One of the main tasks of AIFA, the Italian Drug Agency, is to ensure the economic balance of the National Health System. Analysing consumption and national public spending on pharmaceuticals are key steps in planning health policy interventions in the coming years. Since 2004, this analysis has been carried out every year by Osmed, the National Observatory on the Use of Medicines, an auxiliary organ of AIFA. Osmed analyzes the consumption and expenditure incurred by the state for Class A medicines (essential drugs and chronic diseases) and Class H (drugs used only in hospitals) but also for Class C medicines (all other medicines) the expenditure of which is borne by the citizen. The analysis of Osmed is very important not only to monitor the amount of national health expenditure for drugs whose expenditure is borne by the state, but also allows to evaluate more general aspects such as correlating the use of drugs (whether they are class A, H or C) with the prevalence of specific diseases in the territory.

The term “government of pharmaceutical expenditure” means the set of actions that the government undertakes in order to adjust the expenditure on the purchase of medicines by the National Health System to the financial resources actually available. By decision of the Parliament, the government introduced “ceilings” for pharmaceutical expenditure, divided into territorial pharmaceutical expenditure (or agreed expenditure, for the purchase of class A medicines) and hospital pharmaceutical expenditure (or direct expenditure for the purchase of class A medicinal products when distributed within hospital and class H facilities). AIFA, through the analysis of Osmed, monitors these data and in case of exceeding the established maximum thresholds, intervenes by initiating the procedures to cover the surpluses of pharmaceutical expenditure: 50% will be borne by the Regions, the remaining 50% to be paid by pharmaceutical companies through a mechanism defined as payback.

The payback is a mechanism introduced with the Financial of 2007. Before its introduction, the National Health System purchased class A and class H drugs with a 5% reduction in the price to the public. Since 2007, the payback allows pharmaceutical companies to ask AIFA to suspend the price reduction of 5%, against a cash deposit on current account (pay back, in fact) directly to the regions where the excess occurred. The payment is calculated in proportion to the overrun of the regional expenditure ceiling and can be equal to 5% for direct expenses and 1.83% for expenses under the agreement, for each drug of which the pharmaceutical companies are holders.

Finally, it should be mentioned that since 2017 two funds have been established for the reimbursement to the Regions for the purchase of a category of historically expensive drugs, that of innovative medicines: EUR 500 million per year for the purchase of innovative non-cancerous medicinal products and EUR 500 million per year for the purchase of innovative oncological medicinal products.

Every month AIFA publishes on its website the monitoring of data on pharmaceutical expenditure and communicates the results obtained to the Ministry of Health and the Ministry of Economy and Finance with the same frequency. At 31 May, 30 October and 31 December of each year, it shall verify whether the maximum expenditure ceilings laid down have been exceeded at national level, both with regard to pharmaceutical expenditure in agreement and direct purchases.

As for the current year, to date, AIFA has published the monitoring of pharmaceutical expenditure until the period January-July 2020. In the period indicated, the ceiling of total pharmaceutical expenditure was exceeded by 16.70%, a trend in line with what has happened in recent years.

The pharmaceutical expenditure contracted net from the National Health System in the period January-July 2020 calculated net of deductions such as regional tickets and paybacks in force, amounted to 4,523,EUR 8 million, showing a considerable decrease compared to the previous year (-EUR 145.7 million). That is, for now all the regions have respected the planned expenditure ceiling.

Consumption is expressed in number of recipes (318.8 million recipes) and shows a reduction (-7.4%) compared to 2019; the incidence of the total ticket is also reduced (-7.2%). While it is observed a decrease of 1,1% (-145,7 million) of the daily doses of drugs dispensed. It is interesting to hypothesize that the effect on the number of recipes can be partly attributed to the strong decrease in April during the lockdown period following the health emergency from Covid-19.
Pharmaceutical expenditure for direct purchases in the first 7 months of 2020, calculated net of current paybacks and funds for innovative non-cancerous and innovative oncology, recorded an absolute deviation from the planned expenditure of + 2,068.0 million euros. In this case no Region has succeeded.

For the drugs included in the fund for innovative non-cancerous medicines, the January-July expenditure, net of payback, amounted to 192.3 million euro, respecting the budget provided by the fund. For the drugs included in the Fund for Innovative Oncology Medicines, the January-July expenditure net of payback amounted to €538.6 million, exceeding the budget foreseen by the Fund.

A brief final consideration: according to Sergio Liberatore, CEO of Iqvia Italia (a global provider of health information and data) the containment of national expenditure has had a heavy impact on the budgets of pharmaceutical companies in Italy. As has been said for some years, it would be useful to consider the payment of treatment on the basis of the benefit to the patient, that is, to measure the cost of new drugs by comparing it with the reduction of expenses related to care, the decrease in the number of admissions, prevention and constant improvement of the state of health.

In relation to this last consideration, we invite you to read the article https://www.jsb-solutions.com/it/le-novita-delle-terapie-avanzate/.