Health technology assessment of biosimilars worldwide: a scoping review

Abstract

Background: Health 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 body: A 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. Conclusion: HTA 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.

Health technology assessment for oral health in the past decade: a scoping review

“…This is an excellent indicator of the comprehensiveness of assessments being published. Although, this is in contrast to previously done reviews on HTAs for other medical fields such as the review by Ascef et al (21), wherein rapid reviews were the most common type. It is due to the increasing demand and need for faster HTA generation (20).…”

Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

“…Thus, trust in the rigour of the existing EMA biosimilar approval system to support substitution is the only thing that remains to be communicated by regulators, although the publication by Kurki et al, 2021 [ 38 ] is a step on the way. Ultimately, the implementation of substitution depends on political incentives for member states as well as their health technology assessment (HTA) bodies’ reviews [ 40 ].…”

An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare

“…For this, these drugs are identified with a black symbol (inverted triangle) with corresponding text in the SmPC and IF. With this new approach, the strengthening of the PV of all medicines has been seen, increasing the transparency, communication, and trust [ 55 , 56 ].…”

“…Despite the numerous benefits that biosimilars bring, there exist notable disparities in their utilization, namely cost savings and market shares. These disparities pose significant questions regarding the safety, efficacy, and interchangeability of these drugs [ 56 , 57 ].…”