Swiss drugmaker Roche has launched its novel biologic RoActemra in the UK, offering patients with rheumatoid arthritis access to a new class of drugs for the disease and a powerful new option to slow its progression.

RA is a chronic, progressive and disabling autoimmune disease that affects around 0.8% of the UK adult population. The condition, which typically damages the cartilage and bone surrounding certain joints, can cause severe pain and disability and thereby significantly affect a patient’s ability to carry out day-to-day tasks.

Clinical trials of RoActemra (tocilizumab), which received regulatory clearance in Europe back in January, have demonstrated the drug’s power in reducing the signs and symptoms of the disease when administered as a monotherapy or in combination with methotrexate - the current standard of care - or indeed any other disease-modifying anti-rheumatic drugs (DMARD), thereby having a substantial impact on quality of life.

According to Roche, RoActemra - the first licensed Interleukin-6 receptor antagonist - is capable of achieving clinical remission rates almost six times higher than the current standard of care methotrexate (47% versus 8%). In addition, when given in combination with methotrexate, the drug was shown to halt joint damage in 85% of patients compared to 67% of those given the gold standard alone.

Commenting on its potential, Professor Paul Emery, Professor of Rheumatology at University of Leeds and RoActemra trial investigator, said the drug is “certainly one of the most exciting therapies to have emerged in the last decade [and] a much anticipated addition to the armoury of treatments needed to combat the condition”. Furthermore, he stressed that it is “vital” patients have other options if unresponsive or intolerant to their treatments.

In addition, Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society, described the availability of RoActemra as “a significant breakthrough in the treatment of RA” and that “access to new treatment options is crucially important”, particularly as up to 37,000 patients in the UK are still unable to control their disease with DMARD therapy.

NICE barrier?
However, despite recognising that RoActemra is clinically effective, preliminary appraisal documents published last month by cost watchdog the National Institute for Health and Clinical Excellence conclude that, at a cost of around £9,295 a year for a patient weighing 70 kg, the therapy does not represent a cost-effective use of National Health Service resources.

The Institute’s rejection of the drug has angered the National Rheumatoid Arthritis Society, which says the preliminary position not to allow its use on the NHS for moderate-to-severe forms of the illness is a “bitter blow” for patients, given that the only choices they will have is to retry failed therapies or palliative care, involving high doses of steroids which can carry their own nasty side effects when used long-term.