The National Institute for Health and Clinical Excellence (NICE) has issued final guidance rejecting the use of Bristol-Myers Squibb's Orencia (abatacept) as a second-line treatment for rheumatoid arthritis (RA).

The guidance says that the use of Orencia is not recommended in combination with methotrexate for treating RA in adults whose disease has responded inadequately to one or more conventional non-biological disease-modifying antirheumatic drugs (DMARDs), including methotrexate.

NICE points out that it has already recommended a range of biological treatments for RA. Abbott Laboratories' Humira (adalimumab), Amgen/Pfizer's Enbrel (etanercept), Johnson & Johnson/Merck & Co's Remicade (infliximab), UCB's Cimzia (certolizumab pegol) and Merck Sharp & Dohme's Simponi (golimumab) are options for second-line use, and this is the same point in the treatment pathway at which Orencia is currently being considered, it says.

NICE also notes that it already recommends Genentech/Biogen IDEC's Rituxan (rituximab) for adults with severe active RA who have had an inadequate response to at least one tumour necrosis factor (TNF) inhibitor. In addition, for people who cannot take Rituxan following an inadequate response to at least one TNF inhibitor, the Institute recommends Humira, Enbrel, Remicade, Genentech's Actemra (tocilizumab), Orencia and also Simponi.

The Institute has previously issued a positive recommendation for the use of Orencia in certain circumstances to help people with RA, but the evidence considered by NICE's independent Appraisal Committee did not support using the drug as a second-line treatment option, said Professor Carole Longson, director of the health technology evaluation centre at NICE.

Moreover, she added that the drug's manufacturer had noted that its product would not be cost-effective for second-line use when compared to a range of alternatives including Humira, Enbrel and Cimzia. It therefore suggested that Orencia should be compared with Remicade, the only other intravenous treatment option at this stage in the pathway of care.

However, the Appraisal Committee did not consider this to be a relevant comparison since the route of administration rarely determines which drug to prescribe. This is because devices used to self-administer subcutaneous injections have improved considerably and few people experience problems handling the injection devices. Subcutaneous injections can also be administered at home by a nurse or a family member, it added.

The Appraisal Committee also considered whether Orencia could be a cost-effective treatment option for people for whom treatment with a TNF inhibitor was contraindicated because of congestive heart failure. However, it concluded that it did not consider it appropriate to provide a separate recommendation, given that there was no evidence of how much clinical benefit Orencia may provide in this group of people, and that their health status is not comparable to the overall trial population.

Also, any decision on using biological treatments for this group of people would need a careful balance of the potential benefits and harms for the individual patient because of their complex medical needs, the Committee concluded.

"NICE has already recommended a range of biological treatments for rheumatoid arthritis, providing potential treatment options for people with this condition," Prof Longson pointed out.

www.nice.org.uk