NICE gives the go-ahead for MabThera on the NHS

The National Institute for Health and Clinical Excellence (NICE) has approved Roche's rheumatoid arthritis (RA) drug MabThera (rituximab), for prescription on the NHS in England and Wales.

MabThera, in combination with methorexate, has been recommended as a treatment option for adults with severe active RA, who have had an inadequate response or are intolerant of anti-TNF (tumour necrosis factor) drugs.  

The recommendation follows NICE's rejection of a similar drug, Bristol Myers-Squibb's Orencia, in August 2007 on cost-effectiveness grounds.

"It's a triumph. The search for effective treatment can be a long, agonising journey, littered with dashed hopes.  Now there's no excuse to deny this drug on anything but clinical grounds," said Arthritis Care's chief executive Neil Betteridge.

The drug is already available in Scotland, after NICE's counterpart, the Scottish Medicines Consortium, approved it in November 2006.

NICE has also approved Abbott's psoriatic arthritis drug Humira (adalimumab) for use on the NHS. The drug is recommended as a treatment option for adults with active and progressive psoriatic arthritis when the person has peripheral arthritis with three or more tender joints and three or more swollen joints, and the psoriatic arthritis has not responded to adequate trials of at least two standard disease-modifying anti-rheumatic drugs. NICE has ruled that Humira should be discontinued after 12 weeks if no improvement is seen.

"Following further clarification from the manufacturer on the economic analysis of rituximab, the committee has assessed that these drugs represent the right approach for the NHS to take in the treatment of two severe forms of arthritis," said Andrew Dillon, executive lead for the appraisal.

Primary Care Trusts have a statutory duty to fund NICE technology appraisals within three months of publication.

MabThera is the first and only selective B cell therapy for RA offering a fundamentally different treatment approach.

B cells play a key role in driving the RA disease process and MabThera is thought to break this process so preventing disease effects and leading to lasting benefits for the patient.

Sustained benefits
Data published in June 2007 showed the benefits of MabThera are sustained or greatly improved in the long term.

Data showed that after three courses of the drug in patients who had failed on anti-TNF inhibitors, the number of patients achieving 70 per cent improvement in disease signs and symptoms more than doubled from 11 per cent to 25 per cent, and remission rates also doubled from 6 per cent to 12 per cent.

In total 1053 RA patients were treated with MabThera with almost 70 per cent of patients followed up for more than two years and 11 per cent for more than three years.