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.
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.
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.
To build on the success of 2019, the extended leadership team of the Medvance group met in Paris on February 4 and 5, 2020! Planning 2020, project review, Medvance Academy and a great wine tasting in the heart of Paris – Medvance – Our local experience – your European Market Access success!
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.
- 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
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!
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.
Great start into 2020 with MArS!! We have six presentations accepted at this year’s conference of the German health economists conference (DGGÖ).
The MArS team wishes all a merry and peaceful Christmas and a great start into the New Year!!!
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.