Price negotiations for drugs follow clear and strict frames and rules in Germany. Anyhow, there is flexibility in terms of negotiations and price anchors including the tactical move into an arbitration board decision. Even more important is the related contract between the head association of statutory health insurance fund and the respective pharma company. The experienced negotiator Dr. Stefan Walzer and Bibiane Schulte-Bosse will discuss whether the process is a „live and let die“ or „die hard“ – from the different perspectives.
On September 26 2021 there will be the next national elections in Germany. Current forecasts predict a change in the political environment which might also change the current health care politics. Currently various debates are on-going with respect to the health care market including a change in the insurance system, update on the AMNOG process, further digitalization and much more.
Prof. Uwe Wagschal, well-known political scientist will present latest forecasts and potential implications from a political side, whereas Dr. Stefan Walzer will come up with various scenarios with respect to the impact on the health care market access.
One year ago, a special reimbursement process for digital health applications (so-called DiGAs) was implemented in Germany. Until June 2021, 15 DiGAs have been approved by the authority BfArM and the first one is starting price negotiations now.
DiGA experts Dr. Stefan Walzer and Ariane Schenk (Bitkom Health) will discuss the following items:
Process for DiGAs in Germany
Success factors for DiGAS
Price negotiation frame for DiGAs
Outlook into the future, e.g. DiPAs
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Within the German pharmaceutical market access process a core component is the price negotiation which follows in the second part of the evaluation. Negotiations will be conducted between pharmaceutical company and the Head Association of the Statutory Health Insurance Funds. In case no agreement is reached, each party could call the arbitration board which could then come up with a price agreement. The presenters will discuss the decisions of the last 10 years and potential implications. Furthermore, Prof. Wasem as the former head of the arbitration board will discuss the view of it and his experience.
10 years ago, the German reimbursement system for drugs changed significantly. The AMNOG including a benefit assessment and price negotiation was launched. Threats were seen, but also opportunities – the AMNOG frame was criticized and in some aspects also changed over time. A learning system – as some say.
The speakers have worked and shaped the AMNOG process also before its implementation and have also been working since the start of it in various roles and on different products. The presentation and discussions will shows the following key aspects:
- What are key success factors for a optimal AMNOG process?
- Are there any guidances for clinical development?
- How is the benefit rating and price negotiation correlated? What are drivers?
- What can we expect in the future from the AMNOG?
The presenters Dr. Stefan Walzer and Roman Spelsberg analyzed the current situation of the AMNOG process with respect to price contracting. They will show opportunities and hurdles of the current system as well as current examples. Furthermore, they will also come up with a suggestion how innovative contracting could be implemented in Germany – even further…
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Kanavos et al. just published another analysis on external reference pricing (ERP). ERP is widely applied by many payers across the world and also delivers short term cost savings for health care systems. Conclusions by Kanavos et al. are as follows: “ERP has not regulated prices efficiently and has unintended consequences that reduce the benefits arising from it. If ERP is carefully designed with minimal price revisions, prudent selection of basket size and countries, and consideration of transaction prices, it could be a more effective mechanism enhancing welfare, equitable access to medicines within countries and help promote industry innovation.”
The full article is available in the European Journal of Health Economics.
Price negotiation strategy is most of the times also linked to the available evidence and the potential bet on future data. Gladwell et al. have just published a nice simulation approach with the example in the UK which can also be utilized in the D-A-CH context. For the German AMNOG that approach is also relevant for orphan drugs earlier in the process also with the G-BA and for any pharmaceutical within the price negotiations with the GKV-SV.
The article is available in Value in Health.
MArS has long-lasting experience in (price) negotiations in the D-A-CH regions. We have also developed an internal and successful negotiation boot camp utilizing virtual reality. Contact us for a live demonstration.
The Head Association of Digital Health Care (SVDGV) has just been established in 2019 also driven by the new regulations on reimbursement for medical apps. MArS is a member and joined the working groups on reimbursement and evidence.
MArS has a vast majority of experience in the German reimbursement landscape, submissions and price negotiations and will be able to also transfer that into the new field for reimbursement of medical apps. Contact us.