The Fairway to Market Access    -    from clinical stage to pricing & reimbursement

Kompetenz für den Marktzugang von Arzneimitteln und Medical Devices

Buoy 0 – starting line

Scope of clinical data required for national health authorities before initiating the market access processes


• Study endpoints, i.e. mortality, morbidity and health-related QoL

• Study design

• Patient-related benefit of subpopulations addressed

• Nature and extent of patient-related improvement against SoC

• Disease incidence and product volume forecast



To the right of starting line



Buoy 1

Upfront assessment of the legal/regulatory environment


• Early benefit assessment according to §§35a/-137h SGB V

• New examination and treatment methods (NUB) for class IIb/III medical devices

• Readiness for AMNOG process according to §130b SGB V



Buoy 2

Assessment of Product Performance


• Nature and outcomes of treatment alternatives for the targeted indication

• Improvement over a G-BA stipulated appropriate medical intervention (zVT)

• Real world evidence reported and size of the targeted disease condition



Buoy 3

Market Access Readiness


• Evaluation of market sectors and conditions for pricing and reimbursement

• Setting of the competitive landscape i.e. provider preferences, payer constraints

• Engagement of key stakeholders, i.e. medical counselling, patient engagement



Buoy 4

Assessment of market processes


• Market size, volume sales, reimbursement, number of customers

• Outline of commercial operations, i.e. marketing & sales objectives

• COGS and profit margin




Buoy 5

Organizational progress


• Strategic imperatives and resource allocation

• Project and actions plan, i.e. launch management

• Controlling and securing the operational success




To the right of the finishing line



Licensing authority                                                 HTA bodies

(BfArM, PEI)                                                        (G-BA, IQWiG)



negotiation of reimbursement price with GKV-SV



Hospital procurement department                  Health insurance funds







(BfArM – Federal Institute for Drugs and Medical Devices │ G-BA – Federal Joint Committee │ IQWiG – Institute for Quality and Efficiency in Health Care │ PEI – Paul Ehrlich Institute │

HTA – Health Technology assessment)






Market Access Medical Devices Pharma Marktzugang von Arzneimitteln weltweit

Market Access Medical Devices Pharma Marktzugang von Arzneimitteln weltweit