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!

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.

Country update Germany January 2020 – what’s new for market access?

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.

As summary:

  • 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

MArS has vast experience in submissions, pricing and negotiations in Germany for pharmaceuticals, medical devices and diagnostics.

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

Price discussion on new drugs in Germany

The availability of Zolgensma in the USA has also fuelled the price discussion for new drugs in Germany. Zolgensma is approved in the USA for the treatment of children with spinal muscular atrophy (SMA) and can (potentially) cure the disease. The drug has not yet been approved in Germany – European approval is expected next year.

Now there are two big discussions in Germany: On the one hand the handling of drugs that have not yet been approved in Germany and on the other hand the pricing of these drugs.

The handling of drugs prior to approval is clearly regulated in the Drug Hardness Ordinance (AMHV) on the so-called Compassionate Use Programme and provides for a cohort programme care of German patients. The drug is made available free of charge! The individual case regulation, which is now also criticized by the health insurance companies, is also clearly regulated by the so-called “Nikolaus” judgment from the year 2005 and is especially made for life-threatening diseases.

As far as the price is concerned, it should be noted that 1) SMA only affects 500 patients throughout Europe, i.e. approx. 80 patients in Germany (!) – so with 100 insurances on average 1 patient per insurance – and 2) without an expectation for high profit in such ultra orphan diseases, no new therapies and medicines will be available in the future either, as the research and investment incentives are then no more given.

Press article on the issue available in German, e.g. in the Badische Zeitung as of November 20 2019: Hoffnung, Leid und viel Geld as well as a comment.

MArS supports you with the optimal reimbursement strategy, pricing for the D-A-CH market and, of course, in a possible early contact and discussion with the statutory health insurance funds.