Ateneo - UPO

First section: The pharmaceutical market and its regulation. Negotiating drug prices and reimbursement (practical cases). Second section: The economic evaluation of drugs (theory and exercises). Third section: Pharmaceutical companies and their roles.

Gianfrate F, Il mercato dei farmaci tra salute e business, Franco Angeli Editore, 2014. Mennini FS, Cicchetti A, Fattore G, Russo P. La Valutazione Economica dei Programmi Sanitari. Il Pensiero Scientifico ed. 2011. Terza Edizione. Further papers suggested during the lectures

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 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.

1) Ongoing learning monitoring. 2) Students with disabilities, Specific Learning Disabilities (SLD), or Special Educational Needs (SEN) can request specific services and tools by contacting the Career Development and Coordination and Student Services Staff and by consulting the dedicated page on the University website: https://uniupo.it/it/servizi/servizi-studentidisabili-e-dsa. Students with disabilities, SLD, or SSEN, after contacting the University Staff, can contact the professor in charge of the course regarding the specific exam methods and educational aspects.

For each Section, both ongoing assessments and final tests are planned.

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.

Ability to manage the market access process for a drug. Ability to perform cost-effectiveness and budget impact analyses. Ability to work in a team on business cases related to drug value propositions and market access.