title: Modelling the budget impact of darunavir in the treatment of highly treatment-experienced, HIV-infected adults in France.
abstract: BACKGROUND
  A key element for payers in the assessment of the economic profile of a medication is its anticipated impact on the evolution of healthcare budgets.
  
  
  OBJECTIVE
  To forecast the impact of the use of darunavir with low-dose ritonavir 600/100 mg twice a day (bid) in highly treatment-experienced, HIV-infected adults who have failed one or more protease inhibitor (PI)-containing regimen on the budget of the French Sickness Fund (French healthcare system) over a 3-year time horizon.
  
  
  METHODS
  A transition state model based on disease severity was developed that compared the evolution of antiretroviral and non-antiretroviral-related direct costs of care in the target population over 3 years (2007-2009) under two scenarios: (1) darunavir enters the French market in year 1; (2) darunavir is not available to the target population during 2007-2009. Model inputs were derived from a targeted analysis of the French hospital database in HIV, the darunavir POWER 1 and 2 trials and other relevant clinical studies.
  
  
  RESULTS
  In the scenario where darunavir was available from year 1, the proportion of patients in the lower, more costly CD4 cell count strata (≤ 100 cells per mm³) was consistently lower than in the scenario without darunavir in each year of the model (17.0% vs 19.2%, 13.9% vs 18.3% and 10.8% vs 16.8% for years 1, 2 and 3, respectively). As a result, over the entire 3-year period, the net increase of antiretroviral drug costs (+ 5.6 million Euros; €), resulting from the substitution of older, cheaper PIs by darunavir, is expected to be fully compensated by savings in hospitalization costs (€-9.7 million) and expenditures for other HIV-related (non-antiretroviral) medications (€-7.3 million), leading to a net saving of €11.4 million or 2.9% of the total budget in the scenario without darunavir. Various sensitivity analyses confirmed these projected savings.
  
  
  CONCLUSIONS
  The use of darunavir/ritonavir (DRV/r) 600/100 mg bid, in combination with other antiretroviral agents, in highly pre-treated, HIV-infected adults who have failed one or more PI-containing highly active antiretroviral therapy regimen is not expected to increase the budget of the French healthcare system, in comparison with a scenario without darunavir. Further research is needed to estimate the budget impact of the use of DRV/r in less treatment-experienced, HIV-infected individuals in France.
authors.affiliation: INSERM, Unité Mixte de Recherche (UMR) S 720, and Université Pierre et Marie Curie-Paris 6, UMR S 720, Paris, France. xavier.colin@cemka.fr
authors.forename: Xavier
authors.initials: X
authors.lastname: Colin
authors.forename: Antoine
authors.initials: A
authors.lastname: Lafuma
authors.forename: Dominique
authors.initials: D
authors.lastname: Costagliola
authors.forename: Erik
authors.initials: E
authors.lastname: Smets
authors.forename: Josephine
authors.initials: J
authors.lastname: Mauskopf
authors.forename: Pascal
authors.initials: P
authors.lastname: Guillon
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000191:economics*; D002017:Budgets; D018791:CD4 Lymphocyte Count / Q000191:economics; D017322:Clinical Trials, Phase II as Topic; D000069454:Darunavir; D016527:Drug Costs; D004351:Drug Resistance; D005602:France; D006678:HIV / Q000187:drug effects; D015658:HIV Infections / Q000188:drug therapy / Q000191:economics* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000191:economics* / Q000627:therapeutic use; D017048:Health Care Costs; D006801:Humans; D015233:Models, Statistical; D015337:Multicenter Studies as Topic; D012367:RNA, Viral / Q000191:economics; D016032:Randomized Controlled Trials as Topic; D013449:Sulfonamides / Q000191:economics* / Q000627:therapeutic use; D017211:Treatment Failure; D019562:Viral Load / Q000191:economics
chemical_list: D017320:HIV Protease Inhibitors; D012367:RNA, Viral; D013449:Sulfonamides; D000069454:Darunavir