National Institute for Health and Clinical Excellence (NICE)
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NICE recommends golimumab for the treatment of psoriatic arthritis
The National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance recommending golimumab (Simponi, Merck Sharpe & Dohme) for the treatment of psoriatic arthritis.
Additional information from the manufacturer, considered by the independent Appraisal Committee following a consultation on its earlier draft recommendation, suggests that golimumab may be added to the list of treatment options already recommended by NICE for this condition.
Specifically, golimumab is recommended as an option for the treatment of 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 1991. The recommendation of golimumab for use within the NHS is also dependent on the patient access scheme agreed between the manufacturer and the Department of Health, whereby the manufacturer provides both of the available doses of golimumab (50 mg and 100 mg) to the NHS at the cost of the 50 mg dose.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “We already recommend three TNF inhibitor treatments for psoriatic arthritis that has not responded to first-line treatment. We're glad that extra information from the manufacturer has meant that our Appraisal Committee now feels confident in recommending golimumab as a fourth treatment option. We recognise that patients may welcome the option of a self-injectable treatment that only has to be administered once a month.”
The final draft guidance is now with consultees, who have the opportunity to appeal against it. NICE has not yet issued final guidance to the NHS.
Notes to Editors
1. NICE technology appraisal 199 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 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.
About the appraisal
1. 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.
2. 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. 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.
3. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
4. NICE produces guidance in three areas of health:
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