Strategic advice on Pricing & Reimbursement Pathways in Germany

For retail drugs, prices need to be negotiated and agreed with the GKV-SV (GKV-Spitzenverband). Our team of consultants can assist you through this process:

• Germany allows immediate commercialization after marketing authorization with pharma, Biotech and MedTech manufacturers being free to set their price during the first six months with full reimbursement and no payback of the difference between the launch price and negotiated refund amount
• Since the AMNOG (Arzneimittelmarkt-Neurodnungsgesetz) new medicines are subject to an assessment of the added therapeutic benefit which is carried out by the G-BA (Gemeinsamer Bundesausschuss) with the support of the IQWiG (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) in month 1-6 after the introduction of a medicine in Germany.
• This is followed by price negotiations with the GKV-SV in month 7-12 after the introduction of a medicine in Germany. If an agreement is reached, the new refund amount will take effect retroactively from month 7 onwards and is published in the German price database Lauer Taxe
• If no agreement is reached in price negotiations, there is an arbitration procedure

Insights into Germany’s Medical Devices Market 

Germany is the third most lucrative medical devices market in the world and is regulated by the EU Medical Device Regulation (MDR). It is important to choose the right strategy to enter the German medical devices market in order to be successful. There are significant differences according to the setting of care and the indication:

• For medical devices used in the hospital in-patient setting the principle of “permission with veto right” applies, i.e. new examination and treatment methods can be used here as long as they have not been excluded by the G-BA in accordance with §137 c SGB. Medical devices used in the hospital in-patient setting typically need to be covered via DRGs but there are special pathways for more expensive devices to be funded, such as the “Zusatzentgelte” (additional funds) for hospitals to secure additional funding, or the “Neue Untersuchungs- und Behandlungsmethoden (NUB)” (new methods), which is a funding source for new diagnostic tools and devices.
• For medical devices in the outpatient sector the opposite principle applies, i.e. reimbursement of medical devices in the outpatient sector at the expense of the statutory health insurance system is subject to the so-called permission provision, which means that they may not be used at the expense of the statutory health insurance system unless there is a positive decision by the Joint Federal Committee (G-BA). The CE marking for medical devices, which is essential for market entry, does not imply any reimbursement by the SHI, but it is a mandatory prerequisite. For specific types of devices there are particular pathways e.g.:
  • Medical devices with a low material value – so-called practice supplies
  • Medical devices that are reimbursable as aids are subject to an additional quality check through inclusion in the list of aids and are subject to different price-based contractual reimbursement rules.

The Impact of the Digital Health Care Act (DVG) IN GERMANY

For eHealth, it is crucial to assess the classification and P&R pathways. With the enactment of the Digital Health Care Act (DVG) in 2019 digital health applications (DiGA), which are prescribed by physicians and psychotherapists, can be reimbursed by statutory health insurance. Other digital innovations such as software or AI based algorithms may fall under the pathways for medical devices described above or could be reimbursed as part of a procedure or underlying reimbursement code.