Frustration at NICE decision

The National Rheumatoid Arthritis Society (NRAS) has expressed their frustration at NICE's provisional decision not to allow patients with rheumatoid arthritis to routinely switch from one Anti-TNF drug to another. This is the second time NICE has appraised the sequential effectiveness of multiple biologic therapies following NRAS's successful appeal of negative NICE guidance on switching in 2007.

Over time, some patients find that whichever Anti-TNF they have been taking becomes less effective and have found benefit from being able to switch to another Anti-TNF. This practice is common among Consultant Rheumatologists managing patients with RA and has been under threat since NICE's decision earlier in the year.

NICE had previously ruled that patients should not be allowed to switch from one Anti-TNF (adalimumab, etanercept and infliximab) to another on the grounds of inefficacy despite the fact that many rheumatoid arthritis sufferers in the UK find this to be beneficial. The reassessment of switching TNF inhibitors included two additional therapies, rituximab and abatacept. The recommendations that are now out for consultation, advise that rituximab should be made available as a treatment option if patients have responded inadequately to DMARDS or at least one Anti-TNF therapy. Adalimumab, etanercept and infliximab should only be used following the failure of a previous TNF inhibitor in the context of research. Abatacept is not recommended as a treatment option after the failure of a TNF inhibitor which is a major blow as this has been shown to be a clinically effective treatment.

NICE have issued this provisional guidance despite hearing evidence from patient and clinical experts that emphasised the importance of the availability of multiple options for people whose disease had not responded to initial treatment with a TNF inhibitor. The Appraisal Committee accepted that individual patients respond differently to different anti-TNF therapies and it is not possible to predict the effectiveness of a second treatment. However, NICE maintain that there is not enough clinical evidence to support the beneficial experience of patients and clinicians of switching to a second Anti-TNF and that it is not cost effective to do so even where patients do benefit.

Ailsa Bosworth, NRAS Chief Executive said: “This NICE decision is as confusing as it is frustrating. Individual patients respond very differently to different therapies and only some patients will benefit from treatment with rituximab following the failure of DMARDS and Anti-TNF therapies. Abatacept would be another good option in their care pathway which has again been denied. NICE don't seem to understand that Rheumatoid is a complex disease with different clinical sub-sets, i.e. it is not just ‘one' disease, and therefore we need access to biologic therapies with different mechanisms of action as people's disease can be driven by different parts of the immune system and access to one TNF, or two under certain circumstances, followed by Rituximab is just not adequate, when there are other effective treatments available. NICE still states that there is not enough clinical evidence to recommend switching to a second TNF inhibitor after the first has stopped working but we know from talking to our members and people across the country with RA and clinicians that this can be incredibly effective in helping people manage their RA and keep them active and in work.”

Dr Chris Deighton, Consultant Rheumatologist at Derbyshire Royal Infirmary and clinical advisor to NRAS said: “I am extremely disappointed by NICE's recommendations. Patients who fail on their first anti-TNF already have very bad rheumatoid arthritis and deserve more choice than just rituximab. We will be doing our best to ensure that the final appraisal offers more treatment options for patients.”

The NRAS also expressed their dismay at the decision by NICE not to recommend tocilizumab (RoActemra) for the treatment of moderate to severe rheumatoid arthritis.

The combined impact of both NICE's recommendations come as a bitter blow to patients with very advanced disease. NRAS have condemned this decision that leaves very limited treatment options for people with severe RA.

Ailsa Bosworth, Chief Executive of NRAS said: “The combined effect of these two NICE decisions this week will be to drastically limit the treatment options for people with severe rheumatoid arthritis. If NICE's recommendations become final guidance, patients with severe RA who have failed on previous Anti-TNFs will only have access to rituximab in the NHS and only very restricted access to a second Anti-TNF. NICE seem not to understand that RA is not a one size fits all disease. RA patients can react very differently to different treatments. With such limited treatment options, some patients will be left with the unacceptable choices of being put back onto treatments they have already failed on, or taking large doses of steroids which have extremely unacceptable side effects such as osteoporosis when given over the long term. These recommendations would deny our most severely ill rheumatoid arthritis sufferers vital steps in their treatment pathway. We simply cannot accept that individuals should be denied the chance of at least regaining some quality of life and condemning them to a life of pain and disability, which could be as or even more expensive to the NHS as well as society as a whole if people, as a consequence of not being able to access clinically effective therapies, lose their jobs.”

Professor David Scott, Consultant Rheumatologist from Norfolk and Norwich University Hospitals and clinical advisor to NRAS said: “I am very disappointed that NICE have yet again not recommended the use of tocilizumab. It is bad news for patients with severe rheumatoid arthritis who know that there may be a new treatment available to help them when others have failed but that they cannot access it through the NHS. For NICE to recommend further Anti-TNFs but not new therapies that have a different mode of action such as tocilizumab will deny some patients a vital life line. This is a truly retrograde step by the Institute that we will be challenging very strongly through the consultation.”