INTRODUCTION
Life expectancy in Italy is 83.1 years, second highest in Europe after Spain
Healthcare per capita spending is EUR 2,483 which is below the EU average (EUR 2,884)
In 2017, 8.8% of GDP spending was on healthcare, 1% below the EU average of 9.8%
The Italian Health Service established in 1978. As per the constitution, the Central government collects the taxes and determines the national statutory benefits package. It is the responsibility of 19 regions and two autonomous regions to deliver healthcare services. A general manager appointed by the governor at the local level is responsible for providing the services.
Healthcare system is decentralized in 3 levels
National level: The Ministry of Health makes three-year plans, and healthcare policies are made accordingly
Regional level: Regional bodies implement healthcare plans based on the resources. Different co-payments exists because of the disparity in the geometry
Local level: Local level is responsible for delivering the healthcare services
FUNDING
Public financing accounted for 75.8% of healthcare spending, accounting for 9.1% of GDP. The public sector is financed through a corporate tax (approximately 35.6% of the total in 2012) and a fixed proportion of national value-added tax revenue (approximately 47.3% of the total in 2012).
The regional bodies can generate their own revenues.
The local bodies can raise additional revenues so that the government can make additional spending.
PRIVATE HEALTHCARE SYSTEM: Private healthcare system plays a minor role in the Italian healthcare system accounting for 1% of total expenditure. Six million people possess additional private health insurance.
COVERAGE
The coverage in Italy is universal. All the citizens of Italy and legal foreign residents are covered. Temporary visitors can get healthcare services by paying the cost of therapies.
Service at the point of use is free based on the positive and negative list. Positive list includes pharmaceuticals, inpatient care, preventive medicine, outpatient specialist care, home care, primary care, and hospice care. Negative list includes cosmetic surgery; services covered only on a case-by-case basis (orthodontics and laser eye surgery); and services for which hospital admissions are likely to be inappropriate (cataract surgery).
COST SHARING AND OUT-OF-POCKET SPENDING
Patients no need to pay anything for the general practitioner. For specialists, the out-of-pocket payment for specialists is about a maximum of EUR36.15.
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ORGANIZATION AND DELIVERY OF HEALTHCARE SYSTEM
Primary care:
Primary care will be provided self-employed and independent physicians, general practitioners, and pediatricians. The payment levels, duties, and responsibilities of GPs are based on the consultation between central agencies and GP's trade unions.
Outpatient care:
Local health units or by public and private accredited hospitals provide outpatient care. The patient can opt public or private accredited hospital but not the specialist. Outpatient specialist visits are provided by specialists who have contract with the National Health Service.
Hospitals:
Public funds are provided to public and private hospitals. Public hospitals are managed by local health units or as semi-independent public enterprises. Additional funds are provided for teaching hospitals.
DRUG PRICING AND REIMBURSEMENT
In Italy, reimbursement decisions are made at the central level. After getting approval from regulatory bodies, manufacturing company submits for reimbursement in one of the following categories.
Class A: Drugs which are indicated for chronic diseases and life-saving drugs
Class C: Drugs which are not covered by the NHS
Class H: Drugs which are delivered at the hospitals
AIFA determines the prices based on innovation and classifies the new products as follows:
Treatment for serious diseases
Treatment intended to reduce the seriousness of diseases
Treatments for non-serious diseases
The extent of added benefit is determined based on clinical benefit and competitors.
AIFA uses the following classification to quantify the clinical benefit considering the primary endpoint and surrogate endpoints:
Major
Partial
Minor
Based on the above scores, the extent of therapeutic innovation was classified as
Important
Moderate
Modest
PRICING APPROVAL PROCESS
Once the drug was approved, the manufacturer has to negotiate with the Pricing and Reimbursement Committee.
Criteria that are considered for these negotiations are
Cost-effectiveness for pharmaceuticals indicated for therapies for which there was no proper treatment
Risk-benefit ration compared to other therapies
Costs of other medicines with the same therapeutic efficacy
Market share of new pharmaceuticals
Prices and consumption in other countries within Europe
Economic impact on NHS
Drugs which are classified under Category C are free priced.
The drug price negotiations are considered at the central level. However, the local levels have different co-payment rates based on the revenues of regions.
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