Leading European agency recognises clinical and cost-effectiveness of steroid-free Elidel cream for treating eczema

Main Category: Public Health
Article Date: 29 Jun 2004 - 4:00 PDT

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Patient groups and clinicians today praised a decision by the National Institute for Clinical Excellence (NICE), the influential UK authority responsible for evaluating the cost-effectiveness of medicines, recommending the use of Elidel Cream (pimecrolimus) for treating certain cases of atopic eczema (AE). The decision means that patients and clinicians will continue to benefit from a steroid-free therapy.

The Final Appraisal Determination (FAD) released by NICE earlier today recommends that Elidel should be used for the treatment of moderate AE on the face and neck in children aged 2-16, where the disease has not been controlled by topical corticosteroids and there is a risk of adverse effects from further steroid use.

The decision comes after doctors and patients challenged a preliminary recommendation issued by NICE on 5 April 2004, which questioned whether Elidel should be made available on the National Health Service (NHS). In today's FAD, NICE said it had been persuaded by clinical experts that Elidel was a useful treatment option for moderate facial AE in children.

Dr. Tom Poyner, Vice Chair of the Primary Care Dermatology Society, said: "This is good news for general practitioners who can now continue to prescribe Elidel for some patients with atopic eczema. Some patients and parents, as well as healthcare professionals, experience problems and have concerns when using topical steroids on the face. This decision now allows GPs to continue to offer Elidel as an effective alternative to steroid treatment."

Margaret Cox, Chief Executive of the National Eczema Society, said: "Eczema can be an extremely distressing condition for children and parents, especially if it appears on the face. Patients go through real physical and emotional problems that can interfere with schooling and study, and impairs family and social relationships. The final NICE decision means that many patients and clinicians will now have access to another effective treatment for atopic eczema on the NHS."

The decision on Elidel should be issued by NICE to the NHS in England and Wales within the next 10 weeks. This decision will then form the guidance for clinical practice within the NHS. Full details of the Final Appraisal Determination can be found on the NICE website at http://www.nice.org.uk.

About Elidel

Elidel, developed by Novartis, is the only steroid-free prescription cream and is currently available in more than 80 countries. It is licensed for the short-term and intermittent long-term treatment of mild to moderate atopic eczema, to prevent the progression of flare-ups in both children and adults. Clinical studies have shown that Elidel does not cause skin atrophy, sometimes seen with long-term topical corticosteroid use.

Elidel may be used on all skin surfaces, including delicate areas such as the face, neck and skin folds, with no limits on duration or volume of use. The active ingredient is pimecrolimus, which is derived from ascomycin, a natural substance produced by the fungus Streptomyces hygroscopicus var. ascomyceticus. Pimecrolimus selectively blocks the production and release of cytokines from T-cells. These cytokines in the skin cause the inflammation, redness and itching associated with eczema.

About Atopic Eczema

Atopic eczema (also known as atopic dermatitis) is a chronic, persistent disease in which the skin is typically dry, rough and scaly. Patients suffer from intermittent 'flare-ups' in which the skin becomes red, swollen and itchy, creating an uncontrollable urge to scratch and resulting in broken, oozing and bleeding skin.

The prevalence of eczema has increased steadily in the last 30 years, possibly because of environmental and lifestyle changes. Between 10 and 20% of children will have the disease at some time in their lives, while 1-3% of adults are affected.

This release contains certain "forward-looking statements", relating to the Group's business, which can be identified by the use of forward-looking terminology such as "will continue to benefit", "will now have access", "should be used", "continue to offer", "should be issued", "will … form", "may be used", or similar expressions, or express or implied discussions regarding potential future sales of Elidel. Such statements reflect the current views of the Group with respect to future events and are subject to certain risks, uncertainties and assumptions. There can be no guarantee that Elidel will reach any particular sales levels. In particular, management's expectations could be affected by, among other things, new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78,500 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.

NICE release Elidel E pdf.