Parliamentary Questions on AS and access to anti TNF drugs.

Two Parliamentary questions were put on May 25 this year in the House of Commons. The answers will be given around 6th June.

John Mann (Lab. Bassetlaw): To ask the Secretary of State for Health, what guidance she has issued to trusts on whether they should continue to fund anti-TNF treatments for ankylosing spondylitis prior to the results of the National Institute for Health and Clinical Excellence's appraisal of anti-TNFs being made available.

John Mann (Lab. Bassetlaw): To ask the Secretary of State for Health, for what reasons the National Institute for Health and Clinical Excellence's appraisal of anti-TNFs treatment for ankylosing spondylitis has been delayed.

Replies to Parliamentary questions:

Caroline Flint: Funding for licensed treatments should not be withheld because guidance from the National Institute for Health and Clinical Excellence (NICE0 is unavailable. In December 2006, we issued good practice guidance which asks national health service bodies to continue with local arrangements for the managed introduction of new technologies where guidance from NICE is not available at the time the treatment or technology first became available.

In February 2007, NICE’s appraisal committee commissioned further analysis to inform its appraisal of adalimumab, etancercept and infliximab for the treatment of ankylosing spondylitis. NICE are now expecting to publish final guidance to the NHS in June 2007.

Update on the National Institute of Clinical Excellence (NICE) Appraisal on the use of anti TNF drugs (Adalimumab, Etancercept, Infliximab) in the treatment of AS

Preliminary recommendations
In December 2006 the Appraisal Committee produced an Appraisal Consultation Document to which all consultees, and this includes NASS, were given the opportunity to respond by the end of January 2007.

The ACD made the following recommendations (these are still preliminary and may change).

That adalimumab and etanercept are recommended as treatment options for adults with severe active AS only if all of the following criteria are fulfilled:

The patient’s disease satisfies the modified New York criteria for diagnosis of AS
There is confirmation of sustained active spinal disease as evidenced by activity of at least 4 units on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and at least 4 cm on the 0 to 10 cm spinal pain visual analogue scale on 2 occasions at least 4 weeks apart
The severity of inflammatory activity is assessed to be at least 6 units on the BASDAI at the time treatment with an anti TNF drug is started
Conventional treatment with 2 or more non-steroidal anti-inflammatory drugs each taken sequentially at maximum tolerated or recommended dosage for 4 weeks has failed to control symptoms
Infliximab is recommended as a treatment option for adults with severe active AS only if the patient has been shown to be intolerant of, or have contraindications to the other 2 drugs, or has major difficulties with self administered injection and meets all the treatment criteria already outlined.
Patients should be reassessed at 3 months after initiation of therapy. Treatment should be discontinued in patients who have not experienced a reduction of at least 6 units on the BASDAI from their baseline value.
Response to treatment should be monitored at regular intervals of 3 months. If the original response of at least 6 BASDAI units has not been maintained, assessment should be repeated after 6 weeks. If the original response has not been maintained on both occasions, treatment should be discontinued.
If the patient has had an initial response to treatment of less than 6 BASDAI units, or experiences loss of response later during treatment, prescription of an alternative anti TNF drug is not recommended.

Response to the recommendations
The general response to the recommendations was that they set the initial BASDAI score too high, which would exclude patients for whom the drugs were appropriate, and also demanded that patients, once on the drugs, show a very high level of response to be allowed to continue on the therapy. Consultees would have preferred that the Committee had recommended following the British Society of Rheumatologists (BSR) guidelines for access to anti TNF drugs.

The consultees also felt that the Appraisal Committee still did not understand the nature of AS: that while it is a disease characterised by flare ups, patients do not return to “normal” between flare ups and this is particularly relevant for patients with severe AS who are those likely to be considered for the anti TNF therapy.

Further work commissioned
In February the Appraisal Committee decided they needed further information on which to base their decision on the cost effectiveness of the 3 drugs. They have commissioned some extra analysis to help with their decision and this should be available in the week beginning 14 May for all consultees to comment on.

The next NICE meeting will now be on 27 June 2007.

It is very frustrating for patients that the NICE guidance has been held up in this way: we can only hope that the extra work that has been commissioned will enable the Appraisal Committee to reach an improved decision.

You can look up the progress of this appraisal on the NICE website: www.nice.org.uk

Information to NASS
I am still collecting information on how easy or difficult it is for AS patients to get access to anti-TNF drugs.

I would like to hear from you if you have AS and you have been prescribed an anti-TNF.

Has this helped you to get back to work or to stay in a job which you were finding difficult to hold down before you had treatment?

I would also like to hear from you if you have been prescribed an anti-TNF by your rheumatologist and then been turned down for the treatment.

If you have asked to go on an anti-TNF drug and been turned down, what was the reason given?

In either case it would be useful to know which is your Primary Care Trust (PCT).

Jane Skerrett
Director
May 2007