The National Institute for Health and Clinical Excellence has rejected the use of Bristol-Myers Squibb's Orencia as a second-line treatment for rheumatoid arthritis (RA) on grounds that the drug is too expensive for National Heath Service use.

In draft guidance the cost watchdog said no to Orencia (abatacept) in combination with methotrexate for patients with moderate to severe active RA who have failed to respond to one or more conventional non-biological disease modifying anti-rheumatic drugs (DMARDs).

B-MS conceded in its submission that its drug would not be cost-effective for second-line use when compared with the subcutaneously injected therapies Humira (adalimumab; Abbott), Enbrel (etanercept; Amgen/Pfizer) and Cimzia (certolizumab pegol; UCB) suggesting instead that Orencia should be pitted against Remicade (infliximab; Johnson & Johnson/Merck), the only other intravenous option at this stage in the care pathway. 

But in a blow for the company NICE's Appraisal Committee did not consider this to be a relevant comparison "since route of administration rarely determines which drug to prescribe", particularly as devices to self-administer subcutaneous injections "have improved considerably and few people experience problems handling the injection devices".  

And in further bad news for B-MS, the Committee also looked at whether Orencia could be a cost-effective option for patients in which therapy with a TNF inhibitor is contraindicated, but concluded that the evidence currently available does not support the drug as a cost-effective use of NHS resources in this setting either.

High costs

The costs associated with Orencia vary according to body weight and number of infusions required. But for a person weighing between 60kg and 100kg, the annual price tag is £10,171 in the first year and £9,444 thereafter, which is simply too expensive compared with other therapies available. 

Commenting on the decision, Sir Andrew Dillon, NICE Chief Executive, said while the Institute recognises that RA can be an extremely debilitating condition and that patients need a range of options following failure of first-line treatment, "the evidence available to the committee did not support the use of Orencia as a second-line option".

He also noted that the cost regulators has already endorsed seven biological treatments, including Orencia, for use at various points in the pathway, once conventional DMARDs have been tried, giving patients a variety of different options.