Cost regulators for the National Health Service in England and Wales are recommending the use of Johnson & Johnson unit Janssen-Cilag’s Stelara as a treatment option for adult patients with moderate to severe forms of psoriasis.
As expected, the National Institute for Health and Clinical Excellence has published a Final Appraisal Determination endorsing the use of the drug on the NHS, but only when the disease is classed as severe – as per the Psoriasis Area Severity Index and Dermatology Life Quality Index – and the patient is unresponsive or intolerant to standard systemic therapies such as ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation).
Stelara’s (ustekinumab) seal of approval is also conditional upon a pricing agreement under which the manufacturer provides the 90mg dose necessary for patients weighing more than 100kg at the same total cost as for a single 45mg vial, to help keep treatment costs at around £9,335 a year and thereby reduce the burden on the NHS’ already stretched cash resources.
And to further protect the NHS’ coffers the Institute has also stipulated that treatment should be stopped in patients who have failed to show an adequate response to the drug – by showing a 75% reduction in the PASI score or 50% reduction alongside a five point cut in the DLQI rating – by week 16 of therapy.
Stelara is a fully human monoclonal antibody and the first in a new class of biologics targeting the cytokines interleukin-12 and -23. The drug won European Union approval earlier this year after clinical trials showed that two-thirds of patients experienced significant skin clearance (75%) by week 12 and sustained efficacy through at least week 76 when treated every 12 weeks.
