Getting access for patients to new medications in Germany – the biggest challenges in the HTA process and how to address them: Interview with Carsten Schwenke

Today, regulatory approval doesn’t ensure anymore, that patients benefit from new therapies. As statisticians, we also need to ensure access and reimbursement for new treatments in the different markets around the world.

The process to gain this access and reimbursement in Germany comes with very specific challenges. Yet, due to the large impact of Germany on other countries via the complex reference pricing system and the size of the population of Germany, we must understand these topics.

Carsten Schwenke gathered experiences across therapeutic areas with many companies since the start of the new process in Germany. This makes him the most experienced and best connected statistician in the world for this topic.

By listening to this interview, you will

• get an understanding of the importance of the HTA process in Germany,
• learn about key processes and stakeholders to reach successful reimbursement,
• get an overview about common challenges, and
• learn when and how to address these issues.

In this episode, we cover the following questions:

• Why do we need a value dossier in Germany, when we launch a new medication?
• Who are the key stakeholders in the AMNOG process?
• How does the process look like from a high-level perspective?
• How is the evidence provided to regulators like EMA different from the analyses provided to GBA?
• What are the typical problems, many companies struggle with and what are your recommendations to address them?
• Many people are familiar with the NICE process in England or the ICER in the US. What is different in Germany?
• Where can people find further information about this process?

Further resources for you about the German system and this episode are:

• Webinar series from PSI with Carsten Schwenke (video on demand only for PSI members)
• GBA homepage with submissions
• IQWiG homepage and the methods paper
• IQWiG in dialogue,
• GMDS,
• biometrical colloquium
• Carsten Schwenkes homepage – SCOSSIS

About Carsten Schwenke