NRAS Statement on NICE ACD

re switching anti-TNFs

Statement from the National Rheumatoid Arthritis Society

29 April 2008

Switching anti-TNFs for rheumatoid arthritis to be denied according to recommendation by NICE ACD

RA sufferers hit for second time in a week with ‘short-sighted’ NICE guidance

The National Institute for Health and Clinical Excellence (NICE) has today issued its Appraisal Consultation Document (ACD) on sequential use of anti-TNF therapy for rheumatoid arthritis (RA) which, together with last week’s negative decision on abatacept, could slash the number of licensed and effective biologic treatment options available for people with severe RA from five to just two.

The NICE ACD states that: “adalimumab, etanercept and infliximab, within their licensed indications, are not recommended for the treatment of rheumatoid arthritis after the failure of a tumour necrosis factor alpha (TNF-α) inhibitor”. If the ACD becomes final guidance, this could mean that up to 60,000 people in UK who have the moderate to severe form of the disease would not be allowed to switch from one anti-TNF to another if their response to the first treatment decreases over time.

Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society, comments:

“If this decision by NICE becomes guidance as it will severely limit the treatment options available to people with rheumatoid arthritis. Together with last week’s decision to refuse abatacept, NICE would be reducing the treatment options available for people with severe RA from five clinically proven drugs to just two.”

There are five licensed treatments for rheumatoid arthritis patients who have failed on two or more DMARDs (adalimumab, etanercept, infliximab, rituximab and abatacept). If all were available and could be used in a clinically effective way, based on disease profile as part of an integrated care pathway, then people with RA would have five different treatments available to help them manage their disease as it progressed over time. About 25% of people with the disease have sero-negative RA for whom rituximab may not be the best option. Under NICE’s proposed guidance these people will have only one biologic agent available to them.

Ailsa says:

”It is a bitter blow to find that NICE is not recommending switching when consultants have been successfully switching patients for a number of years. I am on my third TNF and my inflammation is currently better controlled now than for many years. The way in which we are able to use these drugs in the UK lags way behind the rest of Europe sadly. You are better off having RA in Holland or Sweden than you are in the UK.”

The average age of onset of RA is between 40 and 60 years old – although the disease can affect people of any age. This means that people can be living with RA for 20-30 years or longer.

“Rheumatoid arthritis is a life long condition that causes significant pain and disability. In order to manage this condition for a long period of time people need as many treatment options available to them as possible.”

According to the Department of Work and Pensions (2001), £2.148 billion was paid to people who were claiming incapacity benefit because of arthritis and related conditions. 1 In 1999-2000 9.4 million working days were lost in the UK because of RA.¹ A survey last year by NRAS found that nearly 30% of respondents had given up work because of RA; over a quarter of them within one year of diagnosis and over half within 6 years of diagnosis.²

“Keeping people in work is a key objective of the government. One of the important things which these biologic drugs have achieved is enabling people to remain working or return to work. At the BSR conference last week Dame Carol Black (National Director for Health and Work) delivered an important presentation on the health of the working age population. She emphasised the need to prevent people with long term conditions (such as rheumatoid arthritis) from losing their jobs in the first place and moving from income tax payers to benefits claimants. This decision flies in the face of this aim and many more people will go on to lose their ability to work.”

“It’s about time NICE took on board the government Health Select Committee’s recommendations , published in January, recommending the inclusion of work related disability and the wider societal costs in the cost effectiveness economic modelling. It is astonishing that the government cannot seem to grasp that spending by the Department of Health in 2008 will save costs down the line. Until the government really starts to do some joined up thinking, this inability to reflect the real cost effectiveness of providing a drug will continue.”

Ailsa concludes:

“The refusal by NICE to approve abatacept last week has already denied RA sufferers in the UK one valuable treatment option and there is a real danger that a further two treatment options will be taken away from them. We strongly urge NICE to take into account the needs of real people in their final guidance ensure that people with RA continue to have access to the treatments they so desperately need.”

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About NRAS:

• The National Rheumatoid Arthritis Society (NRAS) was launched in October 2001 and in a relatively short time has become established as the campaigning voice in the UK for people with Rheumatoid Arthritis.
• NRAS provides a total one-stop-shop with support, information and advocacy for all people in the UK with RA, their carers and families.
• NRAS has a national volunteer network, a group of people with the disease who provide peer to peer support and provide additional resource to help NRAS in many different ways.

Case studies are available

For more information, please contact:

Jon Pike, Press Officer for NRAS

Tel: 07989 850 195

References:

1. Arthritis Research Campaign, The Big Picture, May 2002: 

2. National Rheumatoid Arthritis Society. I Want To Work Survey. April 2007.

To view the full ACD please click here