following a full submission:
tofacitinib (Xeljanz®) is accepted for restricted use within NHSScotland.
Indication under review: in combination with methotrexate for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
SMC restriction: for use in patients with psoriatic arthritis whose disease has not responded adequately to at least two conventional DMARDs, given either alone or in combination.
Two phase III studies demonstrated superiority of tofacitinib when compared with placebo in reducing signs and symptoms of psoriatic arthritis in patients who had not previously received a TNF inhibitor medication and in those with an inadequate response or intolerance to tumour necrosis factor inhibitors.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of tofacitinib. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
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