In Germany, a new market access and reimbursement process for digital health applications (DiGAs) was introduced in early 2020. In our approx. 45-minute webinar, you will learn what this new process looks like and which similar processes may exist in a European comparison. The French expert Guy Eiferman from the Market Access consulting agency Nextep will speak about the French process. The webinar will conclude with a panel discussion on the main differences and similarities between France and Germany as driving forces for digital innovation in Europe.
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 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.
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.