CEA-1

Cost-effectiveness analysis (CEA) – Part 1

The cost-effectiveness analysis makes it possible to compare alternative treatments with the advantages (eg avoided disease cases, response times, years of life gained) obtained with each one. The evaluation of the therapeutic options taken into consideration occurs by inserting the total costs associated with the treatment to the numerator, while the benefits are reported in…

Esiti

Outcomes in healthcare

  To perform a pharmacoeconomic analysis on a drug, the drug must provide an outcome (a documented efficacy). In particular we talk about “efficacy” when clinical efficacy (defined as the relationship between positive and undesirable effects) is obtained under controlled conditions within a clinical study, while we talk about “effectiveness” when the result is reached…

costs

The types of costs in healthcare

The direct costs are divided into health (medical) and non-health (non-medical) costs: the first refer to costs for the health system in terms of prevention, diagnosis, treatment and follow-up of the disease (medical visits, drugs, hospitalizations … ), while the latter concern the non-medical costs of the patient and other subjects (for example relatives) due…

Marketing authorization

Types of Marketing Authorization (MA)

Once the phase III clinical trials have been completed, the pharmaceutical company collects all the data produced in a dossier to request the granting of the Marketing Authorization (MA) to the regulatory authorities. The agencies involved in the granting of MA for a new drug or modifications to one already on the market are the…

Budget concept

The main pharmacoeconomic analyses

The wide demand for care to which health systems must cope often comes up against limited budgets, giving rise to problems of access to treatments. The pharmacoeconomics  is therefore used to identify and measure, comparing them, the effects and costs associated with the administration of available drugs. Among the main techniques used in this field…

Ricerca e sviluppo

The new drugs: from discovery to marketing

The European Federation of Pharmaceutical Industries and Associations (EFPIA) reports that from the moment a new active substance is synthesized to the one in which it is marketed it takes about 12-13 years of Research and Development (R & D), during which it meets to numerous risks and costs. In particular, please note that in…