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.
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.
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 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…
Register now for our new free webinar! https://us02web.zoom.us/webinar/register/3016007018391/WN_jAWzjHTbSK2m2fUXJoqLtg
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
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.
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.
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.
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.
To build on the success of 2019, the extended leadership team of the Medvance group met in Paris on February 4 and 5, 2020! Planning 2020, project review, Medvance Academy and a great wine tasting in the heart of Paris – Medvance – Our local experience – your European Market Access success!
MArS has created another country profile update for Germany as of January 2020 – a summary is available below – the full report is available on request.
- G-BA post-resolution comittments need now to follow the new IQWiG guide
- Digital care Act: Milestones for the specifications of process documents by the BfArM and GKV-SV were made public. Applications for health apps are expected to be open in April 2020.
- New draft law under discussion with respect to emergency care
- Draft law also discussed with respect to an additional supervisory resources for selective contracts with respect to medical devices and new procedures including the set-up of an arbitration board