OBJECTIVES:

Emergence of high-cost biopharmaceutical products has increased the budgetary burden on payers, who responded with performance-based or financial schemes to provide optimal access. Across both single payer (EU) markets, and decentralized private payer markets (US), Innovative Access Arrangements (IAA) have been essential to manage uncertainties around value proposition of biopharmaceutical innovations. This research aimed to analyse the differences in implementation of IAA across US and EU.

METHODS:

A non-systematic review of literature was used to construct a database of IAAs implemented between 2015 and 2019. Consultation with industry experts, review of payer communication was utilized to supplement the data. A list of product characteristics, such as first-in-class vs. follow-on entrant, value proposition over standard-of-care, potential follow-on indications over time horizon, as well as manufacturers’ prior experience with innovative access agreements were evaluated and synthesized for each IAA.

RESULTS:

We identified 67 IAAs (60% from US, 40% from EU) that were further evaluated based on above-mentioned product characteristics. Out of these, 18 (27%) were in Oncology, followed by 10 (15%) each in Virology, Cardiology & Diabetes while CNS and Rare Disease led the rest. IAAs in oncology were observed predominantly in EU, while the rest were implemented in the US. First-in-class products constituted over 75% of IAAs with a balanced split between the continents and tend to have more performance-based agreements (86%) to capitalize on its innovativeness. Additional analyses are ongoing to identify product characteristics such as extent of improvement over standard-of-care, robustness of efficacy data to postulate a set of characteristics for respective IAAs.

CONCLUSIONS:

Payers in the US and the EU follow different strategies and priorities in implementation of IAAs based on budgetary burden and uncertainty around product value. Engaging payers in line with their preferred IAA approach to address key objections can help create more customized arrangements to optimize patient access.