cyclingNICE has issued a positive Final Appraisal Determination (FAD) recommending RoActemra monotherapy for patients with severe rheumatoid arthritis (RA) for use on the NHS. 

The decision is based on a dossier of data that included results which show RoActemra helps almost four times as many patients achieve remission than those treated with a leading anti-TNF monotherapy. The guidance brings England and Wales in line with Scotland, where RoActemra has been available as monotherapy or in combination with methotrexate to Scottish patients for a year. 

RoActemra is a first of its kind biologic and the only interleukin-6 (IL-6) receptor antagonist licensed for the treatment of patients with severe RA. Biologics are used by as many as 60% of patients who do not respond to conventional drugs (called conventional disease-modifying anti-rheumatic drugs or cDMARDs). Biologic treatments are often given in combination with methotrexate; the positive determination for RoActemra as monotherapy is an important step forward in the care of patients with severe RA as more than one third of patients are unable, or do not wish to take methotrexate. 

“RA is a persistent, destructive disease which can occur at any age; if the inflammatory process is not kept under control, the disease results in significant pain and deformity, with very poor quality of life, and reduced life expectancy” said Professor Paul Emery, Arthritis Research UK Professor of Rheumatology, Chapel Allerton Hospital, Leeds. “To keep the disease under control, conventional drugs are generally used initially. However, they may be poorly tolerated or ineffective. In such cases, the availability of newer biologic treatments, which work differently to suppress the disease are crucial, and broadening the treatment options for patients with severe RA is vital in controlling the disease. In this respect, the approval of RoActemra monotherapy provides clinicians and patients with a significant new option to help manage the symptoms of severe RA.”

RoActemra monotherapy has been recommended by NICE, in addition to its current use in combination with methotrexate, for the treatment of patients with severe RA whose disease has not responded to intensive therapy with a combination of cDMARDs.