New Report Highlights Challenges in Evaluating Biosimilars

Global panel also provides guidance on assessing the value of biosimilar drugs.

New research provides an overview of gaps and challenges in the value assessment of biosimilars and identifies potential approaches to address them. 

The report, “A Systematic Literature Review of Gaps and Challenges in Value Assessment of Biosimilars – A Report of the ISPOR Biosimilar Special Interest Group,” was published in the August 2023 issue of Value in Health. 

“Worldwide, few health technology assessment (HTA) agencies have produced a position statement on how to assess the value of a biosimilar or have provided detailed guidance under which circumstances which technique of economic evaluation applies to biosimilars,” says senior author Professor Steven Simoens, PhD, MSc, a health economist in the Department of Pharmaceutical and Pharmacological Sciences at KU Leuven in Leuven, Belgium, in a news release. “As a result, value assessment practices of HTA agencies for biosimilars have varied between jurisdictions.” 

The consensus-based report was developed from a systematic review of the relevant literature on the topic, internal meetings, input received during ISPOR conference presentations and finally, on 2 rounds of written peer review by members of the ISPOR Biosimilar Special Interest Group.

Methods to address challenges in biosimilar value assessment include:

• Conducting a price comparison when biosimilar reimbursement is requested for the same indication as the reference biologic.
• Conducting a full economic evaluation in other specific circumstances. For instance:
  • When the reference biologic is not reimbursed or is not the standard of care
  • When the biosimilar and reference biologic have different administration forms
  • When the biosimilar and reference biologic use different administration devices

The report also describes and provides approaches to several specific challenges:

• • Extrapolation of indication
  • Assessment in biologic-naïve and in biologic-experienced patients
  • Nocebo effect
  • Managed entry agreements
  • Value-added services
  • Health gains at population level

“Shedding light on the methodology of economic evaluation for biosimilars may serve to inform future biosimilar value assessments,” notes concluded lead author, Evelien Moorkens, PhD, MSc, market access specialist. “Improved methods used in the value assessment of biosimilars may contribute to reduced uncertainty from decision makers’ perspectives and better access to these therapies.”