The National Health Service cost regulator for England and Wales is sticking with its initial decision to bar patients from access to Roche’s rheumatoid arthritis drug RoActemra, which is freely available in Scotland.

According to the National Institute for Health and Clinical Excellence, RoActemra (tocilizumab) therapy carries a price tag of around £9,295 a year for a patient weighing approximately 70 kg, which, according to its cost-effectiveness model, is too expensive for use on the NHS.

The decision to reject the drug was made despite the fact that, in clinical trials, compared to disease-modifying anti-rheumatic drugs (DMARDs) alone RoActemra was able to significantly reduce the signs and symptoms of the RA, regardless of previous therapy or disease severity, clearly showing its potential to improve quality of life.

And the news comes just a day after the Institute published guidance on the use of biologic therapies to treat the disease, rejecting the use of Orencia (abatacept) after failure of TNF inhibitors and banning the cycling of anti-TNF therapies, thus heavily restricting the treatment options available to patients.

The National Rheumatoid Arthritis Society has expressed dismay at NICE’s negative opinion on RoActemra, and says the move “drastically limits” patients’ options for treatment and will come as a “bitter blow” to those with advanced stages of the disease.

“If NICE’s recommendations become final guidance, patients with severe RA who have failed on previous Anti-TNFs will only have access to [MabThera] rituximab in the NHS and only very restricted access to a second Anti-TNF,” said the Society’s chief executive Ailsa Bosworth. “With such limited treatment options, some patients will be left with the unacceptable choices of being put back onto treatments they have already failed on, or taking large doses of steroids which have extremely unacceptable side effects such as osteoporosis when given over the long term”.

'Retrograde step'
“For NICE to recommend further Anti-TNFs but not new therapies that have a different mode of action such as tocilizumab will deny some patients a vital life line. This is a truly retrograde step by the Institute that we will be challenging very strongly through the consultation,” added Professor David Scott, Consultant Rheumatologist from Norfolk and Norwich University Hospitals and clinical advisor to NRAS.

But the Institute said that while it is minded not to approve the drug there is still chance it could make it onto the NHS, as its Appraisal Committee has asked Roche for more information to help it determine whether there are any circumstances in which the drug might be considered a cost effective use of resources.

Specifically, NICE is after cost-effectiveness analyses from Roche regarding the use of RoActemra in patients who have failed to respond to previous TNF inhibitors and who are intolerant to, or unsuitable for, treatment with MabThera, as well as its use in people whose RA has responded inadequately to previous therapy with MabThera.

There is currently no cure for RA, a chronic, progressive and disabling autoimmune disease affecting 1% of the UK adult population and costing the NHS is £560 million and the economy £1.8 billion a year from sick leave and work-related disability, but experts agree it is critical to have on hand a range of treatment options for patients who have failed to responded to a TNF inhibitor.

“With no cure, finding ways to relieve pain, improve mobility and reduce long term damage are the goals in treating rheumatoid arthritis," said NICE chief executive Andrew Dillon. "We want to know how [RoActemra] 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 stressed.