Anakinra is licensed for use in Europe and in the USA. In the USE and Europe it is licensed for “the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone”. The licensed dose is 100mg daily by subcutaneous injection, and treatment “should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis”. This is also the only indication that the policy considers medically necessary. Case reports suggest that this drug may be useful for nephritis associated with lupus and other conditions but the drug should be still considered experimental until more evidence becomes available.
American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines.
Guidelines for the management of rheumatoid arthritis
Arthritis Rheum 2002; 46: 328-346
B Ostendorf at al, Preliminary results of safety and efficacy of the interleukin 1 receptor antagonist anakinra in patients with severe lupus arthritis Annals of the Rheumatic Diseases 2005;64:630-633