Market Access for Pharmaceutical Products - Trends and Challenges

In the fiercely competitive world of the pharmaceutical market, understanding the landscape inhabited by regulators, diverse payers and technical bodies and knowing how to reach these decision-makers are of vital importance.

The ongoing budget constraints imposed on health care, new ways of managing health care and general demographic changes, coupled with new, innovative and often more expensive pharmaceutical products, present ever more challenging hurdles to securing Market Access and access to patients.

Health care decision-makers around the world are searching for the ideal way to manage health care systems so they meet the needs of the population and optimize use of resources. Decisions on the reimbursement of medicines are now increasingly made using cost-effectiveness, cost-containment and value-based rationales, whereas in the past, it was mainly safety and efficacy which guided such decisions.

Market Access strategy

For all the talk about Market Access, not everyone seems to be able to define it. Who are the new key stakeholders, exactly? Is it true that it is no longer the prescribing doctor who decides which drug a patient should use? Is Market Access only about containing costs for the public budget, or are there benefits for patients and society as well? This course is based on learning through discussion with leading international experts on Market Access.

You will gain skills and insight that will enable you to develop the Market Access strategy that best responds to the demands of constantly changing political climates, health care systems and emerging key influential institutions.

WHAT YOU WILL LEARN

On the course, you will increase your capacity to understand and deal with crucial Market Access issues. You will learn about key trends in Market Access, how Market Access decisions are made, and how these decision-making frameworks affect evidence-based requirements for new health care interventions. You will:

• Acquire a basic market access vocabulary
• Gain insight into the Market Access methodologies toolbox
• Get an overview of the key challenges involved in Market Access
• Identify the key stakeholders and their influence on the drug reimbursement and prescription process in some of the most important markets (e.g. USA, UK, Germany, Italy and France)
• Gain an understanding of payers’ perspectives of key markets and of new reimbursement models impacting Market Access
• Integrate skills enabling you to demonstrate product value
• Discuss new aspects of Market Access like digital health and Value-Based Health Care

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 hot topics, challenges and relevant issues through a combination of lectures, discussions, group work, and case studies.

The topics include

• Introduction to Market Access – who are the actors in Market Access and what roles do they play?
• Key hypotheses for the outlook for the pharmaceutical market
• What is the role of the patient in Market Access?
• 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
• 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 and trends in the USA, Germany and the UK.

PARTICIPANTS

The course is aimed at providing continuing professional development for professionals working in the pharmaceutical industry, particularly those 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 of administration and marketing. Please note, however, that the course is not an advanced course for Market Access specialists.

The course is preapproved as an elective in the Master of Industrial Drug Development (MIND) programme and the Master of Medicines Regulatory Affairs (MRA) programme.

Participants must

• Hold a relevant bachelor degree or equivalent
• Have a minimum of 2 years of relevant job experience
• Be proficient in English

COURSE DETAILS

Course dates

5 days, 12-16 August 2019, 9:00-16:30 at the University of Copenhagen, South Campus.

Course fee

DKK 19,900. The fee includes teaching, course materials, and all meals during the course and examination.

Course directors

Janine Traulsen, Associate Professor/External Lecturer, Department of Pharmacy, University of Copenhagen

Marlene Gyldmark, Global Head Outcomes Research, Health Economics and Health Policy, Roche Diagnostics International, Diabetes Care AG, Switzerland

Other course teachers

Daniel Suhr, Managing Director, Two Scenarios, Denmark

Prof. Dr. Med Joerg Ruof, Dept of Public Health, Hanover Medical School, Germany

Tove Holm-Larsen, Managing Director, Pharma Evidence, Denmark

Jakob Kjellberg, Professor, University of Copenhagen and Program Leader at Vive, Denmark

Arne Kohler, Principal, The Boston Consulting Group, Sweden

Bettina Ryll, MD/ PhD, Melanoma Patient Network Europe

The course also includes additional speakers.

EXAMINATION

An optional examination is available (3 ECTS credits at Master's level) in the form of an essay (case story), based on an extended literature list, to be handed in by 17 September 2019 at 14:00. The course is preapproved as an elective in the MIND and MRA programmes at the University of Copenhagen. The exam is obligatory for Master’s students.

COURSE REGISTRATION

NB: Course registration and contact must go through Copenhagen Summer University website, as this course is provided under the Copenhagen Summer University concept this year.