golimumab (Simponi) (AS)

following a full submission:

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

Indication under review: treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

SMC restriction: golimumab is restricted to use in accordance with the British Society for Rheumatology (BSR) guidelines for anti-TNFα agents in adults with ankylosing spondylitis. Golimumab is restricted to use at a dose of 50mg only.

In a placebo controlled study golimumab 50mg and 100mg were superior to placebo given every four weeks in terms of the proportion of patients who achieved at least 20% improvement in the Assessment in AS International Working group Criteria at week 14. An indirect comparison indicates that golimumab has similar efficacy to two other anti-TNFα agents used in the treatment of ankylosing spondylitis.

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