esbriet (pirfenidone) – remains an option for patients with FVC in the 50% to 80% range only.

Other than these drugs, treatment options include oxygen therapy, pulmonary rehabilitation, and lung transplant, and patients with IPF generally have a terrible prognosis with the median survival from diagnosis just two to five years.

Boehringer did not carry out a dedicated clinical trial to show the benefit of Ofev in this less severely affected population, but provided subgroup analyses from two earlier studies – INPULSIS and TOMORROW – plus open-label extensions.

Patient organisation Action for Pulmonary Fibrosis (APF) said NICE's decision followed a six-year campaign – backed by patients, families, and medical experts – to end the restrictions on Ofev in IPF.

The move means all patients can receive treatment at diagnosis and "no longer have to watch and wait while their condition deteriorates before getting the medicines they need," it said in a statement.

The NHS should make Ofev available within 90 days of the announcement by NICE, which means in mid-March 2023.

However, since the drug can only be prescribed by doctors in ILD Centres in England or general hospitals in the other three UK nations, patients may have to wait to get an appointment with a specialist respiratory doctor.