Johnson & Johnson’s new psoriasis drug Stelara has moved a step closer to being approved for use on the National Health Service in England and Wales, after an appraisals committee for the National Institute for Health and Clinical Excellence gave it the thumbs up earlier this week.

Stelara (ustekinumab) is a fully human monoclonal antibody and the first in a new class of biologics that targets the cytokines interleukin-12 and -23. The drug was given the all clear by the European Commission earlier this year, based on clinical data showing that two-thirds of patients experienced significant skin clearance (75%) by week 12 and sustained efficacy through at least week 76 when Stelara was administered every 12 weeks.

The committee has recommended that Stelara be used by NHS doctors for the treatment of adult patients with plaque psoriasis, after deeming it a cost effective use of resources if the disease is classed as severe - scoring 10 or more on the Psoriasis Area Severity and Dermatology Life Quality Indexes - and patients have not responded or are intolerant to standard systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation).

Furthermore, treatment with Stelara costs £12,882 in the first year and £9,335 per year thereafter based on 45mg vials, but patients weighing over 100kg require twice the amount thereby doubling the expense. To address this additional burden on the NHS J&J has proposed a patient access scheme under which it will offer 90mg vials for patients over 100kg at the same price as a single 45mg dose, and the committee has taken this into account in its cost assessment.

In addition, the committee has stipulated that treatment should be stopped in patients who have not adequately responded to Stelara - by showing a 75% reduction in the PASI score or 50% reduction alongside a five point cut in the DLQI rating - after 16 weeks of therapy.

The closing date for any comments on this preliminary recommendation is June 6, and a second appraisal committee meeting is scheduled for June 24, but so far it is looking good for the drug and for patients who meet the treatment criteria.