30 Oct
Latest News

The potential impact of the 2020 US presidential election on global health care pricing

The expert teams of MArS and PSE will summarize the results of the US presidential election before detailed discussions and finding on the potential health care changes and its global impact will be discussed. Most likely the potential price referencing of US prices to a global country basket will be included as other specific items.

Register now for the free webinar on November 24 2020at 9pm CET / noon PT: Register

28 Sep
Latest News

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

16 Mar
Latest News

Work environment given the COVID-19 outbreak

Dear clients, network partners, friends!!

Most of companies are moving now into home-office-based business given the outbreak of the COVID-19 virus! Home-office sounds easy, it is not always, especially if you have not (yet) a grown culture on that kind of work.

We at MArS always work from our home-offices, and we have specific tricks and recommendations you need to follow in order to make it successful! On the work environment section of our website you can find already some suggestions.

But please take this as an offer: Contact me or any MArS member to get insights how home-office can be made a successful story given the difficult situation we are currently all in.

Take care and stay at home!!

11 Mar
Latest News, Publications

New analysis on external reference pricing shows negative impact on drug availability

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.

MArS has experience in pricing research and strategy as well as in price negotiations and can hence assess the ERP impact on the D-A-CH countries in detail.

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