The estimated cost of MK-8527 produced at scale for once-monthly oral HIV pre-exposure prophylaxis in low- and middle-income countries

The objectives were to estimate the potential generic production cost of MK-8527, a novel once-monthly oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) in development for HIV preexposure prophylaxis (PrEP), and to assess implications for cost-effectiveness and access in low-income and middle-income countries (LMICs). A cost estimation study using shipment level active pharmaceutical ingredient (API) data and established cost+ modelling methods to project scalable generic production pricing was performed. The Trade Vision LLC database was searched (January 2020 to December 2025) for records of MK-8527 API exports to India. A weighted mean API cost was calculated and combined with annual dosing assumptions (11 mg/month). Standardized cost+ components were applied, including formulation, API loss, packaging, transportation and tariffs, profit margin, and taxation. Sensitivity analyses explored variation in API pricing. Three API shipments were identified, yielding a weighted mean API cost of $9878/kg. Estimated generic production cost for monthly PrEP dosing was $4.49 per person-year (ppy). Sensitivity analyses produced a range of $4.46-$24.91 ppy. These estimates are substantially below published PrEP cost-effectiveness thresholds of approximately $100 ppy in sub-Saharan Africa and up to $200 ppy in high-incidence settings. MK-8527 could be manufactured at extremely low cost, suggesting that intellectual property and licensing arrangements, rather than production feasibility, will determine equitable access in LMICs. Early voluntary licensing agreements could facilitate timely generic entry and affordable global scale-up if clinical efficacy is confirmed.