HTA in Europa - mig.tu-berlin.de · 03 04 IQWiG PBAC HEK CEDAC 93 PMPRB 94 EAK PPB 99 CT 96 CFH 02...

Reinhard Busse, Prof. Dr. med. MPH FFPHFG Management im Gesundheitswesen, Technische Universität Berlin

(WHO Collaborating Centre for Health Systems Research and Management)&

European Observatory on Health Systems and Policies

HTA in Europa

(Mögliche) Themen

• HTA-Institutionen und ihr Mandat

• HTA vs. anderer Formen von Evidenzbasierung im Gesundheitswesen

• EUnetHTA: Strukturen und Inhalte

• EUnetHTA: Common core HTA

• HTA in Europa: die Zukunft

03 04

IQWiG

HEKPBAC

CEDAC

93

PMPRB

94

EAK

PPB

99

CT

96

CFH

02

NoMA

2000

PHARMAC

PBB

NICE

05

Institutionen für HTA, Arzneimittel-Postlizensierungsevaluation und QS

HAS

1987 89

SBU

ANDEM/

ANAES

KCE „New“

NICE

91/92

TA-SWISS

95

CAHTA

FinOHTA

98

SMM

AETS AETSA

UETS

NCCHTA

DAHTA

0197

DIHTA

DACEHTA

• Aufgaben (§139a, Abs. 3)– Erstellen von Evidenz- und HTA-Berichten,

– Ausarbeitungen zur Qualität und Wirtschaftlichkeit der Versorgung,

– Bewerten von medizinischen Leitlinien,

– Empfehlungen für Disease-Management-Programme,

– Nutzenbewertung von Arzneimitteln und

– Erstellen von allgemeinverständlichen Bürgerinformationen „zur Qualität und Effizienz in der Gesundheitsversorgung“

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen

Seit 2005

2/3 Arzneimittel

NICE – National Institute for Health and Clinical Excellence

• durch Krankenversicherungsgesetz vom 13.8.2004 entstanden als Verschmelzung von ANAES (HTA & Krankenhaus-Akkreditierung), CT (Arzneimittelevaluation), CEPP (Medizin-produkte), FOPIM (Informationen) + neue Aufgaben

• Aufgaben– Absolute und vergleichende Nutzenbewertung von Arzneimitteln,

Medizinprodukten und anderen Technologien,– Erarbeiten und Verbreiten von medizinischen Leitlinien,– Implementation kontinuierlicher ärztlicher Fortbildung,– Akkreditierung öffentlicher und privater Leistungserbringer

(Krankenhäuser und Netzwerke),– Empfehlungen und Ausarbeitungen für zuzahlungsfreie Leistungen bei

chronischen Krankheiten (hier hat Frankreich von den dt. DMPs gelernt),

– Erstellen und Verbreiten von Informationen und– Evaluation der Qualität der Gesundheitsversorgung im Bezug auf die

Gesamtbevölkerung.

HAS – Haute Autorité de santé

Direkte Ergebnisse:

Qualität, Zufrieden-

heitStrukturen

Patienten

Gesundheit der

Bevölkerung

Gesund-heits-

“Outcome“

Andere Politikbereiche

Ernährung/ Landwirtschaft

Umwelt

Gesundheitssystem

Akkreditierung von Leistungs-erbringern; kont. Fortbildung;

Health Technology Assessment

Klassische QS/Benchmarking:

„do the thing right“

Leitlinien/ Disease Management Programme:„do the right thing“

Primär-prävention

Techno-logien

Finanzielle Ressourcen

Human-ressourcen

Techno-logien

Prozesse/Leistungen

Leistungserbringende Person (insb. Arzt)

Leistungserbringende Institution

Technologie

Struktur

Erlaubnis, tätig zu werden/eingesetzt zu werden (Marktzutritt)

Approbation Konzession (bei privaten Krankenhäusern)

Zertifizierung (Medizinprodukte), Zulassung bzw. Registrierung (Arzneimittel)

Aufnahme in GKV-System Abgeschlossene Weiterbildung; „Zulassung“

Zulassung; „Akkreditierung“ Aufnahme in/Ausschluss aus Leistungskatalog (Health Technology Assessment)

• Notwendigkeit der Beteiligung an externer Qualitätssicherung

• Notwendigkeit eines internen Qualitätsmanagements • Offenlegung von Struktur-, Prozess- und Ergebnisdaten • Notwendigkeit der regelmäßigen Fortbildung

Beschränkung auf spezifische Indikation/ Patienten/ Leistungserbringer

Auflagen an GKV-Abrechenbarkeit

Mindestmengenregelung für Technologieanwendung pro Leistungserbringer und Jahr Prozess

Ex-ante: • Leitlinien • Disease Management Programme • Clinical Pathways/Behandlungspfade

Indikationsstellung (Wird das Angemessene/ Notwendige/ Richtige gemacht?)

Ex-post: • Utilization Review/Überprüfung der Indikationsstellung

Prozessqualität (Wird es richtig/gut gemacht?)

Überprüfung der Leitlinienbefolgung z. B. hinsichtlich Dokumentation, Einhalten von Zwischenschritten

Ergebnis

Kurzfristig • Parameter: Introperative/stationäre Letalität/Mortalität, Komplikationsraten

• Methodik: Benchmarking, league tables …

Langfristig (Was nutzt es dem Patienten?)

• Parameter: Überleben, Lebensqualität, Ereignisfreiheit …

• Methodik: Benchmarking, league tables …

(„Community effectiveness“-Ergebnisse, die bei Entscheidungen zum Leistungskatalog berücksichtigt werden können)

Direkte Ergebnisse: Mortalität, Kompika-tionen …Strukturen

Patienten

Prozesse/Leistungen

Gesundheit der

Bevölkerung

Gesund-heits-

“Outcome“



Umwelt

GesundheitswesenTechno-logien


Human-ressourcen

Primär-prävention





Health Technology AssessmentHAS

HASHAS

HAS

+ andere HAS

HAS

(zukünftig)


Patienten

Prozesse/Leistungen

Gesundheit der

Bevölkerung

Gesund-heits-

“Outcome“



Umwelt



Human-ressourcen

Primär-prävention



„do the thing right“NICE

NICE


Health Technology AssessmentNICE

Healthcare

Commission

(ex Com. Health

Improvement)

DoH („National

Service Frameworks“)

Postgraduate Med. Educ.

and Training Board


Patienten

Prozesse/Leistungen

Gesundheit der

Bevölkerung

Gesund-heits-

“Outcome“



Umwelt



Human-ressourcen

Primär-prävention





Health Technology AssessmentG-BA/ IQWiG

G-BA/ BQS/

GKV-Vertragspartner

G-BA/ IQWiGIQWiG/ ZÄQ/ KBV/

Fachgesellschaften …

Länder/ GKV-Vertragspartner

LänderKammern/ G-BA

(Primary)ResearchInnovation

Synthesis/assessment(SR & CEA)

(global)

Impact & applicability

appraisal(local)

Decisionmaking

DisseminationUtilization

Technologies

(drugs,

devices ...)

SystematicReviews and HTA in the Knowledge chains

EvaluationMonitoring

EvaluationDissemination

UtilizationDecisionAppraisalSynthesisResearch

Scientificprocess

Deliberativeprocess



(global)


appraisal(local)

Health systeminterventions

Population

interventions

(public health)

Individual

interventions

(clinical practice)

Technologies

(drugs,

devices ...)

SRs and HTA in the Knowledge chains


EvaluationUtilizationDecisionAppraisalSynthesisResearch




Decisionmaking


Different types of technologies/interventions



(global)


appraisal(local)


Population

interventions

(public health)

Individual

interventions

(clinical practice)

Technologies

(drugs,

devices ...)







Decisionmaking


Health technology assessment = HTA

Health intervention assessment = ”HIA”

Public health assessment = ”PHA”

Health policy assessment = ”HPA”

The semantics of HTA

EvidenceKnowledgesynthesis



(global)


appraisal(local)


Population

interventions

(public health)

Individual

interventions

(clinical practice)

Technologies

(drugs,

devices ...)







Decisionmaking


Clinical policy making

Public health policy making

Health policy making

The semantics of policy making



(global)


appraisal(local)


Population

interventions

(public health)

Individual

interventions

(clinical practice)

Technologies

(drugs,

devices ...)






Decisionmaking


Po

licy a

na

lysis

Policy analysis

Need for stronger policy analysis perspective

HIC LMIC

Healthsystempolicies

Clinical

policies

EVIPNet

HTA: Need for policy perspectiveand LMIC country perspective?

AHPSR

WHO-

HEN

AHPSR - Alliance for Health Policy and Systems Research

EVIPNet - EVIDENCE-INFORMED POLICY NETWORK

WHO-HEN – Health Evidence Network

INAHTA

EUnetHTA

G-I-N

European

Observatory

Formulierung der Policy Question

Vorbereitung eines HTA-Protokolls

Aufarbeitung der Hintergrundinformationen / Bestimmung des Status der Technologie

Formulierung der Forschungsfragen

Sicherheit

Quellen

Bewertung

Synthese

Wirksamkeit

Quellen

Bewertung

Synthese

Soziale /

Ethische Impl.

Quellen

Bewertung

Synthese

Organisato-rische Impl.

Quellen

Bewertung

Synthese

Ökonomisch

Quellen

Bewertung

Synthese

Schlussfolgerungen / Empfehlungen

Peer Review und Veröffentlichung(en)

Evaluationsrahmen

Aspekte Outcome Parameter Sicherheit • Mortalität (zuschreibbar zur Anwendung der Technologie)

• Morbidität/Behinderung (zuschreibbar zur Anwendung der Technologie)

Wirksamkeit • Veränderungen der Mortalität (gesamt bzw. spezifisch) • Veränderungen der Morbidität/ Behinderungsgrad (gesamt bzw.

spezifisch) • Veränderungen der Lebensqualität

Soziale/ Ethische • Compliance • Akzeptanz • Zufriedenheit • Präferenzen • Informations- bzw. Beratungsbedarf

Organisatorische/ Professionelle

• Veränderungen in der Verweildauer • Veränderungen in den Personal- bzw. Bettenbedarfs • Ausbildungs-, Schulung- oder Trainingsbedarf

Ökonomische • Kosten und Kostenveränderungen in Vergleich zur gängigen Praxis • Kosten-Effektivität, Kosten-Nutzen

NICE, HAS,IQWiG

NICE

Kriterien der Marktzulassung

• Sicherheit

• Pharmazeutische Qualität

• Wirksamkeit

Kein Vergleich mitbereits vorhandenen Therapieoptionen

Health Technology Assessment:Efficacy vs. Effectiveness

EfficacyEfficacy• explanatory trials

• highly selected

populations

• comparator: placebo

• outcomes: clinical,

morbidity, mortality, adverse effects

• ‘what it says on the packet’

EffectivenessEffectiveness• pragmatic trials

• few exclusions

• comparator: ‘current

(best) practice’

• outcomes: patient-

focused, down-stream resources

• ‘the real life effect’

Health Technology Assessment:Efficacy vs. Effectiveness

EfficacyEfficacy• explanatory trials

• highly selected

populations

• comparator: placebo

• outcomes: clinical,

morbidity, mortality, adverse effects

• ‘what it says on the packet

EffectivenessEffectiveness• pragmatic trials

• few exclusions

• comparator: ‘current

(best) practice’

• outcomes: patient-

focused, down-stream resources

• ‘the real life effect’Evidence GapEvidence Gap

LicensingLicensing

AppraisalAppraisal

IQWiG NICE HAS

Arzneimittel - Kriterien für Bewertungund Entscheidung

XXF&E-Kosten der Hersteller

XXXXXSoziale, ethische Erwägungen

XXXXXXXXAuswirkung auf Budget

XPrioritäten der Regierung

X

X

X

X

X

AT

X

X

X

X

X

AU

X

X

X

X

X

CA

X

X

CH

X

X

X

FI

X

X

X

X

FR

X

X

X

X

X

NL

X

X

X

NO

X

X

X

X

X

NZ

X

X

X

X

SE

Auswirkungen auf Bevölkerungsgesundheit

Bedarf der Gesellschaft

Verfügbarkeit von Behandlungsalternativen

Pharmakologische/Sonstige Merkmale

Kosteneffektivität

Patientennutzen

Therapeutischer Nutzen

Kriterium

X

X

X

X

X

UK

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

EUnetHTA Project 2006-2008

• 59 institutional partners– 34 Associated Partners: national/regional HTA agencies, MoH,

research institutions, international organisations (Cochrane Collaboration)

– 25 Collaborating Partners: e.g. WHO, OECD, CoE

• 24 EU Countries

• 2 EEA (Norway, Iceland)

• Switzerland

• 4 institutions in countries outside Europe (Israel, Australia, Canada, USA)


EUnetHTA Objectives

The general objective:

To establish an effective and sustainable European Network for Health Technology Assessment – EUnetHTA - that informs policy decisions

The general strategic objective of the Network:

To connect public national HTA agencies, research institutions and health ministries, enabling

effective exchange of information

support to policy decisions by the Member States


EUnetHTA Strategic Objectives

� Better coordination of HTA activities

� Less duplication

� Increase the HTA output and input to

decision-making in the Member States and EU

� Strengthen the link between HTA and healthcare policy making

� Support countries with limited experience with HTA

More effective use of national resources put into HTA

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

EUnetHTA two strands

1. Development of an organisational framework for a sustainable European network for HTA

2. Development of practical tools to fit into this framework


EUnetHTA Work Packages (WPs)

WP1: Coordination (DACEHTA, Main Partner)

WP2: Communications (SBU, DAHTA)

WP3: Evaluation (NOKC)

WP4: Common Core HTA (FinOHTA)

WP5: Adapting existing HTAs to other settings (NCCHTA)

WP6: Transferability to policy (DACEHTA, TU Berlin)

WP7: Monitoring emerging technologies and HTA prioritisation (HAS, LBI)

WP8: Support system in Member States without institutionalised HTA (CAHTA)

WP 4 Starting points

WP4

• HTA implemented differently across European countries

� Compromised applicability of foreign reports

• HTA reports lack a standardised information structure

� Extraction of data from reports may be difficult

EUnetHTA | European network for Health Technology Assessment | www.eunethta.net WP4

DUPLICATION

WP4 Objectives

Specific Objectives

Production of 2 Core Models for HTA

Model for therapeutic (medical and surgical) interventions

Model for diagnostic technologies

Production of 2 HTA Reports based on the models

HTA on Drug Eluting Stents (DES)

HTA on multi-slice CT

EUnetHTA | European network for Health Technology Assessment | www.eunethta.net WP4

General Objective

To define and standardise elements of an HTA to facilitate

shared understanding of HTA and promote the international use of HTA results

Core

WP4 EUnetHTA | European network for Health Technology Assessment | www.eunethta.net WP4

(Kristian Lampe)

WP4 EUnetHTA | European network for Health Technology Assessment | www.eunethta.net

Safety

Effectiveness

Economic

Organisational

Legal

Social

Ethical

Core

WP4 EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu WP4

Safety

Effectiveness

Economic

Organisational

Legal

Social

EthicalTechnology 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. (INAHTA 2005)


Domains

• Health problem and Current use of the technology

• Description and technical characteristics of technology

• Safety

• Effectiveness

• Costs, economic evaluation

• Ethical aspects

• Organisational aspects

• Social aspects

• Legal aspects

WP4

Workin pro

gress,

not for

citatio

n


Basic structure and concepts

WP4

• Basic concepts defining assessment elements:

• Domain

Wide framework, angle of viewing

”Effectiveness”

• Topic

A specific area within a domain. May be discussed under more than

one domain

”Effectiveness / Mortality”

• Issue

An even more detailed area within a domain. Expressed as a

question

”Effectiveness / Mortality / What is the effect on mortality from target

condition?”

”Effectiveness / Mortality / What is the effect on overall mortality?”


Workin pro

gress,

not for

citatio

n


Topic 1

Topic 2

Topic 3

Topic 1

Topic 2

Topic 3

Topic 4Topic 1

Topic 2


Issue 1

Issue 2

Issue 3

Issue 4

Issue 5

Core model for medical and surgical interventions

WP4WP4 EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu WP4

Workin pro

gress,

not for

citatio

n

IssuesTopicsDomain

16355Total

278Organisational aspects

297Legal aspects

117Social aspects

168Ethical analysis

65Costs and economic evaluation

184Effectiveness

227Safety

153Description and technical characteristics

166Health problem and current use


Core matrix

WP4

NOT CORE

CORE

Importance / Relevance

Transferability

NOT CORE

NOT CORE

BORDERLINE CORE

BORDERLINE CORE

BORDERLINE

Work in progress, not for citation


Core model for medical and surgical interventions

Work in pro

gress,

not for c

itationEffectiveness Domain – TOPICS

Mortality (with 4 issues)

Morbidity (with 6 issues)

Function / Health Related Quality of Life (with 6 issues)

Patient Satisfaction (with 2 issues)

Topics and issues within effectiveness (selection)

WP4

Would the patient be willing to have the intervention

again?

Patient satisfaction

What is the effect of the intervention on disease specific

health-related quality of life?

Function / HRQL

What is the effect of the intervention on global health-

related quality of life?

Function / HRQL

What is the effect of the intervention on function? Function / HRQL

What is the effect on mortality due to other causesMortality

What is the effect of the intervention on the mortality due

to other causes than the target disease?

Mortality

What is the effect of the intervention on overall mortality?Mortality


Work in progress, not for citation


Element Cards

WP4

• Structured method of providing infromation

• One card defines one element (Domain/Topic/Issue)

• Provides Information on

•Question

•Methods applied to answer the question

•Answer

• Metadata (e.g. unique identifier, judgement on

importance)

EUnetHTA standard for reporting


Workin pro

gress,

not for

citatio

n


From Core Model to Core Topic DES

WP4

1. The relevance of each assessment element is

considered in the context of the technology at hand.

2. If an element is relevant, the generic issue is

translated into one or more practical research

question(s).

3. Relevant questions are answered in the Core HTA

using typical research methodologies.

4. RESULT: a structured report in which information

on a particular issue can be found at a standard

location (whether in paper or electronic form).



Current Core HTA on DES

WP4

• 8 domains completed at first public draft (+ safety

delayed)

• Focus on comparing DES vs. BMS due to time and

resource limitations. In some domains wider approach might be useful

• Purpose of core HTA on DES: testing the model

and providing an example

• Not for current decision-making


Work in pro

gress,

not for c

itation

EUnetHTA | European network for Health Technology Assessment | www.eunethta.euWP4 EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu WP4

Current Core HTA on DESEffectiveness DomainKunz et al.

• Chapter under revision to include data on long-term efficacy data published in 2007

• Issues for which data are available: • Overall Mortality (1,2,3 yr.)

• Cardiac Mortality (1,2,3 yr.)• Non-Cardiac Mortality (1,2,3 yr.)

• Target Vessel Revascularisation (1,2,3 yr.)

• Non-Fatal Myocardial Infarction (1,2,3 yr.)• CABG (1,2,3, yr.)

Work in pro

gress,

not for c

itation

EUnetHTA | European network for Health Technology Assessment | www.eunethta.euWP4 EUnetHTA | European network for Health Technology Assessment | www.eunethta.eu WP4

Current Core HTA on DESEffectiveness DomainKunz et al.

• Issues for which data are not available:

• Severity or frequency of Angina Symptoms • Reults of tests

• Cardiac specific drug treatment• Need for Hospitalization

• Health related Quality of Life• Cardiac specific Quality of Life

• Return to work

• Return to previous living conditions / ADL• Patients satisfaction (worth it? again?)

Work in pro

gress,

not for c

itation


Next steps within WP4

WP4

• Core Model and Core Topic DES have been presented in

the HTAi – Conference in Barcelona and are available at www.eunethta.net

• Opportunity to provide structured feedback on both

through webbased form given to:

• project partners• interested public

• 2nd Core model (for diagnostic technologies) and 2nd

Core HTA (on multi-slice CT)

• Final reports available in late 2008



International Symposium

20th November 2008

www.eunethta.net

THANK YOU

HTA in Europa - mig.tu-berlin.de · 03 04 IQWiG PBAC HEK CEDAC 93 PMPRB 94 EAK PPB 99 CT 96 CFH 02...

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Transcript of HTA in Europa - mig.tu-berlin.de · 03 04 IQWiG PBAC HEK CEDAC 93 PMPRB 94 EAK PPB 99 CT 96 CFH 02...