Ateneo - UPO

The course is divided into three parts:
Block 1: pharmaceutical market; pharmaceutical companies and their functions.
Block 2: regulation of the pharmaceutical sector; early access to the market (conditions, restrictions, and limitations).
Block 3: the economic evaluation of drugs (pharmacoeconomics).

Ad hoc readings

The course aims to illustrate the economic and legislative context in which pharmaceutical companies operate and to define their main characteristics and functions. The course also aims to provide the tools to perform the main pharmacoeconomic analyses (economic evaluation and budget impact analysis).

None

Frontal lessons; case studies; testimonials; exercises

Block 1: written test with open questions.
Block 2: oral exam.
Block 3: written test with open questions and exercise.

Block 1: The pharmaceutical market: national and international trends; composition of the market by therapeutic class, dispensation regime, reimbursement, patent conditions. The drug companies: characteristics; organizational structure; main functions. Drug research and development: phases, economic aspects, patents, localization, relationships between companies (co-research and development, licensing, patent assignment). The functions of access and relationship with subjects other than prescribers (market access, public affairs). The commercial function (marketing and sales).
Block 2: The National Health Service: essential characteristics and relations with pharma companies. The regulation of the pharmaceutical sector: pre-marketing regulation and Marketing Authorization; price, reimbursement, and managed entry agreements; regional and local policies (formularies, purchases, alternative forms of distribution, clinical governance). The recognition of drug innovativeness by AIFA through the use of domains and effects on access to the NHS. The early access programs (94/98, 648/96 etc.). The conditions, restrictions, and limitations on access by the NHS structures. The therapeutic equivalence of medicinal products from a scientific, regulatory, and legal point of view. Regional pharmaceutical policies and their impact on prescribing appropriateness and market access.
Block 3. Introduction to Health Technology Assessment (HTA). The economic evaluation of drugs: principles, methods, phases. Data for economic evaluation: efficacy, costs, quality of life. Economic evaluation based on decision models. Budget impact analysis: methods and differences with respect to economic evaluation.

At the end of the course the students will have learned the main features of the pharmaceutical market and companies. They will also have learned about the regulatory environment in which pharmaceutical companies operate. Finally, they will have learned the main techniques of pharmacoeconomic analyses by applying them to concrete cases and interpreting the results for the purpose of drug assessment and reimbursement.