Ateneo - UPO

First part: pharmaceutical market and its regulation (price & reimbursement: case-studies).

Second part: pharmaceutical companies and their organizational structure.

Third part: economic evaluation of drugs (theory and exercises)

Part 1: Pisano G, Science Business, 2006, Harvard Business School Press;
Gianfrate F, Il mercato dei farmaci tra salute e business, Franco Angeli Editore, 2014.

Part 2: Readings list provided by the professor.

Part 3: Mennini FS, Cicchetti A, Fattore G, Russo P. La Valutazione Economica dei Programmi Sanitari. Il Pensiero Scientifico ed. 2011. Terza Edizione.

The course aims at (i) making students aware of the regulatory context of the pharmaceutical companies, of innovation processes in the pharmaceutical industry, on the organizational structure and the main functions of the pharmaceutical companies (ii) and carrying out drugs comparative analysis from an economic perspective.
Knowledge and competences will be applied to case studies focused on negotiation of prices and reimbursement and exercises on economic evaluation and budget impact analysis.
Students are expected to be more autonomous in managing drugs market access issues and to improve communication skills thanks to case-studies discussion and group project.

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The course is organized in traditional lectures, exercises (on economic evaluation and budget impact analysis), case-studies and guest speakers coming from the pharmaceutical industry (on negotiation of drugs prices and reimbursement. Students are also required to work on two groups projects. The topic and organisation of groups projects are presented during the first classes Students are required to participate fully in class and pull their weight in group work. Group projects will be graded.

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Grading is based on:
• one written exam (60% of the final grade); all topics discussed during the course will be covered by the final exam, which will include open question (no multiple choice) and exercises
• groups project results (20% of the grade each).

First part: pharmaceutical market and its regulation.
The Italian health care system: main aspects and relationships with the industry
The pharmaceutical market: international and national trends. Aggregate trends and their split per main therapeutic areas, distribution systems, reimbursability status, and patent status.
Pharmaceutical market regulation: Pre-Marketing Regulation, Marketing Authorisation, Price and Reimbursement, Managed Market Entry Contracts, Regional and Local Policies (formularies, procurement, distribution systems, actions on prescribing behaviour); the recognition of the innovativeness of medicines by AIFA through the use of domains.

Second part: pharmaceutical companies and their functions. The principles of public health and pharmaceutical governance.
Pharmaceutical companies: organisational structure and main functions
Research and Development: phases, economics, relationships among companies (co-research, co-development, licensing, patent negotiation)
Market access and Public affairs
Marketing and sales. Health and pharmaceutical governance implemented by Central Government, Regions and Health Authorities.

Third part: economic evaluation of drugs
An introduction to Health Technology Assessment
Economic evaluation of drugs: principles, methods, phases. Models of economic evaluations.
Budget impact analysis: differences from the economic evaluation.
Practical examples of budget impact analysis and economic evaluation of drugs.

Understanding how the environment may influence the performance of the pharmaceutical industry and knowing how to be up-to-date on environmental changes.
Managing market access for medicines.
Carrying out cost-effectiveness and budget impact analysis.
Being able to participate in group work focused on market access and value proposition.