Discount helps Boehringer gain NICE backing for Ofev

Boehringer Ingelheim's Ofev looks set to be made available on the UK NHS for idiopathic pulmonary fibrosis (IPF) after a positive verdict in NICE draft guidance.

The latest appraisal consultation document was published at the end of last week and recommends that Ofev (nintedanib) be made available to IPF patients with reduced lung capacity (a forced vital capacity or FVC of 50 to 80 per cent), provided Boehringer provides the drug at an undisclosed discounted rate.

The undiscounted price of Ofev is £2,151.10 for 60 capsules, which equates to a daily cost of £71.70 at the recommended dose of two capsules per day.

The guidance also recommends that treatment with the drug be discontinued if FVC drops 10 percent or more in a 12-month period, while the cost effectiveness of the drug in people with an FVC of more than 80 per cent was "not within the range considered to be a cost-effective use of NHS resources," said NICE.

Ofev was launched in Europe earlier this year, based on trials which demonstrated a consistent, statistically significant reduction in the annual rate of decline in FVC compared to placebo. Boehringer's drug cut the decline by 45 to 68 percent, depending on the patient group and also reduced the rate of IPF exacerbations.

The NICE backing is good news for Boehringer as it competes in the IPF market with Esbriet (pirfenidone) from Roche's InterMune unit, which has a head start in the market having been introduced in 2011.

The two drugs represent the first alternative to oxygen therapy, pulmonary rehabilitation, and lung transplant for patients with IPF, a potentially fatal disease characterised by damage and scarring to the tissue surrounding the small airways in the lungs.

There are estimated to be around 5,000 cases of IPF diagnosed each year in the UK, with the incidence of the disease rising - although interestingly this does not seem to be linked to increasing age or improvement in diagnosis.

Both Ofev and Esbriet could face competition in future from Genoa Pharmaceuticals' inhaled version of pirfenidone - in Phase 3 testing - as well as drugs in mid-stage testing including Bristol-Myers Squibb's BMS-986020, AstraZeneca's tralokinumab, Gilead Sciences' simtuzumab, Biogen Idec's STX-100 and FibroGen's FG-3019.

The active ingredient in Ofev is also approved at a higher dose in a lung cancer therapy - called Vargatef - which was recommended for NHS use by NICE in July, after it was launched in the UK in January.

Comments on the draft guidance for Ofev in IPF can be filed until 2 October, and a second appraisal committee meeting is scheduled for 15 October.