Cost-Effectiveness of Single- Versus Generic Multiple-Tablet Regimens for Treatment of HIV-1 Infection in the United States

Abstract

BackgroundThe possibility of incorporating generics into combination antiretroviral therapy and breaking apart once-daily single-tablet regimens (STRs), may result in less efficacious medications and/or more complex regimens with the expectation of marked monetary savings. A modeling approach that assesses the merits of such policies in terms of lifelong costs and health outcomes using adherence and effectiveness data from real-world U.S. settings.MethodsA comprehensive computer-based microsimulation model was developed to assess the lifetime health (life expectancy and quality adjusted life-years—QALYs) and economic outcomes in HIV-1 infected patients initiating STRs compared with multiple-table regimens including generic medications where possible (gMTRs). The STRs considered included tenofovir disoproxil fumarate/emtricitabine and efavirenz or rilpivirine or elvitegravir/cobicistat. gMTRs substitutions included each counterpart to STRs, including generic lamivudine for emtricitabine and generic versus branded efavirenz.ResultsLife expectancy is estimated to be 1.301 years higher (discounted 0.619 QALY gain) in HIV-1 patients initiating a single-tablet regimen in comparison to a generic-based multiple-table regimen. STRs were associated with an average increment of $26,547.43 per patient in medication and $1,824.09 in other medical costs due to longer survival which were partially offset by higher inpatients costs ($12,035.61) with gMTRs treatment. Overall, STRs presented incremental lifetime costs of $16,335.91 compared with gMTRs, resulting in an incremental cost-effectiveness ratio of $26,383.82 per QALY gained.ConclusionsSTRs continue to represent good value for money under contemporary cost-effectiveness thresholds despite substantial price reductions of generic medications in the U. S.

A meta-analysis comparing 48-week treatment outcomes of single and multi-tablet antiretroviral regimens for the treatment of people living with HIV

“…Ten studies were summarized in the previous review [ 11 ]. Three additional studies were identified and are reported in this publication [ 23 , 44 , 45 ]. One study, evaluating overall ART changes in 3850 PLWH, found that modifying therapy resulted in a mean additional cost of €14 (SD €216; range −€528 to +€831) per month per patient [ 44 ].…”

“…Toxicity and therapy simplifications were cited as the leading causes for regimen changes [ 44 ]. Economic outcomes have been modeled using simulations and insurance claims data including comprehensive computer-based microsimulation to compare the cost-effectiveness of STR to MTR for initial treatment and concluded that the ICER of STR to MTR is $26,383 per quality-adjusted life year [ 45 ]. A multivariate regression model study using Medicaid medical and pharmacy claims data was completed to determine the impact of ART pill burden in 2174 PLWH [ 23 ].…”

“…Improved clinical outcomes could in turn result in lower resource utilization and cost effectiveness of therapy. In fact, the economic studies included in this update indicated lower risk of hospitalization, as well as an ICER of approximately $26,000, which is within the range of willingness to pay thresholds [ 45 ]. It should be noted that these economic findings are based on OS and modelling, with inherent selection bias based on variations in patient characteristics and multiple assumptions which may or may not accurately reflect the treatment paradigm in a real-world setting.…”

Patient perspectives on de‐simplifying their single‐tablet co‐formulated antiretroviral therapy for societal cost savings

“…Approaches to reduce drug costs such as ARV mono or dual therapy are being explored but are not currently widely utilized. The use of generic formulations after patent expiry of proven ARV products has also been extensively discussed . With recent or imminent patent expiry of many core agents used in ART, the greater use of generic ARV drugs has become of immediate relevance to policy makers, plan holders, prescribing physicians and patients; some countries have begun incorporating generics into their HIV health policies in order to reduce costs .…”

Generic substitution of antiretrovirals: patients’ and health care providers’ opinions

“… 17 , 18 However, it remains a controversial strategy with conflicting results presented in published cost-effectiveness analysis. 19 , 20 …”