New PrEP option and employer coverage considerations 

Over the past 40 years, scientific advancements have significantly increased the options for preventing HIV. PrEP (pre-exposure prophylaxis) is a medication that can reduce the risk of contracting HIV. PrEP is available for HIV-negative individuals either as a daily pill or a long-acting injectable given by a healthcare provider. Until recently, the only injectable formulation of PrEP required a shot every two months, but this June the FDA approved a biannual injectable, Yeztugo. While group health plans are required to cover other formulations of PrEP along with specified baseline and monitoring services from in-network providers without cost-sharing, under current guidance they are not required to cover Yeztugo without cost-sharing.  

Plan coverage requirements

When no-cost coverage of PrEP for high-risk individuals was first required as a USPSTF “A” recommendation, Truvada was the only FDA-approved formulation. An updated recommendation effective Aug. 31, 2024 requires no-cost coverage for all three PrEP formulations that were approved at that time: daily pills Truvada and Descovy and an every-other-month injectable Apretude. Plans can cover a generic without cost-sharing and subject the brand version to cost-sharing only if cost-sharing is waived when the generic is inappropriate for an individual. But medical management techniques can’t favor one formulation over another, and are only permitted if frequency, method, treatment or setting are unspecified in the USPSTF recommendation.  

Absent further guidance, or another update to the USPSTF recommendation, group health plans are not required to add Yeztugo to the formulary for coverage without cost-sharing. Nevertheless, as with all ACA-mandated preventive services, plans must have an exceptions process in place that is more expedient and accessible than the plan’s routine exceptions process and waives cost-sharing when a provider determines the no-cost options are medically inappropriate. 

Employer considerations

Despite significant progress in HIV prevention and treatment, approximately 64% of individuals who could benefit from PrEP are not utilizing available therapies. Employers can play a role in preventing the spread of HIV by providing education, comprehensive insurance coverage and flexible time off for medical appointments. When deciding whether to cover Yeztugo with or without cost-sharing, employer plan sponsors may want to consider the following: 

Prevention and adherence. When taken as prescribed, PrEP can decrease the risk of acquiring HIV from sexual activity by 99%. Recent studies show that while short-term adherence (3 months) can be high, long-term adherence (1 year) drops significantly. Factors such as affordability, access, how often medication is taken and intolerance due to side effects can hinder long-term adherence. The initial treatment of Yeztugo involves an injection combined with two days of oral therapy, followed by subsequent injections every six months. Adherence with Yeztugo is likely to be higher than with other available PrEP therapies, even the daily pill.  

Cost. The annual cost for Yeztugo is approximately $28,000 to $30,000. These expenses exceed those of other PrEP therapies. Yeztugo costs almost 10 times as much as generic Truvada. However, preventing HIV is substantially more cost-effective than treating it, with models showing that every transmission prevented saves more than $1.1 million in lifetime health care expenses. Consider reviewing past PrEP utilization, adherence and resulting plan costs, and compare with future projections if Yeztugo is included in the formulary with and without cost-sharing. The potential for improved adherence with Yeztugo versus the other formulations along with the high efficacy may outweigh the initial increase in cost. 

Access and stigma. The persistent stigma surrounding HIV can create barriers to accessing PrEP therapies and maintaining adherence. For example, repeated requests for time off may raise questions from supervisors and coworkers. Employees who may be uncomfortable or find it difficult to ask for time off for medical appointments may prefer biannual Yeztugo. Offering multiple PrEP formulations, making it easy for employees to take time off for routine screenings and health checks, and addressing HIV-related stigma in the workplace can make it easier for employees to access PrEP. 

Before making a final coverage decision, employers will want to confirm coverage options and potential member out-of-pocket costs with their carriers, TPAs and PBMs. Employers should also be ready to address questions from plan members. Offering a range of medication choices will enable plan members to pursue the option that best fits their needs — and once you look at your plan data you may find it benefits your bottom line in the long run.  

Mercer is part of a coalition of companies to help achieve what was once thought impossible – the end of the HIV epidemic in the US by 2030. We hope you’ll join us as we learn, innovate and collaborate to achieve the greatest impact. Learn more at healthaction.org/endhiv.