There is limited guidance from HTA and reimbursement authorities on when and how to conduct economic evaluations for biosimilars reimbursement decision making. This Forum aims to outline ISPOR’s research on methodological issues for biosimilars value assessment that are not addressed in practice.

Interviews with HTA experts across jurisdictions confirmed that a current priority in value assessment processes for biosimilars is to efficiently reach positive reimbursement decisions for these products at a price that is lower that the initial originator’s price. This is to ensure cost reductions soon after biosimilars availability. The natural evolution has been to streamline protocols for biosimilars value assessment, that now rarely involve formal economic evaluations, or involve evaluations based solely on cost-minimization criteria. In theory, particularities such as biosimilar manufacturers requesting reimbursement for: 1) indications granted based on evidence extrapolation; 2) populations/formulations for which the originator has not been assessed; 3) indications for which the originator is not reimbursed; can prompt a full cost-effectiveness analysis at the HTA level. However, this has not been a common requirement across jurisdictions.

As a result of this streamlining process and of setting the focus on price criteria, aspects such as how to comparatively account for value-added services offered by biologic manufacturers, or how to capture QALY gains generated by biosimilars availability, have not been formally considered. In general, there has been limited flexibility to account for less traditional elements of value, different risks for different patient subgroups, adherence-related factors and patient preferences (e.g., regarding potential ‘nocebo’ effects). It is still in question whether it would be feasible to valorize these issues at the HTA level. This Forum explores these issues internationally, based on an interview study conducted by the ISPOR Biosimilar SIG, and reflects on limitations of current value assessment frameworks for biosimilars in Europe and the United States.