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Structured Abstract Importance Pre-exposure prophylaxis (PrEP) is a proven effective intervention to reduce risk for HIV infection, but changes in policies that lead to increased out of pocket PrEP costs or that decrease access to convenient PrEP locations could reduce PrEP coverage, resulting in excess HIV infections and costs. Objective To estimate the impacts of federal policy changes on PrEP coverage, new HIV infections and costs associated with new HIV infections Design Estimation of excess HIV infections under different policy impacts were conducted using parameters from a previously published ecological model of the relationship between PrEP coverage and new HIV infections. Costs were estimated for the treatment of infections not averted under different scenarios. Setting United States Participants There was no individual participation in research activities; population-based data sources were used to describe the population-level PrEP use and new diagnoses under different hypothetical changes in PrEP coverage. Exposures Percent of people with indications for PrEP who are taking PrEP Main Outcome and Measures Estimated change in new HIV infections under different assumptions of change in PrEP coverage; costs of treatment for avoidable HIV infections and net costs of avoidable infections after accounting for costs of PrEP medications. Results Even modest reductions in PrEP coverage would result in thousands of avoidable HIV infections. An absolute 3.3% annual reduction in PrEP coverage over the next decade would result in 8,618 avoidable HIV infections, with lifetime medical costs of over $3.6 billion (discounted) for treatment of the unaverted HIV infections. Conclusions and Relevance Changes in policy that reduce PrEP uptake would result in avoidable HIV infections and increased costs for HIV treatment. Maintaining policies and programs that support PrEP uptake offers benefits for health and is estimated to result in net cost savings. Key points Question What are the likely impacts on HIV transmissions and healthcare costs if policy changes result in decreased PrEP utilization in the United States? Findings Under assumptions of even modest reductions in PrEP use, we estimated thousands of HIV infections would fail to be averted over the next decade, and billions of dollars of additional treatment costs would accrue to the healthcare system. Results of the study We used historical descriptive data on the US HIV epidemic to quantify the relationship between PrEP coverage and trends in HIV diagnoses and to estimate future trends in HIV infections if PrEP coverage were to be rolled back. If PrEP use declines modestly – about 3% annually – we estimate that 8,618 new infections would fail to be averted in a decade because of lowered PrEP uptake, and the estimated lifetime medical costs of these unaverted infections would be $3.6 billion (discounted) and $9.3 billion (undiscounted). Meaning Changes in healthcare priorities and policies, especially those that increase out of pocket costs of PrEP or reduce the convenience of engaging in PrEP care, risk rolling back our progress in ending the HIV epidemic, accruing avertable HIV infections, and incurring increased costs for medical care of people whose HIV infections were avoidable.