SMIMIF115U Market Access for Pharmaceutical Products – trends and challenges
Please note this is course description is for the study year 2014/2015. For updated information on dates, prices etc. in other semesters please visit www.mind.ku.dk.
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?
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
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
- an insight to the toolbox of the market access methodologies
- an understanding of market access and its relation to the entire pharmaceutical organization
- gained insight into the key challenges of obtaining market access
- a knowledge of the key stakeholders & their influence on the drug reimbursement and prescription process.
- an understanding of the requirements and differences in perspectives of payers from key markets, and how these are changing
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
- Class Instruction
- 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 case study: Before 1 October 2014 at 4 PM.
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.