Lenacapavir, an injectable medication, has shown promising results in two recent clinical trials, the PURPOSE 1 and 2 studies, demonstrating its superiority over oral PrEP in preventing HIV infection. The twice-yearly injections significantly reduced HIV incidence among women and men who have sex with men and people who are gender diverse.
The study results sparked excitement in the medical community, with many experts predicting rapid changes to guidelines and standard treatment practices. However, challenges lie ahead due to the high cost of lenacapavir, which is currently priced at $44,000 per year. Insurance companies may initially try to avoid paying for it by requiring documentation that patients have failed PrEP with generic FTC/TDF.
While efficacy is undeniable, cost-effectiveness is a concern. A recent report compared the costs of lenacapavir to 100,000 condoms, which can prevent HIV, pregnancy, and other sexually transmitted diseases. The comparison suggests that lenacapavir may not be as cost-effective as previously thought.
Several factors contribute to this issue:
1. Low adherence to oral PrEP in the PURPOSE studies due to the injection design.
2. Significant cost differences between cabotegravir and generic TDF/FTC, limiting accessibility.
3. Cost-effectiveness simulations indicate that widespread use of lenacapavir would not be feasible in EU/US.
As lenacapavir prepares for FDA approval expected in 2025, its distribution is likely to be prioritized for high-risk groups, including those with excellent insurance coverage and those living in states that fund prevention programs. However, it remains uncertain whether the treatment will be widely adopted due to cost constraints.
Source: https://blogs.jwatch.org/hiv-id-observations/index.php/whos-going-to-get-lenacapavir-for-hiv-prevention/2024/12/08