director of research hta unit “a. gemelli” university hospital · hta unit at mcgill university...

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


Agenda

HTA’s MapDecentralizing HTAToward hospital based HTAConclusion


HTA’s Map

WHO

HTA?

Macro

What

Meso

Micro

DRUGS DEVICES PROCEDURES

BEFOREDURING

AFTER

WHEN


HTA’s Map

HTA UnitHospitals, HCOs

HTA AGENCYMeso

Micro

BEFOREDURING

AFTER


WHOMacro

WHAT

WHEN


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

http://www.mcgill.ca/


Toward hospital based HTA

“Bringing HTA into practice”Pressures to micro-economic efficiencyTechnology-organization interaction


JAMA, October 20, 1999-Vol 282, No. 15


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


HTA’s Map

HTA & NICEMeso

Micro

BEFOREDURING

AFTER


WHOMacro

Clinical GovernanceFramework WHAT

WHEN


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)


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)


Micro economic efficiency

Hospitals operating under budget constraintspayment mechanisms based on DRGsInternal marketsResponsibility and autonomy at HCOs’level

- Financial equilibrium


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


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 €)


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


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


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”)


Conclusion (1)

EfficacyCost effectivenessEthical issuesPatient perspective (populations)

System level

Patient perspective (specific groups)Hospital budget impactOrganizational impactOverlapping

Hospital level


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

2

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

3

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)

4

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

5

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,, …

6

““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.

8

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

9

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

10

«« 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

11

« 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

12.10.2006Dr. Gottfried Endel 2

© HVB-EBM

HTA

• Role of HTA in Theory• Impact of the health care system• The Austrian experience• Future developments


© HVB-EBM

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.)


© HVB-EBM

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


© HVB-EBM

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


© HVB-EBM

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


© HVB-EBM


• Influence of law and judicial system– Decisions by official authorities

• voting

– decisions by courts• case law• depends on opinions of experts and judges


© HVB-EBM


• 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!


© HVB-EBM

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


© HVB-EBM

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


© HVB-EBM

The Austrian experience

• Fragmented healthcare system– Hospital care (>11 regulations)– Outpatient care (>12 regulations)– Rehabilitation (> 4 authorities)– Long term care (> 10 regulations)


© HVB-EBM


• Different reimbursement systems

VSTR

VSTR

VSTR

VSTR

VSTR

VSTR

VSTR

MetahonoPos 1

MetahonoPos 2

MetahonoPos 3

• Cataloge of procedures


© HVB-EBM

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

http://www.sozialversicherung.at/esvapps/page/page.jsp?p_pageid=110&p_menuid=61065&p_id=5

http://www.sozialversicherung.at/esvapps/page/page.jsp?p_pageid=110&p_menuid=61065&p_id=5

http://www.sozialversicherung.at/esvapps/page/page.jsp?p_pageid=110&p_id=3&p_menuid=59337

http://www.sozialversicherung.at/esvapps/page/page.jsp?p_pageid=110&p_id=3&p_menuid=59337

http://www.hauptverband.at/esvapps/page/page.jsp?p_pageid=219&p_menuid=63044&p_id=5

http://www.hauptverband.at/esvapps/page/page.jsp?p_pageid=219&p_menuid=63044&p_id=5


© HVB-EBM

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/

http://www.eunethta.net/

http://www.euro.who.int/HEN

http://www.inahta.org/inahta_web/index.asp

http://www.htai.org/

director of research hta unit “a. gemelli” university hospital · hta unit at mcgill university...

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