Economic savings versus health losses: the cost-effectiveness of generic antiretroviral therapy in the United States.

BACKGROUND U.S. HIV treatment guidelines recommend branded once-daily, 1-pill efavirenz-emtricitabine-tenofovir as first-line antiretroviral therapy (ART). With the anticipated approval of generic efavirenz in the United States, a once-daily, 3-pill alternative (generic efavirenz, generic lamivudine, and tenofovir) will decrease cost but may reduce adherence and virologic suppression. OBJECTIVE To assess the clinical effect, costs, and cost-effectiveness of a 3-pill, generic-based regimen compared with a branded, coformulated regimen and to project the potential national savings in the first year of a switch to generic-based ART. DESIGN Mathematical simulation of HIV disease. SETTING United States. PATIENTS HIV-infected persons. INTERVENTION No ART (for comparison); 3-pill, generic-based ART; and branded ART. MEASUREMENTS Quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY). RESULTS Compared with no ART, generic-based ART has an ICER of $21,100/QALY. Compared with generic-based ART, branded ART increases lifetime costs by $42,500 and per-person survival gains by 0.37 QALYs for an ICER of $114,800/QALY. Estimated first-year savings, if all eligible U.S. patients start or switch to generic-based ART, are $920 million. Most plausible assumptions about generic-based ART efficacy and costs lead to branded ART ICERs greater than $100,000/QALY. LIMITATION The efficacy and price reduction associated with generic drugs are unknown, and estimates are intended to be conservative. CONCLUSION Compared with a slightly less effective generic-based regimen, the cost-effectiveness of first-line branded ART exceeds $100,000/QALY. Generic-based ART in the United States could yield substantial budgetary savings to HIV programs. PRIMARY FUNDING SOURCE National Institute of Allergy and Infectious Diseases.