Affordable Access

Access to the full text

Health technology assessment of biosimilars worldwide: a scoping review

Authors
  • Ascef, Bruna de Oliveira1
  • Lopes, Ana Carolina de Freitas1
  • de Soárez, Patrícia Coelho1
  • 1 The University of São Paulo, Av. Dr. Arnaldo, 455, sala 2228, São Paulo, SP, CEP: 01246-903, Brazil , São Paulo (Brazil)
Type
Published Article
Journal
Health Research Policy and Systems
Publisher
BioMed Central
Publication Date
Aug 26, 2020
Volume
18
Issue
1
Identifiers
DOI: 10.1186/s12961-020-00611-y
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundHealth technology assessment (HTA) should provide an assessment of a technology’s effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity, their extrapolation to one or more conditions, and the risks of interchangeability and substitution. We aimed to complete a scoping review within the context of HTA organisations to synthesise HTA reports on biosimilars and to map the extension, scope and methodological practices.Main bodyA scoping review methodology was applied. The sources for biosimilars HTA reports were database searches and grey literature from HTA organisation websites up to June 2019. HTA reports of biosimilars were classified as full HTA, mini-HTA or rapid reviews. Data were extracted and recorded on a calibrated predefined data form. We identified 70 HTA reports of biosimilars of 16 biologic products (65.71% in 2015–2018) produced by 13 HTA organisations from 10 countries; 2 full HTAs, 4 mini-HTAs and 64 rapid reviews met the inclusion criteria. Almost all the rapid reviews gave no information regarding any evidence synthesis method and approximately half of the rapid reviews did not appraise the risk of bias of primary studies or the overall quality of evidence. All full-HTAs and mini-HTAs addressed organisational, ethical, social and legal considerations, while these factors were assessed in less than half of the rapid reviews. The immunogenicity and extrapolation of one or more conditions were often considered. The majority of full-HTAs and mini-HTAs contained an assessment of switching and a discussion of an educational approach about biosimilars. No HTA report rejected the adoption/reimbursement of the biosimilar assessed.ConclusionHTA of biosimilars are emerging in the context of HTA organisations and those that exist often duplicate reports of the same biosimilar. Most HTA reports of biosimilars do not conduct a systematic literature review or consider economic issues. No report has rejected the adoption/reimbursement of biosimilars. There is a need to standardise the minimum criteria for the development of HTA on biosimilars to ensure a better understanding and better decision-making.

Report this publication

Statistics

Seen <100 times