Anti-TNF

The National Institute for Health and Clinical Excellence (NICE) has updated its position on the use of anti-TNF treatments for rheumatoid arthritis (RA) and ankylosing spondylitis (AS).

Rheumatoid arthritis

NICE published its guidance for the use of anti-TNF therapy for people with RA in October 2007.

NICE announced that:

• all three anti-TNF treatments, adalimumab, etanercept and infliximab, are available to people with RA who have not responded to other treatments;
• people with RA will be able to try an alternative anti-TNF if they experience an adverse reaction i.e. if your body reacts badly to the treatment, you can be offered another type of anti-TNF.

On 21 July 2008, NICE made a further announcement:

• the option to try a second anti-TNF treatment if the first one fails, known as sequential use, will not be recommended on the NHS;
• an exception can be made where the prescribing of a second anti-TNF can be justified for research purposes.

The issue of sequential use was further examined following an appeal by Arthritis Care, working alongside other service-user and professional groups, that was upheld by an appeals panel in April 2007 (please see below).

Leading up to the announcement in July, Arthritis Care, working with the Arthritis and Musculoskeletal Alliance (ARMA), the umbrella group for service user, professional and research organisations, continued to put pressure on NICE to acknowledge the benefits of allowing sequential use.

ARMA will now be appealing against the decision.

Ankylosing Spondylitis

NICE published its guidance for the use of anti-TNF therapy for people with AS in May 2008.

NICE announced that:

• two of the three anti-TNF treatments, adalimumab and etanercept are available to people with severe AS who have not responded to other treatments;
• infliximab was not recommended as an effective treatment;
• the use of a second anti-TNF if you do not respond the first one was not recommended;
• people with AS will be able to try the alternative anti-TNF if they experience an adverse reaction to the first one i.e. if your body reacts badly to the treatment, you can be offered the other available anti-TNF.

As with all NICE guidance, health providers have three months from the date of publication to make recommended therapies available to people who need them.

A long wait

Abigail Page, Head of Policy and Campaigns at Arthritis Care, said: "People with RA and AS have had to wait an extremely long time to receive guidance on these life-changing treatments. Although we welcome the final decision on the use of anti-TNF treatment for people with RA and AS, we are disappointed at the rejection of sequential use.

"RA and AS are extremely variable conditions and people often respond to treatments in very different ways. It is impossible to know exactly how people will respond in advance of starting a particular anti-TNF. Not allowing the option of a second, or even third, anti-TNF is denying people the chance of a potentially life-changing treatment and forcing them to return to therapies that do not work for them.

"People with any form of arthritis should be able to expect the widest range of treatment options and we will continue to push this important issue".

In December 2006, Arthritis Care, working alongside other voluntary and professional bodies, formally appealed against a decision by the National Institute for Health and Clinical Excellence (NICE) regarding access to anti-TNFs.

NICE had ruled that people with rheumatoid arthritis should not be allowed to receive a second form of anti-TNF treatment if they had already tried one form with no success (known as sequential use).

April 2007 hearing 

The formal appeal from the Arthritis and Musculoskeletal Alliance (ARMA), a coalition of service user groups and medical organisations, said there is evidence to show that many people who have been tried unsuccessfully on one type of anti-TNF, have gone on to derive benefit from another.

An appeal hearing took place in April 2007. The panel at the hearing upheld some parts of the appeal and ruled that the appraisal committee at NICE needs to reconsider their guidance. This means that NICE was required to re-assess their decision on not allowing sequential use of anti-TNF treatment.

Treatment vital for many

The Policy and Campaigns team at Arthritis Care, said:

“Anti-TNF treatment is hugely important for people with rheumatoid arthritis. Successful treatment with anti-TNFs can be life-changing and it is vital that people should be given every chance to benefit from this treatment. We did not agree with NICE that there is insufficient evidence to justify the expense of sequential use and now hope that people are given the chance to receive these important treatment options.”

Anti-TNF: These are a type of medication that work by blocking the action of a chemical called tumour necrosis factor (TNF). TNF is thought to play an important role in driving the inflammation and tissue damage in certain kinds of inflammatory arthritis.

Appraisal: The process by which NICE makes an assessment of the clinical and cost-effectiveness of treatments. In the context of drug treatments, this is called a "technology appraisal".

Guidance: Following an assessment of a health technology, NICE issues guidance which the NHS uses to determine the treatments the public can expect to receive. For example, if NICE issues guidance recommending the use of an anti-TNF therapy, the NHS must offer that treatment when a service-user meets the set criteria. The NHS is legally obliged to offer treatments featured in NICE guidance within three months of its publication.

National Institute for Health and Clinical Excellence (NICE): "NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health". From their website

Sequential use: Some people do not respond to certain anti-TNF therapies. Switching to an alternative anti-TNF has, in some cases, shown positive results. This is called sequential use. You can only switch to another anti-TNF if you experience an adverse reaction to the one you are taking or in the case of RA, if it can be justified for research purposes.