Ateneo - UPO

Module 1 (2.5 CFU): Health Technology Assessment (HTA). Risk-benefit profile and comparative evaluation. Economic evaluation of medicines: cost-effectiveness and budget impact analysis.
Module 2 (2.5 CFU): Methods for drugs evaluation and the relevant pricing. Pricing and reimbursement (P&R) in the major European Countries. Market access for medicines in Italy. P&R in Italy. Critical access areas: rare diseases, combination therapies, and target therapies. Regional access.

There are no textbooks. Reading materials will be suggested lecture by lecture.

Students are expected to learn how do the national and European regulatory and HTA agencies work; the organizations that negotiate drug pricing and reimbursement; and the economic evaluation techniques applied to pharmaceuticals.

The students should have attended the course in "Introduction to management".

Lectures, exercises, and case discussions.

Students with physical disabilities, Learning Disorders (DAA), or Special Educational Needs (BES) can request specific services through university staff and contact the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti (https://uniupo.it/it/servizi/servizi-studentesse-e-studenti-condizione-di-disabilit%C3%A0-e-dsa). Students with physical disabilities, Learning Disorders (DAA), or Special Educational Needs (BES), after having contacted the Staff, may get in touch with the course instructor regarding the exam details and the teaching issues.

Written exam with open- questions and exercises ore case discussions, covering the entire programme.

Module 1: Introduction to HTA, to its dimensions and economic evaluations. Absolute and relative risk-benefit profile. Patient-reported outcomes and experince. Cost-effectiveness analysis. Budget impact analysis.
Module 2: Markte access: introduction, strategy and tools. Pricing and reimbursement in the major European countries. Pricing and reimbursement in Italy. Managed Entry Agreements (MEA). Regional and local policies. Focus on orphan drugs, advanced therapies, and combination therapies.

By the end of the course, the student will be familiar with the comparative assessment of new medicines, and the market access policies and strategies.