The National Institute for Health and Clinical Excellence has asked Roche to provide more evidence on RoActemra to help it decide whether the drug has a place in the National Health Service for the treatment of rheumatoid arthritis.

In appraisal consultation documents posted on its website in October the cost regulator initially said no to RoActemra’s (tocilizumab) use on the NHS for moderate-to-severe forms of the illness on the basis that, at an approximate cost of £9,295 a year for a patient weighing approximately 70 kg, the therapy is just too expensive to be considered a cost-effective use of resources.

The decision was reached despite the fact that, in clinical trials, when administered alone or in combination with methotrexate - the current standard of care - or other disease-modifying anti-rheumatic drugs (DMARD), RoActemra significantly reduced the signs and symptoms of the RA, regardless of previous therapy or disease severity, compared to DMARDs alone, thereby offering patients a potentially substantial impact on quality of life.

There is currently no cure for RA, a chronic, progressive and disabling autoimmune disease affecting 0.8% of the UK adult population, and so treatment strategies focus on reducing its symptoms, which can cause severe disability and ultimately affect a person’s ability to carry out everyday tasks. But these therapies do not always work, and patients unresponsive to therapy need other options to help prevent their disease from worsening.

And now, following a second appraisal consultation the Institute remains steadfast in its belief that RoActemra should not be tried in patients before other biologics on the market, such as etancercept, but says it needs further information in order to determine in what circumstances, if any, the drug might be used on the NHS.

“We don’t all respond to drugs in the same way, so having a range of treatment options is important”, said NICE head Andrew Dillon. “We want to know how tocilizumab can help, but we need to be sure that it offers real additional benefits for patients – and we need to be confident that those benefits justify the cost,” he said, explaining the request to Roche for more data.

Specifically, the cost watchdog has asked for: a re-analysis of the cost effectiveness of RoActemra as an addition to the treatment sequence in patients unresponsive to prior anti-TNF therapy; an indirect comparison of the clinical and cost effectiveness of the drug with MabThera (rituximab); and a cost-effectiveness analysis of RoActemra as an addition to the treatment sequence for patients in which treatment with MabThera has failed.

Potential positive
While the appraisal committee is “minded not to recommend the use of the drug”, this additional information “could result in the final guidance being positive”, the Institute said.

The National Society for Rheumatoid Arthritis has, however, slammed the Institute’s preliminary recommendations to bar RoActemra from the NHS. Stressing that there is a “clear unmet need for people who fail on Anti-TNF therapy”, its chief executive Ailsa Bosworth said the decision is “a bitter blow for patients”.

Approximately 25%-30% of patients are primary non-responders to biologic Anti-TNFs, and another 20% are secondary non-responders, she said, and claimed that NICE’s appraisal committee has not only failed to “adequately understand” the burden of the disease but has also “significantly under-estimated” the “true cost of returning people to palliative care”.

A spokesperson form Roche was not available for comment.