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You may be wondering when you can access Yeztugo (lenacapavir), the new injectable PrEP option that provides six months of protection against HIV with just one dose.
While Yeztugo is already technically available in the U.S., actually getting it is difficult. That’s because most health insurance providers don’t cover Yeztugo today — but there’s reason to be optimistic that will soon change.
Here’s what we know about how insurance providers will approve Yeztugo, and why it might get fast-tracked.
Is Yeztugo available now?
Yes, Yeztugo is available in the U.S. today. The FDA approved it in June 2025 under priority review, which means the approval process took just four months instead of the usual 10 months.
The approval was based on compelling results from two large clinical trials called PURPOSE 1 and PURPOSE 2. In PURPOSE 1, zero (0) participants who received Yeztugo became infected with HIV. In PURPOSE 2, only two out of over 2,000 participants became infected — meaning 99.9% remained HIV-negative.
The health insurance Yeztugo coverage challenge
Here's where it gets complicated: just because a medication is FDA-approved doesn't mean your insurance will cover it right away. Because Yeztugo is so new, most insurance providers haven't added it to their coverage lists yet.
The waiting game is a normal part of the process. Insurance companies need time to evaluate new medications to make sure they're not just safe and effective, but also worth the cost compared to existing options.
How insurance companies decide what to cover
When a new medication like Yeztugo comes out, insurance companies go through a careful review process to determine how it fits into their coverage offerings. This process can take anywhere from a few months to over a decade, depending on the review’s findings and how high of a priority offering the medication is.
Step 1: Health Technology Assessment (HTA)
Insurance companies and independent organizations evaluate all the research on the new medication. HTA reports answer questions like:
- Does the medication work?
- Which patients benefit the most?
- Is there meaningful improvement in health status?
- Is it safe?
- Can we afford to pay for all people who might need the medication?
Step 2: Negotiating costs
Insurance companies work directly with Gilead (the company that makes Yeztugo) to negotiate prices and rebates before making final coverage decisions.
Step 3: Approving coverage
Insurance companies review the results of the HTA and decide if/how to add the new medication to their “formulary”, which is simply the list of medications and products they cover. Once Yeztugo is added to your insurance provider’s formulary, you’ll know what level of coverage is provided, and healthcare providers can easily check your eligibility.
Keep in mind that some insurance providers will approve coverage faster than others, due to factors like priority review status, therapeutic area, and the specific formulary management practices of the insurer.
Why Yeztugo could get fast-tracked
Several factors suggest Yeztugo could become widely covered sooner than usual:
It got special FDA treatment
Yeztugo received "breakthrough therapy" and "priority review" designations from the FDA. These labels are reserved for medications that could significantly improve treatment for serious conditions. Insurance companies often move faster on medications with these designations.
The clinical results are impressive
The effectiveness shown in clinical trials — a 99% risk reduction in HIV infections without significant safety concerns — is remarkable. These results make it easier for insurance companies to justify coverage.
There's a clear medical need
Current daily PrEP pills work well, but many people struggle with taking a pill every single day. A twice-yearly injection addresses a real gap in HIV prevention options.
It has WHO backing
The World Health Organization recommended lenacapavir as "the next best thing" to an HIV vaccine, calling it "a transformative step forward." That kind of endorsement often accelerates insurance coverage decisions.
Gilead is being proactive
The company isn't just waiting for insurance coverage to happen. They're actively educating provider, systems and decision makers about Yeztugo and have created programs to help people access Yeztugo while insurance coverage expands.
While you wait for insurance coverage, Gilead has created programs to help:
- For people with commercial insurance: Their co-pay program can reduce your out-of-pocket costs to as little as $0
- For people without insurance: Their assistance program provides Yeztugo free of charge to eligible individuals
Freddie can help you find assistance programs you’re eligible for and help you access PrEP at the lowest cost. Book a free virtual appointment with a Freddie clinician to discuss your options.
It's getting major scientific recognition
Lenacapavir was named "Breakthrough of the Year" by Science Magazine in December 2024 — that's like getting an Oscar for medical breakthroughs. The extra media attention could help speed up insurance adoption.
When will Yeztugo be widely available?
Based on the special circumstances around Yeztugo, we predict it will be more readily covered by insurance starting early-to-mid 2026.
How to get Yeztugo
HIV prevention options are developing rapidly, and Yeztugo could be a game-changer for many people. While you might need to jump through a few extra hoops to get it right now, all signs point to it becoming much easier to access soon. We'll keep updating this information as things develop.
Interested in discussing your PrEP options? Book a free virtual appointment with a Freddie clinician.
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