Transcript www.kanitadayalitip.org

Hospital-based HTA
Marco Marchetti
Università Cattolica del Sacro Cuore
''A. Gemelli'' University Hospital
HTA Unit Director
Ulysses Project - International Masters Program of Health
Technology Assessment and Management
European Program Director, Italy
Agenda
1. Premise
2. Background



Process of Decentralization
The role of Hb-HTA
The beginning of Hospital Based HTA experience
3. The experience of HTA Unit at “A.Gemelli”
University hospital
4. The international survey





Objective of the survey
The Conceptual Model
Methods & Results
Discussion and Conclusion
Next steps
1. Premise

Features of HTA
 Definition
 Methods
 Objectives
Features of HTA
Definition
HTA is a multidisciplinary field of policy analysis. It studies
the medical, social, ethical, and economic implications of
development, diffusion, and use of health technology
International Network of Agencies for Health Technology Assessment (2002)
Methods
HTA uses the best available scientific evidence on the medical,
social, ethical, and economic implications of interventions
used in health care.
Objectives
The HTA process allows identify best practices
in health care, thereby enhancing safety,
quality and cost savings
2. Background
 Process of Decentralization
 The role of Hb-HTA
The beginning of Hospital Based HTA
Experience
Decentralization process
Even though Technology Assessment
developed to meet central policies’ needs,
the advancements in health care systems
have raised worldwide the necessity of an
HTA’s progressive decentralization
Catananti, Cicchetti e Marchetti, 2005. Italian Journal of Pub Health, 2(2): 23-29
Decentralization process
…as a matter of fact:
Available HTAs, centrally produced by Agencies
are frequently:
 Not relevant to hospital problems
 Delivered too late to be useful (12-18 months)
 Not user friendly for healthcare decision makers
 Unable to incorporate local data
 Produce policy advice that does not reflect local
priorities and local values.
The role of Hb-HTA
 The diffusion of the use of HTA logic in HCOs,
can be considered as a way for hospital
managers to respond to three different
environmental “pressures”:
1. to improve the level of efficiency and effectiveness
(micro-economic efficiency) as a key to improve the
efficiency of the entire system (macro-economic
efficiency)
2. the progressive acknowledgement of the relevance
of the "context" factor
3. to the diffusion of
“evidence based medicine culture”
The beginning of Hospital Based
HTA Experience
1982 CEDIT…
“The CEDIT is a hospital-based agency for the
assessment of medical technology. Created in
1982, the CEDIT is responsible for
formulating advice for the Director General of
the Assistance Publique-Hôpitaux de Paris
(AP-HP) on the opportunity, extent and
mode of diffusion of technological
innovations in AP-HP hospitals”.
The beginning of Hospital Based
HTA Experience
Edinburgh, ISTAHC Meeting 1999
The beginning of Hospital Based HTA
Experience reporting
2005
2003
2005
2005
2003
2001
Experiences of HB-HTA









Canada (Mc Gregor & Brophy, 2005),
Denmark (Ehlers, 2006)
Italy (Catananti et al. 2005)
Andalucia (Briones et al., 2005)
Austria (Wild, 2005)
Sweden (Rehnqvist, 2005)
France (Baffert et al. 2005)
Switzerland (Wasserfallen; Zuellig, 2005)
Australia (Maddern, 2005).
3. The experience of HTA Unit at
“A.Gemelli” University hospital
 Context
 Purpose and structure
 What kind of Health technologies are
assessed
 Rationale of assessment
 Assessment process
HTA Unit Presentation
Context
Regulation context
Italian National Health Care System (NHCS),
 NHS provides universal coverage and comprehensive health care,
free of cost or at a nominal charge upon delivery.
 NHS is defined as a public system financed by taxes.
 Public hospitals funding system is based on DRGs system
for hospitalized patients and on outpatients fee for the other patients.
Organization context
Agostino Gemelli University Hospital
Employees
 Physicians
 Nurses
 Total
Beds
962
1,967
4,634
 Acute ordinary beds
 Rehabilitation beds
 Day hospital beds
Number of discharges
Number of outpatients treatments
1,425
82
192
57,156
1,920,145
Rome
HTA Unit Presentation
Purpose and Structure
Mission
The HTA unit is part of the General Directorate which is
supervised by the General Director. Its purpose is to counsel top
management in decisions making on resource allocation, using
transparent, fair and consistent evaluation process.
Technology Assessment
 Medical devices
 Diagnostic test
 Medical equipment
R&D
 Internal R&D
 Economic evaluation
Communication
 Newsletter HTA unit
Staff
Clinical Governance
 Institutional Certification/
/Accreditation
 Risk management
Education
 International master
Ulysses
 Courses in HTA
It employs
multidisciplinary
expertise:
 1 clinician
(in charge)
 2 biomedical
engineers
 1 engineer
expert in quality
 5 health
economists
 1 statistician
What kind of health technologies
are assessed
 New Medical Device
 A device available on the market but not still used at
Gemelli University Hospital
 Innovative MD
 High unit cost
Pain relief
system
 Implantable MD (mainly)
Interspinous
System
Drug eluting
stent
What kind of health technologies
are assessed
 Medical equipment
 Innovative
 high impact (on patient
Proton
therapy
safety, economic,
organizational)
 Diagnostic Test
 Innovative
 high unit cost
Genetic
Test
Ablatherm HIFU
Rationale of the Assessment
 Guarantee the introduction of health technologies really
appropriates for the hospital using an evaluation process
founded on evidence based medicine
 Assess all implication linked to the possible technologies
introduction. Particularly it is take into account the
following dimensions:




safety
regulatory status
economic issues
organizational impact
Assessment Process
The work flow
Application of Technology
Elaborated by clinicians with
administrative department manager
and pharmacy service support, and
approved by department director.
HTA Unit
Writing of
assessment report
Final approval by COFT
(Pharmaco-therapy Commission)
based on assessment report
information
 Clinicians
 Management control
unit
 Health directorate
 Purchase Unit
 Intern pharmacy
service
Department 2
Department 3
Purchase Unit
Department 1
HTA
unit
Health DIrectorate
Management &
Control Unit
Department 4
Department 5
Virtuous Circle of the process of new
technology introduction
Purchase
needs
analysis
Purchase
strategies
definition
Assessment
of purchased
technologies
impact on
organization
Ri-definition
of needs
Monitoring
Results of 2008 activities
During the 2008 the staff in charge of HTA Unit
completed the following report for each filed of
application:
 33 reports of new medical devices introduction
 10 reports of diagnostic tests introduction
 12 reports of new medical equipments introduction
Consideration on the first experiences and
report of Hb-HTA
The investigation on the previous
experiences of Hb-HTA shows:
 a remarkable interest of scientific community on
this phenomena
 lack of published scientific evidence focused on
Hb-HTA
 needs of in depth examination
So a survey has been developed and
performed world wide
The Interest Sub Group on Hospital Based
Health Technology Assessment
 During the year 2006 an Interest Sub-Group (ISG)
dedicated to the application of HTA logic and tools at
hospital level has been established within HTAi.
 The purpose of ISG is to serve as a forum for focused
discussions among HTAi’s members with similar
HTA-related interests.
 HBHTA ISG’s mission is to gather professionals
involved in the use of HTA logic at an organization
level in order to support both managerial and clinical
decision-making processes.
The Interest Sub Group on Hospital Based
Health Technology Assessment
 ISG’s members have firstly met in Adelaide during
HTAi 2006 Annual Meeting where they shared their
perspective in the use of HTA logic within health
care organizations.
 At that time a study on how HTA activities should be
introduced and implemented within hospitals and other
health care organizations, was still not available.
 After Adelaide’s meeting a world-wide survey has been
launched within ISG’s members in order to investigate
this emerging phenomenon.
 Preliminary results from this survey were presented
during the HTAi 2007 Annual Meeting in Barcelona
 In HTAi Meeting in Montreal final results are now
presented
3. The international survey
 Objective of the survey
 The Conceptual Model
 Methods & Results
 Discussion and Conclusion
 Next steps
Objective of the survey
To investigate the worldwide kind
of application of HTA logic, methods and
tools within hospitals and other health
care organizations in order to support
managerial decision making as well as
clinical practice.
The conceptual model
Before starting with the survey, because different approaches (tools,
methods, organizational models) are adopted in Hb-HTA at
international level a literature review was performed
….A conceptual model was defined…
The model identifies four different groups, depending on:
1. the focus of the action, and on
2. the level of complexity of the organizational solution implemented
for performing HTA processes within hospitals
Organizational
Complexity
Focus of Action
High
(Team
group unit)
Low
(individual)
Clinical Practice
Managerial
Decision making
Q3
Q4
Internal Committee
Model
HTA Unit
model
Q1
Q2
Ambassador
model
Mini HTA
model
Methods & Results
The sampling
The survey was submitted to the population of 64
members (individuals) of the HB-HTA Interest SubGroup active in 50 different health care
organizations.
Period
The survey was performed from April 29th, 2007
to May 6th, 2008
Methods & Results
Questionnaire template

General information:




Part I: Description of Health Care Organization:








health technologies assessed;
HTA dimensions assessed (efficiency, efficacy, safety, etc.);
priority criteria;
stakeholders role.
Part III: Description of the outputs:



mission of the HTA activities (to inform clinical practice and/or produce information to support
managerial decision making);
who performs HTA activities;
for whom HTA activities are performed;
formal and informal link with external organizations;
Part II: Description of HTA activities within the HCO:


identification and contact information of the responders;
organization profile;
delivering settings of the organization.
kinds of produced reports;
tools of reports’ dissemination.
Part IV: HTA Training activities:


participation in HTA training activities;
organization of HTA training activities.
Results
Responders (n=33)
Mexico
3%
Colombia
3%
Australia
6%
New Zealand
3%
Austria
3%
Denmark
9%
France
3%
Brasil
3%
Germany
3%
Responders
per Countries
USA
3%
Canada
12%
The Netherlands
3%
Italy
31%
Switzerland
6%
Sweden
6%
Spain
3%
Organization profile (n=33)
Profile of
responders
organization
Research Institution
6%
Industry
3%
Other
3%
Governamental
agency
21%
Academia/University
12%
Teaching Hospital
40%
Public Health Care
Organization
15%
Delivery setting
No. % on 33
33,3%
Hospital Care Network 11
63,6%
Hospital
21
12,1%
Practitioner Office
4
36,4%
Ambulatory Care Clinic 12
9,1%
Behavioral Health
3
9,1%
Home Care
3
6,1%
Nursing Home
2
21,2%
Subacute Care Setting 7
30,3%
Rehabilitation Setting 10
12,1%
Hospice
4
30,3%
Clinical Laboratory
10
6,1%
Other
2
100,1%
Not specified
8
Total
97
The delivery
setting
Delivery settings of the main organization profiles (%)
Organization profile
Teaching Hospitals operate
mainly at inpatient and
outpatient level, committing
themselves to LTC in 25%
of cases.
On the contrary Public HCOs
are more focused on LTC
(43%) and Outpatient
Settings (33%), while
Hospital Care accounts for a
24 %
Results
Teaching
Hospital
37,5
37,5
25
Hospital
Outpatient settings
LTC
Public HCO
23,8
0%
33,3
20%
40%
42,9
60%
80%
% delivery setting activities
100%
Organizational complexity
High
Team-group-unit
Low
Individual
Organization profile Internal Committee HTA unit Ambassador Model Mini HTA
Governmental agency
1
4
1
0
Academia/University
0
1
2
0
Public Health Care
Organization
2
2
0
0
Teaching hospital
3
9
0
1
Research institution
0
2
0
0
Industry
1
0
0
0
Other
0
1
0
0
Total
7
19
3
1
Total
6
3
4
13
2
1
1
30
HTA
Models
HTA Units and organzation profile of ISG members
teaching hospital
HTA
Unit
9
governamental agency
4
research institute
2
public health care organization
2
other
1
academia/university
1
industry
0
0
1
2
3
4
5
No.
6
7
8
9
10
Mission and organizational complexity
Organizational complexity
Mission
High
Team-group-unit
Low
Individual
Internal Committee HTA unit Ambassador Model Mini HTA Total
Informing clinical
practice
Supporting decision
Only making process
Informing clinical
Both practice and
Total
0
1
1
0
2
0
5
0
0
5
7
7
13
19
1
2
1
1
22
29
HTA mission in HTA units
Mission
in HTA
unit
5%
26%
69%
to inform clinical
practice
to support management
decision-making
both
Results
Professional competences
used in HB-HTA
Professional profiles in HB-HTA
Clinician
Management
Health economist
Epidemiologist
Biomedical engineer
Information specialist
Public health specialist
Other
Biostatistician
Ethicist
Sociologist
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
0
always
often
sometimes
rarely
never
Other
Emerging
technologies
Organizational
procedures
Communication
Technologies
(CT) support
system
Clinical
procedures
Combined
technologies
Medical
devices
Drugs
Biomedical
equipments
No. Of Institutions
Results
Assessed technologies in
Hb-HTA
Evaluated Technologies
30
25
20
15
10
5
Assessed dimensions
Assessed Dimensions
Safet y
Organizat ional impact
Efficacy
Effect iveness
Budget impact
Cost -effect iveness
Pat ient perspect ive
Et hical issues
Sat isfact ion
T echnical product ivit y
Ot her
0
10
20
30
40
50
60
70
80
90
100
%
Criteria to prioritize
HTA activities
Prioritization
criteria
relevance
Economic concern
Clinic relevance
Public health concern
Political concern
Public and media concern
Other
Relevance
(1=most relevant, 6=less relevant)
Median 25° percentile 75° percentile
2
1
3
1
1
1
2
1
3
3
2
4
4
3
5
6
3
6
Results
HTA outputs 2006
HTA
Outputs
per type
and
production
level in
2006
Yes
Mean
Assessment reports
25
Others
20
Technical queries
15
10
5
Clinical practice guidelines
0
Biomedical equipments investment
plan
Quick response service
Issues on emerging technologies
Pre-assessment
Results
Target users of Hb-HTA activities
Target Users of HTA activities
Industry 0,9%
National/regional
HTA bodies 10,8%
Other health care
organizations 4,1%
Hospitals 11,1%
A collaborative
network for HTA
3,9%
Other 0,9%
Internal users
52,6%
Discussion & Conclusion
 The survey among the Hospital Based ISG
members provides an overall picture on how HTA
is performed in the health care organization in
terms of institutions profile, HTA organizational
model, involved competences and assessed
technologies
 Further studies could be useful in order to
analyze and standardize HTA method applied in
Health Care Organization
Next steps
 To enlarge the survey submitting the
questionnaire to other hospitals not listed
among ISG HB-HTA group, that are
experiencing hospital based HTA activities
 Actually the working group is developing a
second survey order to analyze and
standardize HTA method applied in Health
Care Organization.
Thank you for your
attention
[email protected]