HTA in Germany

Institute for Quality and Efficiency in Health Care

IQWiG

Alric Rüther MD PhD

German Health Care System

2

Patient

Physicians

Associations

(federal; regional)

Hospital

Organisations

(federal; regional)

Federal Associations

of SF

SF in one region

Physicians HospitalsSickness Funds

Federal Parliament

Federal Assembly Federal Council

State Ministries

(Health)

Federal Ministry

of Health

Statutory Health Insurance: Federal Joint committee

Adapted from Health Care systems in transition: European observatory on health care systems, WHO

Self Administrating Body

Decisions on reimbursement

3

Social Code Book V (SGB V) § 35b, 1

“All insured persons receive access to

treatments which are necessary to

reduce mortality or morbidity or to

increase health-related quality of life.”

Basis: German Law

necessary to

What is needed for reimbursement?

Medical Necessity

The benefit must be proven

The benefit must be of meaningful magnitude

The intervention must be the only way to achieve this magnitude of

benefit

Efficiency

No evaluation of any benefit-cost-ratio without professional proven

benefit of medical intervention

4

Toolbox HTA

Basis: German Law

§139a SGB V

Institute for Quality and Efficiency in Health Care

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The IQWiG

• Founder: Federal Joint Committee (GBA)

• Independency: „Foundation for Quality and Efficiency

in Health Care “

• Financing: levy on inpatient and outpatient

healthcare services,

IQWiG produces independent, evidence-based

(supported by proof) reports e.g. on:

Drugs (benefit and cost-benefit assessment)

Non-drug interventions (e.g. surgical procedures,

medical devices, diagnostic and screening methods)

Treatment guidelines (CPGs) and Disease

Mangament Programmes (DMPs)

In addition IQWiG provides easily understandable

health information for patients and the general

community

IQWiG tasks according to § 139a SGB V

Self governance in the German SHI

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reimbursement

decisions

evidence based

information

Department of Health

GBA/ Federal Joint

CommitteeHospitals, Physicians,

SHI Funds , Patients

legal supervision

commission

GKV-SpiVerbNational Association of

SHI Funds

decisions on maximum

reimbursable price

commission

IQWiGInstitute for Quality and

Efficiency in Health Care

IQWiG is allowed to act independently in terms of acute medical contents

relevant to Health Care

Objective

„(4)The Institute must ensure that

the assessment of medical benefit

is carried out according to the

internationally accepted standards

of evidence-based medicine.‟

German social code, book V

§ 139a (IQWiG)

Hierarchy of evidence (G-BA / IQWiG)

Therapy and Screening

I Randomized controlled

trials (RCTs) and syste-

matic reviews of RCTs

II Prospective controlled

cohort studies

III Retrospective controlled

studies

IV Case series and other

uncontrolled studies

V Case reports, expert

opinion, non-clinical

research, etc.

Diagnosis

Randomized controlled trials

(RCTs), systematic reviews

of RCTs, and other

interventional studies

Cross-sectional and cohort

studies on test accuracy

Other test accuracy studies

Case reports, expert opinion,

non-clinical research, etc.

-

Federal Joint Committee (G-BA): Verfahrensordnung (Code of procedures) Chapter 2, §11 (2-4) and §13 (2)

http://www.g-ba.de/institution/auftrag/Verfahrensordnung/ http://www.g-ba.de/downloads/62-492-422/VerfO_2009-12-17.pdf

The m

ore

you g

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ow

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iera

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the

be

tter th

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stific

atio

n h

as to

be

to d

o s

o.

German law (SGB V §35b)

Improvement of state of health

Reduction of duration of illness

Extension of length of life

Reduction of side-effects

Improvement of quality of life

IQWiG Methods

Mortality

Morbidity (complaints and

complications)

Health related quality of life

Intervention related burden

Patient satisfaction

Patient relevant endpoints

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IQWiG Methods:

• Principle of causality

• Bias

• Dramatic effect

• Transparency

• Reliability

https://www.iqwig.de/download/General_Methods_4-0.pdf

Versorgungsstrukturgesetz (VStG) “Structure of Health Care Act”

From January 1st 2011: AMNOG: German law on the

reorganization of the pharmaceutical market for the statutory health

insurance (§35a SGB V)

From January 1st, 2012: §137 SGB V: Relevant changes

concerning HTA for new health care interventions

New legislation: “Structure of Health Care Act”

Why?

Pharmaceuticals:

Improvement of patient relevant benefit

„free price from market entry“ not durable

Medical interventions:

Improvement of patient relevant benefit

Support of innovation

Control of hospital entry

AMNOG: German law on the reorganization of the pharmaceutical

market for the statutory health insurance (since 01/01/2011)

most important:§35a SGB V

benefit assessment for new chemical entities (NCE)

and new indications

assessment starts with market entry

additional benefit?

reference price / price negotiations (also valid for private

sector)

AMNOG

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Drug assessment according to AMNOG

Economic

evaluation

Can ask for

Module 1

• Administrative information

• Summary

Module 2

• General information on the drug

• Description of approved indication

Module 3

• Description of appropriate comparator

• Number of patients with relevant additional benefit

• Costs for the SHI

• Requirements for quality-assured application

Module 4

• Systematic review of the benefit and additional benefit

(description of methods and results)

• Description of patient groups with a relevant additional benefit

Module 5

• Full texts of references

• Data on the documentation of information retrieval

• Study reports for all manufacturer-sponsored trials

• Approval documents (CTD 2.5, 2.7.3, 2.7.4)

• Evaluation report of the regulatory authority

• Checklist for the review of formal completeness

Submission in

German only,

Module 1-4 to be

published

Submission

in English

possible,

not to be

published

AMNOG: the dossier

Challenge: Value-based pricing

„… the extent of the added benefit … has

to be quantified as follows:

(1) Major added benefit

(2) Considerable added benefit

(3) Minor added benefit

(4) Unquantifiable added benefit

(5) No added benefit

(6) Less benefit‟

Regulation on the Benefit Assessment of Drugs*, §5 (7)

*According to § 35a (1), S. 6+7, SGB V

*Approach in dossier assessment (according to AMNOG) of Ticagrelor (Brilique), provisional translation

German version: https://www.iqwig.de/download/A11-02_Ticagrelor_Nutzenbewertung_%C2%A735a_SGB_V_.pdf

Actual approach*

Regulations for reimbursement of medical devices

in ambulatory and hospital care: key differences

G-BA = Gemeinsamer Bundesausschuss (Federal Joint Committee); SGB = Sozialgesetzbuch (Social Code Book)

Ambulatory care (§135):

Innovations may not be used

in ambulatory care, unless

G-BA decides in favour of

the innovation

(“Erlaubnisvorbehalt”).

Hospital care (§137c):

Innovations may be used in

hospital care, unless G-BA

decides against it

(“Verbotsvorbehalt”).

Book V of the Social Code (SGB V)

Medical Devices and Procedures

Coverage with Evidence Development (CED)

Decision

by G-BA

Reimbursement

granted

Decision

postponed

Reimbursement

denied

Application to

assess procedure

in ambulatory care

Application to

assess procedure

in in-hospital care

Procedure has

“potential”

Device

involved?

Conditional

Reimbursement,

Trial funded by

G-BA

No

Conditional

Reimbursement,

Trial (co)funded

by industry

IQWiG report on

effectivenessReassessment

of procedure

Yes

Trial

execution

Trial protocol and

budget fixed

+ - ?

Decision

by G-BA

Device industry

application to

assess procedure

Non-industry

application to

assess procedure

Procedure has

no “potential”

-?

Medical Devices and Procedures

HTA established as independent, reliable and necessary

Principles of work at IQWiG

Independent

Objective and evidence-based

Patient-oriented

Transparent

Scientific

The new Structure of Health Care Act introduces new HTA

processes

Decision Making in Health Care in Germany

Summary:

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Resources for HTA: the Networks

XX.XX.20XX Autor / Titel 23

Institute for Quality and Efficiency

in Health Care (IQWiG)

Im Mediapark 8

D-50670 Cologne

Telefon +49-221/3 56 85-0

Telefax +49-221/3 56 85-1

info@iqwig.de

www.iqwig.de

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Many thanks for slides provided: Thomas Kaiser, Julia Kreis, Stefan Sauerland