Abstract
ObjectivesTo evaluate the cost-effectiveness of a new generation integrase inhibitor (INI), dolutegravir (DTG), in France, in treatment-experienced (TE) and INI-naïve HIV-infected adults with at least two classes resistance compared to raltegravir (RAL), by adapting previously published Anti-Retroviral Analysis by Monte Carlo Individual Simulation (ARAMIS) model.MethodsARAMIS is a microsimulation Markov model with a lifetime time horizon and a monthly cycle length. Health states are defined as with or without opportunistic infection and death. In the initial cohort, efficacy and safety data were derived from a phase III study comparing DTG to RAL. Antiretroviral treatment algorithms, accounting for patient history, were based on French guidelines and experts opinion. Costs are mainly including treatment costs, routine HIV and opportunistic infection care, and death. Utilities depend on CD4+ cell count and the occurrence of opportunistic infections.ResultsThe ARAMIS model indicates in the TE population that DTG compared to RAL over a life time is associated with 0.35 additional quality-adjusted life years (QALY; 10.75 versus 10.41) and additional costs of €7,266 (€390,001 versus €382,735). DTG increased costs are mainly related to a 9.1-month increase in life expectancy for DTG compared with RAL, and consequently a longer time spent on ART. The incremental cost-effectiveness ratio (ICER) for DTG compared with RAL is €21,048 per QALY gained. About 83% and 14% of total lifetime costs are associated with antiretroviral therapy and routine HIV care respectively. Univariate deterministic sensitivity analyses demonstrate the robustness of the model.ConclusionDTG is cost-effective in the management of TE INI naive patients in France, from a collective perspective. These results could be explained by the superior efficacy of DTG in this population and its higher genetic barrier to resistance compared to RAL. These data need to be confirmed with longer-term real life data.
Highlights
Human immunodeficiency virus (HIV) is a retrovirus that infects immune cells, resulting in a progressive decline in CD4+ cell count and immune function, and leaving patients susceptible to acquired immunodeficiency syndrome (AIDS) with increased risk of being affected by life-threatening opportunistic infections (OI) and cancer.Due to substantial improvements in the clinical management of HIV and the use of highly active antiretroviral therapy (HAART) in the last 15 years, the life expectancy of HIV-infected individuals has increased from approximately eight years from time of diagnosis and presentation to over 30 years.[1, 2]HIV engenders a large economic burden for the individual, health care system and society
The Anti-Retroviral Analysis by Monte Carlo Individual Simulation (ARAMIS) model indicates in the TE population that DTG compared to RAL over a life time is associated with 0.35 additional quality-adjusted life years (QALY; 10.75 versus 10.41) and additional costs of €7,266 (€390,001 versus €382,735)
DTG increased costs are mainly related to a 9.1-month increase in life expectancy for DTG compared with RAL, and a longer time spent on ART
Summary
Human immunodeficiency virus (HIV) is a retrovirus that infects immune cells, resulting in a progressive decline in CD4+ cell count and immune function, and leaving patients susceptible to acquired immunodeficiency syndrome (AIDS) with increased risk of being affected by life-threatening opportunistic infections (OI) and cancer.Due to substantial improvements in the clinical management of HIV and the use of highly active antiretroviral therapy (HAART) in the last 15 years, the life expectancy of HIV-infected individuals has increased from approximately eight years from time of diagnosis and presentation to over 30 years.[1, 2]HIV engenders a large economic burden for the individual, health care system and society. In Europe, mean annual costs of care for an HIV/AIDS patient have been estimated to range from €9,894 (in 2007 in Italy) to €20,170 (in 2010 in France), dependent upon the country and the proportion of patients being treated with antiretroviral therapy (ART). [3, 4] In France, the economic cost of HIV was modelled in a study by Sloan et al (2012), which reported that the estimated lifetime cost of treating an HIV-infected person was €535,000/patient (€320,700 [discounted]), assuming a mean life expectancy of 27.4 years. In case of virological failure, a combination of three active molecules, including a PI/r, is recommended.[5] These combinations have been shown to have transformed HIV infection from a fatal disease into a chronic condition.[6] In 2010, 118,450 patients are treated with ARTs and covered by the French Healthcare Insurance System. Despite advancements, 16% of those experienced virological failure.[7]
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