2 The technology

2 The technology

Golimumab (Simponi), Merck Sharp & Dohme

Marketing authorisation

Golimumab is indicated for the treatment of 'adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C‑reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs)'.

Recommended dose and schedule

Golimumab is administered by subcutaneous injection. The recommended dosage is 50 mg once a month, on the same date each month. The summary of product characteristics recommends that continued golimumab therapy should be reconsidered if there is no evidence of therapeutic benefit within 12 to 14 weeks of starting treatment (that is, after 3 to 4 doses). For patients with a body weight greater than 100 kg whose disease does not respond adequately after 3 or 4 doses (50 mg each), the summary of product characteristics states that increasing the dosage of golimumab to 100 mg once a month may be considered. If there is still no evidence of therapeutic benefit after 3 to 4 additional doses of 100 mg, continued golimumab therapy should be reconsidered.

Price

The list price of golimumab is £762.97 for a 50‑mg pre‑filled disposable injection and £1,525.94 for a 100‑mg pre‑filled disposable injection (excluding VAT; British national formulary [BNF] online [accessed September 2017]). Merck Sharp & Dohme has agreed a patient access scheme with the Department of Health. This will make the 100‑mg dose of golimumab 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. Assuming a patient has 50 mg every month, the annual cost of treatment with golimumab is estimated at £9,156. Because of the patient access scheme, this cost would remain the same for patients with a body weight greater than 100 kg whose disease does not respond adequately to 50 mg per month and who subsequently have monthly doses of 100 mg.

  • National Institute for Health and Care Excellence (NICE)