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 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.
The digital care act passed the German parliament and includes especially also the reimbursement of health care apps by German statutory health insurance funds. The process for market access will include an evaluation and registration at the German registration institution BfArM and thereafter a price negotiation with the Head Association of the Statutory Health Insurance Funds (GKV-SV). How these various steps will be detailed is still open. However, now the milestones are made public when the process steps will be published.
- The draft legal framework will be published by the Ministry of Health in January. There will also be the opportunity of commenting the draft.
- BfArM guidance on the details about the process, procedure, method and requirements are bing Mae available in February
- The final framework and BfArM guidance is planned to be available in March 2020
- From April 2020 onwards the BfArM online platform as well as the option for consultations will be up and running and also fast track submissions are then possible.
So, get started and prepared for reimbursement of digital apps in Germany.
MArS has experience in the AMNOG process which might be quite similar to the BfArM process and especially the price negotiations with the GKV-SV. MArS has also developed the MArS Negotiation Boot Camp utilizing latest technology including Virtual Reality in order to be optimally prepared for a successful price negotiation. Contact us!