title: Economic savings versus health losses: the cost-effectiveness of generic antiretroviral therapy in the United States.
abstract: 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.
  
  
  METHODS
  Mathematical simulation of HIV disease.
  
  
  METHODS
  United States.
  
  
  METHODS
  HIV-infected persons.
  
  
  METHODS
  No ART (for comparison); 3-pill, generic-based ART; and branded ART.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  The efficacy and price reduction associated with generic drugs are unknown, and estimates are intended to be conservative.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  National Institute of Allergy and Infectious Diseases.
authors: Massachusetts General Hospital, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.
authors: Rochelle P
authors: RP
authors: Walensky
authors: Paul E
authors: PE
authors: Sax
authors: Yoriko M
authors: YM
authors: Nakamura
authors: Milton C
authors: MC
authors: Weinstein
authors: Pamela P
authors: PP
authors: Pei
authors: Kenneth A
authors: KA
authors: Freedberg
authors: A David
authors: AD
authors: Paltiel
authors: Bruce R
authors: BR
authors: Schackman
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D000480:Alkynes; D019380:Anti-HIV Agents / Q000191:economics* / Q000627:therapeutic use*; D048588:Benzoxazines / Q000191:economics / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D003521:Cyclopropanes; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D004338:Drug Combinations; D016568:Drugs, Generic / Q000191:economics* / Q000627:therapeutic use*; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008962:Models, Theoretical; D063065:Organophosphonates / Q000191:economics / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D018894:Reverse Transcriptase Inhibitors / Q000191:economics / Q000627:therapeutic use; D000068698:Tenofovir; D014481:United States
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D004338:Drug Combinations; D016568:Drugs, Generic; D063065:Organophosphonates; D018894:Reverse Transcriptase Inhibitors; D003841:Deoxycytidine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; C098320:efavirenz