When and How to Conduct Health Technology Assessments for Biosimilars?

Published May 13, 2024

Learnings From an ISPOR Special Interest Group Report Mapping HTA Practices

Lawrenceville, NJ, USA—May 13, 2024—ISPOR—The Professional Society for Health Economics and Outcomes Research announced today the publication of a report from the ISPOR Biosimilars Special Interest Group highlighting the need for clearer guidance on when and how to conduct health technology assessments (HTAs) for biosimilars. The report, “Mapping HTA Agency Approaches for Biosimilar Value Assessment: An ISPOR Special Interest Group Report” was published in the May 2024 issue of Value in Health.

“The role of HTA in informing pricing and reimbursement decisions for new biologics is generally well-established,” said author Teresa Barcina Lacosta, MSc, PharmD, PhD, KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium. “However, it is less evident how HTAs can inform pricing and reimbursement decisions for biosimilars, which are marketed after demonstrating comparable efficacy, safety, and immunogenicity to their respective originators. This study reflects on the evolution of the role of HTAs for biosimilars and has aimed to investigate current HTA agency approaches for biosimilar value assessment.”

Members of the Special Interest Group conducted semi-structured interviews with HTA experts in Egypt, Brazil, Canada, Colombia, United States, Malaysia, Australia, Bulgaria, Hungary, Italy, Sweden, and United Kingdom to map current HTA practices for biosimilars. The research shows that it has been challenging for national competent authorities to define HTA’s role for biosimilars and that there is a lack of consensus in this respect. Nevertheless, based on the confirmed therapeutic comparability between biosimilars and originators, it is no longer common practice to systematically assess new biosimilar entrants via HTAs.

The authors conclude that in jurisdictions that rely on an established framework for biosimilar regulatory approval, reimbursement decisions can generally be based on price comparisons and an HTA submission is not needed. However, conducting HTAs for biosimilars can be relevant when: (i) the originator is not reimbursed; (ii) the biosimilar marketing authorization holder seeks reimbursement for indications/populations, pharmaceutical forms, methods and routes of administration that differ with respect to the originator; or (iii) a price premium is sought for a biosimilar based on an added-value claim.

“HTA agencies’ priority in jurisdictions that rely on an established regulatory framework for biosimilars has been to efficiently reach positive reimbursement decisions for biosimilars at lower prices than the initial originator’s price,” noted Lacosta. “In line with these objectives, biosimilar value assessment has been simplified, with an increasingly common practice to rely on price negotiations rather than on HTA methodologies. In the midst of streamlining these value assessment processes; this study shows that conducting HTAs for biosimilars can still be relevant under specific circumstances. However, HTA guidelines have generally been developed for on-patent pharmaceuticals, without considering particularities relating to biosimilars. In this respect, our study has highlighted the need for clearer guidance at the HTA level.”

About ISPOR’s Biosimilars Special Interest Group
The group’s mission is to identify and discuss emerging issues of biosimilars, as related to their originator biologics, focusing on health economics and outcomes research and reimbursement policy.

Biologic drugs, which are large molecules such as proteins and nucleic acids, have established themselves as critical therapies that have changed the course of disease for several life-threatening diseases and conditions impacting patients’ quality of life, such as chronic diseases, rheumatoid arthritis, and various cancers. Despite their benefits, biologics are costly and pose a significant financial burden on healthcare systems.

Biosimilars, as defined by the US Food and Drug Administration, are biologic products that are highly similar to the reference product, notwithstanding minor differences in clinically inactive components, with no meaningful differences in safety, purity, and efficacy. They offer an opportunity for improving access to high-priced biologic therapies, particularly for patient groups that had limited availability of the originator biologic due to cost constraints. Despite the availability of biosimilars, challenges in their value assessment and barriers in policy and clinical decision making may limit their widespread use. Click here to learn more.


Further Reading:

—The Professional Society for Health Economics and Outcomes Research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2022 impact factor score is 4.5 and its 5-year impact factor score is 6.2. Value in Health is ranked 8th of 87 journals in health policy and services, 21st of 105 journals in healthcare sciences and services, and 69th of 380 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.

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