NICE Decision 'Fantastic' - Lifeline Given To Thousands, Says Arthritis Care, UK

Main Category: Arthritis / Rheumatology
Also Included In: Palliative Care / Hospice Care
Article Date: 14 Jun 2007 - 1:00 PDT

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Thousands of people with rheumatoid arthritis have been given new hope by the National Institute for Clinical Excellence which has granted an appeal overturning its decision to limit access to life-changing 'anti-TNF' drugs. The about-turn means that NICE will reconsider its draft guidance to the NHS to prevent patients from trying a second anti-TNF treatment if the first does not work for their condition. For many, that initial decision had meant pain, disability and poverty.

'People eligible to receive anti-TNF treatment are, by definition, people with severe rheumatoid arthritis - a disease which, if left untreated, leads to serious disability, often at a young age. If not properly treated, those with the most severe form die on average within five years,' said Arthritis Care chief executive Neil Betteridge, who has had rheumatoid arthritis since he was three years old. Through their umbrella group, the Arthritis and Musculoskeletal Alliance (ARMA), of which Betteridge is chair, Arthritis Care,and other interested parties, launched an appeal for NICE to reconsider the draft guidance, issued in November 2006.

The Appeal Panel met in April, and today (June 12th) it announced its finding that the NICE Health Technology Appraisal Committee had been 'unreasonable' in deciding, on the evidence presented, to deny a second anti-TNF treatment. The cumulative result was 'perverse' guidance, the appeal panel said.

The panel's decision is that the NICE guidance must now be reconsidered by the committee. If they examine all available evidence, yet still offer the same advice, their reasons should be fully explained.

'It is a credit to the robust methods of NICE that they have listened to evidence from ARMA 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 RA. They now know that if they cannot take one anti-TNF, or it stops working for them, they may have alternatives available', said Betteridge.

'The challenge now is to ensure that the evidence NICE considers in its reappraisal is reliable and comprehensive, with the individual's health and safety paramount', he added.

'It is fantastic that people may now get a 'second bite of the cherry'. There are three drugs of this type, and obviously patients want to try the other two if the first does not work for them. The alternative is often a life on incapacity benefit, with no opportunity to live fully and productively', said Betteridge, 'How can it be better to be on benefit, using expensive orthopaedic, physiotherapy, and palliative care services than to be tax-paying workers getting on with life?' About 400,000 Britons have rheumatoid arthritis, a disease in which the immune system does not protect the body, but appears to ravage it with a chemical called Tumour Necrosis Factor (TNF). Of that number, about 10 per cent (4,000) have severe rheumatoid arthritis.

The drugs concerned in the NICE appeal are the so-called 'anti-TNF's' or 'TNF-blockers', infliximab, etanercept, and adminulab. They work by inhibiting the TNF attacks, and their use can return someone from disability and despair to full and active life in the workplace.

But last November NICE, which bases its decisions on cost effectiveness to the NHS, issued draft guidance restricting 'sequential use' of anti-TNF drugs. Any patient who had failed to gain significant benefit from one anti-TNF drug was not to be allowed to see if another would work instead.

'The three anti-TNFs have a a different make-up, and each is administered in a different way. We argued that there is enough evidence to show that people often benefit from one anti-TNF having failed on another - quite enough evidence to justify the expense of permitting sequential use', said Betteridge. ' We're talking about people for whom these drugs are the last hope, for whom there is nothing else beyond palliative care and a return to drugs already shown to have failed them', he said.

Rheumatoid arthritis appears to be caused in the body by a chemical agent called a cytokine, known as a TNF-alpha. A group of drugs called biologic agents - anti-TNFs, TNF blockers or TNF inhibitors - were developed to block the cytokine and neutralise its activity.

To qualify for anti-TNF treatment, people with rheumatoid arthritis must be prescribed it by a consultant rheumatologist. They must already have failed to respond well to other at least two of the cheaper, disease-modifying anti-rheumatic drugs (DMARDS), including methotrexate.

Arthritis is the UK's biggest single cause of physical disability, affecting around nine million people. Rheumatoid arthritis is the UK's commonest form of inflammatory arthritis, affecting some 400,000 people. Its precise cause is unknown, and still being researched, but it is regarded as a types of autoimmune disease. It can occur at any age and is characterised by persistent inflammation of many joints. 75% of those with rheumatoid arthritis are women. Arthritis Care, which was established in 1947 and celebrates its Diamond Jubilee this year, is the UK's largest voluntary organisation committed to supporting people with arthritis.

Arthritis Care free confidential helpline: 0808 800 4050, 10am-4pm weekdays

http://www.arthritiscare.org.uk

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