Cost regulators are now backing the use of AbbVie's Humira on the National Health Service in England and Wales as the first approved treatment for skin condition hidradenitis suppurativa (HS).
The National Institute for Health and Care Excellence has published final draft guidance recommending use of Humira (adalimumab) as per its marketing authorisation - i.e. the treatment of active moderate to severe forms of the condition in adults with an inadequate response to conventional systemic therapy.
Also known as acne inversa, HS affects nearly one million people in the UK, who experience recurrent, painful abscesses and nodules in specific areas of the body including the groin and underarm which are often very uncomfortable, painful and can lead to scarring.
European approval in August last year was based data from the PIONEER Phase III studies, which showed that patients taking the drug achieved a significantly greater response - defined as at least 50% reduction from baseline in total abscess and inflammatory nodule count - versus those on placebo.
Alice Butler, medical director of AbbVie UK, said NICE's endorsement "marks a very important step for patients with HS who can often suffer painful, difficult-to-heal symptoms".
"We are extremely pleased that healthcare professionals will be able to offer more options, outside of traditional treatments which include antibiotics and steroids, to help patients manage their HS symptoms which can often be mistaken for other skin conditions."
Earlier this year, the Institute said it was minded not to recommend the drug, because of uncertainties thrown up by the data provided, and thus asked AbbVie 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.