MAP - Market Access Podcast

All patients within all populations should have access to high quality medications that improve their health outcomes regardless of race, ethnicity, socio-economic status or any other individual factors,  wrote Dr. Utibe R. Essien in an  Jama article 2021 . But how does reality look like? Equality in access starts with the generalizability of RCT data and the inclusion and excl...

Canadian health care reimbursement might be seen as complex and difficult. Well, not totally wrong… The reimbursement veteran Dr. Stefan Walzer discusses with the Canadian experts Louise Perrault and Nicole Tunstall the process for reimbursement and the specifics of Quebec. What are requirements and what might be important early steps to consider in order to plan for success. Additionally, the pri...

EU Joint HTA will become reality for ATMPs and therapies in oncology by the end of 2024.   Anyhow, methods and processes are not yet communicated and established as of March 2023. Furthermore, there are no opportunities for early consultation to plan clinical trials and/or EU joint HTA dossiers. The core question still remains for which endpoints and comparators data would need to be submitte...

Cancer care is a challenge in all countries. Now imagine, how difficult it is to organize and manage cancer care in a war zone!   In this special MAP Podcast episode the Ukrainian market access expert Yevgen Brovko explains the situation and market access of cancer care before the Russian invasion and the current state in Ukraine. After a more broad overview, he also explains the Uk...

Regulatory processes might vary across the world, EMA and FDA are mostly known, but what are drivers by Health Canada? What to consider when expanding e.g. from the US into Canada with a medical device? Are there differences between US FDA and Canadian decisions for drugs? And if so, why? The reimbursement veteran Dr. Stefan Walzer and the regulatory expert for Canada, Fraidianie Sévignè, discuss...

In Europe, there are at least as many reimbursement assessment processes in place as European countries. Some of these are transparent and clearly defined like the German AMNOG process, others are even more complex and sometimes even unclear, dependent also on the product of interest. Anyhow, the European Commission has already decided that a European joint assessment will come into place in...

It seems to be a given, that prices in the US are higher than in the rest of the world. But what might happen, if the US refuses to pay these higher amounts anymore? There are already changes either approved or heavily discussed like the pricing inflation act, the cap on out-of-pocket cost and the opportunity for Medicare negotiating prices starting in 2026. If the global price system changes...

Companies launching oncology drugs sometimes struggle with existing reimbursement pathways and negotiations with payers, mainly in Europe, but also in other parts of the world. Evidence generation is the start of every drug development, but especially in oncology the design is important – not only that payers want to get a proof of a longer survival, but they also have further needs in their...

In Europe there are many different options to get engaged with payers across different jurisdictions. Given the complexity, the benefit of these might be questioned by some. However, if the pathway is clear and the company knows how to approach payers and asks the right questions it provides valuable insights securing commercial success. Within the podcast the European, UK and German pathways are...

New, innovative drugs are assessed within the so-called AMNOG process in Germany. Given the legal nature of this process, lawyers also play an important role. At the end of the AMNOG process there is a legal contract – and also important, lawyers are experienced in negotiations by nature? If this is true and how lawyers can support market access teams is discussed between the AMNOG expert Dr. Stef...

In this special podcast episode Dr. Stefan Walzer jumps into the latest trends and researches around market access, reimbursement and pricing presented and discussed just beginning of November 2022 at ISPOR Europe. From 6th to 9th of November the leading European experts including Dr. Stefan Walzer have met and discussed in Vienna. Discussion topics ranged widely around market access and...

Given the current reforms and adaptions in the German system, one can wonder if the German market might remain the most attractive to launch pharmaceutical products and especially orphan drugs. Are there still ways to get innovative products into the market and get paid well? What do we need to know in order to still gain from the strengths of the German market size and economic power? This might...

Not everybody can be a statistician, but >The Effective Statistician< Alexander Schacht argues, that every Market Access Manager should work with statisticians and should learn how to communicate statistics effectively. Together with Dr. Stefan Walzer he is framing the needs and importance of statistics in the context of market access and reimbursement.  Don’t miss t...

Digital health could improve the efficiency, care and way patients are treated in all health care systems in the next years. Germany has started by implementing digital health applications (“DIGAs”) and is currently on its way to improve the digital infrastructure in hospitals. Anyway, some core questions remain such as reimbursement for high risk medical devices, e.g. artificial intelligence (AI)...

Within the opportunity of contracting in the German health care market, prices, reimbursement and integrated care paths could be agreed on. However, for some medical devices, especially in the outpatient setting, selective contracts could be the most attractive pathway to enter into reimbursement agreements. Dr. But which health insurance companies should contacted and how? What makes a conta...

Dr. Stefan Walzer, market access expert, and his guest Dr. Andree Battes, expert in artificial intelligence (AI), are discussing the future of market access within the health care industry. How could AI support market access planning, submissions and negotiations, especially with the ever-increasing data? How could AI be beneficial in defining an optimal price anchor? And finally, w...

Dr. Matthies used to be at the epicenter of the DIGA launch in 2020. He was the managing director of the Health innovation hub: digital health think tank of the federal ministry of health in Germany. The first project of agile lawmaking in Germany. What are key takeaways and learnings from 2 years DiGAs? What are pitfalls with a focus on BfArM and the German payers (GKV-SV)? How to be successful i...

The UK has always been on the forefront of market access with its unique pathways within England, but especially also considering Wales, Ireland and Scotland as well. Furthermore, since the Brexit there were new innovation paths introduced. The core question remains, how one could identify the optimal path for their product (including digital health)… Dr. Stefan Walzer and his guest...

The Swiss healthcare system is rather complex but at the same time quite effective. High expenditures into health care corresponds with high life expectancy. However, what are the core processes in Switzerland with regards to health care delivery? What is the path towards innovation pricing and new price models? And what is the status quo on (health care) digitalization?   Dr. Stefan Wal...

What have been the main changes after 10 years of AMNOG for pharmaceutical companies? What have been the biggest successes within these years? For orphan drug the benefit evaluation process was eased in order to keep incentives high. Have price expectations been up met - by both sides? After 10 years of AMNOG first conclusions and recommendations for changes can be made.   Take the chance to...

Israel spends only 7.6% of the GDP on healthcare – significantly less than most other Western OECD countries. At the same time Israel has a higher life expectancy and lower infant mortality. So, better results for less money?! How does Israel do this? Dr. Stefan Walzer and Mirel Stelian are discussing in depth, how the application and reimbursement process works and what options are...

The market access process in the Netherlands can be very special, especially for medical devices. Besides standard reimbursement processes with evidence-based medicine assessments, there are also more pragmatic pathways available. How do these work and what needs to be considered before moving into the Dutch health care market? Listen to the insightful discussion of Dr. Stefan Walzer and the...

Belgium has created a similar fast-track process as in Germany even though that some differences exist. Anyway, core question with new processes is always how the rules are being interpreted and applied. So, how important are clinical studies and when are those required? What are the price levels and negotiations components of the process? Can companies with a successful track record in Germany al...

Europe is one continent, with one Union (plus the UK)… Health policy is still the responsibility of each individual country and hence there are still (at least) as many reimbursement pathways as countries. Planning for business success in health care is hence difficult? Not necessarily according to Dr. Stefan Walzer and Esther Nzenza. Both show up important topics and to dos in order to plan and e...

EU joint HTA will become reality in the next few years as communicated recently by the European Commission. However, applicability and implementation questions are still open such as timing, inclusion into national regulations and HTA processes in the EU member states. In Canada a similar process, including a single joint HTA process which is then being implemented in the respective provinces, has...