The National Institute for Health and Clinical Excellence (NICE) has issued a Final Draft Guidance (FAD) stating that it does not recommend the use of Bristol-Myers Squibb's Orencia (abatacept) as a second-line treatment for rheumatoid arthritis (RA).
Adults whose disease has responded inadequately to one or more conventional non-biological disease-modifying anti-rheumatic drugs (DMARDs) and are currently being treated with Orencia in combination with methotrexate should have the option to continue therapy until they or their clinicians consider it is appropriate to stop, says NICE, which emphasises that it has not yet issued its final guidance to the NHS on the use of Orencia in these circumstances.
The Institute also points out that it has already recommended a range of biological treatments for second-line treatment of RA, the same point in the treatment pathway at which Orencia is currently being considered, ie, 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).
NICE adds that it also recommends Roche's MabThera (rituximab) for adults with severe active RA who have had an inadequate response to at least one tumour necrosis factor (TNF) inhibitor, while for people who cannot take MabThera following an inadequate response to at least one TNF inhibitor, it recommends Humira, Enbrel, Remicade, Roche's RoActemra (tocilizumab), Simponi - and Orencia.
"Nice has previously issued a positive recommendation for the use of abatacept in certain circumstances, to help people with RA," said Dr Carole Longson, director of NICE's health technology evaluation centre. However, she added: "the Appraisal Committee concluded that using abatacept as a second-line treatment option was not supported by the evidence provided. Indeed, the manufacturer of abatacept had noted that their product would not be cost-effective for second-line use when compared to a range of alternatives," which included Humira, Enbrel and Cimzia.
Until NICE issues its final guidance, NHS bodies should make decisions locally on the funding of specific treatments, the Institute says.
However, the National Rheumatoid Arthritis Society (NRAS) says it is "very disappointed" that NICE is "shutting the door" for some RA patients who are unable to take anti-TNF therapy. The decision will leave a group of patients with no biologic options after failure of two conventional DMARDs, following which pain and disability are likely to increase, it says.
The alternative treatment available to some would be MabThera, although this is less suitable for those with sero-negative disease and it is not licensed for use post-DMARD failure or passed by NICE for use at this point in the patient pathway, says NRAS.
Asking this group of patients to continue on DMARDs when they have failed at least two including methotrexate and have a disease activity score (DAS) greater than 5.1 "is condemning them to a life of pain and misery, with worsening disease which offers an ever-decreasing quality of life," said the group’s chief executive, Ailsa Bosworth.
"For these patients, long-term, high-dose steroids may become the only option, an option which is not recommended by NICE," she said.