The golden glow surrounding Roche’s MabThera (rituximab) intensified today after the Swiss giant launched its multi-billion dollar drug in the UK for a new indication – to treat severe active rheumatoid arthritis – opening the door to a significant new market and treading a path to its stated intention of becoming the world’s biggest rheumatology company by 2012, matching its pole position in oncology.

MabThera is already on the market in the USA, Canada and Mexico for RA – where it is marketed as Rituxan by Roche’s partner Genentech – and where it helped push the US firm’s sales for the first quarter alone to $477 million.

Roche itself booked a staggering 1.15 billion Swiss francs ($921 million) for MabThera in the same period and analysts believe that the new indication could add in excess of a billion dollars to sales, despite it currently only securing approval as second-line therapy after anti-TNF drugs, such as the equally big-selling Enbrel (etanercept). These tumour necrosis factor inhibitors broke the mould for rheumatoid arthritis patients, whose treatment options prior to their launch centered on analgesics and disease-modifying anti-rheumatic drugs, and Roche hopes the entry of MabThera will have the same revolutionary effect for the 30% of adults with severe RA who have failed on anti-TNF therapy.

Between 1999 and 2000, some 9.4 million working days were lost to RA and the disease is estimated to cost England alone £1.2 billion in direct and indirect costs every year. MabThera is given as two infusions over a two-week period, with remission generally lasting six-12 months, at a cost of £3,492.60 to the UK’s National Health Service. But Roche may have to wait a little bit longer before it is able to determine take up, as the country’s cost effectiveness body - the National Institute for Health and Clinical Excellence – is yet to make its decision on whether it will allow primary care trusts to fund the treatment. With many PCTs facing financial difficulties amid huge deficits, they often use a lack of NICE guidance as a reason not to authorise prescription.

On the positive side, MabThera has been placed on NICE’s new single-track appraisal system – brought in for Roche’s Herceptin (trastuzumab) and designed to speed up the entire process. However, because of the backlog, Roche is not now anticipating a decision until 2007, having previously hoped to hear this summer. In Scotland, however, the picture is different, with the Scottish Medicines Consortium expecting to make its recommendations in September. But its confidence remains high and spokespeople for Roche told PharmaTimes World News that the cost-effectiveness package is very strong, with data showing a cost per QALY (quality adjusted life year; a common measure of cost-effectiveness) of £12,000, making it less expensive than anti-TNF drugs.

RA affects almost 400,000 people in the UK alone and, of these, some 100,000 will have the severe active form. However, in the UK just 10% of patients receive biologic therapy compared to 50% of those in the USA.