golimumab (Simponi)

following a full submission:

golimumab (Simponi®) is accepted for restricted use within NHS Scotland.

Indication under review: In combination with methotrexate, for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease modifying anti-rheumatic drug therapy including methotrexate has been inadequate.

Golimumab, in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.

SMC restriction:  golimumab is restricted for use in accordance with British Society for Rheumatology guidance on prescribing TNFα blockers in adults with rheumatoid arthritis (2005). Golimumab is restricted to use at a dose of 50 mg only.

There are no head to head studies comparing golimumab with other TNFα inhibitors in the treatment of rheumatoid arthritis.  Golimumab plus methotrexate was superior to methotrexate alone for the primary endpoint (ACR20 response and improvement in HAQ-DI) in patients with active rheumatoid arthritis despite methotrexate treatment.

The economic case was demonstrated for golimumab when used at a dose of 50 mg. The economic case was not demonstrated for the 100 mg dose of golimumab.

Golimumab is also licensed for use in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. SMC cannot recommend the use of golimumab in this setting, however, as the company submission related only to its use in patients with an inadequate response to methotrexate.