Biological Drugs in Italy: Ambits of Application, Treatment Perspectives and Cost-related Considerations

Lara Gitto
University of Catania and CEIS Sanità, University of Roma “Tor Vergata”, Via Columbia 2 – 00100 Roma (Italy)

Abstract:

The role played by biologics in the treatment of dermatologic, rheumatologic, gastroenterological, neurological, and oncologic pathologies has become more and more important in recent years, even though their employment is still limited, especially in Italy.

The limited diffusion of biologics is due to a number of causes, including, in particular, the delay in the process for admitting them among the “category H” drugs (hospital drugs) and, consequently, the non-availability of the latter in all the public health facilities, as well as their high costs.

Biologics are prevalently used for the therapy and treatment of dermatologic, rheumatologic, neurological, oncologic and gastroenterologic pathologies.

In dermatology, biologics proved effective in psoriasis treatment. The molecules that have been studied more in depth, are etanercept, efalizumab, infliximab, adalimubab and alefacept. Each one of these molecules is at present monitored within the context of the PSOCARE project to verify its tolerability, efficiency and long-term effectiveness. The first ranking drug with respect to number of prescriptions, in Italy is etanercept, administered to 3,374 patients (2009 data), followed by cyclosporine. In Italy, the Regions have identified 155 reference centers providing treatments with biological drugs.

The use of biologics in rheumatology is more recent, dating back to the last 6 years. In Italy, there are already four biological drugs on the market that are being used for various indications in the field of rheumatology, while many more are at the moment being confined to the use within study protocols and trials that are under way both in Italy and abroad. The high costs inherent in a therapy with such drugs have called for the setting up of a special Observational Study Register of the Ministry of Health in collaboration with the Italian Society of Rheumatology. The ANTARES project has singled out a number of rheumatologic centers of excellence that were given the possibility of prescribing and administering the biological agents under strict control. In 2004, the ANTARES database included 3,902 patients. Lately, the use of biologicals in dermatology and rheumatology has been analyzed by a single multicentric research project, MonitorNet, which compares in the clinical practice the biological drugs in terms of safety, effectiveness and suitability.

Biological drugs are used in neurology for treating demyelizating diseases (multiple sclerosis). The interferons (Rebif® - IFN-beta 1a - in the 22 mcg and 44 mcg preparations, Avonex® - IFN-beta 1a, Betaferon® - IFN-beta 1b) have been used in the last 15 years with positive results. The marketing of natalizumab (Tysabri®) is more recent and still limited in Italy.

The use of the biological drugs allowed to obtain extremely interesting results in oncology. In Italy there are at least fifteen biological drugs currently used, while those undergoing clinical trials exceed a thousand. The first biological drug to be used has been Herceptin®, which has proved useful in reducing the risk of relapse in the operable mammary tumor in over 50% of cases. The latest molecules being used include lapatinib, which is effective in countering the appearance of breast tumor metastases.

As regards the use of biological drugs for other pathologies, new evidences have been provided by the scientific literature with respect to amyloidosis, osteoporosis, connective tissue diseases, Behçet illness, adult Still’s disease, familial Mediterranean fever, sarcoidosis, polychondritis, polymyalgia rheumatica, uveitis, SAPHO syndrome and lumbosciatalgia.

The 2008 OSMED Report points out that, within the context of the administration of  drugs by public health facilities, biological immunosuppressors account for 8.7 percent of the total consumption of the “Antineoplastic drugs and immunomodulators” category.

The total spending for biological immunosuppressors, which amounts to 388.4 million euro, is due for the most part to anti-TNF-α drugs (346.6 million euro). Because of the high unit cost, the spending on biologics is still limited in Italy. In Europe, Italy ranks last in the use of biologics.

A number of studies have been conducted with the purpose to investigate the market dissemination potential of biologics. A further element for consideration relates to the actual availability of the drugs: authorization for a H drug must go through a process that varies depending on the Region and, within the same Region, on the individual Local Health Authority (LHA) and even the individual hospital. As a consequence, drug prices are affected too: they might depend on a negotiation between the LHA and the pharmaceutical firm for the drugs supply.

A problem requiring a solution concerns the regional differentiation of the pharmaceutical codices, particularly with reference to life-saving biotechnological products and the treatment of incurable diseases, that should be granted to the greatest number of patients.