PBI35 Local Policies on Biosimilars: Are They Designed to Optimize Use of Freed Resources?

Abstract

Biosimilars enhance competition, offering a less-expensive alternative to an existing medicine or pushing alternative medicines to lower their prices, freeing up resources. Different policies have been implemented by national, regional and local policy-makers to enhance uptake of biosimilars, but the evidence on actions taken by health care organisations (HCOs) is limited. This research investigates policies on biosimilars implemented at the local level in the Italian National Health Service. Data were retrieved through a structured questionnaire, administered online over the period from October 2019 to January 2020 to the general managers of all 199 public HCOs. 76 organisations completed the survey (the response rate was 38% nationwide and 47%, 33% and 27% in the Northern, Central and Southern regions, respectively). Almost all regions were represented with a region-specific response rate ranging from 11% to 100%. Almost all HCOs implemented information/educational initiatives on biosimilars. 75% of HCOs performed systematic impact evaluation of biosimilars, focusing on their economic impact. Only 21% of HCOs detect patient under-treatment due to budget constraints and how availability of cheaper drugs could help. Prescription targets on biosimilars vs. originators and off-patent vs. in-patent molecules sharing the same indication have been introduced in 62% and 75% of HCOs, respectively. Prescribers reaching targets are mostly rewarded trough monetary incentives. According to 25% of respondents their HCO is involved in studies on biosimilars, but few respondents provided evidence of these studies. Despite some limitations, two main results were found. On the one hand, HCOs show a quite high level of proactivity regarding policies on off-patent bio-drugs. On the other, it seems that structured actions aimed at appropriately reallocating resources gained through patent expiration are still lacking, since a minority of HCOs collects evidence on untreated or undertreated patients and are involved in post-marketing studies on biosimilars.