Study Finds Guidance Is Needed for Health Technology Assessments of Biosimilars

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Australia, Québec, and Sweden have defined processes for reimbursements by health technology assessments, but the United States has a low reliance rate.

Clear guidance on how and when to conduct health technology assessments (HTAs) of biosimilars is needed due to differences in perception of HTAs' role in the biosimilar space for authorities deciding pricing and reimbursement, according to a study published in Value in Health. HTAs are used for the safe and cost-effective adoption of medications, which is well established for new biologics but has challenges when applied to biosimilars.

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According to the study authors, because of characteristics of the regulatory frameworks for biosimilars such as approval based on pharmacokinetic/pharmacodynamic studies and extrapolated indications, HTAs and payers have to adapt to these different frameworks. Although some challenges have been resolved, there has been some debate on certain circumstances, such as available strengths, pharmaceutical forms, and methods and routes of administration when using HTAs. Additionally, investigators noted that some cases, such as when “the originator is not reimbursed at the time of the assessment” and “a price premium is sought by a biosimilar marketing authorization holder (MAH) based on an added-value claim,” still remains unclear on how to proceed.

Currently, there is little information for how to address these concerns with biosimilars. Therefore, investigators of the study aimed to investigate the current approaches for biosimilar value assessment via health technology agencies. In the study, data on biosimilar value assessment were collected, which included how to approach reimbursement when the originator was not reimbursed or when the originator and biosimilar were in different strengths, pharmaceutical forms, had different methods of administration, and/or different content, according to the study authors.

Investigators interviewed 20 health technology experts in Africa, America, Asia, Australia, and Europe, which were complemented with findings from literature, including full-text publications, conference abstracts and presentations, research posters, and institutional documents. The interview guide consisted of 21 open-ended questions, with each interview conducted by 2 investigators. Interviews were conducted via email or online via Microsoft Teams for approximately 40 to 60 minutes.

Investigators found that in Australia, Québec (Canada), and Sweden, there are defined processes for reimbursements by health technology assessments. They added that the agencies accepted the regulators' comparability for biosimilars and have simplified pathways for assessment, including an economic evaluation technique. Further, other countries streamline the process of reimbursement conditions for biosimilars without HTA. In England, biosimilars are automatically reimbursed under the same conditions as the originator, according to the study authors.

Key Takeaways

  1. Some countries (Australia, Canada, Sweden) have streamlined processes for biosimilar reimbursement, often relying on existing regulatory approval.
  2. In England, biosimilars are automatically reimbursed under the same conditions as the original biologic.
  3. The US lacks a national program, with HTAs being conducted by various payers.

However, they also found that in other regions of the world, reliance on HTAs is low. In the United States, the investigators noted that there is no international program that provides guidelines for coverage, so a variety of health plans and interest groups conduct HTAs, including for biosimilars. According to the study authors, the Institute for Clinical and Economic Review has published assessments to inform decision made by public and private payers, including Medicaid, and have considered the evaluation of biosimilars not within their scope. However, biosimilars can be evaluated at the therapeutic class level, but it is rarely conducted in the United States and has led to challenges in how to determine coverage for biosimilars.

The investigators concluded that 4 categories need evidence to help streamline the use of HTAs: the costs and resource use for data on biosimilars with pharmaceutical forms, methods, and routes of administration that differ from the originator; stakeholders’ product-related and adherence issues; real-world data on the value of biosimilars; and impact of biosimilar availability and access, as well as the offer of value-based services.

References

Barcina Lacosta T, Inotai A, Pereira CL, Barbier L, Simoens S. Mapping Health Technology Assessment Agency Approaches for Biosimilar Value Assessment: An ISPOR Special Interest Group Report. Value Health. 2024;27(5):543-551. doi:10.1016/j.jval.2024.01.018

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