SMIMIF115U Market Access for Pharmaceutical Products – trends and challenges

Volume 2015/2016
Education

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 Master of Drug Management (MDM) 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?

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 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 & 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, health economics
  • Stakeholders – who they are, what are their perspectives, how and when to engage with “payers”
  • Health economic aspects of marketing – economic and financial considerations, core concepts and vocabulary
  • Pricing and reimbursement – global vs. local optimization, reference pricing systems in various markets.
  • Competencies – which skills and training are necessary to develop effective personnel; cross-functional teams
  • Patient centricity – the importance of understanding that the end-user must be the focal point during the entire process
Learning Outcome

On completion of the course participants should be able to:

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

  • Participate in professional multi-disciplinary groups and be able to contribute with a market access perspective on pharmaceuticals
Literature

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).

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
The course is for professionals working in the field of pharmaceuticals. It is intended 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, however, that the course is not an advanced course for market access specialists.
The course is organized as an intensive 10-day course and comprises lectures, group discussions, presentations and discussions. In order to emphasize the flow of the process, the course is to a large extent based on the use of cases in both lectures and assignments.
  • Category
  • Hours
  • Class Instruction
  • 40
  • Exam
  • 20
  • Preparation
  • 22,5
  • Total
  • 82,5
Credit
3 ECTS
Type of assessment
Written assignment
An 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 case study: 1 October 2015 at 4 pm.

Re-exam

1 November 2015.

Criteria for exam assesment

To pass the exam, the participant must have:

  • Written a comprehensive and structured report on a selected case in their own words based on relevant literature.
  • Demonstrated an ability to find, understand and report relevant literature for the selected case.
  • Demonstrated knowledge of the principles and terms used in the field of market access for pharmaceutical products.
  • Demonstrated an understanding of the central concepts and disciplines relevant for the selected case.