Payer uncertainty around value proposition of bio-pharmaceutical innovations and consequent price have impacted time-to-patient-access across public reimbursement countries. Manufacturers have therefore opted for performance-based or financial schemes to mitigate such uncertainties to provide optimal access. This research aimed to analyse product characteristics that are most suited for various types of innovative arrangements with payers.

A non-systematic review complemented by an extensive review of grey literature were used to construct a database of IAAs implemented since 2015. Consultation with industry experts, review of payer communication was utilized to close remaining gaps in the IAA database. A comprehensive list of product characteristics, including but not limited to 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 identified agreement.

We identified 80 IAAs (50% from US, 33% from EU) since 2015 that were further evaluated based on above-mentioned product characteristics. Out of these, 27 (34%) were in Oncology, followed by 10 (12.5%) each in Virology, Cardiology & Diabetes while CNS and Rare Disease led among the rest. First-in-class products constituted over 70% of IAAs and tend to have more performance-based agreements to capitalize on its innovation, whereas follow-on products have higher probability of negotiating utilization-based or financial schemes with Payers. Additional analyses are ongoing to identify intrinsic product characteristics such as extent of improvement over standard-of-care, robustness of efficacy data to postulate a robust set of characteristics for respective IAAs.

With increasing payer uncertainties around bio-pharmaceutical innovations, manufacturers should consider options for innovative agreements based on intrinsic product characteristics significantly ahead of regulatory approval. Engaging payers to identify explicit objections can help create more customized arrangements right at the time of launch (vs. as an after-thought) to optimize patient access.