ACCESS TO ANTI TNF DRUGS

Update on the National Institute of Clinical Excellence (NICE) Appraisal on the use of anti TNF drugs (adalimumab, etanercept, infliximab) in the treatment of AS

**Update - April 2008, Awaiting the outcome of the appeal**

The appeal against the NICE decision to exclude infliximab and to stop AS patients benefiting from switching to another anti TNF (except in very limited circumstances) went ahead on 31 March. The limited circumstance in which switching is possible is that if a patient in the first 12 weeks of treatment develops an intolerance of 1 of the 2 approved drugs, they are allowed to try the other. Effectively, as we argued in our appeal, 3 possible drug treatments are being whittled down to one chance, and one chance only, for AS patients to try an anti TNF.

There were 2 appeals: one from NASS and one from the manufacturer, Schering-Plough.

The NASS appeal team consisted of 2 patients, both of whom would be disadvantaged if the current Final Appraisal Determination (FAD) stands, a clinician and the Director.  NASS is very grateful to everyone who attended the appeal on their behalf. If you want to read the original appeal submissions in full they are on the NICE website (insert link).

Please be reassured that if you already on infliximab, you are allowed, under the current NICE FAD, to continue on it.

We now have to wait for a decision from NICE as to whether the appeal is turned down, goes back for minor changes or is referred back to the original Appraisal Committee.

We should have an answer from the Appeal Panel on what is happening next in about 3 weeks: whatever their decision is, will affect how long it will be before the NICE guidance is finally published.  This website will be updated as soon as we have any news.

NASS is mindful that patients are concerned to have guidance in place as soon as possible and will be doing everything we can to bring this about.

 

**Update - 28 January 2008**

NASS, after careful thought by the trustees and Director, has decided to appeal the NICE decision on access to anti TNF drugs.  Here at NASS we are concerned that infliximab will not be available at all for future patients and that patients will not be able, except in very limited circumstances, to try a second anti TNF if they lose response to the first one they try.

The appeal will be held on 31 March: one other organisation has also lodged an appeal.  The progress of the whole appraisal will depend on the outcome of the appeal but here at NASS we will naturally be pressing that the NICE guidance be put in place as soon as possible after the appeal has been heard.

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NICE DISAPPOINT WITH DECISIONS ON THE TREATMENT OF RHEUMATOID ARTHRITIS

NICE has just announced that the drug abatacept has been turned for use by rheumatoid arthritis (RA) patients and is not recommended by NICE.  The abatacept appeal was heard on 17 March.  NICE have also turned down the sequential use of the 3 anti TNF drugs adalimumab, etanercept and infliximab for RA patients in an Appraisal Consultation Document (ACD) issued recently. While an ACD is not their final guidance, it is very disappointing to see that this is their decision at this stage. 

Are you waiting to go on anti TNF?

 

In the meantime, if your consultant thinks you would benefit from an anti TNF drug there are clear statements from the Department of Health that patients should not be denied treatment simply because there is no NICE decision in place (Good Practice Guidance on Managing the Introduction of New Healthcare Interventions and Links to NICE Technology Appraisal Guidance, December 2006, see www.dh.gov.uk )

In practice, the situation in England and Wales is mixed with some patients having relatively few problems in accessing anti TNF treatment and other patients being denied it.  In Scotland, all 3 drugs are available.

 You should discuss this with your consultant and contact the NASS office for more information if you want to take this further.

THE VIEW FROM THE DEPARTMENT OF HEALTH

A NASS member received an email in April from the Department of Health which re states the position on access to treatment which NICE guidance is not in place:

Click here to read the email

 

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The Final Appraisal Determination (FAD) from NICE is available from Monday 12 November.  To summarise it, NICE recommends adalimumab and etanercept for the treatment of AS in the circumstances outlined in more detail in the FAD.  Infliximab is not recommended but patients already on this drug can continue on it.

If patients try one of the two recommended drugs and within the first 12 weeks of use are shown to be intolerant of it, it is recommended they be allowed to try the other one.

But if patients either do not respond or lose response on either adalimumab or etanercept, it is not recommended they be allowed to try the other approved drug. 

To read the FAD in full please click here

News Coverage

The news regarding NICE's decision was covered on 12 November 2007 in the national press. Please see the links below for more details:

The Daily Mail

The Evening Standard

Channel 4 News

Click here to read the full NASS statement

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NASS tells MPs about living with AS

February 2008 

On 19th February 2008, NASS took two patients and two clinicians to Westminster to meet with MPs so that they could learn first hand how ankylosing spondylitis affects the daily lives of hundreds of patients and, in particular, how some of their needs are still not being met. 

Jim Burford and Hannah Vernon (AS patients)

Parliamentarians heard from NASS member Hannah Vernon who highlighted the problem of late diagnosis, the impact of severe pain on her employment record and the brighter situation she is facing now she is receiving anti-TNF treatment. 

From left to right - Dr R Taylor MP,
Jane Skerrett (Director) and Mr Andrew George MP

NASS Director, Jane Skerrett said, “this was a hugely valuable session. MPs now recognise the complexities of living with AS - how many young people are unable to work because of their AS and how the disease can be devastating in terms of pain, fatigue and loss of quality of life - and this will motivate them to champion the issues of AS patients and their families in Parliament which could help affect real change”. 

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HAVE YOU HAD UNEXPECTED SIDE EFFECTS TO MEDICATION?

If you think you’ve had a side effect to a medicine you’re taking, did you know that you can report this using a Yellow Card (www.yellowcard.gov.uk).

The Medicines & Healthcare products Regulatory Agency (MHRA) collects Yellow Card reports from people taking medicines, as well as from healthcare professionals such as doctors, pharmacists and nurses, and uses these reports to identify side effects which might not have been known about before. If a new side effect is found, the MHRA will review the way that the medicine can be used, and the warnings that are given to people taking it.  

For more information about reporting side effects, or to fill in a Yellow Card, go to www.yellowcard.gov.uk.  

Visit www.mhra.gov.uk to find out more about the MHRA, the UK government body which aims to protect public health by making sure that medicines and medical devices work properly and are acceptably safe.

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UK VOLUNTEERS DIAGNOSED WITH AS NEEDED FOR RESEARCH

As many of our members will know, NASS has been involved in recruiting volunteeers for research into AS.  If you are interested in getting involved please click here

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MAJOR GENETIC BREAKTHOUGH FOR ANKYLOSING SPONDYILITIS BRINGS TREATMENT HOPE  Click Here for full Info

Research funded by the Wellcome Trust and the Arthritis Research Campaign has identified two genes implicated in the ankylosing spondylitis. The research, published online in Nature Genetics, suggests that a treatment currently being trialled for Crohn's disease may also be applied to the disease. 

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MEMBERS AREA NOW UP AND RUNNING

Our members area is now up and running, and includes the return of the forum. Please log onto the area for more details.

 

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