Author: Florian Stieglitz, Market Access Consultant
The Kintiga team supported our client to gain a clearer understanding of the legal and regulatory risks, including confirmation of AMNOG applicability and gained an overall understanding of the AMNOG process and its strategic implications, enabling a well-informed pricing and reimbursement strategy for the German market.
Client Challenge
A small, single drug biopharma company preparing the German launch of its repurposed drug for a rare metabolic disease sought strategic support to:
- Understanding the German AMNOG system and first steps towards a launch
- Assessment of potential a AMNOG obligations (HTA) not only but also with regard to the market exclusivity granted by EMA
- Understand risks related to orphan status and the €30M revenue threshold
- Evaluate pricing potential and value drivers in the German healthcare context
The client planned the launch of a repurposed drug for an ultra-orphan indication in Germany but faced legal uncertainty regarding AMNOG obligation, lack of experience in the AMNOG system as well as in the German market, creating significant risk for pricing and reimbursement strategy. Since the asset involved was the only marketable drug for the company and Germany is by far the most important market in the EU – the stakes at disposition were high.
Kintiga Approach
The Kintiga team conducted a full analysis on the complex study setup and assessed the evidence in regard to the AMNOG process as well performed a comprehensive analogue pricing assessment using our proprietary MAIS database and mapped HTA outcomes of comparable assets, focusing on comparators, value messages, and differentiation. We also evaluated existing pricing assumptions, developed a structured pricing corridor from a payer perspective, and facilitated workshops with external legal experts to validate AMNOG positioning and refine risk scenarios.
The Kintiga team supported our client to:
- Align internally and with external legal experts on implications and next steps
- Determine AMNOG applicability and legal positioning
- Conduct comprehensive market access risk assessment
- Form an understanding of the respective clinical studies and identify key value drivers for the German system.
- Prepare a fully educational course on the German AMNOG system, identify key opinion leaders and outline first steps and strategic imperatives for a launch in Germany.
Results
The project delivered a legal expert-supported draft letter to the G-BA addressing AMNOG obligations, along with an end-to-end market access risk assessment for Germany and complete educational course for the German AMNOG system as well as analysis of key opinion leaders in Germany. It also included a comprehensive overview of the standard of care and competitive landscape, a tailored value proposition aligned with German HTA requirements, and the identification of national key opinion leaders (KOLs) for potential advisory engagement.
As a result, the client was able to fully understand the AMNOG system, to clarify the applicability of AMNOG and strengthen their legal positioning, anticipate challenges related to the €30 million orphan drug exemption threshold, gain a deeper understanding of pricing potential and value drivers within the German HTA landscape and obtained a list of important KOLs for the therapeutic area in Germany. This enabled strategic preparation for engagement with the G-BA and the launch in Germany, work conducted in this project was basis for a follow-up order for the whole market access in Germany.
Find out how Kintiga can help shape your strategy for your next product launch in Germany, backed up by clinical and economic evidence. Contact us now at enquiries@kintiga.com.
Glossary of terms:
- G-BA – Gemeinsamer Bundesausschuss: The Federal Joint Committee in Germany responsible for determining the reimbursement and benefit assessment of medical services and pharmaceuticals within the statutory health insurance system.
- AMNOG – Arzneimittelmarkt-Neuordnungsgesetz: The German Pharmaceutical Market Restructuring Act.
- HTA – Health Technology Assessment
- KOL – Key Opinion Leader
