ArticleThe Lancet regional health. Europe2026
Cost-effectiveness of lenacapavir versus tenofovir disoproxil fumarate plus emtricitabine for pre-exposure prophylaxis to prevent HIV-1 transmission in gay, bisexual, and other men who have sex with men in Spain.
Article in The Lancet regional health. Europe, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Abstract
Background: Lenacapavir (LEN), a twice-yearly subcutaneous capsid inhibitor, has demonstrated superior efficacy over daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as HIV pre-exposure prophylaxis (PrEP) in clinical trials. No European cost-effectiveness analyses have been published to date. We aimed to assess the cost-effectiveness of LEN versus TDF/FTC as PrEP for gay, bisexual, and other men who have sex with men (GBMSM) in Spain. Methods: We developed a deterministic, compartmental HIV dynamic transmission model stratified by age (from 16 up to 100 years) and four sexual-activity risk strata, calibrated to Spanish epidemiological data (2019-2023) using Latin Hypercube Sampling (100,000 runs) with local optimisation. Outcomes included quality-adjusted life-years (QALYs) and direct costs (2023€), both discounted at 3% annually over a 20-year horizon, from the Spanish National Health System perspective. Deterministic one-way sensitivity analysis (OWSA) and probabilistic sensitivity analysis (PSA; 1000 iterations) were conducted, alongside a price-threshold analysis. Findings: In the base case, LEN PrEP generated 2983 incremental QALYs at an incremental cost of €60.68 billion compared with TDF/FTC, yielding an incremental cost-effectiveness ratio (ICER) of €20,342,776 per QALY gained. At Spain's gross domestic product per capita willingness-to-pay threshold (€33,395/QALY), the vial price would need to fall from €21,088.55 to €769.36 per semi-annual injection to be cost-effective-a 96.4% reduction. In the PSA, the ICER of the means was €11,052,594/QALY and the probability of LEN PrEP being cost-effective was 0.001. Interpretation: LEN PrEP provides meaningful health benefits compared with TDF/FTC but at a cost far exceeding the accepted Spanish willingness-to-pay threshold. At current pricing, it is not cost-effective under any scenario examined and would require an approximate 96% price reduction to become cost-effective. While LEN represents a promising long-acting HIV prevention strategy, its population-level value is currently constrained by affordability. Substantial price reductions will likely be required to enable equitable access and realise its full public health potential. Funding: None.
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