Focus on Italy
As an aid to clients we have prepared a number of landscape pieces in which we share a summary of the key aspects which affect pricing and reimbursement rates, as well as market access in each of the markets. This article focuses on Italy.
Italy’s National Health Service is called the Servizio Sanitario Nazionale (SSN). It is important to realise that the SSN is largely under the control of the regional governments and is administered by the local health authorities. The result of this is that there are often differences in how regional and central government decisions are made in terms of access to products.
The National Health Service is largely funded through national and regional taxes, supplemented by co-payments for pharmaceuticals and outpatient care. Patient co-payments for pharmaceuticals were first introduced in 1978 and are regulated at both national and regional level. In Italy the most important bodies to be aware of are:
The Ministry of Health fulfils the function of the overall steward of the health system and defines the livelli essenziali di assistenza (or essential level of care, LEA) to be delivered across the country.
The Italian Medicines Agency (AIFA) is the national authority responsible for drugs regulation in Italy. AIFA approves the pharmaceuticals that can be produced, used and marketed in Italy and authorizes clinical trials.
Regional health agencies (ASR) of which there are 21 (19 Regions and 2 Autonomous Provinces). The regions have full jurisdiction on health care, carrying out goal-setting and planning; funding their spending through regional taxes and user charges. They are free to decide whether to keep the purchasing role at the ASR level or transfer it to the ASLs.
Local health authorities (ASL). ASLs funding varies from region to region (see above). ASLs are further divided into Districts; each District has coverage of approximately 60,000 people. In 2012 there were 143 ASLs and 826 Districts in the SSN.
AIFA is responsible for the economic assessment of the drug and for negotiating at a national level pricing and reimbursement.
- Economic evaluation is carried out by the Technical Scientific Committee (CTS) who deliver a consultative opinion on the drug and provides the classification for reimbursement.
- The Prices and Reimbursement Committee (CPR) negotiates with pharmaceutical companies the prices of medicinal products reimbursed by the National Health Service based on the classification provided by CTS.
- There are also 6 advisory committees covering the major therapeutic areas, each comprised of up to seven members who are leading clinical experts in their fields. The committees contribute to the work of the agency’s technical scientific commission (CTS) and its pricing and reimbursement committee (CPR) by carrying out evaluations and providing opinions on regulatory and scientific matters.
Whilst pricing & reimbursement of drugs is mainly decided at the national level, the Regions make the decision as to whether the drug is added to the regional formulary or not and they can also decide upon different patient co-payments.
Regulation of medical devices and aids falls within the remit of the Ministry of Health’s General Directorate for Medical Devices, Pharmaceutical Services and Care Safety. Medical Devices in Italy are not subject to P&R negotiation at the national level, thus funding must be negotiated at the regional or local level.
AIFA (through the CTS) classifies pharmaceuticals into three categories:
- Class A - products reimbursed by the SSN with or without co-payment and distributed either by pharmacies or by hospitals
- Class H -products that are fully reimbursed by the SSN, but can only be distributed by hospitals.
- Class C -drugs that are entirely paid for by patients, except when regional health departments include specific drugs in reimbursement schemes.
Implications for Research Projects
In Italy it is essential to undertake research at both the National and Regional levels in order to gain insights into the possible outcomes and to understand how to influence them. This, of course, requires we recruit the right respondents:
For all projects in Italy, the appropriate national targets would be professionals related AIFA i.e. members, ex-members and clinical members of the advisory committees.
As the regional influence is so important it is essential to include ASR respondents in all but very early stage projects.
If likely local uptake needs to be assessed, then for primary care the appropriate targets will be the ASL and for secondary care the local level payors for hospital drugs will be the head of pharmacy/formulary pharmacist and the budget holder/head of clinical department.
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