The first biosimilar was approved by the European Medicines Agency in 2006. Since then, diverse policies aimed at increasing the use of biosimilars in clinical practice have been implemented at the national, regional and local level in Europe. It has been shown that these can lead to differences in uptake and related savings within a country. Authors Bertolani and Jommi found that most studies related to this focus on interchangeability and substitutability recommendations made at national and regional levels. However, information on the actions taken by local healthcare organizations regarding prescribing behaviour are limited and there is no evidence on how local authorities implement policy frameworks aimed at appropriately reallocating resources gained through patent expiration. Using Italy as a case study, with its decentralized healthcare system, authors investigated policies on biosimilars implemented at the local level in the Italian National Health Service.

In Italy, the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) supports the European Medicines Agency position on biosimilars. However, AIFA advises that the final decision on interchangeability is left to the prescriber. In Italy, Regional Health Authorities are responsible for planning healthcare services, allocating financial resources and pharmaceutical tendering. Local health authorities are responsible for implementing national and regional policies locally.

To investigate the implementation of policy at a local level, authors administered a structured, validated questionnaire, online to all of Italy’s 199 public health care authorities. They obtained responses from 76 organizations in 16 of 21 Italian regions. This showed that:
– 89% of local healthcare authorities implemented information/educational initiatives on biosimilars
– Prescription targets on biosimilars versus originators were introduced in 62% of local healthcare authorities
– Prescription targets on off-patent versus in-patent molecules were introduced in 75% of local healthcare authorities
– Prescribers reaching targets are mostly rewarded through monetary incentives
– 75% of local healthcare authorities performed systematic impact evaluation of biosimilars
– 21% of local healthcare authorities detected patient under-treatment due to budget constraints

These results reveal that, at a local level, there is a high level of proactivity by healthcare authorities regarding actions on prescribing behaviour for off-patent biologicals in Italy. However, the authors note that structured actions aimed at appropriately reallocating resources gained through patent expiration are still lacking.

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Reference
1. Bertolani A, Jommi C. Local policies on biosimilars: are they designed to optimize use of liberated resources? Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(4):163-70. doi:10.5639/gabij.2020.0904.027

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