Economic Savings Versus Health Losses: The Cost-Effectiveness of Generic Antiretroviral Therapy in the United States

Harvard University, Cambridge, Massachusetts, United States
Annals of internal medicine (Impact Factor: 17.81). 01/2013; 158(2):84-92. DOI: 10.7326/0003-4819-158-2-201301150-00002
Source: PubMed


Chinese translation
U.S. HIV treatment guidelines recommend branded once-daily, 1-pill efavirenz-emtricitabine-tenofovir as first-line antiretroviral therapy (ART). With the anticipated approval of generic efavirenz in the United States, a once-daily, 3-pill alternative (generic efavirenz, generic lamivudine, and tenofovir) will decrease cost but may reduce adherence and virologic suppression.
To assess the clinical effect, costs, and cost-effectiveness of a 3-pill, generic-based regimen compared with a branded, coformulated regimen and to project the potential national savings in the first year of a switch to generic-based ART.
Mathematical simulation of HIV disease.
United States.
HIV-infected persons.
No ART (for comparison); 3-pill, generic-based ART; and branded ART.
Quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY).
Compared with no ART, generic-based ART has an ICER of $21 100/QALY. Compared with generic-based ART, branded ART increases lifetime costs by $42 500 and per-person survival gains by 0.37 QALYs for an ICER of $114 800/QALY. Estimated first-year savings, if all eligible U.S. patients start or switch to generic-based ART, are $920 million. Most plausible assumptions about generic-based ART efficacy and costs lead to branded ART ICERs greater than $100 000/QALY.
The efficacy and price reduction associated with generic drugs are unknown, and estimates are intended to be conservative.
Compared with a slightly less effective generic-based regimen, the cost-effectiveness of first-line branded ART exceeds $100 000/QALY. Generic-based ART in the United States could yield substantial budgetary savings to HIV programs.
National Institute of Allergy and Infectious Diseases.

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    • "This offers the potential for the replacement of branded FDCs by cheaper generics containing the same active drugs administered as separate pills [10] [11]. It was recently shown that decoupling of branded FDCs into separate generic and branded drugs could result in considerable cost savings [12] [13]. Current pressures to control healthcare expenditures in many countries could encourage the decoupling of branded FDCs. "
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    ABSTRACT: Administering drugs as fixed-dose combinations (FDCs) versus the same active drugs administered as separate pills is assumed to enhance treatment adherence. We synthesized evidence from randomized controlled trials (RCTs) about the effect of FDCs versus separate pills on adherence. We searched PubMed for RCTs comparing a FDC with the same active drugs administered as separate pills, including a quantitative estimate of treatment adherence, without restriction to medical condition. The odds ratio (OR) of optimal adherence with FDCs versus separate pills was used as common effect size and aggregated into a pooled effect estimate using a random effect model with inverse variance weights. Out of 1258 articles screened, only six studies fulfilled inclusion criteria. Across medical conditions, administering drugs as FDC significantly increased the likelihood of optimal adherence (OR 1.33 (95% CI, 1.03-1.71)). Within subgroups of specific medical conditions, the favourable effect of FDCs on adherence was of borderline statistical significance for HIV infection only (OR 1.46 (95% CI, 1.00-2.13)). We observed a remarkable paucity of RCTs comparing the effect on adherence of administering drugs as FDC versus as separate pills. Administering drugs as FDC improved medication adherence. However, this conclusion is based on a limited number of RCTs only.
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    • "At present, it is the cost of goods and services that contributes the major portion of cost to aHSCT-GT, and when there are more providers of these goods, they should become less expensive. In the current context of HIV-1 treatment, where the cost of lifelong ART therapy is estimated to be $420,000–$755,000 USD per individual, with 73 % of the cost going toward ART [63, 64], and even the conversion to generic once daily ART, estimated to only reduce lifetime costs by ~ $42,000/patient [65], successful gene therapy for HIV-1 could be cost effective [18, 54]. "
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    ABSTRACT: Despite the success of antiretroviral therapy in suppressing HIV-1 replication and extending the life of HIV-1 infected individuals, this regimen is associated with risks for non-AIDS morbidity and mortality, requires life commitment, and has a high cost. In this context, gene therapy approaches that have the potential to cure HIV-1 infection present a clear option for eradication of the virus in the next decades. Gene therapy must overcome concerns related to its applicability to HIV-1 infection, the safety of cytotoxic conditioning required for cell-based approaches, clinical trial design, selection of gene-modified cells, and the restrictive cost of manufacturing and technology. These concerns are discussed herein in the context of the most relevant gene therapy studies conducted so far in HIV/AIDS.
    Full-text · Article · Jan 2014 · Current HIV/AIDS Reports

  • No preview · Article · Jan 2013 · Annals of internal medicine
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