In recent years, many policies have been implemented across the European Union to enhance the appropriate use of drugs and to contain pharmaceutical cost [1, 2].
The 3-hydroxy-3-methylglutaryl coenzyme A (HMGCoA) reductase inhibitors (statins) were first used in patients with myocardial infarction (MI) and hypercholesterolemia. Several clinical trials, cohort studies and reviews largely acknowledged statins effectiveness: their beneficial effects were evident as lipid-lowering agents in patients with ischemic heart disease (IHD), other atherosclerotic cardiovascular diseases (CVD), diabetes, and even in the treatment of asymptomatic individuals [3–12]. These clinical trials had major implications for cholesterol management that resulted in an increase in the number of patients for whom statins may be considered clinically appropriate , such raising the expenditure, at least before the patent expiration of some molecules.
Thus, a wide range of measures to contain the cost of statins was developed in many Countries (e.g. Norway), including lists of preferred generic substitutions and/or medicines for which the patients are reimbursed (Austria and Finland), and co-payment policies (USA, Canada). The effect of these policies was assessed in recent studies with regards to drug expenditure, adherence therapy, or health outcomes [14–19].
Even though Italy has one of the lowest rates of use in Europe , the consumption of statins has constantly increased during the last decade, almost quadrupling its level from 14.67 DDD/1000 inhabitants per day (DDD/1000 inh. day) in 2000 to 51.70 DDD/1000 inh. day in 2010 [21, 22]. Compared to 2010, in 2011 (the latest available data for a whole year) statin consumption still increased (+7.7%) while the expenditure decreased (−13.1%) Despite this fact, statins rank first in expenditure as a cardiovascular drug subgroup .
Most of the costs are charged to the Italian National Health Service (Servizio Sanitario Nazionale, SSN) which provides universal coverage.
In order to contain the cost of drugs, a co-payment policy was first introduced in Italy in 1978, then abolished in January 2001 by the national government, and subsequently it was reintroduced at the local level by some regions, following the decentralization trend  of the policy-making government.
The change in Italian Constitutional Chart in 2001, determined a devolution process that transferred legislative, administrative and considerable fiscal powers to regions. According to this, the central government was granted the exclusive power to set “essential levels of care” (Livelli Essenziali di Assistenza, LEAs), a package of benefits that are publicly funded and must be guaranteed to all citizens in all regions. Most essential drugs are included in LEAs. At the same time, regions have almost full control over the provision of services, regulation, and funding with the mandate to provide LEAs . LEAs hold regions accountable to national standards.
Thus, since 2002, regions have made different choices regarding co-payment policies with subsequent significant cross-regional variation among patient charges for drugs . In regions with a co-payment policy, patients are required to contribute to the cost of pharmaceuticals by a fixed amount per prescription, ranging from 1 to 5 euros, depending on the region . On the other hand, the criteria for the reimbursement of statins were issued and periodically revised at the national level. They contained specific indications, inspired by clinical practice and guidelines, that determined whether the statins could be prescribed and reimbursed for specific diseases and conditions . Their introduction had a dual purpose: cost containment and a more appropriate use of these drugs . In November 2004, according to new scientific evidence, criteria for reimbursement for lipid lowering agents were revised by the new Italian Drug Agency (AIFA). The new criteria (Nota AIFA 13) restricted statin reimbursement to high risk users, based on a national risk profile for primary CVD prevention while they extended reimbursement for patients with diabetes in secondary CVD prevention [30, 31].
The aim of this study was to evaluate the impact of the national and regional cost containment measures on statin use in Italy during the period May 2001 – December 2007.