Market Access Pathways for Medical Devices in the German Hospital Sector Oliver Martini Director Government Affairs & Policy Germany Medical Devices, Pharmaceuticals and Consumer
Funding Pathways for Medical Devices Medical Devices Inhospital Ambulatory II. Department with III. Day-surgery at IV. Ambulatory I. Main department ext. physiscians the hospital Sevices DRG AOP-contract acc. Fee for Service DRG ZE to 115b SGB V (EBM) Fee for Service ZE Fee for Service Heilmittel (EBM) (EBM) Reimbursement Scheme 3
Reimbursement Check-up for Innovations OPS Procedure New Technology Code? = new Method Potential acc. Outcome > Standard? § 137c(3) Outcome > Standard? SGB V? Costs covered by Costs > Standard? DRG? Regular Care NUB? NUB? Regular Care 4
Market Access for Hospital Innovations Standard process • New Diagnostic or Treament Method? • Clinical & economic relevance? Method is covered by DRG adequate? • Cost difference > fiirst standard diviation of DRG costs? NUB- €€€€ NUB- Application Status 1 Negotiation Hospital Potential of relevant treatment alternative acc. 137c (3) SGB V 5
New Process for Disruptive Innovations with High Risk Medical Devices with very Invasive Character First time NUB Application High Risk Medical Device with very Regulated by Invasive Character (MPhR) MeMBV Medical Device Method Evaluation Regulation Disruptive Innovative Method with new theoretical-scientific concept 6
Market Access for Disruptive Innovation • First-time NUB Application? • MP Risk class IIa / III & very invasive character? • Aignment with Manufacturer NUB- €€€€ NUB- Application Status 1 Negotiation Potential acc. Hosptial 137c (3) SGB V HTA Dossier submitted by hospital & & Statements & Method with new scientific- Benefit Assessment Dossier theoretical Concept? 2 weeks 1 month 3 month 7
Benefit Assessement of the Innovation G-BA Code of Procedure (Verfahrensordnung) Measure Assess Decide G-BA Decision Rapid HTA by • Method paper 4.2 A B A • Pharma approach No RCTs, but Full Evidence Negative • Only RCT accepted Potential for an Accepted evidence, Alternative Treatment harmful Option CED 8
Challanges of Innovation Payment Clause acc. to § 137e/h social code book V • Early Benefit Assessment of Inpatient Methods – Early dialogue on relevance of new method too late and insufficient – Decision on potential high evidence threshold comparative trial – Missing SOP for reassessment, if a method was excluded from DRG based on missing potential benefit – Missing SOP for evidence generation uncertainty in planning and calculation • Coverage with evidence development directive according to § 137e SGB V – Duration of procedures on determination of the CED decision and the CED study high risk for comparative advantage in terms of innovation and profitability – High cost uncertainty and missing compensation options – Uncertain reimbursement risk of lower ROI than expected 9
Announced Changes of the nnovation Payment Clause acc. to § 137h SGB V through Medical Appointment Service and Care Law (TSVG) • Early dialogue with Joint Federal Committee (G-BA) • NUB application of the hospital needs “agreement” instead “consultation” with the medical device manufacturer (MDM) • No proof of “potential” as treatment alternative by G-BA / IQWiG / no comparative trials needed at NUB application • G-BA will sponsor all Coverage with Evidence Development (CED) trials unless the medical device manufacturer (MDM) will sponsor it (fast track) • Fast Track for CED trial , as company sponsored CED trial commissioned by an independent institution / institute listed by the FJC • Ambulatory care: Payback of investment by the MDM after access to the remuneration system for ambulatory care
Supports BVMed members & forces the political discussion 11
Question? 12
Oliver Martini Director Government Affairs & Policy Germany Medical Devices, Pharmaceuticals and Consumer Charlottenstraße 59 ││ D - 10117 Berlin Cell: +49 - 173 54 55 932 omartini@its.jnj.com http://www.jnj.com
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