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BMS wins wider NICE Orencia arthritis approval

But only after cutting the drug's price

BMS Orencia abatacept 

The UK's National Institute for Health and Care Excellence (NICE) has widened its recommendation for the use of Orencia in treating rheumatoid arthritis (RA).

Bristol-Myers Squibb lowered the price of its drug late last year in the hope of persuading the watchdog that it was cost-effective after being rejected by NICE in August.

The patient access scheme persuaded NICE to launch a rapid review of its original decision, illustrating the instrumental role the discount played in reversing that assessment.

Orencia (abatacept) is now recommended to treat RA in combination with methotrexate after conventional drug treatments - disease-modifying anti-rheumatic drugs (DMARDs) - have failed.  

NICE's final guidance puts Orencia on a par with rival biologics like Abbott's Humira, Wyeth's Enbrel, UCB's Cimzia and Roche's Actemra, to which it was unfavourably compared on money grounds before.

NICE said Orencia with methotrexate is recommended as an option for RA only if the disease has responded inadequately to two conventional non-biological DMARDs including methotrexate.

It also has to be used in line with recommendations on those other drugs – and must come with the price cut.

In 2010 NICE recommended Orencia in RA if there had been an inadequate response to one or more TNF inhibitors and when patients cannot receive Roche's MabThera because it is contraindicated or withdrawn because of an adverse event.

“This guidance will widen the choice of treatments available at this stage of the treatment pathway, by offering abatacept in specific clinical circumstances, and only if the manufacturer provides it with the discount agreed as part of the patient access scheme,” explained Professor Carole Longson, director of NICE's Health Technology Evaluation Centre.

Launched in 2006, Orencia is a 30-minute intravenous infusion and, while amounts vary due to body weight and number of doses, costs around £12,000 a year - although how much the discount will knock off that has not been made publicly available, at BMS's request.

A subcutaneous formulation of Orencia, now cleared for marketing in Europe and accounting for close to a third of total Orencia sales in the US, has proven as effective as Humira in the first head-to-head trial of the two RA drugs.

BMS' brand has a different mechanism of action from its rival, binding to the CD80 receptor and blocking T cell proliferation.

However, injectable biologics for RA are likely to have stiff competition relatively soon from new oral products such as Pfizer's Xeljanz (tofacitinib), recently-approved and tipped for sales of over $2bn.

24th April 2013

From: Sales

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