Decode the G‑BA
with MBM Future Health
♣ Ensure that patients receive the best possible treatment.
♣ Achieve a fair reimbursement for your medicine.
♣ Reach your full potential in the AMNOG procedure.
♣ Ultimately, rely on my long-standing experience at the G-BA. ♣
Identifying the best strategy for a global clinical development of innovative medicines is extremely challenging.
Uncertainty increases when evidence is scarce, as it is often the case in rare diseases and precision medicine. What is the best value proposition for future assessment and reimbursement? Which endpoints will – in the end – be considered patient-relevant? Is the launch in Germany a good option?
♣ Together with you, I identify the best scenario to ensure optimum results for your medicine. ♣
Launching a product is a critical task.
Procedures at the G-BA are complex. Decision-making authorities are difficult to understand. How to decrypt evidence-based decision making? How to make an informed decision on your individual case with your team?
♣ Get tailored advice on decision-making procedures at the G‑BA for your individual case. ♣
Your unique benefits
G-BA Expertise
You benefit from my long-standing experience as G-BA Officer.
Your personal Expert
You receive advice solely from me.
Operating worldwide
You want me in person!
Dr. Meriem Bouslouk-Marx
MEET
Dr. Meriem Bouslouk-Marx
♣ Extensive experience at the G-BA ♣ Individual advice for a wide range of therapeutic areas ♣ First-hand knowledge of evidence-based decision criteria for reimbursement ♣ Specialisation in Orphan Drugs including Cell and Gene Therapy Products ♣ Scientific Consultation ♣ Professional Network with Complementary Expertise ♣ Medical background including Tropical Medicine ♣ Public Health projects ♣ International Experience ♣ Multilingual (German, French, Arabic, English) ♣ Lecturer in Market Access ♣ Public Speaker ♣
in action
Lecturer and Speaker at the Market Access Society (MAS). MORE INFORMATION
Adviser at Project HERCULES, a Duchenne UK Global Collaboration. MORE INFORMATION
Speaker at the Brazilian Health Regulatory Agency Anvisa. GENE AND ADVANCED THERAPIES: Creating Value in the Patient Journey and the Health System. MORE INFORMATION
Adviser with the Alliance for Regenerative Medicine (ARM). Getting Ready: Recommendations for Timely Access to Advanced Therapy Medicinal Products (ATMPs) in Europe. MORE INFORMATION
in references
AMED, Japan Agency for Medical Research and Development (2020) Development Trend Survey of Ultra Orphan Drugs. MORE INFORMATION
Schoonveld, E. (2020). The Price of Global Health: Drug Pricing Strategies to Balance Patient Access and the Funding of Innovation (3rd ed.). Routledge. MORE INFORMATION
OECD, Organisation for Economic Co-operation and Development (2018) Pharmaceutical Reimbursement and Pricing in Germany. MORE INFORMATION
Mit der EMA auf der Überholspur
Article published in Tagesspiegel Background Gesundheit & E-Health on 26 February 2021
Im Standpunkt ordnet Arzneimittel-Expertin Meriem Bouslouk-Marx die politischen Entscheidungen und Verfahren in Deutschland und der EU zur Zulassung und Verteilung von Impfstoffen auch vor dem Hintergrund öffentlich geäußerter Kritik ein.
With EMA on the fast track
Pharmaceutical expert Meriem Bouslouk-Marx takes a stance on the political decisions and procedures for approval and distribution of vaccines in Germany and in the EU, also in the light of public criticism.
Efficacy Controversy Hits European COVID-19 Vaccine Rollout
Article published in Pharmaceutical Executive
Donald Macarthur and Dr. Meriem Bouslouk-Marx discuss post-approval findings of national committees in Europe charged with deciding the best strategy to use a new COVID-19 vaccine in their populations.
By end-January 2021, three COVID-19 vaccines had received conditional marketing authorizations (valid one year) by the European Commission…
G-BA benefit assessment of new orphan drugs in Germany: the first five years
Article published in Expert Opinion on Orphan Drugs
The January 2011 introduction of benefit assessment through the Act on the Reform of the Market for Medicinal Products in Germany, better known as AMNOG (Arzneimittelmarktneuordnungsgesetz), created a new way to assess the value of patented medicines at the time of launch for use as a basis to determine their ongoing reimbursement. This Act was basically intended to counteract increasing drug prices…