Technology: Pathways for innovative and non-innovative Devices in - - PowerPoint PPT Presentation

Pathways for innovative and non-innovative Devices in Germany

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November 14th, 2017 Page 1

• AiM. A company of the IGES Group.

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Assessment in Medicine

Reimbursement Strategies for Medical Technology: Pathways for innovative and non-innovative Devices in Germany

GTAI Market Presentations & Topics MEDICA, Düsseldorf, November 14th, 2017

Pathways for innovative and non-innovative Devices in Germany

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Contents

• Introduction
• Reimbursement Germany
• Outpatient
• Inpatient
• Summary

Pathways for innovative and non-innovative Devices in Germany

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Who we are

IGES Group The Knowledge Corporation

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Coverage Coding Payment

CE Mark Core „Reimbursement“ Issues Prescription & Use

The reimbursement chain

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Inpatient

Reimburseability = subject to prohibition „downstream coverage decision“

Coverage principles Germany

Outpatient

Reimburseability = subject to approval „upstream coverage decision“

Germany

European Market Approval – CE Mark

Innovative medical device defining a new diagnostic or therapeutic method

Source: Own Illustration

Federal-wide coverage decision maker: The Federal Joint Committee (G-BA)

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Coverage with evidence development program

Since 2013:

Source: Own illustration

§ 137c, SGB V § 135, SGB V

G-BA G-BA IQWiG

Outpatient setting Inpatient setting

Trial Trial data

Initiative from G-BA Initiative from industry

Method with the potential of a necessary treatment

• ption

„Insufficient data“

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Assessment in Medicine

Reimbursement Germany Outpatient

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Reimbursement: Outpatient setting

Centralized coverage decision Regulations / Payment schemes Initiators Insurances Health Care Providers

Separate contracts

KBV GKV- Spitzen- verband

EBM tariff G-BA SHI Scheme

De-centralized coverage decision Single insurances Health Care Providers

Individual decisions Insurances Patients/pro viders Single Insurances

Source: Own Illustration

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Assessment in Medicine

Reimbursement Germany Inpatient

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Reimbursement: Inpatient setting ICD- 10 GM OPS DRG

Extra rates (ZE) Innovation payments, new diagnostic

• r therapeutic methods (NUB)

Running costs per case Diagnosis Codes Procedure Codes One DRG (lump sum payment) per case Potentially applicable in addition to the DRG payment:

Source: Own Illustration

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Reimbursement: Inpatient setting

Source: Own Illustration

Hospitals treat cases & provide data to the DRG institute DRG institute analyzes data from year t Year t Year t+1 Year t+2

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

DRG system year t+2 based on real-life average costs

Data-based system in 2017: over 1,250 DRGs, additionally 191 ZE extra rates The calculation is based on real-life cost data reported by reference hospitals (approx. 350) All DRG values are recalculated yearly

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• Two phases:
• 1. Application by hospitals (to the DRG institute, InEK) September / October
• 2. If application approved: negotiations (individual hospital vs. insurances)
• No official assessment of benefit / clinical evidence in this process

Source: Own illustration

Reimbursement Level = NUB negotiations yes/no Result by Jan. 31st

DRG-related NUB assessment InEK

The NUB process for step by step innovations

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Source: Own Illustration

G-BA

Reimbursement Level = NUB negotiations yes/no

No communication / no interaction between InEK and G-BA DRG-related NUB assessment InEK

Rapid Benefit Assessment

If method is subject to the new process, two assessment lines apply:

The NUB process for high risk game changers (§ 137h SGB V process)

Neither “potential” nor benefit proven Potential shown Benefit proven

Coverage status = will SHI pay for it at all?

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Assessment in Medicine

Summary

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Summary

• Mostly clear reimbursement pathways in Germany
• Outpatient
• Innovations: Coverage hurdle first
• Federal-wide decisions via G-BA
• Selective contracts
• Single case decisions
• Non-innovations: where is the piggyback opportunity?
• Separate processes for specialties apply

(e.g. drug-alike devices, medical aids) Level of challenge

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Summary

• Inpatient
• Innovations: Coverage hurdle comes second
• What is the current payment?
• Is NUB needed?
• Am I affected by the new evidence assessment?
• Strategy evaluation!
• Non-/step-by-step innovations: Payment hurdle first
• What is the current payment?
• Is NUB needed?
• Convincing hospitals with return on investment and/or

clinical value

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• AiM. A company of the IGES Group.

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Assessment in Medicine

AiM GmbH Michael Weisser

• COO & Authorized Representative -

+49 7621 705 105 0 info@aim-germany.com

www.aim-germany.com