Market Access for Pharmaceutical Products – trends and challenges

Course content

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 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 selected countries 
  • Trends in key markets 
  • Patient centricity – the importance of understanding that the end-user must be the focal point of the entire process.
Education

Master of Industrial Drug Development (MIND) - elective

The course is preapproved as an elective in 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 pressures and general demographic changes coupled with highly innovative 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.

Although everyone seems to be talking about market access, very few are able to define it. Who are the 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?

Learning outcome

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 in 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 maximize market access strategy.

  • Integrated competencies on how to demonstrate product value.

The course is organized as an intensive 5-day course and comprises lectures, group work, case studies and discussions.

The compulsory syllabus comprises a collection of scientific articles, review papers and case studies corresponding to approximately 500 pages (extra 200 pages self-selected literature for the optional exam).

The course is designed as continuing professional development for professionals in the pharmaceutical industry, particularly in regulatory affairs, medical affairs and sales and marketing, including decision-makers and administrators in the public and private sectors. The course offers an excellent introduction for those less familiar with market access and will provide a deeper understanding for those with experience within administration and marketing. Please note, the course is not an advanced course for market access specialists.

Applicants must meet the following criteria:
• A bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering or equivalent.
• At least two years of relevant work experience related to development of medicines
• Proficiency in English

Oral
Collective
Continuous feedback during the course of the semester
ECTS
3 ECTS
Type of assessment
Written assignment
Type of assessment details
A written assignment. Individual written assignment based on a relevant set of questions provided by the course managers and based on an extended literature list.
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 exam: Announced at the MIND programme's webpage

Re-exam

The exam form for the reexam is the same as the ordinary exam. Se dates in the examplan at the MIND programme's webpage

Criteria for exam assessment

To pass the exam the students should demonstrate the following:

Knowledge

  • 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.

 

Skill

  • 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.

 

Competence

  • As a professional, be able to participate in multi-disciplinary groups and contribute with a market access perspective on pharmaceuticals

Part time Master and Diploma courses

  • Category
  • Hours
  • Class Instruction
  • 40
  • Preparation
  • 22,5
  • Exam
  • 20
  • English
  • 82,5

Kursusinformation

Language
English
Course number
SMIMIF115U
ECTS
3 ECTS
Programme level
Part Time Master
Duration
5 days
Placement
Summer
Price

See course fee details at MIND-programme webpage

Schedulegroup
August
Capacity
25 participants
Studyboard
Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
  • Department of Pharmacy
Contracting faculty
  • Faculty of Health and Medical Sciences
Course Coordinators
  • Janine Marie Traulsen   (15-6e65726d72693278766579707769724477797268326f7932686f)
  • Marlene Gyldmark   (16-6f63746e67706730697b6e666f63746d4275777066306d7730666d)
Course co-director: Janine Marie Traulsen, Ph.D. External Lecturer, Social & Clinical Pharmacy University of Copenhagen
Course co-director: Marlene Gyldmark, Head Health Economics Outcomes Research & Epidemiology, Isorsia, Switzerland
Teacher

Joerg Ruof, Prof. MD Founder European Institute of Health Outcomes; Jakob Kjellberg, Professor in Health Economics; Tove Holm-Larsen Professor, Ghent University. Additional speakers may be included.

Saved on the 17-04-2024

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