09 Dec
Latest News

Fast track access for apps into the GKV market in Germany

MArS attended the Medical valley Forchheim symposium on the market access pathway for new digital solutions (“apps”) into the statutory health care market. The new law will come into effect January 1 2020. Still open are the templates for the BfArM consultation and the price negotiation frame with the Head association of the statutory health insurance funds (GKV-SV). For the BfArM the regulations can be expected as the new law §33a para. 3 SGB V RefE is now publicly available. In case clinical evidence for a (patient) benefit is proven the app can be included in the BfArM registry / database, if that is not the case this can be provided within the first year of launch.

For the price negotiations MArS expects the regulation frame to be similar (but adapted) as within the AMNOG process. Core drivers will be the European prices (incl.out of pocket cost) as well as the clinical evidence on the product and comparable products. The template for the price negotiations are expected in the next few weeks. The arbitration board is not yet defined and built but is expected soon.

MArS offers the digital industry the experience in the process and contacts with German payers, the BfArM and especially with price negotiations with the GKV-SV. Core services to be provided will be Communication with payers, Pricing – planning, research, design, implementation and Price negotiation.

06 Dec
Latest News

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
20 Nov
Latest News

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.