The Fairway to Market Access    -    pivotal questions

Kompetenz für den Marktzugang von Arzneimitteln und Medical Devices

Buoy 0 – starting line

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


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

• Study design

• Patient subpopulation addressed

• Nature and extent of patient-related improvement against SoC

• Patient and volume forecast



To the right of starting line



Buoy 1

Upfront assessment of the legal/regulatory environment


• Early benefit assessment (§35a SGB V)

• New examination and treatment methods (NUB) for class III medical devices (§§137e, -h SGB V)

• Early dialogue with G-BA



Buoy 2

Assessment of Product Performance


• Improvement over an indicated appropriate medical intervention

• Real-world size of the target population

• Conditions of reimbursement in the targeted indication



Buoy 3

Market Access Readiness


• Evaluation of market sector, e.g. hospital or outpatient sector

• Set-up of competitive intelligence

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



Buoy 4

Assessment of market processes


• Market size

• Volume sales and pricing

• COGS and marketing expenditure vs. expected revenue potential




Buoy 5

Organizational progress


• Strategic imperatives and resource allocation

• Project and actions plan

• Controlling, 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