5.6 Pharmaceutical care
5.6.1 Pharmaceutical provision and reimbursement
The SSN is responsible for providing pharmaceutical care and accounts for the majority of total pharmaceutical spending. Drugs are dispensed through two channels: community and hospital pharmacies. Community pharmacies can be either publicly or privately owned and deliver prescriptions and OTC drugs to citizens living in the community. Hospital pharmacies are in charge of purchasing, stocking and delivering drugs to hospitalized patients. According to the Italian legislation, hospital pharmacies have a discount on the nominal price of pharmaceuticals of at least 50%. This discount and the desire to closely monitor the delivery and administration of certain categories of drugs (e.g. antiretroviral drugs for HIV and AIDS patients) motivated legislation that makes it possible for hospital pharmacies to deliver certain categories of drugs to patients that then use them in the community. More recently, agreement between the SSN and pharmacies has made it possible that community pharmacies deliver drugs to patients ‘on behalf of the SSN’, which means that these drugs are purchased by the SSN (with the relative discount) but delivered by community pharmacies.
Class A medicines
As illustrated earlier (see sections 2.8.4 and 3.7.1), Class A includes essential medicines for the treatment of severe, chronic or acute illness. They are partially reimbursed by the SSN and involve a modest co-payment that varies across regions. These reimbursable medicines are listed in the National Pharmaceutical Formulary (Prontuario Farmaceutico Nazionale – PFN), which is administered nationally by the AIFA and updated every year, or every six months if community public pharmaceutical expenditure as a percentage of total public health-care expenditure exceeds a 13% ceiling. Three main criteria determine inclusion in this class: clinical efficacy that must be proven by an evidence-based literature review, relevance of the disease and cost. AIFA’s Technical Scientific Committee is responsible for assessing new drugs for inclusion in the PFN. For each medicine the PFN provides detailed information on commercial name, active ingredients, dosage instructions, price, manufacturer, etc. Drugs in Class A are available only through a medical prescription. They can be prescribed by a GP or a paediatrician, an on-call doctor, A&E doctor, ambulatory specialist or hospital physician working within the SSN. Some medicines in this class have prescription limitations (known as ‘AIFA notes’) that make them eligible for reimbursement only for patients with specific conditions.
Class C medicines
Class C includes non-reimbursable pharmaceutical products acquired either with or without prescription. The latter group include ‘without prescription’ medicines (farmaci ‘senza prescrizione’ – SP) and OTC drugs (known in Italy as Class C-bis drugs). SP medicines do not require a prescription and cannot be advertised, while OTC drugs also do not require a prescription but can be advertised. This group of pharmaceuticals is not reimbursed by the SSN but at national level, where the physician recognizes the therapeutic benefit for the patient (Law n. 203/2000); those receiving war pensions are exempt from payment. In addition, regions are free to decide whether to fund with their own resources the partial reimbursement of Class C drugs, thus resulting in variations in access at regional level.
Class H medicines
Class H includes pharmaceutical products delivered only within hospitals under specialist supervision and they cannot be purchased in pharmacies. The PFN lists these medicines as it may also determine that only certain categories of centre can administer these drugs.
Every month AIFA publishes a ‘transparency list’ of off-patent drugs that are available on the Italian market, listing both the original medicine and its equivalent substitute (generic), with equal composition in active ingredients, same pharmaceutical form, method of administration, number of units and dosage unit. According to the reference price system introduced in 2001, the SSN reimburses the lowest price among the off-patent pharmaceuticals. For prescription drugs the pharmacist is required to deliver the product with the lowest price and can substitute the original branded medicine unless the physician specifies ‘no substitution’ and if the patient agrees. In cases where the doctor or the patient wants a product with a higher price, the patient pays the difference between the price of the selected product and the reference price.
Where no alternative therapy is available, patients may have access to treatments (under Law No. 648/1996) in the following cases:
- innovative medicines already authorized in other countries, but not yet in Italy
- drugs under clinical investigation, but with recognized benefits
- off-label use.
For inclusion in these special cases an application must be submitted to AIFA’s Technical Scientific Committee, supported by a scientific dossier. Medicines approved under Law No. 648/1996 are reimbursable and funded by the ‘AIFA Fund’, which has been in operation since 2005.
5.6.2 Price setting
Price setting applies only to medicines that are reimbursed by the SSN and is administered at the central level by AIFA through its Pricing and Reimbursement Committee. In 2004, the regulatory scheme for determining pricing and reimbursement at drug launch changed and the Average European Price (AEP) was replaced by a negotiation model, applicable to all products (Fattore & Jommi, 2008).27 This measure was introduced to contain pharmaceutical expenditure, promote competitiveness among companies and secure lower prices for consumers. Price setting of reimbursed pharmaceuticals involves negotiations between AIFA and manufacturers and is strictly linked to a product’s reimbursement classification, following assessment by AIFA’s Technical Scientific Committee on whether it should be included in the PFN (see section 5.6.1).
The following criteria are taken into account to fix the reimbursement price:28
- positive cost–effectiveness ratio of the medical product, where no alternative therapy exists;
- favourable risk-benefit ratio compared to drugs available with the same therapeutic indications;
- evaluation of the financial impact on the SSN;
- costs of the therapy per day, in comparison to products of comparable efficacy;
- expected sale volumes; and
- prices and consumption in other European countries.
The Technical Scientific Committee is responsible for assessing the negotiation outcome between AIFA’s Pricing and Reimbursement Committee and pharmaceutical companies, while AIFA’s Management Board is charged with giving final approval. Prices are determined at ex-factory level and are usually fixed for 24 months. If no agreement on the price can be reached, the original reimbursement decision made by the Technical Scientific Committee to include the product in the PFN is amended and the medicine is reclassified as non-reimbursable (Class C) and, thus, excluded from the positive list.
For non-reimbursable medicines (Class C), prices are freely determined (with some limitations) by manufacturers and monitored by AIFA. Reductions in price are allowed at any time, while increases are permitted in January of odd years.
5.6.3 Pharmaceutical expenditure per capita and defined daily dose consumption
Pharmaceutical expenditure is a significant component of public health expenditure and there is concern about its sustainability in future years. Two driving factors are of particular concern:
- the significant growth of the elderly population and the subsequent prevalence of comorbidities, resulting in an expansion of drug consumption; and
- the introduction of innovative medicines, which are usually more expensive.
To contain pharmaceutical expenditure regulatory measures were introduced in 2002, setting a spending ceiling of 13% of overall health-care expenditure (Law No. 326/2003), both at national and regional level. This limit was subsequently modified in 2009 and set at 13.3% (Legislative Decree No. 78/2009). The expenditure cap does not include hospital pharmaceutical expenditure. Furthermore, the Spending Review in 2012 reduced the budget for drugs used in non-hospital settings (Law No. 135/2012) from 13.3% of total health-care expenditure to 13.1% in 2012 and 11.4% in 2013. Meanwhile, in 2013, hospital pharmaceutical expenditure was allowed to increase from 2.4% of the total budget to 3.5%. From 2013 the regions (50%) and industry (50%) will cover any excess expenditure (over the ceiling) for drugs used in hospital settings.
In 2011 total expenditure on pharmaceuticals reached €26.3 billion, with a share of 75% reimbursed by the SSN and distributed mainly by public and private pharmacies (AIFA, 2011). Pharmaceutical expenditure per capita (including SSN-reimbursed drugs dispensed by public and private pharmacies and co-payments) increased overall by 2.5% in the period 2001–2010. A difference between northern and southern regions is evident, with all southern regions presenting higher levels than the national average of €215 per capita.
Average national consumption by defined daily dose (DDD) of products reimbursed by the SSN is 952 (per 1000), having increased by 2.8% in the period 2009–2010 and by 41.3% compared to 2001 (Montilla et al., 2011). Data analysis by age group reveals that drug use by people aged 75 and over is 17 times higher than the group aged 25–34 (Osservasalute, 2012), highlighting that age is the most predictive factor of drug consumption. Furthermore, drugs acting on the cardiovascular system are the most frequently prescribed (47.4% of total consumption). The consumption of generics (by DDD) has more than tripled in the period 2002–2010, increasing from 14.0% to 51.5% (of the total consumption of SSN). In parallel, during the same period, expenditure on generics increased from 7.0% to 30.4% of total pharmaceutical expenditure. Finally, analysis of antibiotic consumption shows that Italy is among the European countries with the highest use – 27.3 (DDD/1000) in 2010 (Cangini et al., 2011). The wide variability between northern and southern regions is also worth noting, with higher rates in the south.
Both individual pharmacists and the government can be owners of a pharmacy. New requirements were set in 2012, foreseeing one pharmacy per 3300 citizens, a ratio far lower than the previous target (one pharmacy per 4000 citizens in areas with more than 12 500 inhabitants and per 5000 citizens in areas with fewer than 12 500 inhabitants). In 2012, at the national level, a single pharmacy served an average of 3364 inhabitants (Table5.4), which is in line with the European average (Pharmaceutical Group of the European Union, 2012). The number of inhabitants per pharmacy is relatively low in mountainous regions or large rural communities. These regions have deviated from the national targets by opening pharmacies in small municipalities to try to adequately provide pharmaceutical care. The Autonomous Province of Bolzano is an exception, having the highest inhabitants per pharmacy ratio.