The National Institute for Health and Clinical Excellence (NICE) approved the use of Stelara (ustekinumab) in the NHS in England and Wales, for adults with severe cases of psoriasis, in August 2009.
Janssen Cilag’s Stelara is a fully human monoclonal antibody and has been approved for use for patients who are considered to have severe psoriasis, according to the Psoriasis Area Severity Index (PASI) or the Dermatology Life Quality Index (DLQI). The therapy has also been approved for patients who are unresponsive or intolerant to other treatments such as ciclosporin and methotrexate.
In addition, the approval is under the condition of a pricing agreement with the manufacturer, whereby the 90mg vial necessary for patients weighing more than 100kg is provided at the same cost as the 45mg vial, to keep the cost per QALY at £9,335. NICE has also included in the guidance that treatment should be stopped in any patients who fail to show an adequate response to the drug after 16 weeks, judged as showing a 75% reduction in the PASI score, or a 50% drop alongside a 5-point lowering in the DLQI rating.
Further reading - A detailed analysis of the UK pharmaceutical market, including some background information on NICE, is available from Espicom: The Pharmaceutical Market: United Kingdom (published June 2009)