Snapshot: medicine and medical device pricing in Italy

Pricing and reimbursement

To what extent is the market price of a medicinal product or medical device governed by law or regulation?

This depends on the refundability class of the concerned drug.

Under Law No. 326/2003, if a drug cost is reimbursed by the SSN, the price is set through negotiation between the AIFA and the marketing authorisation holder.

However, the price of drugs whose cost is charged to customers can be freely determined by the pharmaceutical company. Nevertheless, price adjustments are limited and can take place only once every two years.

In the case of medical devices, the reference price for each category of medical device is to be used as the basis for an auction for SSN supplies, which takes into account the lower unit purchase prices obtained from data held by the existing observers or communicated by the regions and the manufacturing companies.

Italian law does not envisage any difference in the outpatient and in-patient sectors regarding the above.

Must pharmaceutical and medical device manufacturers negotiate the prices of their products with public healthcare providers?

No, any negotiations over pharmaceutical prices are carried out between the pharmaceutical companies and the AIFA alone. In the case of medical devices, there is no proper negotiation system in force, but public healthcare providers shall comply with the relevant medical devices reference prices.

In which circumstances will the national health insurance system reimburse the cost of medicines?

Medicines are divided into the following refundability classes:

• Class A: including medicines required for the treatment of serious, chronic and acute diseases and those necessary to guarantee the LEAs (see question 1), are reimbursed by the SSN, although prescription charges may be applied;
• Class H: covering the same medicines as Class A, but under Class H they are only supplied in hospitals, and not in chemist’s shops; and
• Class C: medicines are used for the treatment of slight illnesses, and are thus non-essential. These are fully chargeable to customers.

Italian law does not envisage any difference in the outpatient and in-patient sectors regarding the above.

Pursuant to Law No. 648/1996, provided that no therapeutic alternative exists and that the AIFA’s CTS expresses a favourable opinion thereof, the SSN also reimburses innovative medicines marketed in a different country; medicines not yet authorised under clinical trials; and drugs used off-label that may be reimbursed, in exceptional cases, even if a valid therapeutic alternative does exist, provided that AIFA deems that specific use is known and compliant with the researchers conducted on a national and international levels. In any case, data pertaining to Phase II clinical trials must be present. Drugs reimbursed as above are then inserted in a specific list drawn up by the AIFA.

If applicable, what is the competent body for decisions regarding the pricing and reimbursability of medicinal products?

The competent authority is the AIFA’s price and reimbursement department.

The application for reimbursement and pricing negotiations must be started jointly. Specifically, negotiations operate in three steps: submission of the dossier, discussion and final contract. Negotiations usually last 90 days, but this term length is not mandatory. The contracted price is valid for 24 months and is subject to tacit renewal unless the parties decide to renegotiate the terms.

Are manufacturers or distributors of medicinal products statutorily obliged to give a discount to health insurance schemes or third parties?

The relevant rules do not provide for such an obligation.

However, chemist’s shops are allowed to give discounts on all medicines that are directly paid for by customers, provided that the latter are so informed in advance and there is no discrimination among customers. However, promotional sales (eg, three-for-two deals) are forbidden.