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The National Institute for Health and Clinical Excellence (NICE), the independent body that advises the NHS in England and Wales on use of treatments, has agreed to review its draft guidance against the sequential use of different tumour necrosis factor α (TNF-α) inhibitors in patients with rheumatoid arthritis, after an appeal from a group representing patients.
In its appraisal published in November 2006 NICE recommended the TNF-α inhibitors adalimumab, etanercept, and infliximab as options in the treatment of adults who have active rheumatoid arthritis as determined by a disease activity score >5.1 confirmed on at least two occasions one month apart and who have undergone trials of two disease modifying antirheumatic drugs, including methotrexate (unless contraindicated). The appraisal said that treatment with TNF-α inhibitors should be continued only if there was an adequate response—defined as an improvement in the disease activity score of 1.2 points or more—at six months after treatment started.
However, NICE recommended against the use of a second TNF-α inhibitor if a patient had “an inadequate initial response or experienced loss of response later during treatment with a TNF-α inhibitor.”
The institute received six appeals against the appraisal from the Arthritis and Musculoskeletal Alliance (an umbrella group representing people with arthritis, professional bodies, and research organisations in the field of arthritis), the National Rheumatoid Arthritis Society, the Royal College of Nursing, and the drug companies making the three TNF-α inhibitors under consideration, Abbott Laboratories, Schering-Plough, and Wyeth.
In its appeal the alliance reported a study that looked at the effect of allowing patients who withdrew from their first TNF treatment to receive a second TNF (sequential treatment). In a previous study the lack of data on patients receiving a second TNF had made this difficult to analyse. However, a new analysis that was based on 629 patients who received a second TNF used evidence on probability of response and duration of sequential treatment to investigate the cost effectiveness of this approach.
In its appeal the alliance reported, “The results suggest that a second TNF is similarly cost effective to a first TNF.” It argued, “The [NICE] committee has already decided that a first TNF is recommended provided adequate monitoring of ongoing successful response is in place. Our analysis of the evidence indicates that a similar conclusion for a second TNF could be made.”
The appeal panel met in April, and it announced this week that NICE's health technology appraisal committee had been “unreasonable” in deciding, on the evidence presented, to deny sequential treatment. In a statement NICE said, “The appeal panel decided that the appraisal committee needed to take another look at the use of a second anti-TNF treatment where there had been no response to a first anti-TNF treatment.”
Neil Betteridge, chief executive of Arthritis Care, a charity that supports people with arthritis and a member of the Alliance, said, “It is a credit to the robust methods of NICE that they have listened to evidence and are now going to reconsider the issue of switching from one anti-TNF to another in appropriate cases. More importantly, it offers hope for people with the most severe forms of rheumatoid arthritis. They now know that if they cannot take one anti-TNF, or it stops working for them, they may have alternatives available.”
The appeal panel's decision is available at http://guidance.nice.org.uk/page.aspx?o=207026.