Ateneo - UPO

The course will cover the following topics
- Structure and dynamics of the pharmaceutical market.
- Pharmaceutical economics.
- Regulation of the pharmaceutical market.
- Pharmaceutical companies and their organisation (research and development, production, regulatory affairs, market access, marketing and sales).
- Regulatory and Market Access critical areas (Orphan drugs / Drugs for rare diseases, Advanced therapy medicinal products, Personalised medicines, Combination therapies)

There is not a single textbook. Readings for each class will be presented during the first lesson

This course provides students with an understanding of the dynamics of the pharmaceutical market from perspectives of Regulatory Authorities, Health Technology Assessment Agencies, Payers and the Pharmaceutical Companies. After a successful completion of the course, students are expected to understand major pharmaceutical market trends, innovation process in the pharmaceutical industry, management of innovation, pharmaceutical market regulation, market access (approval; price and reimbursement negotiation and market access contracts; access to regional and local markets).

None (apart from English knowledge).

The course is organized in (i) traditional lectures on market dynamics, key regulatory issues, and market access (ii) exercises and one case-study, (iii) groups work.

Students with Physical Disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff "Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti", consulting the University webpage: https://www.uniupo.it/en/services/services- students-physical-or-learning-disabilities.
Students with Physical Disabilities, Learning Disabilities or Special Education Needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

Grading is based on:
- Final exam (open questionnaire) (60% of total grade)
- Case-Study (Global Value Dossier for Drug X) (20% of total grade)
- Groups work (20% of total grade)

- Pharmaceutical economics.
- Pharmaceutical market: global trend.
- Presentation of the case-study: Global Value Dossier for Drug X. Presentation of the groups work.
- Research and Development process, costs and outcome. Patent protection.
- Economic evaluation of patents: how to calculate the Risk-Adjusted Net Present Value.
- Marketing approval.
- Market access: value proposition, stakeholders’ mapping and management.
- Pricing and reimbursement of prescription drugs: theoretical issues and major trends.
- Value-based negotiation framework and managed entry agreements.
- Pricing and reimbursement of prescription drugs in Italy and the other largest 4 European Countries.
- Market access at regional and local levels: formularies, actions on prescribing behaviour, tenders.
- Pricing & Reimbursement for orphan drugs.
- Pricing & Reimbursement for combo-therapies.
- Pricing & Reimbursement for advanced therapy medicinal products and precision medicine.
- Patient access to medicines in Middle and Low Income Countries: main differences with High Income Countries and the China case.
- Organisation of the pharmaceutical companies: focus on Regulatory Affairs, Market Access, Production, Marketing & Sales.
- Class discussion of the Global Value Dossier of Drug X.
- Groups work presentation.

Understanding the regulatory context of the pharmaceutical industry. Being aware of the role of different functions in the pharmaceutical companies.
Integrating scientific competences with economics knowledge and managerial tools. Understanding how to work in a group, to discuss case-studies and to conduct a field research in the area of pharmaceutical economics and management.