NICE Must Rethink Denying Abatacept, Says Patient-voice Organisation Arthritis Care, UK

Main Category: Arthritis / Rheumatology
Also Included In: Palliative Care / Hospice Care
Article Date: 26 Oct 2007 - 2:00 PDT

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In a snub to thousands of people with rheumatoid arthritis, the National Institute of Health and Clinical Excellence (NICE) has published final guidance stating that the drug abatacept (Orencia) is not cost effective for the NHS and should be refused.

The drug for severe rheumatoid arthritis (RA) was only launched in the UK in June. Manufacturers Bristol-Myers Squibb said at the time that it promised long-term efficacy for people with RA who have not responded positively to anti-TNF therapy.

Abatacept is licensed in the UK for use in combination with methotrexate for adults with active moderate to severe RA, who have responded poorly to other disease modifying anti-rheumatic drugs (DMARDs), and to at least one anti-TNF.

'It's a huge blow. This decision will dash the hopes of thousands. The fact that the new-generation drug rituximab (MabThera) was approved recently doesn't mean that all people failed by anti-TNFs will be suitable for it. Abatacept was a bright, new hope for them, and to put it beyond their reach will seem catastrophic', said Arthritis Care's spokesman Jane Spence.

'People qualified to receive anti-TNF treatment already have serious, active rheumatoid arthritis. It's very debilitating and destructive, and if not properly treated, those with the severest form of the condition can kiss goodbye to hopes of halting their disease's damaging progress', she added.

'This harsh ruling means there's no place left to go if you've been failed by rituximab, or the anti-TNF treatments. Whilst NICE is obliged to make its decisions on NHS cost-effectiveness, the narrow focus merely robs Peter to pay Paul. Instead of funding abatacept, now the taxpayer will foot the bill for expensive orthopaedic and palliative care for people who might do well on the drug, if allowed it. Many may end up on disability or incapacity benefits as well', said Spence.

The final NICE guidance, published recently, states that abatacept is not recommended for treatment on the NHS of people with rheumatoid arthritis. However, it says the small number of people who are currently receiving it may continue until they and their clinicians consider it appropriate to stop. 'Arthritis Care speaks up for people with arthritis and we'll make a robust appeal against this ruling. We'll urge NICE to revisit the evidence and reverse its decision, which, if allowed to stand, will deny many who potentially qualify for this treatment, the benefits it offers', said Spence.

The launch of abatacept in the UK followed the grant of its European Commission licence on May 21, 2007. NICE guidance applies to England and Wales. Decisions in Northern Ireland usually mirror NICE's lead. In September, the equivalent body in Scotland, the Scottish Medicines Consortium (SMC), also refused to recommend abatacept.

Arthritis has some 200 forms. It is the UK's biggest single cause of physical disability, affecting around nine million Britons. About 400,000 Britons of all ages 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). Some 10% (40,000) of these have severe RA, and it is people within this group who could benefit from abatacept.

Arthritis Care, established in 1947, is the UK's largest voluntary organisation committed to supporting people with arthritis. It celebrates its Diamond Jubilee this year.

Predating the NHS by one year, the charity works to represent people with arthritis, and to lobby decision-makers on their behalf. It has over 300 branches UK-wide, a free, confidential information helpline; it produces a range of information booklets plus the award-winning Arthritis News, and it actively campaigns locally, nationally and internationally for people with arthritis.

http://www.arthritiscare.org.uk