The National Institute for Health and Clinical Excellence (NICE) has issued a third and final decision against Bristol-Myers Squibb’s Orencia (abatacept) being offered as a treatment for moderate to severe active rheumatoid arthritis (RA) on the National Health Service (NHS).

Last August, NICE issued preliminary guidance rejecting the drug’s use, stating that it would not represent an effective use of NHS resources. It then held a public consultation on the issue, which resulted in a second decision against the drug in October. Appeals were launched by the company, the British Society for Rheumatology, the Royal College of Physicians, the National Rheumatoid Arthritis Society (NRAS) and the Royal College of Nursing, which were heard but not upheld, says the Institute.

“The independent Appraisal Committee who developed the recommendations took into account the severity of the disease when assessing the evidence, as well as the value placed on the benefits of abatacept by people with rheumatoid arthritis, those who represent them and clinical specialists, but found that abatacept does not represent a good use of NHS resources,” said NICE chief executive Andrew Dillon, who was executive lead for the Orencia guidance. He added: “they have, however, recommended that patients currently receiving the drug for rheumatoid arthritis should have the option to continue therapy until they and their clinicians consider it appropriate to stop.”

Mr Dillon also pointed out that in October 2007, NICE had recommended Abbott Laboratories’ Humira (adalimumab), Wyeth’s Enbrel (etanercept) and Schering-Plough’s Remicade (infliximab) for the treatment of RA, and added that Roche’s MabThera/Rituxan (rituximab) is an option for treating severe active RA for some people. “By recommending the use of these drugs, people in England and Wales with this condition have access to effective treatments when they need them,” he said.

However, Ailsa Bosworth, Chief Executive of NRAS, described the decision as “perverse and shortsighted,” and accused NICE of condemning people with severe RA, who have already failed on other therapies, to “a lifetime of misery.”

“For many patients abatacept provides their last chance of controlling the disease. Without this drug, people with severe RA will have to return to medicines they have already failed on or will have to take large doses of steroids which are associated with extremely unacceptable side effects,” said Ms Bosworth. She also warned that palliative care and the burden of ongoing disability associated with severe RA “will result in much greater costs for the NHS than a clinically proven treatment which can make a significant difference to the quality of life of people with severe rheumatoid arthritis.”

Andrew Bamji, president of the British Society for Rheumatology, described the decision as extremely disappointing and a “kick in the face” for a group of severely disabled patients. “NICE is effectively denying desperate patients any last hope of remission from their disease,” said Dr Bamji.

There are about 400,000 people with RA in the UK, some 40,000 of whom suffer from a severe form. Bristol-Myers Squibb submitted evidence to NICE showing that around 3,585 patients, who had over time failed on other biologic treatments, would be eligible to receive Orencia. Only those who responded to the drug would remain on it, and if there was no response, treatment could be stopped very quickly, thereby minimising costs, said Ms Bosworth. She pointed out that Orencia is freely available to people living with RA in France, Germany and other European countries, “but, thanks to NICE, this is not the case in the UK.”

NICE has said that it will consult on its review plans for this guidance in July 2010.