NACC - National Association for Colitis and Crohn's Disease

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NICE recommendations on antiTNF therapy for IBD - updated 27 January 2009

NICE - The National Institute for Health and Clinical Excellence - has been considering the use of antiTNF therapies for Ulcerative colitis and Crohns disease (infliximab for UC and adalimumab and infliximab for CD).

We have the final decision on ulcerative colitis infliximab is not authorised for people with sub-acute (non-urgent) UC and should only be authorised by the NHS for treatment of patients with acute severe UC where ciclosporin is contraindicated. (See NACC Information Sheet on ciclosporin.) The view taken by NICE partly reflects the fact that clinical opinion is divided over the effectiveness of infliximab in treating ulcerative colitis as compared with other standard treatments.

Click here for the NICE recommendations on sub-acute UC

Click here for the NICE recommendations on severe acute UC

There is no decision yet on Crohns Disease. NICE has referred the economic model for further work and revision and there is no date for a further meeting of the Appraisal Committee. NACC is pleased that NICE have responded to the concerns that have been widely expressed.

Click here for the information available on the NICE website

Background:

NICE had provisionally recommended that infliximab and adalimumab should only be available as episodic treatment for severe Crohns disease. This would have meant patients would receive an induction dose (2 or 3 infusions), and then, if the induction dose successfully brought the patient into remission, then further anti-TNF treatment would be provided only when they relapsed. This would mean that regular scheduled treatment (maintenance) would not be available.

NACC believes that maintenance therapy should be available to patients and that the decision should be made by the doctor and patient together after discussing the potential for adverse effects that sometimes occur with these drugs.

NICE received 295 responses to their consultation the third highest number they have ever received. The committee meeting to discuss these took place on 22nd October 2008.

NICE then sought further statements from NACC, gastroenterologists and the manufacturers on the economic model used to assess the drugs. NACC submitted a critique of the model and stated that it needed substantial revision.

NICE was due to consider the drugs again on 22nd January 2009 but has announced that the Appraisal Committee meeting would be postponed for further work on the economic model.

NACC interprets this as a step in the right direction.

At present we do not know what recommendations NICE will make. However, in the part of the last meeting that was open to the public, an official from NICE said they would normally recommend that patients already on a treatment that was not going to be approved should continue on that treatment. Patients currently receiving maintenance treatment should therefore be able to continue even if NICE does not recommend the approach for new patients.

Updated 27th January 2009: we will post further information when it becomes available.

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Swine Flu and IBD

Anyone concerned about Swine Flu can get more information from the NHS Direct website at www.nhsdirect.nhs.uk or by calling 0845 4647. Patients in Scotland can call NHS 24’s dedicated flu line on 08454 24 24 24. If you have flu-like symptoms after returning from Mexico or contact with a swine flu infected person you should stay at home and call your GP. for advice.

Patients on standard doses of immunosuppressant or anti-TNF therapy should not be exceptionally susceptible to Swine Flu, and are advised to continue with their treatment as the risk of active IBD and subsequent need for drugs such as steroids would carry a greater risk than that of contracting the infection. Anyone experiencing flu like symptoms should contact their GP. immediately stating that they are on an immunosuppressant.

Early doses of antiviral medicines such as Tamiflu are thought to be effective in treating people with Swine Flu. There is no known interaction between Tamiflu and standard IBD drugs, and it is not is not thought to have any harmful effects on IBD itself, so Tamiflu may be given on medical advice to IBD patients.