SMIMIF115U Market Access for Pharmaceutical Products – trends and challenges
Master's Programme in Industrial Drug Development - elective
The course is preapproved as an elective in the Master of Industrial Drug Development (MIND) programme, the Master of Pharmaceutical Regulatory Affairs (MPRA) programme and the Master Medicines Regulatory Affairs (MRA) programme and open for freelance students who meet the admission criteria.
In the competitive world of pharmaceutical sales, developing a market access strategy and communicating the value of the brands to the ‘payers’ is at the top of the agenda. In recent years, the field of pricing and reimbursement of pharmaceuticals has become more complex and challenging.
The economic crisis, austerity measures and general demographic changes (aging population) coupled with newer and more expensive drugs has contributed to bigger hurdles in securing market access. Decisions are now increasingly made on cost-effectiveness and cost-containment rationales, whereas only safety and efficacy guided the decision to a greater degree years ago.
Although everyone seems to be talking about market access, very few are able to define it. Who are the new key stakeholders, exactly? Is it no longer the prescribers that decide which drug a patient should use? Is market access only about containing costs for the public budgets or are the benefits for patients and society as well?
This course will provide insight into the key principles and a practical understanding of ‘market access’ as it relates to the pharmaceutical industry. The course starts with an overview of the key stakeholders and current trends in the global market access of pharmaceuticals followed by a review of the hot topics, challenges and relevant issues through a combination of lectures, discussions, group work, and case studies.
The topics include:
- Introduction to market access - marketing trends, defining global market access for the 21st century, its importance for optimizing product launches and its implications for the entire organization.
- Core concepts of market access – defining the concepts, theories and methods relevant for the pharmaceutical industry.
- Value generation – the role of clinical trials, real-world evidence, life-cycle management and health economics.
- Stakeholders – who they are, their perspectives, how and when to engage with ‘payers’.
- Health economic aspects of market access – economic and financial considerations, core concepts and vocabulary.
- Pricing and reimbursement – global vs. local optimization, reference pricing systems in various markets.
- Important decision makers in Germany and the UK
- Trends in the US market – value frameworks, the ICER institute and its influence
- Patient centricity – the importance of understanding that the end-user must be the focal point of the entire process.
After the course, you will have strengthened your capacity to understand and deal with crucial market access issues. You will have learned about key trends in market access and how market access decisions are made and how the decision frameworks affect requirements for evidence for new health care interventions. You will have:
Acquired a basic market access vocabulary.
Gained insight into the toolbox of the market access methodologies.
Gotten an overview of the key challenges of market access.
Identified the key stakeholders and their influence on the drug reimbursement and prescription process some of the most important markets (e.g.: US, UK, Germany and Denmark).
Gained an understanding of payers’ perspective of key markets and of new reimbursement models which are impacting market access.
Developed skills that will allow you to generate, apply and present real world evidence to maximizemarket access strategy.
Integrated competencies on how to demonstrate product value.
The compulsory syllabus comprises a collection of review papers, textbook chapters and case studies corresponding to approximately 500 pages (extra 200 pages self-selected literature for the optional term paper).
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
- 3 ECTS
- Type of assessment
- Written assignmentAn essay (case study) based on an extended literature list. The essay must be 8-15 pages.
- Exam registration requirements
Active participation in the course is a prerequisite for assessment.
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
- Exam period
Deadline for submission of essay: Announced at the MIND and MRA programme's webpage
Announced at the MIND AND MRA programme's webpage.
Criteria for exam assesment
To pass the exam the students should demonstrate the following:
- Explain how health policy affects and creates a framework for market access and the use of pharmaceuticals.
- Identify and describe the key challenges of obtaining market access.
- Identify major stakeholders & their influence on the drug reimbursement and prescription process.
- Explain, reflect upon, and discuss the importance of market access and its relation to the entire pharmaceutical organization.
- Evaluate the relationship and dynamics of regulatory policies, and their implications for reimbursement of new pharmaceutical products.
- Describe, assess and discuss the various perspectives and potential conflicts of major actors associated with pharmaceutical market access.
- As a professional, be able to participate in multi-disciplinary groups and be able to contribute with a market access perspective on pharmaceuticals
- Class Instruction