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.

MArS is now a proud member of the Head Association of Digital Health Care in Germany!!

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.

Market access of health apps for public health insurances in Germany – coming soon

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!

New government in Austria – impact on the medical industry and market access?

What does this mean for the pharmaceutical and medical device industry? MArS has created a country profile update Austria – a summary is available below – the full report is available on request.

Ultimately: Given the structural changes in the overall health care system in Austria it is not expected that there will be major changes within the frame and decision criteria by the Hauptverband and hence market access.

MArS has vast experience in submissions, pricing and negotiations in Austria. Contact us!!

MArS at G-BA legal symposium in Berlin

The G-BA has invited various experts on the topic of “The impact of the EU on the legal frame of the statutory health insurance system in Germany. Experts included Prof. Becker (Max-Planck-Institute), Prof. Ebsen (Goethe University Frankfurt a.M.), Prof. Straeter (Straeter law firm), ministerial officer Schulte (Ministry of Health), Prof. Schaefer (University of Applied Sciences Fulda) and the Head of the G-BA Prof. Hecken.
Various presentations were given with respect to the impact of the new medical device regulation and its potential impact especially on product scarcity. A special focus was also given on the joint EU-HTA recommended by the European Commission.
The conclusions across the speakers for the IVD regulation was that delivery bottlenecks are expected, as the number of Notified Bodies is not sufficient!
  • “Notified Bodies”, which previously carried out the certification, are now accredited. Currently there are only 7 companies that are allowed to certify from 20.5.2020. The small number would delay the certification considerably.
  • Previously, the state authorities were responsible for monitoring medical devices. From 25.5.2020, this will fall within the remit of the BfArm, i.e. the BfArm itself can withdraw medical devices from the market.
  • British Standard Institution issues 2/3 of CE certificates in UK and is now accredited as Notified Body in Germany
On the EU joint  HTA there were mainly still a lot of questions how that could finally be implemented in Germany. There are four key issues that are currently being discussed:
  1. Legally binding: alternative compromise ideas with more scope for the member states are currently being developed for this purpose.
  2. Judicial redress: would an EU HTA assessment be an administrative decision or a preparatory measure to a decision?
  3. Scope: newly authorised medicinal products (proposal D/F: selection of 10 products per year); medical devices (proposal D/F: selection of some high-risk products)
  4. Dispute resolution in proceedings: is a simple or qualified (55 % of Member States with 65 % population) sufficient?
Further insights into the procedure:
  • Normally, the Council negotiates between Parliament and the Commission; this is the first time that parliament mediates between the Commission and the Council.
  • Theoretically, failure would be possible, but would be a major setback for the EU.
  • Agreement between Commission, EU Parliament and EU Council (“Trilogue”) expected in 2020
  • Depending on how long the procedure will last, the question is which country as President of the Council will end the procedure: 1. HY 2020: Croatia; 2. HY: Germany
Prof. Hecken also made it quite clear that the draft regulation is too early for drugs. The results of EUnetHTA should have been awaited and evaluated until 2021. Additionally, there cannot be one EU evaluation without a common methodology paper. And the crucial questions remain: “What is the conclusion of the EU evaluation report? How legally binding will the recommendation / decision be? Will there be a regional scope to reflect the supply context?”
MArS supports our clients in the public policy discussions and helps them also to position with health care payers and their opinions. Additionally, we have a long-lasting experience with respect to successful reimbursement and market access applications (e.g. AMNOG, NUB, OPS, GoÄ submissions) with which clients can improve their own case. More on our service list: Public Relations / Public Relations or Submissions for reimbursement of expenses and Pricing – planning, research, design, implementation