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.
Price negotiations in Germany – live and let die or die hard?!
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.
German elections ahead – potential outcomes and implications on health care market access
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.
1 year DiGAs in Germany – Garden of Eden?
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
Register now for free!
Access to German hospitals – pathways to follow
The pathway to German hospitals for medical devices, digital health applications and drugs can be straight forward in Germany. However, in the meantime there are various pathways available including the famous “NUB” and the newly introduced Hospital Future Act as well as experimental coverage and innovation fund applications. Additionally, investment goods need to differentiate between hospital ownerships.
The presenters, both long-lasting members of the Inpatient committee at the German Health Economic Association, will discuss the various pathways and applicability as well as the correlation to the annual budget negotiations of hospitals and will show the various aspects to consider when planning a launch into the German hospital setting.
MArS goes Clubhouse (again) – 10 years AMNOG
After a great webinar on “10 years AMNOG” on Thursday evening, we are happy to announce that the discussions are expanded into the German-speaking community! MArS Market Access & Pricing Strategy GmbH goes (again) to Clubhouse!! The session on April 1 2021 will be recorded and made available afterwards as well – but even better, join us and discuss directly with well-known experts: Dr. Stefan Walzer, Prof. Dr. David Matusiewicz, Bibiane Schulte-Bosse, Dr. Mathias Flume, Heiko Schellhorn, Prof. Dr. Thomas Hammerschmidt – moderation as always by Lutz Vollmer!!
Join us at Clubhouse!!
10 years AMNOG – what have we learnt for drug development and pricing?
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?
Innovative price contracting in the German AMNOG process – is this the future or just a dream?
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…
Register now for our new free webinar! https://us02web.zoom.us/webinar/register/3016007018391/WN_jAWzjHTbSK2m2fUXJoqLtg
EU HTA to come?
There is a big debate since years on the potential implementation of a joint HTA system across Europe. Core questions on such a system remains on how such an approach could look like and even more important be implemented. The webinar will summarize the current status of the debate and also suggest a way how such a joint HTA could be implemented in the European Union.
Register now: https://us02web.zoom.us/webinar/register/4715954498495/WN_8WnsBaNyQZKf4BFvtgBP4g
G-BA prepared their decision-making capacity given the COVID-19 outbreak
The G-BA has decided today that the COVID-19 outbreak and the related public restrictions are special circumstances in their internal regulations. Hence they can now also utilize videoconferences and written decision-making. See also details on their website. Their decision is still due until the Ministry of Health decides on the resolution.
So, the market access route for drugs, medical devices, diagnostics, vaccinations is still open and ready for (new) innovations.
MArS has vast experience in market access strategy, the writing of applications and related price negotiations. Contact us!
New analysis on external reference pricing shows negative impact on drug availability
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.
MArS has experience in pricing research and strategy as well as in price negotiations and can hence assess the ERP impact on the D-A-CH countries in detail.
MArS teaching at the MedTech Startup School in Tuebingen / Germany
At the start of a product’s lifecycle there are many questions to be answered and many processes to be planned. One of the core areas to cover is pricing and reimbursement as this has a direct impact on the price and patient outreach (“availability”) and hence a company’s revenues flow. MArS is teaching the tools and processes as tutors at the Startup School Tuebingen with a variety of new companies and various bright business ideas.
With our experience in pricing planning, insurance contacts, submissions and negotiations we can help driving a company through the endeavor of market access from the early days until the end.
Price negotiation article published – link MArS negotiation boot camp
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.