title: [Budget impact analysis of antiretroviral therapy. A reflection based on the GESIDA guidelines].
abstract: OBJECTIVE
  The latest version of the Spanish clinical practice guidelines on antiretroviral therapy (ART) in HIV-infected adults, developed by the Spanish AIDS Study Group (GESIDA) and the National AIDS Plan, recommends initiating ART early in certain circumstances. The aim of this study was to estimate the budget impact of this recommendation by using the data from the VACH cohort.
  
  
  METHODS
  We considered a scenario in which all naïve asymptomatic patients would initiate ART if they had <500 lymphocytes, or a CD4/μL count >500/μL if they were older than 55 years, or had high viral load, liver disease, chronic kidney disease or high cardiovascular risk. The study was designed as a cost analysis in terms of annual pharmaceutical expenditure. The only costs included were those relating to the ART combinations analyzed. To estimate these costs, we assumed that this guideline had a penetration of 80%, an adherence of 95% and 12% dropouts.
  
  
  RESULTS
  A total of 12,500 patients were reviewed. Of these, 1,127 (10%) had not initiated ART; CD4 lymphocyte count was 350-500 in 294 (26.1%) and > 500 in 685 (60.8%). If the new clinical practice guideline were applied, 45.2% of naïve patients (95% CI: 42.4%-48.2%) would be advised to start ART. Carrying out this recommendation in hospitals of the VACH cohort would require an additional annual investment of € 3,270,975 and would increase the overall cost of antiretroviral drugs by 3%.
  
  
  CONCLUSIONS
  In the framework of health economics, incorporating economic impact estimates - such as those performed in this study - into clinical practice guidelines would be advisable to increase their feasibility.
authors.affiliation: Asociación Médica AM-VACH, Huelva, España.
mesh_terms: D000328:Adult; D000367:Age Factors; D019380:Anti-HIV Agents / Q000191:economics* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000191:economics; D058070:Asymptomatic Diseases; D002017:Budgets / Q000706:statistics & numerical data*; D018791:CD4 Lymphocyte Count; D003365:Costs and Cost Analysis; D016527:Drug Costs / Q000706:statistics & numerical data*; D004359:Drug Therapy, Combination / Q000191:economics; D004363:Drug Utilization / Q000191:economics; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000191:economics; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D017059:Models, Econometric; D010352:Patient Dropouts; D017410:Practice Guidelines as Topic; D013030:Spain
chemical_list: D019380:Anti-HIV Agents