Antiretroviral therapy in HIV-infected patients: a proposal to assess the economic value of the single-tablet regimen

Abstract

Giorgio L Colombo,1,2 Sergio Di Matteo,2 Franco Maggiolo31University of Pavia, Department of Drug Sciences, School of Pharmacy, Pavia, Italy, 2Studi Analisi Valutazioni Economiche, Milan, Italy, 3Division of Infectious Diseases, Ospedali Riuniti, Bergamo, ItalyBackground: The aim of this study was to assess the economic value of a reduced number of pills in patients infected with the immunodeficiency virus (HIV) and on highly active antiretroviral therapy by a cost-effectiveness model.Methods: An incremental cost-effectiveness analysis of efavirenz, tenofovir, and emtricitabine (TDF-FTC-EFV) as a single-tablet regimen versus a multipill regimen, with reference to untreated HIV-infected patients, was carried out from the perspective of the Italian National Health Service. The comparisons were performed with the help of a Markov decision model over a 10-year time horizon. Based on the ADONE (ADherence to ONE pill) study, it was then possible to identify the utility score increment in patients switching from a multipill regimen of TDF-FTC + EFV therapy to a single-tablet regimen.Results: The single-tablet regimen (0.755 quality-adjusted life-years [QALYs]/year) resulted in better patient quality of life, with a higher number of QALYs than for the TDF-FTC + EFV multipill regimen (0.716 QALYs/year). The single-tablet regimen was the most cost-effective treatment strategy, with an incremental cost-effectiveness ratio of €22,017.00 versus €26,558.00 for the multipill regimen. A 24% decrease in cost of the multipill regimen determined equivalence with the single-tablet regimen in terms of the incremental cost-effectiveness ratio. Univariate sensitivity and probabilistic analysis carried out on the main variables did not highlight significant variations with respect to the base case scenario.Conclusion: The single-tablet regimen resulted in better adherence, and therefore better quality of life as perceived by patients, corresponding to a €4541.00 lower cost-effectiveness ratio per QALY versus the multipill regimen, with a 17% lower cost in favor of the single-tablet regimen. The value determined could be used to identify a maximum potential "premium price" of 29% to be assigned to therapeutic regimens proposing a single-tablet regimen for HIV-infected patients.Keywords: tenofovir, emtricitabine, efavirenz, single-tablet regimen, highly active antiretroviral therapy, quality of life, pharmacoeconomics, adherence