NICE rejects NHS funding Sanofi/Regeneron's Dupixent in asthma

NICE has said “no” to regular NHS funding for Sanofi and Regeneron’s Dupixent (dupilumab) for severe asthma in first draft guidance, citing uncertainties with evidence.

It’s common for NICE to reject drugs at this first draft stage, asking the manufacturer to either drop its price or provide further data or analyses to help with the number crunching.

In the first draft guidance NICE acknowledged that Dupixent is effective for preventing exacerbations in people with severe asthma with type 2 inflammation, compared with standard care.

According to NICE the most relevant use for Dupixent in asthma is for people who are not eligible for GlaxoSmithKline’s asthma biological Nucala (mepolizumab).

But even after a confidential discount Sanofi has offered with Dupixent, the company’s cost-effectiveness estimate was £50,558 per QALY gained.

NICE’s cost-effectiveness committee’s estimate for the same population was £81,676 per Quality Adjusted Life Year (QALY) gained.

This is well above NICE's upper cost-effectiveness threshold of £30,000 per QALY gained.

The committee concluded that dupilumab does not represent a cost-effective use of resources, so could not be recommended for treating severe asthma with type 2 inflammation.

Other issues raised by NICE included a lack of comparative data with other biologicals, and uncertainty in the population eligible for this kind of treatment.

Dupixent, an interleukin-4 and 13 inhibitor, was approved in Europe in asthma in May last year, following a previous approval in eczema.

The type 2 inflammation that this label covers occurs   in allergic-type diseases, and in the case of asthma is associated with elevated levels of eosinophils as well as high levels of fractional exhaled nitric oxide (FeNO), a marker for inflammation.

This indication covers patients who can’t control symptoms using inhaled corticosteroids plus another maintenance drug.

Dupixent is also approved in atopic dermatitis (eczema), and late last year picked up another EU label for chronic rhinosinusitis with nasal polyps.