Italy – a study case of medicines pricing and reimbursement

Abstract

The Italian National Health Service (Servizio Sanitario Nazionale, SSN) is structured at comprehensive levels such as collective prevention and public health, cure and rehabilitation assistance, and pharmaceutical services, with the primary objective of guaranteeing universal access of all Italian citizens, on equal terms, to equitable provision of health services. Italy was used as a case study to explore their healthcare system and their economic regulation and reimbursement of pharmaceuticals. The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) is responsible for regulation related to efficacy, safety and quality, pricing and negotiations for reimbursement of medicines. Among the various negotiation criteria defined in specific legislation, biosimilars and generics enter the Italian market with a discount of at least 20% to the reference medicine. Price review occurs in a periodical basis and upon the emergence of new evidence of efficacy and safety arising from pharmacovigilance or upon request of changes in the therapeutic indications and/or dosage. In addition, conducting the monitoring and analysis of pharmaceutical consumption and expenditure contributes for planning health policy interventions, since it allows for prompt identification of emerging phenomena, framing prescription behaviours, and verifying the effectiveness of regulatory interventions at regional and national levels. Efficacy, safety, and cost-effectiveness analyses are conducted before the introduction of the medicines in the Italian market. It continues to be performed when the drug in on the market with health technologies assessment, constituting a process of permanent investigation of the clinical, economic and social consequences of the medicine’s utilisation. In addition, it allows controlling expenses and identifying avoidable costs.

Variabilidade de preços de aquisição de medicamentos do grupo 1B do Componente Especializado da Assistência Farmacêutica

“…No Reino Unido, cujo sistema de saúde (NHS -National Health System) foi inspiração para a criação do SUS no Brasil 41 , o preço de medicamentos para o NHS é acordado entre o governo e as empresas 21 . Isso é comum em outros países com políticas de negociação de preços centralizada 23,42 . Revisão de estudos sobre fatores que influenciam o preço de medicamentos revelou importante aumento da produção de pesquisas na área, com destaque tanto para estratégias de negociação de preços quanto para abordagens regulatórias no mercado farmacêutico 43 .…”

Pharmaceutical Pricing and Reimbursement Policies: lessons learnt and perspectives for Brazil

“…1 The editorial, eight country case studies, namely Austria, Brazil, Greece, Canada, Italy, United Kingdom (UK), Portugal and the United States (US) (Table 1) and a perspective article about the Pharmaceutical Pricing and Reimbursement Policies (PPRI) network were published by country experts, outlining pricing and reimbursement policies in the context of their respective health systems, considering the life cycle of medicines. [2][3][4][5][6][7][8][9][10] As such, this series and, in particular its country case studies, provided a contribution to the field of pharmaceutical systems research, which is a rather young discipline. The UK alignment of life-science strategy with pharmaceutical regulation, pricing and reimbursement, combined with one of the highest proportions of uptaking of generics in the national health system (NHS); the different uses of health technology assessment (HTA), as in Canada, Italy, Portugal and UK, combining HTA and other pricing strategies, such as external reference pricing; the pricing regulation of generics and biosimilars, as in Austria, are some of the successful experiences to be highlighted (Table 1).…”