Fairway

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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