Abstract

The overarching objective of this analysis is to explore the success of value-based contracts (VBCs) in the USA – more specifically, outcomes-based risk sharing arrangements – developed to enhance product access potential by tying payment to product performance. In addition, the assessment will seek to better understand under which circumstances these contracts work best, and which key contract terms might be more or less critical to the successful implementation of these types of risk-sharing agreements from both payer and manufacturer perspectives. 48 publicly available VBCs in the USA implemented since 2009 were analysed across numerous dimensions including: translation from proposal to real-world implementation, approximate volume of agreements, public perceptions and magnitude of risk across parties. Of the 48 value-based contracts, the top three therapeutic areas that account for more than ½ of the VBCs were diabetes, multiple sclerosis, and cardiovascular disease, all of which are characterized by high prevalence, high on payers’ radars to manage, and high level of competition due to the number of brands and generics available. From this research, key similarities between successful VBCs were identified; agreements are centered around relevant clinical outcomes which can clearly be measured and tracked (such as HbA1c targets or LDL levels), they have clear stakeholder alignment on the rebate + cap structure, and they have proactively defined the party responsible for outcomes data collection. Although some skepticism remains on the real advantage and operational ease of partnering with manufacturers, many USA stakeholders are gaining interest in the potential benefits VBCs can bring to the table for their respective organizations. Nevertheless, several design challenges remain such as identifying measurable outcomes, aligning on the rebate structure, and designating data capture responsibility. Successful contracts will address these challenges through cross-stakeholder buy-in on the framework utilised holistically.

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