Secondary HE analysis on the EFFORT study published!

Existing guidelines support the importance of nutritional interventions for medical inpatients at malnutrition risk to alleviate the impact of malnutrition on outcomes. MArS in conjunction with the investigators of the EFFORT – a pragmatic, investigator-initiated, open-label, multicenter Swiss trial have developed and executed a probabilistic health economic analysis. Our evaluation demonstrates that in-hospital nutritional support for medical inpatients is a highly cost-effective intervention in Switzerland to reduce risks for ICU admissions and hospital-associated complications, while improving patient survival.

The full article is available on the website of the Journal of Clinical Nutrition

MArS has a strong background in health economics, the related data analytics, medical writing and communication with payers. We have developed various health economic analyses in the last years which lead to over 35 manuscripts in scientific journals and more than 150 presentations at conferences.

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.

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.

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!!

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 payersPricing – planning, research, design, implementation and Price negotiation.