The National Institute for Health and Clinical Excellence (NICE) has agreed to take a fresh look at evidence for the sequential use of anti-tumour necrosis factor (TNF) inhibitors in the treatment of rheumatoid arthritis (RA), after campaigners won an appeal against its Final Appraisal Decision (FAD) which stated that patients could try just one of the drugs, without being able to switch to a different medicine in the group if they obtained no benefit from the first.
The drugs involved are Abbott Laboratories’ Humira (adalimumab), Amgen/Wyeth’s Enbrel (etanercept) and Remicade (infliximab), which is manufactured by Johnson & Johnson and sold by Schering-Plough outside the USA.
After considering appeals submitted by Abbott, Schering-Plough, Wyeth, the Arthritis and Musculoskeletal Alliance, the National Rheumatoid Arthritis Society (NRAS) and the Royal College of Nursing (RSN), the Appeal Panel found that, in issuing its FAD for the three drugs, NICE had: failed to act fairly and in accordance with its published procedures, as set out in its Guide to the Technology Appraisal Process; and prepared guidance which was perverse in light of the evidence submitted.
The Panel has also recommended that appraisal of the sequential use of the three drugs, after failure of the first, should be restarted as a new appraisal. “We have written to the Department of Health to ask whether they want us to do this,” said NICE, while a Department official added: “we will now consider NICE’s request to advise on whether a new formal referral is required.”
The Panel decision acknowledges that this appraisal was one of “considerable complexity,” requiring the exercise of considerable judgement by the appraisal committee. While the committee is “well-constituted to make such judgements” it should, when doing so, explain with greater clarity the reasons for its conclusions, the Panel added.
The campaigners point out that, of the 400,00 people in the UK who have RA, as many as 40,000 will need anti-TNF drugs, and that it has been established clinical practice for doctors to start patients on one such drug, then to try a second or third, should the first attempt become unsuccessful.
“We are delighted that NICE have listened to patients and clinicians and agreed to re-look at the evidence for sequential use of anti-TNF drugs,” said NRAS chief executive Ailsa Bosworth. ‘It is vital for people living with rheumatoid arthritis to have access to clinically-proven drugs that can help to reduce the pain, fatigue and disability associated with this devastating disease,” she added.
Dr Brian Muller, medical director at Schering-Plough in the UK and Ireland, added that: “in effect, NICE has returned some flexibility for rheumatologists in the UK to make prescribing decisions about anti-TNF therapies based on both clinical and cost-effectiveness grounds,”
In its judgement, the Appeal Panel comments that this appraisal has been “an unusually protracted process, with many patients no doubt awaiting the final outcome,” and hopes that the reappraisal process will be completed as soon as reasonably possible.
It also points out that there is no possibility of further appeal against the Panel’s decision but that it – and NICE’s decision to issue the guidance – may be challenged through an application through the High Court for permission to apply for judicial review. “Any such application must be made promptly and, in any event, within three months of this decision,” it adds.
