Germany is the number one focus market for pharma, biotech and medtech Market Access as it has the largest population in Europe (around 84.5 million people covered by health insurance) and represents the biggest healthcare market in terms of value in the EU. The German healthcare system offers strong incentives such as immediate reimbursement upon Marketing Authorization for medicines with an initial period of free pricing. Our agency Justin Stindt Consultants is specialized in Market Access Germany and can help you navigate German Market Access.
Market Access Germany – Essential to access the largest EU market for pharma, biotech and medtech
Germany’s universal multi-payer healthcare system consisting of statutory health insurers (“sickness funds”) and private health insurance together covers almost 100% of the population of around 84.5 million. Full reimbursement is granted upon the introduction of a prescription medicine with Marketing Authorization into the German market. There is an initial period of free pricing during which benefit assessment by the G-BA is carried out. This is followed by price negotiations with the GKV-SV to agree on a new reimbursement amount.
Innovative medical technologies can be made available ahead of regular reimbursement decisions which can take many years by leveraging the ‘Trial upon application’ (Antragsgesteuerte Erprobung) process. For more information visit our Trial upon application page.
G-BA’s Role in Market Access: Navigating Early-Advice Consultations and AMNOG Dossier Assessments in Europe’s Largest Market
The G-BA is a critical stakeholder in determining market access to the largest market in Europe and offers early-advice consultations to pharmaceutical companies in accordance with its rules of procedure. For more information visit our G-BA advice meetings page.
The assessment of medicines and the determination of their added value are entrusted to the Gemeinsamer Bundesausschuss (G-BA), which commissions the Institute for Quality and Efficiency (IQWiG) to conduct the HTA. The AMNOG dossier is a critical part of the added benefit assessment and it is fundamental to submit a dossier that is complete, accurate, and oriented towards the G-BA’s requirements. For more information visit our AMNOG dossier page.
Exploring German Market Access: Pricing Strategies for Medicines and Pathways for Medical Devices and Digital Health Apps
Pricing of new medicines in Germany is free for the first six months followed by price negotiations with the umbrella organization of the sickness funds (GKV-SV). For medical devices, there are multiple Market Access pathways. Germany has also created a reimbursed pathway for digital health apps (DiGA). For more information visit our German P&R pathways page.
At Justin Stindt Consulting, our team of experts has extensive experience in providing our clients with tailored support to provide Market Access in Germany as soon as possible at sustainable pricing and reimbursement conditions.
Justin Stindt Consultants is your agency to support you with Market Access in Germany
Justin Stindt Consultants is your consulting firm with experts who have extensive experience in Market Access Germany. As a service provider, our consultancy has helped many clients by engaging the G-BA for scientific advice meetings and develop benefit assessment AMNOG dossiers.
Our consultants also support price negotiations. For medical devices and digital health apps, our agency supports dossiers and negotiations. Many of our consulting firm’s clients have found Germany the place to start for Market Access in Europe and decided to enlist our agency as partner of choice given our footprint and experience in the German market.
Contact our experts today to learn how our agency can tailor our services to meet your unique needs to enable Market Access in Germany.
Market access services for pharmaceutical and biotech products in German
Case studies for German market
- Support entire German Market Access process
- ATU Feasibility Assessment
- HAS early dialogue meeting
