On the economics of broadly neutralizing monoclonal antibodies for HIV prevention in high-income countries.

Aim: To quantify the market opportunity and economic impact of broadly neutralizing monoclonal antibodies (bnAbs) as a novel HIV prevention modality in high-income countries. Materials & methods: Using a decision-tree and revenue model applied to an eligible US population of 1299,708 individuals and projecting to 2040, bnAbs are estimated to capture 1 in 8 PrEP users (12.5% of PrEP users, 95% credible interval 7.3% to 21.1%, equivalent to 8.0% of the prevention-eligible population) following assumed US FDA approval in 2030. All estimates are scenario based and conditional on assumed pricing, uptake and behavior; none are observed outcomes. Critically, roughly half of projected bnAb users, nearly 52,000 individuals, would not otherwise use any biomedical HIV prevention, representing a net expansion of PrEP users (95% credible interval: 21,859-95,581). US manufacturer revenue totaled $12.0 billion discounted at 3% per year to 2030 (95% credible interval $6.2 billion to $21.9 billion), equivalent to $14.5 billion undiscounted, over the 11 years from approval to 2040. Total US payer spending rose 3.6% ($463.6 million annually), though the credible interval crosses zero, and the mean cost per prevention user decreased provided bnAbs are priced at the modeled list price of $14,000 per year, below existing injectable PrEP options. Conclusion: Under the assumptions modeled here, bnAbs could reach roughly one in eight PrEP users in high-income countries, about half of them people not otherwise using biomedical prevention. Whether this translates into an attractive commercial opportunity, and whether per-user prevention costs fall or rise, depends principally on how bnAbs are priced relative to long-acting injectable PrEP. These are projections conditional on assumed efficacy, pricing and adoption behavior, not observed outcomes.