Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
European HTA: From Research to PolicyParallel Forum F34th-7th October, 2006
HTA in Hospital ManagementProf. Americo Cicchetti
Director of ResearchHTA Unit
“A. Gemelli” University Hospital
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Agenda
HTA’s MapDecentralizing HTAToward hospital based HTAConclusion
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
HTA’s Map
WHO
HTA?
Macro
What
Meso
Micro
DRUGS DEVICES PROCEDURES
BEFOREDURING
AFTER
WHEN
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
HTA’s Map
HTA UnitHospitals, HCOs
HTA AGENCYMeso
Micro
BEFOREDURING
AFTER
DRUGS DEVICES PROCEDURES
WHOMacro
WHAT
WHEN
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Decentralizing HTA
HTA Italian Network (25 partners)Ricciardi, Cicchetti, Marchetti, IJPH 3(2) 2005
HTA Swiss Network (SNHTA; 22 partners)Mini-HTA in Denmark
Helers et al (2006), IJTAHC 22(3): 295-301 HTA Unit at McGill University Hospital (Montreal)
Mc Gregor & Brobhy, IJTAHC 21(2) 2005HMOs and Health Care organizations (US)
Luce & Brown (1995), Int J Tech Ass Health Care, 11(1): 79-82Es. Veterans Health Administration Technology Program
HTA in Israeli Medical CentersGreenberg, Petersburg, Vekstein & Pliskin, IJATHC, 21 (2) 2005
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Toward hospital based HTA
“Bringing HTA into practice”Pressures to micro-economic efficiencyTechnology-organization interaction
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
JAMA, October 20, 1999-Vol 282, No. 15
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Setting, delivering, monitoring standards
National Institute for Clinical Excellence (NICE) National Service Frameworks
(NSF)
Professional self-regulation
Clinical governance
Commission for Health Improvement National Performance Framework National
Patient and User SurveyNational Clinical Indicators
Patient & public
involvement
Clear standards of service
Dependable local delivery
Monitored standards
Lifelong learning
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
HTA’s Map
HTA & NICEMeso
Micro
BEFOREDURING
AFTER
DRUGS DEVICES PROCEDURES
WHOMacro
Clinical GovernanceFramework WHAT
WHEN
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
The “ambassadors” at SBU
Ambassadors have to have high legitimacy and clearmandatesAmbassadors have to have resources i.e. definedtimeA contract of what is to be achieved and how helps“Road show” to faculties and county councils is of valueBoth top down and bottom up necessary
Nina Rehnqvist, Executive Director (Rome, June 21st 2005)
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
HTA Units and Mini-HTAs
“Local participation in making analysis can be important to the implementation process”“Analyses of implementation processes show that the course of the decision making process affects implementation process”
Ehlers, L. et al. 2006. Intl. J. Tech Ass. Health Care, 22(3)
“Locally developed HTAs would have grater influence on health policy and decision making process”
McGregor & Bropghy 2005 Intl. J. Tech Ass. Health Care, 21(2)
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Toward hospital based HTA
“Bringing HTA into practice”Pressures to micro-economic efficiencyTechnology-organization interaction
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Micro economic efficiency
Hospitals operating under budget constraintspayment mechanisms based on DRGsInternal marketsResponsibility and autonomy at HCOs’level
- Financial equilibrium
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Decision Making Alternative Approaches
Rational (Evidence Based Management Model based on HTA principles)
Based on scientific evidenceGranting distinctive competenciesCoherent with corporate strategies (Mission, Goals)Shared with professionals (Involvement and commitment)Multi-dimensional (efficacy, cost-effectiveness, organizational impact, equity, appropriateness, safety, ethics …)
Value of innovation
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Policlinico “A. Gemelli”Rome, Italy
(HTA Unit: Estabilished in 2001)
University Hospital and Network(5HCOs; Acute, Rehab, Hospice, Nursing Homes)
3.000 bedsBudget: 400 million €/Year
5.000 employed2004-2006 New tech investment plan (30 million €)
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
HTA Unit
AimTo support top-management decisionmaking
ActivitiesTo produce in-house HTA reports(reports based on external HTAs and on local evidences);To manage a three-year technologyinvestment plan
StructureProfessional staff (Multidisciplinary: MD, Eng, Health Econ)Clinical committee
OtherResearch and training (Ulysse Project; LDL HTA CourseHospital-Industry collaborations on HTA
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Proposals
Investment Budget
HTA-U
Mission(Effectiveness)
(Balance)(Appropriateness)
HTA framework in the Strategic planning process
Goal setting(Selection of strategic options)
Guidelines for technology needs
assessment
Clinical Departments
Strategic PlanFeedback
Implementation of plans
Strategic Monitoring
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Toward hospital based HTA
“Bringing HTA into practice”Pressures to micro-economic efficiencyTechnology-organization interaction
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Technology-Organization interaction
Traditional approach in HTA A more … reasonable approach
Technology is one organizational factor and it is a medium for organizational performanceHealth technologies’ impact depends on resources and skills availability, organizational competencies managerialcapabilities, personnelmotivation, organizationalclimate …
Among health care organizations there is an equal distribution of:- Professional-technical skills- Management skills- Managerial capabilities to control organizational processes
Impacts of health technologies use (eg. outcomes) is independent by otherorganizational factors
It is reasonable to assess health technologies out of theirorganizational context?It seems impossible to solve the problem only designing multi-centricRCTs (the “mean trap”)
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Conclusion (1)
EfficacyCost effectivenessEthical issuesPatient perspective (populations)
System level
Patient perspective (specific groups)Hospital budget impactOrganizational impactOverlapping
Hospital level
Università Cattolica del Sacro Cuore“A. Gemelli” University Hospital and Network
Conclusion (2)
Increasing need for collaboration in HTA (more competencies, more resources)Horizontal specialization
Division of labor (at national-regional levels)
Vertical SpecializationDistribution of competencies among different levels of the health care system
Network as a coordinating mechanism Mutual trust and recognitionSetting quality standards and procedures (shared among network members)
HTA: a tool to improve HTA: a tool to improve patient access to innovation patient access to innovation ––
an industry perspectivean industry perspective
Gastein, 4 October 2006Gastein, 4 October 2006
Andrea RappagliosiAndrea RappagliosiChair, EuropaBio Healthcare CouncilChair, EuropaBio Healthcare Council
ViceVice--President, Corporate Health Policy & President, Corporate Health Policy & Government RelationsGovernment Relations
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Bringing healthcare to patients: Bringing healthcare to patients: the the ““innovation raceinnovation race””
« Drug discovery and development are more like a marathon than a 400-meters dash;
The innovative race is not an “he wins – I win”race, but rather, an “everybody wins” race ».
Bringing innovation to patients is a challenge for all Bringing innovation to patients is a challenge for all stakeholders: regulators, reimbursements, physicians, stakeholders: regulators, reimbursements, physicians,
researchers, policy makers and the industry.researchers, policy makers and the industry.
Source: Scherer FM, 1996 – Comment. In: Helms RB, ed. Competitive strategies in the Pharmaceutical Industry – Washington, DC: American
Enterprise Institute, 269 - 73
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Controversies in innovationControversies in innovation
« Controversies appear when the distribution of expertise during the innovation process does not take into account some potentially interested actors.
The controversies begin when some actors who claim the right to participate to the definition of risks, cost and benefit are not included in the management of innovation ».
Source: Senker, J et al (1999) - EC Targeted Socio-Economic Research (TSER) Project for the period 1998 – 2000 European Biotechnology Innovation System (EBIS)
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Overcoming controversiesOvercoming controversies
“In order for the necessary dialogue to occur there must be greater transparency (including international exchange of evaluations) and a cessation of “emotive” statements that dolittle more than polarise attitudes rather thandevelop partnerships”.
Lloyd Sansom – Chair of PBAC Australia – July 2006
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Beyond semantics: what is Beyond semantics: what is «« valuevalue »» in healthcare?in healthcare?
Most common misunderstandings:
« value » = price Governments, reimbursement authorities,…
« value » = performance Patients, clinicians, industry,, …
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““The first step to wisdom is getting things The first step to wisdom is getting things by their right nameby their right name”” Chinese proverbChinese proverb
Policy-makers face tremendous challenges when making recommendations for the adoption of new therapies.
The perceived value of a therapy may differ depending on whether one is a payer, a patient, a family member, or a physician involved in the healthcare of a patient.
Where healthcare allocation decisions are judgemental and values driven, the fullest possible transparencyand stakeholder involvement are basic and necessary components.
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The 3 pillars of valueThe 3 pillars of value
Defining Measuring Rewarding
Patients / Individual health
System / Management of community health
Economy / Science
Patients = performance
System = wider impact of new technologies
Economic growth, scientific knowledge= parameters
Pricing / ICER on patients
Longterm benefits for communityhealth management
The contribution to economic growth and progress in medicine
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The « value » of innovation should be a reasonable balance between:
Interest of payers:
• Better management of budgets
Interest of patients:
• Better access
Interest ofphysicians:
• Better outcomes
Where the innovative R&D and biotech
industry = appropriate reward for innovation
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«« Coverage criteria sit aside Coverage criteria sit aside the flow of moneythe flow of money »»Eddy, D. M. (1996). “Benefit language: Criteria that will improve quality while reducing costs”. JAMA, 275, 650-657.
Ensuring timely access to and rationale use of medicines for all people is a difficult goal in itself;
Changing relationship between the public and private sectors has become a critical success factor;
Longterm strategic dialogue should be focused on building trust, understanding the mutual benefit and adding value to patient access; and
Reliability, consistency and integrity from both sides are key but:
Allocation of appropriate and adequate fundingAllocation of appropriate and adequate fundingwithin the healthcare system is paramountwithin the healthcare system is paramount
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« Due to budgetary constraints, the light at the end of
the tunnel will be turned off until further notice »
Anonymous
© HVB-EBM
HTA as input to reimbursement decisions
EHFG AM 04.10.2006Dr. Gottfried Endel
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HTA
• Role of HTA in Theory• Impact of the health care system• The Austrian experience• Future developments
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Role of HTA in Theory
What is „technology“?John Kenneth Galbraith referred to it as
“the systematic application of scientific or other organizedknowledge to practical tasks”
(Galbraith, John Kenneth. 1967. The new industrial state. Boston: Houghton Mifflin.)
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Role of HTA in TheoryPubMed search
• SearchMost Recent Queries
TimeResult
#2 Search "health technology assessment" Limits: Publication Date from 2006/01/01 12:13:03 95
#1 Search "health technology assessment" 12:11:42 690
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Role of HTA in Theory
• Information for technology related policy making– Clarify the question– Present the scientific evidence– Recommend a decision
• Demonstrate the impact and outcome of different scenarios
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Impact of the health care system
• Categories of healthcare systems– decisions for purchasing or funding of procedures and
different forms of treatment are made by– official authorities (local or centralised)– contracts between health professionals and official
authorities (local or centralised)– contracts between health professionals and health
insurance companies– contracts between patients and health insurance firms– contracts between patients and health professionals
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Impact of the health care system
• Influence of law and judicial system– Decisions by official authorities
• voting
– decisions by courts• case law• depends on opinions of experts and judges
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Impact of the health care system
• Conductive to HTA– Tax funding
• utilitaristic use of financal resources
– decision by official authorities• global decisions (not individual cases)
– completely described health system• also in private health insurance!
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Impact of the health care systemSACHLEISTUNG
benefit in kind
VERSICHERTERinsured person
Abrechnung, Antragstellungaccounting, application
Beiträge, Selbstverwaltung
contribution, self administration
Leistungsgarantie, Krankenordnung
performance guarantee,rules for insured persons
Leistun
gen
bene
fits
Versich
erung
snach
weis
evide
nce f
or ins
uranc
e
VERTRAGSPARTNERcontracting party
SOZIALVERSICHERUNGsocial insurance
Zahlung, Kontrollpayment, controle
VERTRAG Contract
Use of HTA
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Impact of the health care systemSACHLEISTUNG
benefit in kindVERSICHERTER
insured person
Nationales GesundheitssystemNHS
VERTRAGSPARTNERcontracting party
Leistungsdokumentationdocumentation of benefits
Leistungskatalog, Zahlung, Kontrollecataloge of benefits, payment, control
VERTRAG, ANSTELLUNGcontract, employment
Beiträge, Steuern
contribution, taxes Leistungsgarantie, Krankenordnung
performance guarantee,rules for insured persons
Leistun
gen
bene
fits
Eintrag
ung,
Zuordn
ung
Use of HTA
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The Austrian experience
• Fragmented healthcare system– Hospital care (>11 regulations)– Outpatient care (>12 regulations)– Rehabilitation (> 4 authorities)– Long term care (> 10 regulations)
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The Austrian experience
• Different reimbursement systems
VSTR
VSTR
VSTR
VSTR
VSTR
VSTR
VSTR
MetahonoPos 1
MetahonoPos 2
MetahonoPos 3
• Cataloge of procedures
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The Austrian experience• Use of HTA for
– Appraisal of new procedures– Reimbursement of pharmaceuticals
• Regulated by law• http://www.sozialversicherung.at/esvapps/page/page.jsp?p_pageid=11
0&p_menuid=61065&p_id=5
– Population screening protocol• http://www.sozialversicherung.at/esvapps/page/page.jsp?p_pageid=11
0&p_id=3&p_menuid=59337
– HTA unit of the Main association of social insurance companies
• http://www.hauptverband.at/esvapps/page/page.jsp?p_pageid=219&p_menuid=63044&p_id=5
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The Austrian experience
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The Austrian experience
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The Austrian experience
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Future developments
• Standardisation• Globalisation
– Adaption of work done internationally– EUnetHTA
• http://www.eunethta.net/– Health evidence network
• http://www.euro.who.int/HEN– INAHTA
• http://www.inahta.org/inahta_web/index.asp– HTAi
• http://www.htai.org/
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Future developments
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Future developments
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Future developments
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Future developments
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HTA
THANK YOU FOR YOUR ATTENTION!
VIELEN DANK FÜR IHRE AUFMERKSAMKEIT!
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