Innovation backlog in Germany?

The vfa is referring to the gap between available medicines in Germany compared to the USA. In the period 2015 - 2023, 15 drugs classified by the FDA as very important and 21 as important were approved in the USA but are not available in Germany. As a solution to this innovation backlog, the vfa recommends not only strengthening research in Germany, but also improving the AMNOG process and the reimbursement situation.

Market access in Germany has become more complicated in recent years due to the generally high financial pressure on statutory health insurers (SHI) and in particular as a result of the SHI Financial Stabilisation Act (GKV-FinStG), which came into force in 2022. With the Medical Research Act (2024), the legislator has now at least partially improved the guard rails.

The actual consequences of the GKV-FinStG in particular will only become apparent in the medium and long term. In an international comparison, the German market remains attractive for the time being, but should not allow this position to be jeopardised by increasing restrictions and bureaucracy. 

• Reimbursement from day 1 at the price chosen by the pharmaceutical entrepreneur: Innovative drugs are reimbursed by the statutory health insurance funds at the launch price for a period of 6 months immediately after market launch. These attractive market conditions lead to an average time-to-market of 151 days compared to the EU27 average of 517 days - here Germany, with the largest market in Europe, has been the European leader for many years.
• Transparent and fast evaluation system: A transparent, comprehensible and clearly structured procedure offers legal certainty and planning security. The procedure, including negotiations on a new price, is usually completed after one year.
• Hearing of the pharmaceutical company: The oral hearing gives the company and key opinion leaders the opportunity to comment on the benefit assessment and address critical points with strategic foresight. This is a special feature compared to other European countries and ensures the involvement of both pharmaceutical companies and the medical community in the benefit assessment. The publication of the verbatim protocol provides additional security.

Comprehensive strategic planning offers pharmaceutical companies realisable opportunities to launch their innovative therapies in Europe's most attractive market, Germany.

SKC is happy to support you and your company as a reliable and experienced partner, both strategically and operationally, at every step of the market access process in Germany or in early strategy development. We are the market access special forces.

Sources:

Wachsender Innovationsrückstand (vfa.de)

Marktzugangsmonitoring (vfa.de)

AMNOG Report 2024 (dak.de)