Stelara ustekinumab regulatory update

The U.K.’s NICE issued a final appraisal determination (FAD) recommending Stelara ustekinumab from Johnson & Johnson’s Janssen-Cilag International N.V. unit alone or in combination with methotrexate to treat active psoriatic arthritis only when tumor necrosis factor (TNF) alpha inhibitors are contraindicated but would otherwise be considered or the patient has had treatment with 1 or more TNF alpha inhibitors. The FAD, which is in line with draft guidance issued in December, is also contingent on a patient access scheme in which the company provides the 90 mg dose of Stelara for patients who weigh >100 kg at the cost of the 45 mg dose (see BioCentury, Jan. 19). ...