NICE Recommends Golimumab For The Treatment Of Psoriatic Arthritis

The National Institute for Health and Clinical Excellence (NICE) has today issued final guidance recommending golimumab (Simponi) for the treatment of psoriatic arthritis. Golimumab joins a list of treatment options already recommended by NICE for this condition.

The guidance recommends golimumab as an option for treating active and progressive psoriatic arthritis in adults if it is used as described for the other tumour necrosis factor (TNF) inhibitor treatments - etanercept, infliximab and adalimumab - covered by NICE technology appraisal 199(1). The recommendation of golimumab is also on the condition that the manufacturer provides the 100 mg dose of golimumab to the NHS at the cost of the 50 mg dose, as agreed by the manufacturer and the Department of Health as part of a patient access scheme.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: "We're pleased to recommend golimumab as another option for treating psoriatic arthritis, a condition that can cause significant distress and psychological impact on an individual's life, employment and social activities. We recognise that patients may welcome the option of a self-injectable treatment administered once a month.

"We have already recommended three TNF inhibitor treatments for psoriatic arthritis that has not responded to first-line treatment, and golimumab is a welcome addition."



1. NICE TA199 recommends adalimumab, etanercept and infliximab for the treatment of psoriatic arthritis when the person has peripheral arthritis with three or more swollen joints, and when the psoriatic arthritis has not responded to adequate trials of at least two standard disease-modifying anti-rheumatic drugs (DMARDs), administered either individually or in combination. NICE TA 199 specifies that treatment should be with the least expensive drug, taking into account drug administration costs, required dose and product price per dose. This guidance is available here.

About the appraisal

2. Golimumab (Simponi, Merck Sharpe & Dohme) is a human monoclonal antibody that prevents the binding of tumour necrosis factor (TNF) to its receptors, thereby neutralising its activity. Golimumab has a marketing authorisation for the treatment of active and progressive psoriatic arthritis (alone or in combination with methotrexate) in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

3. The independent Appraisal Committee considered additional information from the manufacturer following a consultation on its first draft recommendation, which initially did not recommend golimumab. The additional manufacturer information, and the agreement between the Department of Health and the manufacturer on a patient access scheme, enabled a positive final recommendation to be made.

4. Golimumab is injected subcutaneously via a pre-filled injection pen. The recommended dose is 50 mg given once a month, on the same date each month. The SPC states that in people who weigh more than 100 kg whose psoriatic arthritis does not show an adequate clinical response after three or four 50mg doses, the dose of golimumab may be increased to 100 mg once a month, taking into account the increased risk of certain serious adverse drug reactions with the 100 mg dose compared with the 50 mg dose. The manufacturer's submission states that the cost of golimumab is £774.58 for a 50mg pre-filled injection pen, and estimates an annual cost of £9294.96. With the agreed patient access scheme, the cost of the 100mg dose is the same as the 50mg dose. This annual cost for golimumab is very similar to the annual costs for adalimumab and etanercept. The annual cost of infliximab varies depending on the weight of the patient. Costs may vary in different settings because of negotiated procurement discounts.