Recent news reports on alleged illicit relationships between prescribers and the pharmaceutical industry bring attention to the problem of the appropriateness of therapies - especially with new high-cost drugs - and of the monitoring systems in place in our country.
We are referring, in this specific case, to psoriasis, a chronic skin disease; an annoying pathology that can extend to large parts of the body, with burning, itching, in some cases complications such as psoriatic arthropathy, reflections on the perception of one's body image, on social relationships and on the quality of life of the affected subject. It is also a widespread disease, with prevalence estimates between 1% and 3% [1].
It is understandable that, in the face of such a common pathology, there is considerable interest in the use of new drugs, also in consideration that the various conventional treatments (topical drugs, Uva and Puva therapy, systemic drugs such as cyclosporine and methotrexate) have not led to definitive results. Hence the interest in a series of medicines called "biological medicines", since they are obtained from living organisms or their products. For the European market, these are four drugs: efalizumab, etanercept, infliximab And adalimumab used for this pathology only recently following the AIFA decisions [2]. A market of great importance, in economic terms, considering that the expenditure in Italian public structures for these four drugs amounted to 408.50 million euros in 2009 (to give a reference: the expenditure for recent antibiotics for exclusive hospital use amounted to 41.20 million euros; that for all types of vaccines to 285.30 million euros) [3].
The Italian Medicines Agency (AIFA) has launched, through the Psocare project, a monitoring of these new therapies, for the purpose of a post-marketing evaluation (pharmacovigilance once they have entered the market, in this specific case carried out through the Psocare network), in consideration that many questions are still open: long-term efficacy, the onset of resistance, rebound phenomena