title: Use of generic antiretroviral agents and cost savings in PEPFAR treatment programs.
abstract: BACKGROUND
  One of the biggest hurdles to the rapid scale-up of antiretroviral therapy in the developing world was the price of antiretroviral drugs (ARVs). Modification of an existing US Food and Drug Administration (FDA) process to expedite review and approval of generic ARVs quickly resulted in a large number of FDA-tentatively approved ARVs available for use by the US President's Emergency Plan for AIDS Relief (PEPFAR).
  
  
  OBJECTIVE
  To evaluate the uptake of generic ARVs among PEPFAR-supported programs in Guyana, Haiti, Vietnam, and 13 countries in Africa, and changes over time in ARV use and costs.
  
  
  METHODS
  An annual survey from 2005 to 2008 of ARVs purchased in 16 countries by PEPFAR implementing and procurement partners (organizations using PEPFAR funding to purchase ARVs).
  
  
  METHODS
  Drug expenditures, ARV types and volumes (assessed per pack, a 1-month supply), proportion of generic procurement across years and countries, and cost savings from generic procurement.
  
  
  RESULTS
  ARV expenditures increased from $116.8 million (2005) to $202.2 million (2008); and procurement increased from 6.2 million to 22.1 million monthly packs. The proportion spent on generic ARVs increased from 9.17% (95% confidence interval [CI], 9.17%-9.18%) in 2005 to 76.41% (95% CI, 76.41%-76.42%) in 2008 (P < .001), and the proportion of generic packs procured increased from 14.8% (95% CI, 14.79%-14.84%) in 2005 to 89.33% (95% CI, 89.32%-89.34%) in 2008 (P < .001). In 2008, there were 8 PEPFAR programs that procured at least 90.0% of ARV packs in generic form; South Africa had the lowest generic procurement (24.7%; 95% CI, 24.6%-24.8%). Procurement of generic fixed-dose combinations increased from 33.3% (95% CI, 33.24%-33.43%) in 2005 to 42.73% (95% CI, 42.71%-42.75%) in 2008. Estimated yearly savings generated through generic ARV use were $8,108,444 in 2005, $24,940,014 in 2006, $75,645,816 in 2007, and $214,648,982 in 2008, a total estimated savings of $323,343,256.
  
  
  CONCLUSIONS
  Among PEPFAR-supported programs in 16 countries, availability of generic ARVs was associated with increased ARV procurement and substantial estimated cost savings.
authors.affiliation: Office of the US Global AIDS Coordinator, US Department of State, Washington, DC 20522-2920, USA. holmescb@state.gov
authors.forename: Charles B
authors.initials: CB
authors.lastname: Holmes
authors.forename: William
authors.initials: W
authors.lastname: Coggin
authors.forename: David
authors.initials: D
authors.lastname: Jamieson
authors.forename: Heidi
authors.initials: H
authors.lastname: Mihm
authors.forename: Reuben
authors.initials: R
authors.lastname: Granich
authors.forename: Phillip
authors.initials: P
authors.lastname: Savio
authors.forename: Michael
authors.initials: M
authors.lastname: Hope
authors.forename: Caroline
authors.initials: C
authors.lastname: Ryan
authors.forename: Michele
authors.initials: M
authors.lastname: Moloney-Kitts
authors.forename: Eric P
authors.initials: EP
authors.lastname: Goosby
authors.forename: Mark
authors.initials: M
authors.lastname: Dybul
mesh_terms: D000349:Africa; D044966:Anti-Retroviral Agents / Q000191:economics* / Q000627:therapeutic use*; D017046:Cost Savings; D003625:Data Collection; D017277:Drug Approval / Q000331:legislation & jurisprudence; D016527:Drug Costs / Q000706:statistics & numerical data; D016568:Drugs, Generic / Q000191:economics* / Q000627:therapeutic use*; D006172:Guyana; D015658:HIV Infections / Q000188:drug therapy; D006205:Haiti; D005102:Health Expenditures / Q000706:statistics & numerical data; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D014744:Vietnam
chemical_list: D044966:Anti-Retroviral Agents; D016568:Drugs, Generic