воскресенье, 24 апреля 2011 г.

NICE Unable To Recommend Golimumab For The Treatment Of Psoriatic Arthritis

The National Institute for Health and Clinical Excellence (NICE) has issued a consultation draft on the use of golimumab for the treatment of psoriatic arthritis. The evidence considered suggests that golimumab is not as effective as a treatment (etanercept) currently recommended by NICE for this condition. Based on this evidence, the independent appraisal committee is unable to recommend golimumab for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. The draft recommendation is available for consultation; NICE has not yet issued final guidance to the NHS.


A NICE spokesperson said: "The independent advisory committee reviewed the evidence on golimumab, including evidence on the nature of psoriatic arthritis, the views of people with the condition, those who represent them, and clinical specialists. The Committee understood that psoriatic arthritis can cause significant distress and psychological impact on an individual's life, employment and social activities.


"NICE currently recommends adalimumab, etanercept and infliximab for the treatment of psoriatic arthritis in people who have peripheral arthritis in technology appraisal guidance199. The cost-effectiveness analyses found that golimumab was not the most cost effective of the available options currently recommended by NICE. As the long term follow-up on adverse event outcomes is yet to be completed, the Committee considered there to be uncertainty about the long-term adverse event profile of golimumab. Whilst recognising the severity of the disease, the Committee concluded that based on the available evidence, golimumab was expected to be more costly than estimated in the economic model and less cost effective than etanercept, and so could not be considered a good use of NHS resources. We welcome comments on this draft recommendation as part of the consultation."


Notes


About the appraisal


1. The consultation document is available here. The consultation closes on October 22.


2. Golimumab (Simponi, Schering-Plough/Centocor) 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. 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 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 50 mg pre-filled injection pen, and estimates an annual cost of ??9294.96. Costs may vary in different settings because of negotiated procurement discounts.


Source:

NICE


View drug information on Simponi.

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