Cost regulators for the NHS in England and Wales are leaning towards a ‘no’ on the use of AbbVie’s Humira to treat the rare inflammatory skin disease hidradenitis suppurativa.

HS, which is also known as acne inversa, is a painful, chronic inflammatory skin disease characterised by recurrent, painful abscesses and nodules on the skin – typically around the armpits and groin, on the buttocks and under the breasts.

European approval in August last year was based data from the PIONEER Phase III studies, which showed that patients given Humira (adalimumab) had greater reductions in the numbers of abscesses and inflammatory nodules than patients given placebo.

But the National Institute for Health and Care Excellence said it is currently “minded not to recommend” the drug within its marketing authorisation for treating moderate to severe cases in patients whose disease has not responded to conventional therapy, because of uncertainties thrown up by the data provided.

As such, AbbVie has been asked to provide more information - including a meta-analysis of the PIONEER I and II trials and revised base-case analyses - to help it better determine Humira’s cost-effectiveness and potential use by the NHS.

As it stands, NICE’s committee concluded that the incremental cost-effectiveness ratios (ICER) for the drug the may lie within the range of £29,000 to £36,000 per QALY gained compared with supportive care, but could be above or below this range. 

Given that these ICERs were associated with substantial uncertainties and did not include all of the preferred assumptions, the committee is unlikely support the drug’s unless new data to convince it otherwise is provided during the next stage of the consultation.