the potential and challenges of health technology assessment: insights from experience ... · 2012....

The Potential and Challenges of

Health Technology Assessment: Insights from

Experience in Europe

Reinhard Busse, Prof. Dr. med. MPH FFPH Department of Health Care Management Berlin University of Technology/ (WHO Collaborating Centre for Health Systems Research and Management) European Observatory on Health Systems and Policies

1 Potential and Challenges of HTA: Experience in Europe 14 November 2012

Presenter

Presentation Notes

Source: Kernick. Introduction to health economics for medical practitioners. Postgrad Med J 2003, 79: 147-150


3

Health budgets (ca. GNP + 1%)

GNP

WHY need for HTA? Technology drive & information overload

Information: publication etc.

Needs (demography, morbidity)

(one role of) HTA

New technologies (and their costs)

Doubts about effectiveness,

appropriate use, cost-effectiveness; large variation in

utilization…

14 November 2012 Potential and Challenges of HTA: Experience in Europe

Inappropriateness

14 November 2012 4 Potential and Challenges of HTA: Experience in Europe

Small-area variation


Factor 10 difference

6

What is “Technology”?

• Greek: technologia • Techni - "art/craft/skill" • Logia - "saying/be about something"

• Narrower: material objects, hardware, devices • Wider: systems, organization methods, techniques


7

What is Health Technology Assessment?

• INAHTA (International Network of Agencies for HTA): – Healthcare technology is defined as prevention and rehabilitation,

vaccines, pharmaceuticals and devices, medical and surgical procedures, and the systems within which health is protected and maintained.

– Technology assessment in health care is a multidisciplinary field of policy analysis. It studies the medical, social, ethical, and economic implications of development, diffusion, and use of health technology.

• EUnetHTA (European network for HTA): – Health technology is the application of scientific knowledge in health

care and prevention. – Health technology assessment is a multidisciplinary process that

summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly rooted in research and the scientific method.


• MTA (Medical technology assessment) HCTA (Healthcare technology assessment) HTA

“The goal of HTA is to provide input to decision making in policy and practice“ (Henshall et al. 1997)

Industry claims Provider preferences

Patient wishes


Health Technology Assessment (HTA)

[...] a form of policy research that systematically examines short- and long-term consequences –in terms of health and ressource use– of the application of a health technology [...]

The goal of HTA is to provide input to decision making in policy and practice. (Henshall et al. 1997)


The interventions (drugs, procedures, complex multidisciplinary activities) which can be provided / reimbursed within the system when delivering health services

The interventions applied to the system to organize service delivery, access, financing, payment of providers, etc.

Broad understanding of ”health technology” in HTA


An example

Practical Purpose „improving survival after myocardial infarction“

Technologies Aspirin Stent Early rehabilitation

Disease Management Programme Payment for Performance 14 November 2012 11 Potential and Challenges of HTA: Experience in Europe

Presenter

Presentation Notes

The implications drawn from such a technology view

12

Use of HTA

Health Technology Assessment /HTA

Appraisal

Consequences: Organization

Patient perspective Ethics/Law

Resources/Costs Education

Politics

Guidelines Scientific documentation: Clinical effect Cost-use

Assessment Clinical research

Clinical practice

Benefits package/ Reimbursement

Priority


Those involved in HTA


Health Technology Assessment /HTA Politics

Guidelines

Scientists HTA-Agencies Universities


Clinical practice

Priority Industry Health care- systems Clinicians Scientists Innovators Patients

HTA-Agencies/Decision-

making bodies

Governments

Policy makers Regulators

HC Professionals Governments

Industry Journalists, Patients


Appraisal

Presenter

Presentation Notes

Skrive HTAi – a Society for all those who undertake and use HTA Under Clinical research: Industry/Technology innovators/clinicians/ HospitalsHC providers Under boksene : NHS,GovernmentsHC payers,Regulators Industry Regulators Decisionmakers patient org Health journalists etc

Layers of questions when deciding upon health technologies

Technical Performance

(devices)/ « Quality »

(drugs)

Implementation

Reg

ulat

ion

on M

arke

t Acc

ess

Hea

lth T

echn

olog

y As

sess

men

t

Effectiveness Can it work here?

Efficacy

Can it work?

Applicability Should we do it here?

How should we do it here?


Presenter

Presentation Notes

Here=need for context Issues of decision-making framing HTA: Macro…hospital, closed budget..open budget Here: Decision-making issues are determining the scope of the assessment Multiple types of evidence Stakeholder involvement in assessment process Clinical Effectiveness The extent to which a specific intervention, procedure, regimen, or service does what it is intended to do under ordinary circumstances, rather than controlled conditions. (INAHTA Glossary) Clinical Performance The ability of a medical device to achieve its intended use as claimed by the manufacturer (GHTF/SC(PD3)/N4:2007)

14 November 2012 15

(Primary) Research Innovation

Evidence synthesis/ assessment (Systematic reviews) (global)

Impact & applicability appraisal (local)

Decision making

Dissemination Utilization

Evaluation Monitoring

Evaluation Dissemination Utilization Decision Appraisal Synthesis Research

HTA

Potential and Challenges of HTA: Experience in Europe

HTA in a chain of knowledge creation 1

14 November 2012 16

(Primary) Research Innovation

Evidence synthesis/ assessment (Systematic reviews) (global)

Impact & applicability appraisal (local)

Decision making

Dissemination Utilization

Evaluation Monitoring

Evaluation Dissemination Utilization Decision Appraisal Synthesis Research

HTA

Potential and Challenges of HTA: Experience in Europe

HTA in a chain of knowledge creation 2

What is the “evidence” in an assessment?

The idea to base decisions on the “best available evidence” implies a “hierarchy” of the

evidence.

“Evidence” is understood as the product of systematic observation or experiment and it is

inseparable from the notion of data.

17 14 November 2012 Potential and Challenges of HTA: Experience in Europe

In-vitro (“test-tube”) research

Animal research

Ideas, opinions

Single case reports

Case series

Case-control studies

Cohort studies

RCT Validity

Validity

Hierarchy of research designs for evidence-based medicine


RCTs other types of evidence


global local

Presenter

Presentation Notes

Systematic approach Transparency, reproducibility (?)

20

Project planning (the ”HTA protocol”)

• Scoping, i.e. what will be studied? – Extensive technology-oriented HTAs: one technology or few technologies,

many or all uses of it/them (e.g. "Hyperbaric oxygen therapy") – Limited technology-oriented HTAs: one technology or few technologies in a

specific setting (e.g. "Hyperbaric oxygen therapy for diving accidents") PICO: patients, intervention, control, outcomes

– Health problem oriented HTAs: one or few health problem(s) and all (or most) technologies used for it (e.g. "Decompression sickness")

• How fast are results needed? – Full HTAs (1-2 years) – Rapid HTAs/ reviews (3-6 months) -> concentration on one/ a few

dimensions – Ultra-rapid reviews (1-12 weeks)

• What will be included in the review? – Original studies, or only review of reviews? – Data provided by industry? -> only publicly available? confidentiality?


Economic Organisational/ professional

Ethical Social Efficacy Safety

Dep

th o

f ana

lysi

s

Ideally

In reality

HTA dimensions in theory and reality

Methodological standards


Presenter

Presentation Notes

Sehr unfassenden Anspruch der nicht immer gerecht wird, Entwicklung der Methodik (aus der Ebm vor allem in der systematik der auswertung Wirksmk anhand klinische Studien Problematisch ist die kritische bewertung anderen lit quellen oder daten quellen oder die standardisierung der bewertung andere aspekte.

22

Draborg et al. International comparison of the definition and the practical application of health technology assessment, IJTAHC 2005: Analysis of 433 HTA reports, published 1989-2002 by 11 agencies in 9 countries (Australia, Canada, Denmark, The Netherlands, New Zealand, Norway, Sweden, UK, USA)


The broad understanding of technologies and the chain of knowledge creation

Oth

er ty

pes

of in

terv

entio

ns


24

EUnetHTA WP8, 2008


Topics • Drugs 28 % • Devices 22 % • Diagnostics 16 % • Surgery 7 % • Other clinical 24 % • Public health 5 % • Delivery 15% • Financial 2% • Governance 3%

(223 HTAs from Canada, USA, England and Denmark)

NICE

03 04

IQWiG

HEK PBAC

CEDAC

93

PMPRB

94

EAK

PPB

99

CT

96

CFH

02

NoMA

2000

PHARMAC

PBB

05

HAS

1987 89

SBU

ANDEM/ANAES

KCE

„New“ NICE

91/ 92

TA-SWISS

95

CAHTA

FinOHTA

98

SMM

AETS AETSA

UETS

NCCHTA

DAHTA

01 97

DIHTA

DACEHTA

Non-drug HTA

Drug HTA

Broad HTA

Institutions undertaking HTA NOKC

25

HTA+


Presenter

Presentation Notes

Beginning - as you can see - already in the late 80ies in Canada the number of these agencies has increased steadily during the last decade. Except in France, Switzerland and Germany and starting Australia in 1993 all institutions additionally evaluate the drug’s cost-effectiveness i.e. the added health value it provides for the public money spent on it. Australien: seit 1987 vergleichende Bewertung von Arzneimitteln, 1993 gesundheitsökonomische Guidelines veröffentlicht

Merging HTA agency into a broader institution 01.01.2004

26

• HTA reports • Early warning reports • Systematic reviews (Cochrane) • Electronic health library • Performance Indicators • Clinical indicators • Quality improvement advice • Patient safety • Priority setting (secretariat)

Ministry of Health: Mandate and budget

Directorate for Health and Social Affairs

Governmental centre Suggestions

• Ministries

• Hospitals

• Clinicians

• Patients

Products:

Monitoring quality

Norwegian Knowledge Centre for the Health Services


HTA

+ in

stitu

tions

http://www.has-sante.fr/portail/index.jsp

HTA and the broader quality agenda

“... quality of care is that component of the difference between efficacy and

effectiveness that can be attributed to care providers, taking account of the

environment in which they work” (Brook & Lohr 1985)


Layers of questions when deciding upon health technologies

Technical Performance

(devices)/ « Quality »

(drugs)

Implementation

Reg

ulat

ion

on M

arke

t Acc

ess

Hea

lth T

echn

olog

y As

sess

men

t

Effectiveness Can it work here?

Efficacy

Can it work?

Applicability Should we do it here?

How should we do it here?


Presenter

Presentation Notes

Here=need for context Issues of decision-making framing HTA: Macro…hospital, closed budget..open budget Here: Decision-making issues are determining the scope of the assessment Multiple types of evidence Stakeholder involvement in assessment process Clinical Effectiveness The extent to which a specific intervention, procedure, regimen, or service does what it is intended to do under ordinary circumstances, rather than controlled conditions. (INAHTA Glossary) Clinical Performance The ability of a medical device to achieve its intended use as claimed by the manufacturer (GHTF/SC(PD3)/N4:2007)

Efficacy • explanatory trials • highly selected

populations • comparator: placebo

• outcomes: clinical,

morbidity, mortality, adverse effects

• ‘what it says on the packet’

Effectiveness • pragmatic trials • few exclusions

• comparator: ‘current

(best) practice’ • outcomes: patient-

focused, down-stream resources

• ‘the real life effect’

Efficacy versus effectiveness


Presenter

Presentation Notes

Wesentliche Faktoren für Unterschiede zwischen „Efficacy“ und Effective-ness sind insbesondere�1. Faktoren auf der Patientenseite (Geschlecht, Alter, Co-Morbidität) – insbesondere dadurch erschwert, dass RCTs oftmals bestimmte Patienten-gruppen ausschließen (insbesondere solche mit Co-Morbidität),�2. unterschiedliche Qualität der Leistungserbringer bei der Durchführung der Maßnahme aufgrund Erfahrung, technischer Ausstattung oder Motivation. Aus Sicht der Gesundheitssystemforschung ist „... quality of care that component of the difference between efficacy and effectiveness that can be attributed to care providers, taking account of the environment in which they work“ (Brook & Lohr 1985)! Tugwell und Kollegen (1984) waren die ersten, die den Versuch unternahmen, �die Konzepte von „Efficacy“ und Effectiveness auf die Bevölkerung zu über-�tragen. Sie führten den Begriff der „community effectiveness“ ein, den sie wie�folgt operationalisierten: community effectiveness=efficacy X diagnostic accuracy X health professional compliance X patient compliance X coverage Die „Formel“ führt einige Variablen auf, die zum Unterschied von „Efficacy“ und Effectiveness beitragen. Die Liste ist jedoch unvollständig und der mathematische Zusammenhang in der vereinfachten Form zweifelhaft. Analysiert man die genannten Variablen, gibt es mit „Coverage“ (also Personen mit entsprechendem Versicherungsschutz für die Leistung) einen systemseitigen Faktor, mit „Compliance“ einen patientenseitigen Faktor und mit diagnostischer Genauigkeit und Compliance (mit entsprechenden Leitlinien) zwei arztseitige Faktoren. Damit fehlen als wesentliche Faktoren zumindest der patientenseitige Zugang zum Leistungserbringer bzw. zur Leistung, von den arztseitigen Faktoren die (technische) Qualität der Leistungserbringung und von den systemseitigen Faktoren die Anreizwirkungen z.B. des Vergütungssystems. Außerdem unterstellt ihre Formel einen festen, für alle Patienten gleichen Wert von „Efficacy“. Bei den meisten medizinischen Leistungen hängt der zu erwartende gesundheitliche Effekt einer Maßnahme jedoch stark vom individuellen Fall ab. Unter Berücksichtigung von Akzeptanzraten (uptake rate) der Arzneimittelbehandlung schlagen die neuseeländischen Guidelines eine Schätzung der tatsächlich behandelten Population nach folgender Formel vor: Akzeptanzrate = Vorstellungsrate x ärztliche Screening-/Diagnoserate x adäquate Verordnung x nicht-medikamentöse Verbesserung/Risikofaktormodifikation x Einlösung der Verordnung x Durch‑/Fortführung der Behandlung durch den Patienten Anzahl der tatsächlichen Anwender = Anzahl der gesetzlich Behandlungsberechtigten x Akzeptanzrate

Efficacy • explanatory trials • highly selected

populations • comparator: placebo

• outcomes: clinical,

morbidity, mortality, adverse effects

• ‘what it says on the packet’

Effectiveness • pragmatic trials • few exclusions

• comparator: ‘current

(best) practice’ • outcomes: patient-

focused, down-stream resources

• ‘the real life effect’ Evidence Gap Evidence Gap


Efficacy versus effectiveness

Presenter

Presentation Notes

Wesentliche Faktoren für Unterschiede zwischen „Efficacy“ und Effective-ness sind insbesondere�1. Faktoren auf der Patientenseite (Geschlecht, Alter, Co-Morbidität) – insbesondere dadurch erschwert, dass RCTs oftmals bestimmte Patienten-gruppen ausschließen (insbesondere solche mit Co-Morbidität),�2. unterschiedliche Qualität der Leistungserbringer bei der Durchführung der Maßnahme aufgrund Erfahrung, technischer Ausstattung oder Motivation. Aus Sicht der Gesundheitssystemforschung ist „... quality of care that component of the difference between efficacy and effectiveness that can be attributed to care providers, taking account of the environment in which they work“ (Brook & Lohr 1985)! Tugwell und Kollegen (1984) waren die ersten, die den Versuch unternahmen, �die Konzepte von „Efficacy“ und Effectiveness auf die Bevölkerung zu über-�tragen. Sie führten den Begriff der „community effectiveness“ ein, den sie wie�folgt operationalisierten: community effectiveness=efficacy X diagnostic accuracy X health professional compliance X patient compliance X coverage Die „Formel“ führt einige Variablen auf, die zum Unterschied von „Efficacy“ und Effectiveness beitragen. Die Liste ist jedoch unvollständig und der mathematische Zusammenhang in der vereinfachten Form zweifelhaft. Analysiert man die genannten Variablen, gibt es mit „Coverage“ (also Personen mit entsprechendem Versicherungsschutz für die Leistung) einen systemseitigen Faktor, mit „Compliance“ einen patientenseitigen Faktor und mit diagnostischer Genauigkeit und Compliance (mit entsprechenden Leitlinien) zwei arztseitige Faktoren. Damit fehlen als wesentliche Faktoren zumindest der patientenseitige Zugang zum Leistungserbringer bzw. zur Leistung, von den arztseitigen Faktoren die (technische) Qualität der Leistungserbringung und von den systemseitigen Faktoren die Anreizwirkungen z.B. des Vergütungssystems. Außerdem unterstellt ihre Formel einen festen, für alle Patienten gleichen Wert von „Efficacy“. Bei den meisten medizinischen Leistungen hängt der zu erwartende gesundheitliche Effekt einer Maßnahme jedoch stark vom individuellen Fall ab. Unter Berücksichtigung von Akzeptanzraten (uptake rate) der Arzneimittelbehandlung schlagen die neuseeländischen Guidelines eine Schätzung der tatsächlich behandelten Population nach folgender Formel vor: Akzeptanzrate = Vorstellungsrate x ärztliche Screening-/Diagnoserate x adäquate Verordnung x nicht-medikamentöse Verbesserung/Risikofaktormodifikation x Einlösung der Verordnung x Durch‑/Fortführung der Behandlung durch den Patienten Anzahl der tatsächlichen Anwender = Anzahl der gesetzlich Behandlungsberechtigten x Akzeptanzrate

Final outcomes

source: PBAC

versus surrogate parameters

14 November 2012 32

89%

47%

6%

60%

27%

3%0%

20%

40%

60%

80%

100%

No erection Incontinence Reoccurance after1 yr.

Medicare Follow-up Metanalysis of RCTsData from: Fowler FJ, Roman A, Barry MJ, Wasson J, Lu-Yao G, Wennberg JE (1993). Patient-reported complications and follow-up treatment after radical prostatectomy - the national Medicare experience 1988-1990. Urology 42: 622-9

Example: Outcomes of prostatectomy


Two possibilities for differences: (1) selection criteria for RCTs, (2) bad

quality under routine conditions

RCT selection RCT participation

Based on: McKee M et al. BMJ 1999;319:312-315

Ben

efit

Pot

entia

l

Not suitable

Participants

Centre/ physician does not participate

Patient not invited and/or excluded

Patient declines

Intervention A Intervention B


Preferred study designs (in 11 countries doing drug HTA)

• preferably “head-to-head” randomized controlled trials (direct comparisons)

• majority favours final outcome parameters (change in mortality, morbidity, quality of life) and studies in “natural” and country specific setting

• But: available are often 24-week RCTs against placebo with highly selected patients and providers conducted in a mixture of countries


Presenter

Presentation Notes

Surrogatparameter kritisch

Country-specific context

(values, budget, priorities, health care delivery system)

Transferability of results


Health Technology Assessment /HTA

Scientists HTA-Agencies Universities


Industry Health care- systems Clinicians Scientists Innovators Patients

HTA-Agencies/Decision-

making bodies

Governments

Policy makers Regulators

HC Professionals Governments

Industry Journalists, Patients



Politics

Guidelines

Clinical practice

Priority Appraisal

Presenter

Presentation Notes

Skrive HTAi – a Society for all those who undertake and use HTA Under Clinical research: Industry/Technology innovators/clinicians/ HospitalsHC providers Under boksene : NHS,GovernmentsHC payers,Regulators Industry Regulators Decisionmakers patient org Health journalists etc

Possible Health Benefits

Core Benefits e.g. “screening”, “pre-natal care”

Actually Covered Benefits e.g. cervical cancer screening with Papanicolau Test;

toxoplasma serology in the first trimester


The benefits package – a model

Presenter

Presentation Notes

That means a detailed specification of technologies covered

Possible Health Benefits

Core Benefits

Actual Benefits

Representative Institutions, e.g.

Parliaments (Law)

Planning Bodies Coverage Commissions

HTA

Third-party

Payers Advisory bodies

(Social) Courts 14 November 2012 40 Potential and Challenges of HTA: Experience in Europe

Criteria

Presenter

Presentation Notes

I have presented in a very simplified way, how of benefits being covered may be defined. Now I will speak about the actors. As I said in Europe only a part of what is possible is covered in the health system. The definition of a package of core benefits is made at the level of representative institutions (macro-level). The second stage, the specification of the services actually being covered. At least, two kind of actors are identified here. Planning bodies, such as local or regional health authorities, involved in the implicit definition of benefits (f.e. ambulatory and hospital care). At the same level, Coverage Commisions (such as the Swiss Federal Coverage Commission, the Federal Standing Committee of Physicians and Sickness Funds in Germany) are involved in the explicit definition of benefits covered. At this level use of HTA seems to be frequent To complete the anatomy of decision making in coverage, a special situation has to be considered. (At least in Germany and Spain) Patients or physicians have the possibility to apply for coverage of benefits not yet included in the so called actual benefits package. The payers take single case decisions, considering the input of advisry bodies (more or less linked to the payer), such as the Medical Service of the Sickness Funds (Germany) or the Medical Inspections (Spain) or the Nat. Health Board (Denmark). HTA and evidence based medicine seems to be used here too. In the case of denial, individuals may litigate the decision in front of Social Courts. Through accumulation of single sentences, Courts may lead to changes in the benefits being covered. This picture is the summary of our main findings

HTA direct after market launch (currently existing mainly for drugs)

Need (disease burden) & Effectiveness (also for patient sub-groups and selected indications)

Additional benefit/ comparative effectiveness (also for patient sub-groups and selected indications)

New drug/ device/ intervention „single technology assessment“:

Important input = structured information (dossier of manufacturer/ promoter)

With price (e.g. Sweden) Without price (e.g. France)

Cost-benefit (comparative, sub-groups …)

reimburseable

not reimburseable

reimbursable only for selected indications or providers, second line … (“optimised“)

only in research (to generate additional data)


• price determined by manufacturer (if additional benefit large) • price negotiated (trend value-based pricing & volume-price) • price regulated

More than YES or NO: Decision Options (e.g. in Switzerland)

Coverage (reimbursement)

Decision

Yes reimbursement without conditions

Yes reimbursement for specific indications Yes in centers which have to fulfil certain

requirements Yes in centers + evaluation registers Yes in evaluation (by benefit commission) No in evaluation (by applicant) No refusal

Source: Swiss Federal Office for Social Security (SFOSS) 14 November 2012 42 Potential and Challenges of HTA: Experience in Europe

Presenter

Presentation Notes

Now I come to the decision options This table shows the decision options the ELK has to oblige the statutory health insurance funds to reimburse certain medical benefits. (here I msut stress that so far I left out one stage because in Switzerland there is the possibiltiy after an application that if the associations of phasicians and staturoy sickness funds both say this treatment method is obviusly uncontroversial it can be reimbursed that it is immediatly reimburse. But if one of the two groups or both say it is controversial that this process starts with this options: First, there is the option to affirm without any conditions/reservations Second, there can be the decision for obligation of reimbursement only for specif indications. A change or extension of reimbursed indications is only possible after two years. The ELK has also the possibiltity to bind the obligation to reimburse to certain conditions so Third there is the option to reimburse only if the techology is provided in certain centres which fulfil specific requirements e.g. provide a minimum volume of the technology in question Fourth, the reimbursement can be reimbursed in certain centres which have to have evaluationregister in order to gather outcomedata Fith, Still this is coverage under monitoring which Ms. Züllig spoke about jesterday in a session and also the experience SFOSS has made with performing evaluations in coordination with the applier Sixth, there is no reimbursement but evaluation by the applier Seventh, this is total refusal of coverage but there is the possibility to reapply after two years

14 November 2012 Potential and Challenges of HTA: Experience in Europe 43

Decision Number Percent

Unrestricted 98 29%

Optimised 188 55%

Only in Research 21 6%

Not recommended 31 9%

Non-submission 4 1%

Total 342 100%

342 individual recommendations in 166 technology appraisals

Number % of opt. rec.

By patient group

158 80%

By price 53 27%

By continu-ation rule

34 17%

By regimen 7 4%

By setting 4 2%

More than YES or NO: Actual decisions in England (results of NICE “Technology Appraisals” 3/2000-8/2009)

France: Clinical Added Value (ASMR) Jan. 2005 - Oct. 2009

4 25

22

28

20

3 7

24 2

1910 13

50

10

20

30

40

50

60

2005 2006 2007 2008 2009 (Jan-Oct)

Major Important Moderate

30.7%

17.5%13.4%

38.5%

34.3%

ASMR I Major

ASMR II Important

ASMR III Moderate

ASMR IV Minor

ASMR V No


Presenter

Presentation Notes

EN NOMBRE D’ASMR FORMULEES AVEC TOTAL EN POURCENTAGE ASMR I II III PIC uniquement (cumul Ins + EI) nbIIIIII 200541022sur 117 200641928sur 149 200721320sur 91 2008253sur 75 2009*257sur 80 %IIIIII 20053,48,518,8total: 30,7 20062,712,818,8total: 34,3 20072,214,322,0total: 38,5 20082,76,74,0total: 13,4 2009*2,56,38,7total: 17,5 *données partielles : période janvier - octobre

http://www.has-sante.fr/portail/index.jsp

EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu

European Network for Health Technology Assessment

Presenter

Presentation Notes

The definition layed down by the grand-father of this project HTA is thus a broad concept with vague borders (Banta 2003), whose focus can be wide or limited to single aspects of a technology (e. g. cost-effectiveness) and which includes both primary data collection and analysis as well as secondary research. These variations reflect differences in the information needs of decision-makers, which in turn reflect the requirements layed down in the regulatory frameworks governing the decision-making process.


The background for EU action: The HTA article in the EU Patients‘ Rights Directive

48

Two problems acknowledged: HTA implemented differently across Europe Reduced applicability of foreign reports Varying structure of reports Extraction of data from reports is often difficult Aim: Attempt to define and standardise elements of an HTA to facilitate shared understanding of HTA and promote the international use of HTA results

Starting points


49

Social aspects

Health problem and current use of technology

Technical characteristics

Ethical analysis

Organisational aspects

Legal aspects

Clinical effectiveness

Costs and economic evaluation

Safety

Domains of HTA

• Identified in previous EU projects, particularly EUR-ASSESS and ECHTA/ECAHI

• Promote the multidisciplinary nature of HTA

Social aspects


50


Topics

Health problem and current use of technology

Technical characteristics

Ethical analysis

Organisational aspects

Social aspects

Legal aspects

Costs and economic evaluation

Safety

Topic 1: Mortality

Topic 2: Morbidity

Topic 3 etc…


Issue 1: What is the effect of the intervention on overall mortality?

Issue 2: What is the effect of the intervention on mortality caused by the target disease?

Issue 3: etc…


51

Assessment elements • Combination of domain-topic-issue • The basic unit of the model. It defines a piece of

information that describes the technology or the consequences or implications of its use, or the patients and the disease for which it is applied.

• Nature of elements may vary across domains, since the consequences and implications are understood and studied differently

• The common denominator for all elements is that they outline a set of information that may be useful when deciding on the use or non-use of technology


52

H T

A

C o

r e

M o

d e

l

Domain 4

Domain 3

Domain 2

Domain 1 AE AE

AE AE

AE

AE AE

AE

AE

AE

AE

AE

AE

AE AE

AE

AE

AE

AE

AE

Pool of Structured HTA Information CORE HTA

Summary of key findings, no recommendation on technology use

Takes into account local epidemiology, resources, values, etc.

LOCAL REPORT

AE AE

AE

AE

AE AE

AE

AE

AE

AE

AE

AE AE

AE

AE

AE

AE

AE

INFO

INFO

INFO

AE = Core element

AE = Non-core element

INFO = Locally produced information that does not follow HTA Core model structure

AE = assessment element


• Policy processes and HTA

• Health systems, health policy and HTA

• HTA producers • Impact of HTA • Needs and demands

of policy-makers • Future challenges for

HTA in Europe


the potential and challenges of health technology assessment: insights from experience ... · 2012....

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