NHS approves new rheumatoid arthritis drug RoActemra

By Dr. Ananya Mandal, MDFeb 23 2012

Britain’s NHS has given its nod of approval to a drug that could reduce the pain in thousands of rheumatoid arthritis sufferers.

RoActemra, which is the first innovation in the field for ten years, is being recommended for patients who have failed on standard treatments. It is the first time RoActemra has been approved for NHS patients in England and Wales with moderate to severe rheumatoid arthritis who are at an early stage in the disease. The drug has been available for early use in Scotland for two years.

In 2010, Nice recommended tocilizumab, reversing an earlier ruling. However, the body stipulated it was only to be prescribed as a "last resort" drug, if all others failed. At the time the drug was said to cost £10,000 a year.

Nearly half of the patients participating in the clinical trial with RoActemra are in remission and have virtually no symptoms – after a year compared with 8 per cent on a commonly used drug called methotrexate. The rate of remission is almost six times higher than on methotrexate alone.

John Isaacs, professor of clinical rheumatology at Newcastle University, said, “Rheumatoid arthritis is an unrelenting disease and it is vital that patients have options available to them when they are no longer responding to, or can no longer tolerate, their current treatment.” It occurs when the body’s immune system attacks the joints causing pain and swelling, most commonly in the hands, wrists and feet. NHS figures suggest it affects 400,000 people in England and Wales, striking three times more women than men. It is most common between the ages of 40 and 70. Half of victims are unable to work through disability within ten years.

At present in England and Wales it is used by only 1,200 patients at later stages of the disease. The decision by the Government’s rationing body, the National Institute for Health and Clinical Excellence (Nice), means up to 40,000 more patients will be eligible. The £9,000 annual cost of RoActemra, also known as tocilizumab, is the same as other advanced ‘biologic’ drugs already being used, but a discount scheme has been agreed with manufacturers Roche.

The new drug is a laboratory-manufactured antibody that blocks the activity of interleukin 6 (IL-6), an important immune system signalling molecule that underpins many inflammatory processes. Because RoActemra works in a completely different way to existing drugs it is likely to be effective in some patients where the other drugs don’t work or have stopped working.

Professor Isaacs said it was vital to treat people as early as possible with the most effective drugs. He added, “We have evidence that if you can stop the disease early, you can change the way it progresses for the rest of the patient’s life. This is particularly important when it strikes at a young age – women can be affected in their 40s and 50s but it can start in the 20s and younger.”

Ailsa Bosworth, chief executive of the National Rheumatoid Arthritis Society, said, “We are delighted with Nice’s decision, as there are so many patients with rheumatoid arthritis in need of tighter disease management. This decision is most welcome as it is vital that patients have effective options available as soon as one treatment approach fails.”

Professor Peter Scott, the charity's chief medical officer, said it was the only drug which could be used under guidance without another treatment called methotrexate, which some people cannot tolerate due to side effects. “I think it's a breakthrough drug,” he said. “I'm delighted with this news.”

Professor Carole Longson, director of the health technology evaluation centre at Nice, said, “Rheumatoid arthritis can have a huge impact on quality of life and for many it’s a disabling condition, so we’re pleased to recommend tocilizumab at an additional stage in treating the condition.” “We have already recommended the TNF inhibitors adalimumab, etanercept, infliximab, certolizumab pegol and golimumab for some people with rheumatoid arthritis as options for use at this stage; tocilizumab is now added as another option alongside these treatments,” she added.

The drug was also approved in December for children with systemic juvenile arthritis, a severe inflammatory disease that can affect those as young as 18 months. Around 2,500 children in Britain are living with the disease, which can persist into adulthood and cause significant disability.