At the close of 2011, the French committee that assesses the medical benefits of new drugs and provides recommendations concerning drug reimbursement (Commission de la transparence) judged that the medical benefits of topical tacrolimus – authorised at the beginning of 2009 – were “insufficient” for its use as a preventive against new outbreaks of moderate to severe atopic eczema.

The committee's decision was based on “the absence of a comparison with an active treatment (topical corticosteroids), uncertainty about long-term safety and the risks of misuse or poor compliance highlighted in a study (...)”.

Atopic eczema is a generally mild skin disorder which flares up episodically and which usually regresses before adolescence. The efficacy of topical tacrolimus in preventing flare-ups is uncertain and its adverse effects profile is disproportionate, in particular due to the concern about the risk of cancer. It also exposes patients to frequent skin irritation and infections. Tacrolimus is reimbursed at 30% by the French (national) health insurance system for more limited uses than those listed in the marketing authorisation. But a study reveals that tacrolimus is prescribed largely outside the reimbursement system.

Topical tacrolimus has a clearly unfavourable harm-benefit balance in the prevention and treatment of eczema, and this drug should be barred from both short- and long-term use.
It is better for eczema sufferers to avoid triggers, apply regular emollients, and use topical corticosteroids appropriately when flare-ups occur.

The restriction of reimbursable indications for topical tacrolimus is not sufficient. The European health authorities should withdraw it from the market altogether in order to protect patients adequately. 

©Prescrire 1 October 2012

"Topical tacrolimus: cancers" Prescrire Int 2012; 21 (131): 239. (Pdf, subscribers only).