Italy has a population of 60.6 million citizens (2017) that reside in 20 regions.
Healthcare coverage is provided by the Servizio Sanitario Nazionale (SSN, or National Health Service), financed through a combination of public and private provision. The Ministry of Health is responsible for overlooking the SSN – and is decentralized into three levels:
Funding comes from the SSN through per capita budgets determined in the PSN, that are transferred to the regional offices and ultimately to the ASL/ATS. Worth noting is that per-capita budgets vary based on regional resources and are adjusted to local needs and policies. Therefore, healthcare access and co-payments can vary geographically.
Remuneration occurs via ‘fee-for service’ taken from the National Formulary List, of which there are two main ones: NTPA (Nomenclature Tariffario delle Prestazioni Ambulatoriali) that is the list of out-patient procedures that are covered through SSN funding and NTPO (Nomenclatore Tariffario delle Prestazioni Ospedaliere) the DRG in-patient list that covers the entirety of hospital activity.
Who are the decision makers/influencers?
There are three national bodies that are responsible for overlooking medical products in the Italian healthcare system, each have varying degrees of responsibility:
Reimbursement and pricing approval process
Manufacturers wanting to introduce new medical devices in the Italian market will not be able to negotiate price and reimbursement options with the Ministry of Health. Instead, funding is sought at the regional or local level. Three regional bodies will influence this process:
For a medical device to be considered safe to use in Italy, it must hold a CE mark. However, being able to market a medical device does not mean the national health service will reimburse it. In fact, new medical devices do not seem to follow a particularly structured reimbursement path, depending much more on provider decisions and local health systems purchasing capabilities.
These points highlight steps that could increase the acceptance and reimbursement of new medical devices:
A recent trend in the Italian reimbursement environment involves the establishment of nationwide health technology assessment agencies. Italy’s regional division had led to the rise of regional committees appointed with the responsibility of evaluating medical devices. A consequence of this division was the fragmentation of patient care and technology across the country.
The European Union’s directive 2011/24 (Cooperation on Health Technology Assessment) will now require member countries to create national HTA (Health Technology Assessment) models led by the government to evaluate and promote cost-effective medical devices. This will be of significant impact to Italy as nationwide systems will be implemented to standardize the selection of medical devices to be used across hospitals. Pushing for collaboration amongst different regions will ensure the most valuable devices, both for costs and innovation, are evaluated and adopted across the country. This might also see specific reimbursement criteria being defined for new devices, a much-needed change to the current system.