The news: Gilead’s long-lasting injection for HIV prevention received FDA approval, but the breakthrough drug comes with a high price tag ($28,218 annual list price). 

One shot of Yeztugo (lenacapavir) every six months reduces HIV transmission by up to almost 100%. For context: Daily pills and monthly shots with similar efficacy for HIV prevention are already approved, but adherence is inconsistent and discontinuation rates are high.

Digging into the details: Gilead says the drug’s $28K annual list price is in line with the cost of current prevention, or pre-exposure prophylaxis (PrEP), meds. However, a study published Wednesday says generic lenacapavir can be produced for $35 to $46 per year, with the potential to drop to $25 with volume growth.

The price disparity reflects at the high end, Gilead's 20-year R&D and trials of the drug plus insurer rebates, and at the low end, what could happen if multiple generic companies produced millions of doses. Still, advocacy groups are calling on Gilead to drop its list price.

Gilead promised to provide lenacapavir to low-income countries at cost. In the US, Gilead offers Yeztugo out-of-pocket assistance of up to $8,000 annually for insured patients and a no-cost program for eligible uninsured patients.

Why it matters: Yeztugo isn’t a vaccine, but the long-acting antiviral is the closest to one since the HIV epidemic began. 

• HIV rates continue to rise in the US, especially in southern states which accounted for more than half of diagnoses in 2023, per the latest CDC data.
• More than 1.2 million people are living with HIV with 38,7000 new infections in 2023, a 3% increase YoY.

Yes, and: The Trump administration is cutting HIV and prevention funding. The CDC provided $1 billion last year which is more than 90% of federal funding for HIV prevention. 

• The Division of HIV Prevention isn’t included in Trump’s proposed budget and CDC currently isn’t reporting new HIV incidence or prevention data because of staff cuts.
• HIV prevention funding already approved by Congress is stalled. Public health advocates are concerned about increased HIV diagnoses similar to during the COVID-19 pandemic when services were temporarily stopped, per AIDS United.
• Lifetime healthcare costs of an HIV diagnosis range from $253,000 to more than $400,000, per Verywell Health.

The takeaway: Another breakthrough drug with a high price tag adds fuel to the long-held idea that pharma puts profits over patients. Drugmakers need to offer and advertise practical solutions, such as direct financial help, and will need to fund more nonprofit programs to change perceptions.

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