MArS - AHEAD

Webinar Reimbursement of Innovative Medical Devices in Germany

Agency for Health Economic Assessment

and Dissemination

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MArS and AHEAD are two separate consulting agencies that collaborate in order to offer high quality market access and reimbursement solutions for the European healthcare setting

MArS UG – Market Access & Pricing Strategy Market access & pricing as well as global clinical development

strategies from a health care payer's perspective in the various lifecycle stages of a medical device or pharmaceutical product

German market access strategies and implementation for pharmaceuticals and medical devices

AHEAD GmbH

is a specialized consulting agency that supports clients in the planning, generation and dissemination of health economic

evidence as well as in obtaining market access and reimbursement for both

medical devices and pharmaceuticals in Germany.

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Dr. Stefan Walzer

9+ years experience in market access & pricing strategy and its implementation

Lecturer at the State University Baden-Wuerttemberg (Germany)

Founder & General Manager of MArS based in Germany

Master in Economics, PhD in (Health) Economics, Diploma in Clinical Trials

30 full text publications > 60 conference presentations

MArS and AHEAD are two separate consulting agencies that collaborate in order to offer high quality market access and reimbursement solutions for the European healthcare setting

Bjoern Schwander

12 years experience in market access and health economic consultancy

Various experience in the planning & implementation of the reimbursement of medical devices in Germany

Founder & General Manager of AHEAD based in Germany

Nursing Diploma, BSc in Applied Health Sciences, Master program in Health Economics

> 20 publications & conference presentations

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79 Mio Germans have either private or statutory health insurance coverage and in 2012 the healthcare expenditure on medical devices in Germany reached 25 billion euros

Statutory Health In-surance

Private Health Insurance

0.0 20.0 40.0 60.0 80.0

70.0

9.0

Number of health insured patients in Germany

Insured persons in millions (Status 11/2012)

2008 2009 2010 2011 201219

20

21

22

23

24

25

26

2122

2325 25

Healthcare Expenditure on Medical Devices in Germany in Billion Euros

Reference Year

Bill

ion

Eu

ros

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For the market access of innovative medical devices in Germany it plays a key role whether a medical device is applied in the inpatient or in the outpatient setting

Inpatient Outpatient

All innovative procedures are permitted with the reservation of prohibition (‚Verbotsvorbehalt‘ SGB V §137c)

All innovative procedures are prohibited until they have been officially approved

(‚Erlaubnisvorbehalt‘ SGBV § 135;1)

Before a new medical device can be applied in the outpatient setting a positive voting from the joint federal committee is

required

The hospitals are allowed to apply all CE marked innovations

Within the hospital (inpatient) new CE marked medical devices can be applied

as long as they are not actively prohibited by the joint federal committee

Long application process in order to gain approval for applying innovations

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There are several possible reimbursement pathways for innovative medical devices depending on whether a medical device is applied in the inpatient or in the outpatient setting

CE Mark

Inpatient

Adequate OPS/DRG available

New OPS/DRG required

‘On-top payment required’

Already reimbursed

OPS/DRG application

NUB (ZE) application

1 2 3

Outpatient

Inclusion in fee

schedules

Individual health insurance coverage

Out of pocket

payments

EBM / GOÄ Application

Selective Contracts

IGeL Application

4 5 6

Application Experimental

Coverage

Additional evidence required

7

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The inpatient reimbursement in Germany depends on whether adequate coding (OPS) and adequate coverage (DRG) is available - if not specific applications need to be performed

CE Mark

Adequate OPS/DRG available

New OPS/DRG required

‘On-top payment required’

Already reimbursed

OPS/DRG application

NUB (ZE) application

12 3

Inpatient

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For the reimbursement of inpatient services in Germany a DRG based system is used: Specific DRGs are defined by a combination of disease (ICD) and procedure (OPS) coding

ICD-GM Coding OPS Coding

German version of the International Statistical Classification of Diseases and Related Health Problems (ICD)

German version of the International Classification of Procedures in

Medicine (OPS = Operationen- und Prozedurenschlüssel)

Specific G-DRG

German Diagnosis Related Groups that are linked to a specific

reimbursement value

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Scenario 2a - after performing an initial coding/coverage research it is obtained that changes in the OPS system are required in order to achieve an adequate reimbursement

2a

Deadline for OPS changes in the following year is end of February in the current year

DIMDI (German Institute of Medical Documentation and Information) provides an application form and is the addressee of the

OPS application

OPS application

The responsible German Medical Society should be involved

Application Form

• Form is released in December• Submission deadline is end of February• Decision is released end of August• Valid from January of the following year

http://www.dimdi.de/static/de/klassi/ops/vorschlagsverfahren/index.htm#vorschlagsformular

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Scenario 2b - after performing an initial coding/coverage research it is obtained that changes in the DRG system are required in order to achieve adequate reimbursement

2b

DRG application

Deadline for DRG changes in the following year is end of February in the current year

InEK (Institute for the Hospital Remuneration System) provides an

application form and is the addressee for DRG applications

The responsible German Medical Society should be involved

Application Form

• Form is released end of November• Submission Deadline is end of February • Decision is released end of August• Valid from January of the following year

http://www.gdrg.de/cms/G-DRG-Vorschlagsverfahren

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Scenario 3 - after performing an initial coding/coverage research it is obtained that an ‘on-top payment’ is required in order to achieve adequate reimbursement

NUB application

Deadline for NUB applications in the following year is end of October in the current year

InEK provides an application form and is the addressee for NUB (Neue Untersuchungs- und Behandlungsmethoden) applications

Each hospital needs to submit an own NUB application – the InEK decides whether a

‘on-top payment’ can be negotiated

3

Application Form

• Form is released in September• Submission deadline is end of October• Decision is released end of January of the

following year and the NUB is then valid

http://www.gdrg.de/cms/content/download/3636/30201/version/1/file/NUB.exe

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Obtaining the inpatient reimbursement strategy is a step-wise approach and in the best case it might be obtained that an adequate DRG reimbursement is already available

Reimbursement is already available!YES

1

3NO NUB (ZE)

application

OPS code available?NO OPS

application2a

NO DRG application

2bYES

Relevant DRG available?

DRG fee adequate?YES

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The inpatient reimbursement process is clearly structured and there is no need to provide any specific clinical or health economic evidence during the application process

For the application of a new medical device in the inpatient sector only a CE mark is required.

The reimbursement fee of a new medical device depends on the available coding, grouping & coverage options.

In a first research step an initial coding/coverage research should be performed in order to identify the best strategy for an innovative medical device.

For each reimbursement pathway there are specific application procedures available – with a clear process & timing structure.

There is no need to provide any specific clinical or health economic evidence during the inpatient reimbursement application process.

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For the outpatient reimbursement there are different strategies available – the best one would be obtaining inclusion in the official fee schedules for outpatient services

CE Mark

Outpatient

Inclusion in fee

schedules

Individual health insurance coverage

Out of pocket

payments

EBM/GOÄ Application

Selective Contracts

IGeL Application

4 5 6

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Scenario 4 – the fee schedule of the statutory health insurance (EBM) and the private health insurance (GOÄ) are valuable reimbursement options for outpatient services

Fee Schedules

4

EBM inclusion

An application needs to present the clinical and economic consequences and should be

submitted via the association of statutory health insurance physicians (KBV)

The joint federal committee decides on ambulatory procedures covered by the

statutory health insurance

A value dossier (rapid HTA) for Germany needs to be submitted to the KBV

GOÄ inclusion

An application needs to outline the clinical and economic consequences of the

procedure

The German Medical Association (Bundesärztekammer) is responsible for applications related to the private health

insurance fee schedule (GOÄ)

The application should be submitted by a medical KOL

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Scenario 5 ‘IGeL Inclusion’ and scenario 6 ‘Selective Contracts’ represent alternative reimbursement scenarios for outpatient procedures in Germany

IGeL Inclusion

IGeL – stands for individual health services (Individuelle Gesundheitsleistungen) that

have to be paid out of pocket by the patients

5

The usual way of including a new service to the IGeL list is applying for inclusion to the

GOÄ schedule

Once a service is listed in the GOÄ schedule it can be offered by each German physician as

IGeL service

Selective Contracts

Precondition is that a procedure has not been excluded from reimbursement by the joint federal committee (see EBM inclusion)

From 1st January 2012 on the statutory health insurances are allowed to reimburse innovative

outpatient procedures (SGB V § 11(6))

A strong clinical and economic argumentation is required in order to convince individual

health insurance funds

6

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EBM Inclusion: Before a method for examination or treatment can be discussed in the Federal Joint Committee (G-BA), an application must be made by one of the G-BA members

• Such an application may be made by the neutral members of the G-BA, the Federal Association of Statutory Health Insurance Funds, the National Association of Statutory Health Insurance Physicians (KBV), the National Association of Statutory Health Insurance Dentists (KZBV), the German Hospital Federation (DKG) or the patient representatives.

• Each application for discussion must contain a detailed justification, including information on the benefits, medical necessity and cost-effectiveness of the method (i.e. diagnostic or therapeutic medical technology) to be discussed, together with a comparison to methods already available.

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An application for inclusion of a medical device in the EBM fee schedule requires a rapid HTA report that outlines the clinical and economic consequences of the new procedure

YES

G-BA application

Submission of a Rapid HTA Report to the KBV

Is the available evidence regarded as adequate?

EBM Inclusion

POSITIVE

NO

Consider IGeL Inclusion

ConsiderSelective Contracting

NEGATIVE

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The outpatient reimbursement process is quite diverse and requires the presentation of specific clinical and health economic evidence during the application process

For the application of a new medical device in the outpatient sector a positive reimbursement decision is mandatory.

The first strategy should be to apply for inclusion in the EBM (statuary health insurance) and GOÄ (private health insurance) fee schedules.

The ‘IGeL inclusion’ (out-off pocket payment) and the ‘Selective Contracting’ (coverage by single/local health insurances) should be seen as fallback strategies.

It is mandatory to provide specific clinical and health economic evidence during the application process.

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In case that a new medical device has a strong innovative potential and there is an need for obtaining additional evidence there is the possibility to apply for an ‘experimental coverage’

CE Mark

Inpatient Outpatient

Application for Experimental Coverage

Additional evidence required

7

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Scenario 7 – a very new strategy to obtain (in- or outpatient) reimbursement for innovative medical devices in Germany is the application for an ‘Experimental Coverage’

EpCo application

An ‘EpCo’ application needs to point out a strong innovative potential and a high unmet

need; the manufacturer needs to carry a specific part of the clinical research costs

The joint federal committee (G-BA) decides on whether a medical device is suitable for

the ‘EpCo programm’

Medical device manufacturers are allowed to apply for such a experimental coverage by

using the specific forms provided by the G-BA

7

Application Form

http://www.g-ba.de/downloads/39-261-1608/2012-11-22_VerfO_137e_Anlagen_I-III.pdf

The detailed process, proposed by the G-BA’ is currently reviewed and commented by the German

Ministry of Health

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Especially for medical devices applied in the outpatient sector the ‘experimental coverage’ program provides an additional valuable reimbursement access strategy

Submission of a Rapid HTA Report to the KBV

YES

G-BA application

Is the available evidence regarded as adequate?

EBM Inclusion

POSITIVE

NEGATIVE

NO

Strong innovative potential & unmet medical need?

Experimental Coverage Application

YES

Consider IGeL Inclusion [Selective Contracting]

NO

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The ‘Experimental Coverage’ program is a new strategy intended to be used for new medical devices with a strong innovative potential combined with a high unmet need

The ‘Experimental Coverage’ program allows medical device manufactures (the first time) to apply for reimbursement directly at the G-BA (usually applications were only possible by G-BA members).

From the manufacturer perspective this strategy is only valuable for medical devices applied in the outpatient sector – as there are currently no strict evidence requirements for the ‘inpatient sector’.

It needs to be taken into account that the manufacturer has to cover a part of the research costs.

A new medical device needs to show a strong innovative potential in a patient population with a high unmet medical need in order to be eligible for reimbursement under the ‘Experimental Coverage’ program.

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There are several opportunities to obtain reimbursement for an innovative medical device in Germany but there are great difference in the time and evidence requirements

CE Mark

Inpatient

Adequate OPS/DRG available

New OPS/DRG required

‘On-top payment required’

Already reimbursed

OPS/DRG application

NUB (ZE) application

1 2 3

Outpatient

Inclusion in fee

schedules

Individual health insurance coverage

Out of pocket

payments

EBM/ GOÄ Application

Selective Contracts

IGeL Application

4 5 6

Application Experimental

Coverage

Additional evidence required

7

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In summary the German reimbursement process for inpatient medical devices is faster and requires less clinical evidence compared to outpatient medical devices

Time Demand for obtaining Reimbursement

Evi

den

ce R

equ

irem

ent

Outpatient

Inpatient

OPS/DRG

NUB

GOÄ(IGeL)

EBM

SelectiveContracts

Experimental Coverage

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MArS and AHEAD are two separate consulting agencies that collaborate in order to offer high quality market access and reimbursement solutions for the European healthcare setting

We can support you by performing product specific analyses, developing strategies and implement reimbursement

European Market Access, Pricing and Reimbursement Strategies

Realization of market access, pricing and reimbursement solutions for Germany (and other European countries)

Value Dossiers and HTA Reports Systematic Literature Reviews Value based Pricing Health Economic Evaluations …

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Please use our more than 20 years of combined experience in market access, reimbursement, payer strategy and in health economics in order to bring your product ahead

Contact: Stefan WalzerGeneral ManagerE-mail: stefan.walzer@marketaccess-pricingstrategy.deHomepage: www.marketaccess-pricingstrategy.de

Contact: Bjoern Schwander General Manager

E-mail: bjoern.schwander@ahead-net.de

Homepage: www.ahead-net.de