guselkumab (Tremfya)

following a full submission:

guselkumab (Tremfya®) is accepted for restricted use within NHSScotland.

Indication under review: alone or in combination with methotrexate (MTX) 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: (i) patients whose disease has not responded adequately or who have been intolerant to two previous conventional disease-modifying antirheumatic drug (DMARD) therapies but have not received biologic DMARD therapy (biologic-naïve population); (ii) patients whose disease has not responded adequately to conventional DMARDs and one or more tumour necrosis factor (TNF) inhibitors (biologic-experienced population); and (iii) patients in whom TNF inhibitors are contraindicated or not tolerated.

Three phase III studies demonstrated superiority of guselkumab when compared with placebo in reducing signs and symptoms of psoriatic arthritis in patients who had not previously received a tumour necrosis factor (TNF) inhibitor medication and in those with an inadequate response or intolerance to TNF inhibitors.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.