2 The technology
2.1 Golimumab (Simponi, Schering Plough) is a human monoclonal antibody that prevents the binding of TNF to its receptors, thereby neutralising its activity. In October 2009, golimumab, in combination with methotrexate, received a marketing authorisation for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including methotrexate has been inadequate. The summary of product characteristics (SPC) notes that golimumab has also been shown to improve physical function in this population. In February 2011, the marketing authorisation was amended to indicate that golimumab has also been shown to reduce the rate of progression of joint damage as measured by X‑ray when given in combination with methotrexate.
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 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 dosage 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 rheumatoid arthritis does not show an adequate clinical response after three or four doses, the dosage may be increased to 100 mg once a month. The cost of a syringe or pen pre-filled with 50 mg of golimumab is £774.58 ('Monthly Index of Medical Specialities' [MIMS], December 2010). The annual drug cost of golimumab is £9295 (50 mg dose). Costs may vary in different settings because of negotiated procurement discounts.
2.4 The manufacturer 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. Details of the patient access scheme are provided separately from this document as part of the evidence submitted.