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

Ann Intern Med. 2013 Jan 15;158(2):84-92. doi: 10.7326/0003-4819-158-2-201301150-00002.


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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adenine / analogs & derivatives
  • Adenine / economics
  • Adenine / therapeutic use
  • Alkynes
  • Anti-HIV Agents / economics*
  • Anti-HIV Agents / therapeutic use*
  • Benzoxazines / economics
  • Benzoxazines / therapeutic use
  • Cost-Benefit Analysis
  • Cyclopropanes
  • Deoxycytidine / analogs & derivatives
  • Deoxycytidine / economics
  • Deoxycytidine / therapeutic use
  • Drug Combinations
  • Drugs, Generic / economics*
  • Drugs, Generic / therapeutic use*
  • Emtricitabine
  • Female
  • HIV Infections / complications
  • HIV Infections / drug therapy*
  • Humans
  • Male
  • Models, Theoretical
  • Organophosphonates / economics
  • Organophosphonates / therapeutic use
  • Quality-Adjusted Life Years
  • Reverse Transcriptase Inhibitors / economics
  • Reverse Transcriptase Inhibitors / therapeutic use
  • Tenofovir
  • United States


  • Alkynes
  • Anti-HIV Agents
  • Benzoxazines
  • Cyclopropanes
  • Drug Combinations
  • Drugs, Generic
  • Organophosphonates
  • Reverse Transcriptase Inhibitors
  • Deoxycytidine
  • Tenofovir
  • Emtricitabine
  • Adenine
  • efavirenz