FRLBX06 - Oral Abstract Session
The clinical and economic impact of a generic first-line antiretroviral regimen in the U.S.
Presented by Rochelle P. Walensky (United States).
R.P. Walensky1, P.E. Sax2, Y.M. Nakamura3, M.C. Weinstein4, P.P. Pei3, K.A. Freedberg1, A.D. Paltiel5, B.R. Schackman6
1Massachusetts General Hospital, Harvard Medical School, Boston, United States, 2Brigham and Women's Hospital, Harvard Medical School, Boston, United States, 3Massachusetts General Hospital, Boston, United States, 4Harvard School of Public Health, Boston, United States, 5Yale School of Medicine, New Haven, United States, 6Weill Cornell Medical College, New York, United States
guidelines recommend once-daily, one-pill efavirenz/emtricitabine/tenofovir as
a preferred first-line ART regimen. With the anticipated availability of
generic efavirenz in the US, the cost of a once-daily, three-pill alternative (generic
efavirenz, generic lamivudine, tenofovir) will decrease, but adherence and
virologic suppression may be lower. We project the clinical impact, cost, and
cost-effectiveness of the generic-based vs. brand-name options.
an HIV simulation model (CEPAC-US), we examine 3 strategies: 1) No ART (for
comparison); 2) three-pill generic-based ART; and 3) one-pill brand-name ART.
Inputs are from peer-reviewed data: ART efficacies (24-week suppression: 78% generic-based
vs. 85% brand-name); drug costs are 25%
of average wholesale price (AWP) for generics and 77% of AWP for others ($8,600/year
vs. $15,370/year for the regimen); the cohort is 84% male, mean CD4
317/µl. From the US health system perspective (2010 USD), we
report incremental cost-effectiveness ratios (ICERs, $/QALY) compared against a
$100,000/QALY threshold. We also project
the potential annual savings for those initiating ART (incident diagnoses,
~2,500) and those eligible to switch to the generic-based regimen (prevalent
Results: Compared to No
ART, generic-based ART has an ICER of $21,600/QALY. Compared to generic-based ART, brand-name ART increases lifetime costs by $43,900, and
per-person survival gains by 0.36 quality-adjusted life years (due to increased efficacy and reduced
resistance from emtricitabine compared to lamivudine), for an ICER of $121,300/QALY (Table).
ICERs are sensitive to decreases in generic-based ART efficacy and to
generic drug costs; most plausible combinations lead to ICERs >$100,000/QALY
(Figure). Estimated annual savings if all eligible US
incident/prevalent patients switched to the generic-based regimen are $1.01B.
to a slightly-less effective generic-based regimen, the cost-effectiveness of
the guideline-recommended brand-name regimen exceeds the $100,000/QALY
threshold. Switching to generic-based regimens would yield substantial savings
for programs that fund HIV treatment.
| ||Per person life expectancy
(QALYs)*||Per person lifetime cost*
|Three-pill generic-based ART||12.09||305,200||21,600|
|One-pill brand-name ART||12.45||349,100||121,300|
|QALY: Quality-adjusted life year; ICER: Incremental cost-effectiveness ratio.
*QALYs and costs discounted at 3% annually; undiscounted life expectancy for one-pill brand-name = 19.33 QALYs.|
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