BIOLOGIC monotherapy RoActemra has been issued with a positive Final Appraisal Determination by the National Institute for Health and Care Excellence (NICE). The promising treatment, which has been available in Scotland for a year as monotherapy or in combination with methotrexate, has been recommended for use on the NHS and could benefit up to 20,000 severe rheumatoid arthritis (RA) patients in England and Wales. The decision was based on data illustrating that RoActemra benefits nearly four times as many patients to achieve remission than those treated with a leading anti-tumour necrosis factor (TNF) monotherapy.
Current conventional drugs are often ineffective or have negative side effects, and in up to 60% of instances where this is the case, a biologic treatment is given in combination with methotrexate. However, more than one-third of patients are unable, or do not wish to take methotrexate, leaving few treatment options available. RoActemra, by contrast, is the first biologic of its kind that will be available as a monotherapy, and is the only interleukin-6 receptor antagonist licensed for the treatment of patients with severe RA.
Results from a pivotal Phase IV trial (ADACTA), which formed part of the submission to NICE, showed that RoActemra IV monotherapy aids almost four times as many severe RA patients, for whom methotrexate is considered inappropriate, achieve remission compared with patients treated with a commonly used anti-TNF monotherapy, adalimumab (DAS28<2.6 [remission] 39.9% versus 10.5%, CI 3.1–10.3, p<0.0001). Furthermore, mean change of DAS28 was significantly greater for RoActemra (–3.3) compared with adalimumab (–1.8) (difference –1.5, CI –1.8 to –1.1, p<0.0001). These results highlight the superiority of RoActemra IV monotherapy over adalimumab monotherapy for reducing the signs and symptoms of RA.
“We are delighted that NICE, as part of its re-assessment of seven biologics currently available on the NHS, has decided to widen access to RoActemra for patients with severe RA and extend its use into the monotherapy setting,” said Ms Senam Beckley-Kartey, Immunology Country Medical Leader, Roche Pharmaceuticals, St Albans, UK. “However, while NICE has maintained that biologics should be available to those patients most severely affected by RA, we do feel that NICE has missed an opportunity to extend the use of these medicines for patients with moderate disease, who still experience painful and debilitating symptoms. We will continue to work with NICE to ensure that no patient misses out on the treatments they need now and in the future.”