Madrid, September 13th 2012

Fondacion Gaspar Casal

Aspectos fundamentales del Sistema de Salud Italiano: reformas en curso y desafios

Americo Cicchetti Director of ALTEMS Graduate School of Health Systems’ Economics and Management Catholic University of Sacred Heart Vice President Italian Society of Health Technology Assessment Director Health Technology Assessment International

Public Declaration of transparency/interests* The view and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to AIFA

N.B. < I am not receiving any compensation> or < The compensation received is based on the collective bargaining agreement>

*Americo Cicchetti, in accordance with the Conflict of Interest Regulations approved by AIFA Board of Directors (26.01.2012) and published on the Official Journal of 20.03.2012 according to 0044 EMA/513078/2010 on the handling of the conflicts of interest for scientific committee members and experts

Interests in pharmaceutical industry NO Currently Last 2 years

More than 2 years but less than 5 years

ago

More than 5 years ago (optional)

Direct interests:

Employment with a company x

Consultancy for a company x

Strategic advisory role for a company x

Financial interests x

Ownership of a patent

Indirect interests:

Principal investigator x

Investigator x

Individual’s Institution/Organisation receives a grant or other funding

x

ALTEMS – Graduate School of Health Systems’

Economics and Management

Established in 2009 at the Catholic University of Sacred Heart (Rome campus) as a result of a scientific collaboration between the faculty of Economics and the faculty of Medicine and Surgery

ALTEMS operates within the field of Health Economics and Healthcare management and offers qualification-based training at various stages in the professional development of people employed in the field of private and public healthcare.

About ALTEMS

In addition to joint activities with the mentioned faculties, ALTEMS has engaged a useful cooperation with the “A. Gemelli” University hospital , creating the unique challenge of putting into practice experimental and innovative research and training activities in line with the moral principles of the Catholic University, based on the centrality of Human Beings.

Source of information

• Italian MoH, Offical Data (National Health information System)

• Italian Medicines Agency

• National Institute of Health

• National Agency for Regional Health Care

• Osservasalute (National observatory on health in the Italian regions)

• OECD

Agenda

• Introduction and historical overview

• Organizational Structure

• Financing

• Regulation and Planning

• Physical and Human resources

• Provision of health care services

• Assessment of the health system

INTRODUCTION The Italian NHS: 2012

Population

Source: National Institute of Statistics, 2011

Major demographic indicators

Indicators 1970 1980 1990 2000 2003 2006 2009

Total population (1000s) 52.771 55.657 56.737 57.189 57.478 58.435 59.870

Population female (% of total) 51,3 51,3 51,4 51,4 51,4 51,4 51,4

Population aged 0-14 years

(% of total) 22,9 20,5 16,5 14,5 14,4 14,2 14

Population aged 65 years and over

(% of total) 10,5 12,9 14,6 17,7 18,2 19,6 20,2

Population growth (% annual) 0,5 0,21 0,08 0,05 0,78 0,52 -

Population density (people/km²) 178,6 187,3 188,2 189 191,2 197 201,2

Fertility rate, total (birth per women

aged 15 to 49 years) 2,42 1,64 1,33 1,23 1,26 1,35 1,41

Birth rate crude (per 1000 people) 17 11,7 10,2 9,5 9,4 9,6 9,5

Death rate crude (per 1000 people) 9,8 9,9 9,6 9,8 10,1 9,5 9,8

Age dependency ratio 50,3 49,9 45,2 47,4 48,2 50,9 52

Source: OECD, 2009b and National Institute of Statistics, 2011

Major causes of death

Top 7 Leading Causes of Death in Italy – 2007:

• Heart disease 224.577 (39,2%) • Cancer 172.825 (30,2%) • Respiratory Diseases : 37.642 (6,6%) • Accidents 24.308 (4,2%) • Diseases of the digestive system 23.391 (4,1%) • Diseases of the nervous system 20.695 (3,6%) • Diabetes 19.780 (3,4%)

Top 7 Leading Causes of Death in America – 2007:

• Heart disease 616,067 (25.4%) • Cancer 562,875 (23.2%) • Stroke 135,952 (5.6%) • Chronic Lower Respiratory Diseases 27,924 (5.3%) • Accidents 123,706 (5.1%) • Alzheimer's Disease 74,632 (3.1%) • Diabetes 71,382 (2.9%)

Source: National Institute of Statistics, 2011

Source: CDC, 2011

Major financial indicators

Source: International Monetary Fund

GDP (billion €)

Italian GDP trend (1994-2007)

% variation on previous year

GD

P (

consta

nt prices –

bill

ion €

) %

varia

tion o

n p

revio

us y

ear

Footnotes: baeseline for constant prices= year 2000; (E)= estimation

GDP growth rate (2001-2012e)

-6

-4

-2

0

2

4

6

8

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 (e)

GDP growth rate (%)

Comulative GDP growth

ORGANIZATIONAL STRUCTURE The Italian NHS: 2012

Overview

• Italy’s health care system is a regionally based national health service (Servizio Sanitario Nazionale - SSN) that provides universal coverage free of charge at the point of service.

• The system is organized into three levels:

National, which is responsible for ensuring the general objectives and fundamental principles of the national health care system

Regional and Local, which through the regional health departments, are responsible for ensuring the delivery of a benefits package (LEA) through a network of population based LHUs (ASL) and through public and private accredited hospitals.

Italy’s health care system: historical background and recent reform trends

• 1978: A national health service (SSN) was established by Law 833/1978.

• 1992–1993: The government approved the first reform of the NHS. This involved the start of a process of devolving health care powers to the regions and a parallel delegation of managerial autonomy to hospitals and local health units.

• 1999: Legislative Decree 229/1999 launched a new reform package which deepened the regional devolution process, envisaged the reorientation of the internal market reforms, and regulated the introduction of clinical guidelines to guarantee quality in health care

• 2000: Legislative Decree 56/2000 prescribed that the National Health Fund would be replaced with a National Solidarity Fund and mandated that fiscal federalism should be in full operation by the end of 2013

• 2001: Constitutional Law No. 3, 18 October 2001, modified the second part of the Italian Constitution (Title V), providing regions with more powers

• 2009: Law n. 42/2009, the federative health system is definitively put in place

Organization of the NHS

Under the Italian Constitution, responsibility for health care is shared by the state and the 20 regions.

•The state has exclusive power to set the ‘essential levels of care’ (livelli essenziali di assistenza - LEA), or basic package, which must be available to all residents throughout the country, and is responsible for ensuring the general objectives and fundamental principles of the national health care system.

•Regions have virtually exclusive responsibility for the organization and administration of publicly financed health care.

Organizational structure of the

Italian NHS

Italian Local Health Enterprises Local Health Enterprises, average population and average area per LH Enterprises (Km2) per Region. Years 2002-2009

Source: Osservasalute Report, 2003 – Istat. www.demo.istat.it. Year 2010 - Italian National Agency for Regional Healthcare Systems (Age.Na.S)

FINANCING The Italian NHS: 2012

Source of funds

Source: MoH 2011

Taxation is the main pillar of NHS financing

Public health expenditure per person in selected OECD countries (US $ PPP, 2008)

Source: OECD, 2010

Source: OECD, 2010

Private health expenditure/GDP Public health expenditure/GDP

Private and Public health expenditure as % of GDP in selected OECD countries (2008)

Financial challenges for Italian NHS

Fonte: Elaborazione dell’autore su dati Ministero della Salute e Ragioneria Generale dello Stato (anno 2011)

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Sum 2001- 2010

Mean

GDP growth rate (%) 1,8 0,4 0,3 1,2 0 1,5 1,7 -1 -5 1,1 2 0,2

Helthcare exp. (variation %) 8,5 4,7 2,9 7,5 6,9 2,9 4,2 3,2 2,8 0,9 44,5 4,45

NHS financing (Variation %) 8,2 6,1 3,9 4,9 7 4,5 4,8 8,2 3 0,9 51,5 5,15

Pooling of funds

Under Ministry of Health specifications, health care funding should be allocated to three different health care categories as prescribed below:

• public health services in working and living environments (5%)

• community health care (51%)

• hospital health care (44%).

Regions can then choose how to allocate resources within different programmes. Thus, the percentages fixed by the Ministry of Health can be modulated at the regional level in accordance with regional planning targets.

REGULATION AND PLANNING The Italian NHS: 2012

ASSESSMENT OF THE HEALTH SYSTEM

The Italian NHS: 2012

Challenges for the Italian NHS

• Meeting the needs of an ageing population

• Managing chronic diseases

• Improving risk management

• Developing information systems

• Reducing interregional differences in quantity and quality of care.

• Governing innovation (HTA)

• Spending review

Efficiency of resource allocation in health care

• Regionalization of the health care system

• Interregional differences in socioeconomic indicators

Strong imbalances among regions:

• Southern regions have a smaller bed stock, a greater presence of private facilities and a poorer endowment of advanced medical equipment

• Higher income groups consume more private specialist care than would be predicted

Technical efficiency in the production of health care: the patients

Users’ satisfaction with the levels of service provision in each region reflects distinctive patterns: north–south divide characterizes levels of satisfaction.

Most frequent and most deeply felt concerns of the population deal

with waiting times, especially for specialized outpatient care. Unlike in

other OECD countries, attention has focused on waiting times for

specialist consultations and diagnostic tests.

Governing Innovation (HTA - 1)

• Drugs – A National body (AIFA) responsible for licencing, price setting,

reinbursement, vigilance, re-assessment and national drug formulary revision

– Regions manage local formularies often re-assessing pharmacutical producs

– National expenditure cap (13%)

• Medical devices and equipment – Enter in the market having CE marks without reference price

– National formulary introduced in 2011

– National expenditure cap to be introduced in 2013 (5,2%)

Governing Innovation (HTA - 2)

• AIFA

– Is experimenting an HTA-like approach to assess products dossier

– Some experiments in patient involvement

– Associeted Partner in EUNetHTA

• Agenas

– Established a group on HTA

– Issued 10 HTA reports financed by the MoH (2009-12)

– Coordinate the RIHTA (Rete Italiana di Health Technology Assessment)

– Knowledge sharing platform (to be completed)

– Associated Partner in EUNetHTA

• Regions

– Really Active: Lombardia, Veneto, Emilia Romagna, Basilicata

– Formally active: Tuscany, Piemont, Puglie, Lazio

• Local Health Units and Hospitals – A network of hospital Based HTA Units

The hospital

Beds 1653

Surgical interventions 25.399

Employees 4.634 (962 doctors)

Number of departments 18

Ward units (medical and surgical) 54

Admissions (Y) 91460

ALOS 8,1 days

Bed occupancy rate: 94,20%

ER treatments 73.374 (26,5% adm)

Diagnostics services 7,4 million

MDs expenditures 32mil €

Drug expenditures 89 mil €

Total budget 565 M €

HTA Unit (UVT)

Mission

•To support top-management decision making regarding medical technologies

Activities

•Assessment of medical devices and diagnostic tests (mini-HTA)

•3Y investiment plan

•Proactive Disinvestiment Process

Scope

•Medical equipment

•Medical devices

•Diagnostic tests

Structure

•Professional staff (Multidisciplinary: MD, Eng, Health Econ, information specialists)

•Clinical committee

Other

•Research and training (Ulysse Project; LDL HTA Course)

•Hospital-Industry collaborations on HTA

FOR MORE INFORMATION: HTTP://WWW.EURO.WHO.INT/__DATA/ASSETS/PDF_FILE/0006

/87225/E93666.PDF

THANK YOU! acicchetti@rm.unicatt.it