2 The technology
2.1 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 antirheumatic drug (DMARD) therapy has been inadequate. The summary of product characteristics (SPC) notes that golimumab has also been shown to improve physical function in this population.
2.2 Golimumab is contraindicated in people with moderate to severe heart failure, hereditary problems of fructose intolerance, active tuberculosis and other severe infections. Before initiating therapy, physicians should evaluate people for prior evidence of hepatitis B virus infection, and both active and inactive (latent) tuberculosis infection. The SPC states that the needle cover on the pre-filled golimumab injection pen contains latex and therefore may cause allergic reactions in people with latex sensitivity. The SPC reports that the most common adverse reactions are upper respiratory tract infections, including nasopharyngitis, pharyngitis, laryngitis and rhinitis. For full details of adverse effects, contraindications, special warnings and precautions for use, see the SPC.
2.3 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 cost of golimumab is £774.58 for a 50 mg pre-filled injection pen (excluding VAT, 'MIMS' February 2011 edition), which is equivalent to an annual cost of £9294.96 (based on the 50 mg dose). Costs may vary in different settings because of negotiated procurement discounts.
2.4 The manufacturer of golimumab has agreed a patient access scheme with the Department of Health, in which the 100 mg dose of golimumab will be available to the NHS at the same cost as the 50 mg dose. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.