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 1.S.002 1.S.002 Pathways for innovative and non-innovative Devices in Germany AiM. A company of the IGES Group. November 14 th , 2017 Page 1
Contents Introduction Reimbursement Germany Outpatient Inpatient Summary 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 2
Who we are IGES Group The Knowledge Corporation 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 3
The reimbursement chain CE Mark Core „Reimbursement“ Coverage Issues Coding Payment Prescription & Use 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 4
Coverage principles Germany Innovative medical device defining a new diagnostic or therapeutic method European Market Approval – CE Mark Germany Inpatient Outpatient Reimburseability = subject to Reimburseability = subject to approval prohibition „downstream coverage „upstream coverage decision “ decision “ Federal-wide coverage decision maker: The Federal Joint Committee (G-BA) Source: Own Illustration 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 5
Coverage with evidence development program Since 2013: Initiative from G-BA § 137c, SGB V „Insufficient data“ Inpatient G-BA setting Method with Trial the potential of a necessary IQWiG treatment Trial data option Outpatient G-BA setting § 135, SGB V Initiative from industry Source: Own illustration 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 6
Assessment in Medicine Reimbursement Germany Outpatient 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 7
Reimbursement: Outpatient setting Single Insurances Insurances Individual Patients/pro decisions viders Single Insurances insurances Separate Health Care contracts Health Care Providers Providers SHI Scheme De-centralized coverage decision KBV EBM G-BA GKV- tariff Spitzen- verband Centralized coverage Regulations / Payment decision schemes Initiators Source: Own Illustration 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 8
Assessment in Medicine Reimbursement Germany Inpatient 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 9
Reimbursement: Inpatient setting Running costs per case ICD- OPS DRG 10 GM Diagnosis Codes Procedure Codes One DRG (lump sum payment) per case Potentially applicable in addition to the DRG payment: Innovation payments, new diagnostic Extra rates (ZE) or therapeutic methods (NUB) Source: Own Illustration 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 10
Reimbursement: Inpatient setting Data-based system in 2017: over 1,250 DRGs, additionally 191 ZE extra rates Hospitals treat DRG system DRG institute cases & provide year t+2 based on analyzes data The calculation is based on data to the DRG real-life average from year t institute costs real-life cost data reported by reference hospitals (approx. 350) Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Year t Year t+1 Year t+2 All DRG values are recalculated yearly Source: Own Illustration 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 11
The NUB process for step by step innovations Two phases: 1. Application by hospitals (to the DRG institute, InEK) September / October Reimbursement Level = InEK DRG-related NUB assessment NUB negotiations yes/no Result by Jan. 31st 2. If application approved: negotiations (individual hospital vs. insurances) No official assessment of benefit / clinical evidence in this process Source: Own illustration 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 12
The NUB process for high risk game changers (§ 137h SGB V process) If method is subject to the new process, two assessment lines apply: Reimbursement Level = InEK DRG-related NUB assessment NUB negotiations yes/no No communication / no interaction between InEK and G-BA Benefit proven G-BA Rapid Benefit Assessment Potential shown Neither “potential” Coverage status = will SHI pay for it at all? nor benefit proven Source: Own Illustration 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 13
Assessment in Medicine Summary 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 14
Summary Mostly clear reimbursement pathways in Germany Outpatient Innovations: Coverage hurdle first Federal-wide decisions via G-BA Level of Selective contracts challenge Single case decisions Non-innovations: where is the piggyback opportunity? Separate processes for specialties apply (e.g. drug-alike devices, medical aids) 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 15
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 1.S.002 Pathways for innovative and non-innovative Devices in Germany November 14 th , 2017 Page 16
Assessment in Medicine AiM GmbH Michael Weisser - COO & Authorized Representative - +49 7621 705 105 0 info@aim-germany.com www.aim-germany.com 1.S.002 1.S.002 Pathways for innovative and non-innovative Devices in Germany AiM. A company of the IGES Group. November 14 th , 2017 Page 17
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