PURPOSE: To provide guidance to and raise awareness of workshop participants regarding methodological issues surrounding the value assessment of biosimilars

DESCRIPTION: The use of biosimilars faces significant gaps and challenges in terms of their health technology assessment, which have not yet received sufficient attention in the health economic literature and in guidelines issued by many health technology assessment agencies.

This workshop will explain the following methodological issues in the value assessment of biosimilars:

• the choice of the appropriate technique of economic evaluation (cost-minimization or other) and of the appropriate comparator.
• the approach to filling the clinical evidence gap when the marketing authorization of the biosimilar has been granted on the basis of extrapolation (and no phase 3 clinical trial data are available).
• the approach to value assessment of biosimilars in treatment naïve patients and in patients previously treated with biologics/biosimilars.
• whether value assessment of biosimilars should account for the potential ‘nocebo’ effect and how.
• the management of uncertainty and barriers to uptake related to biosimilars and the role of managed entry agreements.
• the valuation of value-added services.
• the societal valuation of expanding access to treatment in terms of capturing QALY gains at population level.

The workshop explores these issues based on a systematic literature review conducted by the ISPOR Biosimilar SIG (presented by Steven Simoens and Evelien Moorkens) and discusses these issues from the perspective of health technology assessment agencies (presented by Dalia Dawoud) and of pharmaceutical industry (presented by Delphine Courmier).