It looks as if Bristol-Myers Squibb’s arthritis treatment Orenica will not be made available to patients with rheumatoid arthritis on the National Health Service, after the National Institute for Health and Clinical Excellence issued second draft guidance rejecting its use.

The move follows a public consultation after which the Institute considered all the evidence it was presented against its preliminary decision, but this failed to overturn its position that adding Orencia (abatacept), the first in class of so-called selective T-cell co-stimulation modulators, to the NHS drugs menu would be an ineffective use of resources, as the drug has consistently failed to fall under its cost-effectiveness ceiling benchmark of £30,000 per QALY (quality-adjusted life year).

Explaining the decision, a spokesperson for the Institute said: “NICE has recently recommended rituximab [Roche’s MabThera] for rheumatoid arthritis. The evidence shows that abatacept can cost about twice as much as rituximab but offers similar benefits. Whilst recognising the severity of the disease, the Committee concluded that based on this evidence, abatacept could not be considered a good use of NHS resources.”

B-MS dissapointed

Naturally, B-MS is disappointed with the news. Frank Pasqualone, European Vice President and General Manager, UK, at the company, argued that Orencia “has been shown to be an effective option for patients with severe RA for whom treatment with other biologic therapies is not working,” and that “NICE’s decision could prove to be a false economy because data show that patients whose disease is not adequately controlled are expensive to care for.”

Consequently, the company intends to appeal the decision and, in the meantime, says it will continue to make Orencia available commercially, working with primary care trusts to secure access for specific patients who might benefit from the drug. A spokesperson could not be reached for further information on the basis of the company's appeal.

NICE has confirmed that, subject to any appeal being received, it expects to issue final guidance to the NHS towards the end of 2007.