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SMIMIF115U  Market Access for Pharmaceutical Products – trends and challenges Volume 2017/2018

Course information

LanguageEnglish
Credit3 ECTS
LevelPart Time Master
Duration
21-25 August 2017
Placement
Summer
Schedule
5 days
Course capacity25 participants
Continuing and further education
Price

DKK 19,000/EUR 2,600. Fee includes teaching, course materials, all meals during course and examination.

Study boardStudy Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
  • Department of Pharmacy
Course responsible
  • Lourdes Cantarero Arevalo (13-74777d366b69767c697a6d7a77487b7d766c36737d366c73)
Course co-director: Marlene Gyldmark, Head of Modelling, Outcomes Research, Statistics and Epidemiology, F. Hoffmann-La Roche AG
Lecturers
Anne Koldby, Value Demonstration Manager, F. Hoffmann-La Roche AG
Guillaume Dedet, Technical Officer Health Technology and Pharmaceuticals, Division of Health Systems and Public Health, World Health Organization, Regional office for Europe
Adri Tolstrup, Director Public Affairs, Global Market Access Novo Nordisk A/S
Ulla Kirkegaard Madsen, Danish Health and Medicines Authority, Pharmacies and Reimbursement
Mette Hammer, Global Market Access Director. HEOR GLP-1 & Biopharm. Global Marketing. Novo Nordisk A/S
Tove Holm-Larsen, Managing Director, Pharma Evidence
Edith Frénoy, Director Market Access/HTA EFPIA (European Federation of Pharmaceutical Industries and Associations)
Joshua Ray, head of Health Economics, MORSE, F Hoffmann – La Roche (Basel, Switzerland)
Linus Jönsson Market access in CNS disorders Vice President, Medical & Regulatory Sciences, H. Lundbeck A/S Karolinska Institutet, Stockholm, Sweden
Professor Rafael Bengoa, Former Director of Health Systems (World Health Organization)

Additional speakers may be included.
Saved on the 22-12-2016
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 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.
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 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.

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).

Teaching and learning methods
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.
Formal requirements
Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
Academic qualifications
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.
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Exam (SMIMIF015E)
Credit3 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 scalepassed/not passed
Censorship formNo external censorship
Exam period

Deadline for submission of essay: Announced at the MIND and MRA programme's webpage

Re-exam

Announced at the MIND AND MRA programme's webpage.

Criteria for exam assesment

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 be able to contribute with a market access perspective on pharmaceuticals
Workload
CategoryHours
Preparation22,5
Class Instruction40
Exam20
Total 82,5
Saved on the 22-12-2016