ISSUE:

Outcome-Based Risk Sharing Agreements (OBRSA), such as outcomes-based or leasing agreements, hold promise to address both financial risk and clinical uncertainties in market access of innovative products. OBRSA so far have primarily been implemented on a case-by-case basis with varying success. Yet, systematic evaluation of these cases has been limited. Without a standardized approach, it remains difficult to assess past experiences, and formulate best-practices. To move forward, decision makers and technology developers need information on the specific settings and circumstances in which OBRSAs are appropriate and when they should be avoided.

OVERVIEW:

This Issue Panel will debate whether OBRSA have a role in supporting market access of innovative products and, if so, what types of products, and what should the agreements look like?

Dr. Elisabeth Fenwick will moderate this session in which David Thomson will start with a brief overview of OBRSAs – what they are and how they have been used. He will set the scene by presenting their strengths and weaknesses, and expectations around two upcoming UK OBRSA pilots.

Dr. Saskia Knies will reflect on past experiences from the perspective of an HTA-organization and HTx-consortium. She will defend that OBRSAs appear promising in theory, but in practice have not yet delivered the desired results. Alternative arrangements such as simple price discounts can achieve similar outcomes with greater simplicity.

Dr. Renske ten Ham will argue that OBRSAs can support market access of innovative drugs. However, better understanding is needed of prerequisites for successful implementation, which include disease and product characteristics. She will present an approach to assess impact of OBRSAs on population health using a gene therapy-case study.

Before moving to an interactive discussion, Dr. Fenwick will outline recent work exploring circumstances where OBRSAs might be an option to address uncertainty by both the technology developer, ánd the payer.