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Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (EVG/COBI/FTC/TAF) (Genvoya) Fixed-Dose Combination, Oral Tablet) [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Nov.
| Drug Product | Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide fumarate 10 mg, FDC product) |
| Treatment | EVG/COBI/FTC/TAF 150/150/200/10 mg taken once daily with food |
| Comparators | Recommended regimens based on US DHHS.3 INSTI-based regimens:
|
| Study Question | “To conduct a cost-minimization analysis of EVG/COBI/FTC/TAF 150 mg/150 mg/200 mg/10 mg versus appropriate comparators, over a one-day horizon and from a government perspective, in patients with HIV-1 infection.” |
| Type of Economic Evaluation | Cost comparison (drugs costs only) |
| Target Population | Patients with HIV-1 infection |
| Perspective | Health care system |
| Outcomes Considered | Virological success, defined by the proportion of patient with plasma HIV-1 RNA < 50 copies/mL at 24 and 48 weeks |
| Key Data Sources | |
| Cost |
|
| Clinical Efficacy | Based on five phase 3 clinical trials:
|
| Harms | Based on same studies noted earlier |
| Time Horizon | Daily |
| Results for Base Case | The daily cost of EVG/COBI/FTC/TAF ($▬) was calculated to be ▬ to the daily cost of DTG/ABC/3TC ($41.38) and less costly than the other recommended regimens, including EVG/COBI/FTC/TDF, with cost savings ranging from $▬ to $▬ daily. |
| Results from the Sensitivity Analysis | The manufacturer conducted an alternate analysis where they considered comparators deemed alternative regimens in the US DHHS guidelines. These included:
|
| The daily cost of EVG/COBI/FTC/TAF is less costly than all alternative regimens, with cost savings ranging from $▬ to $▬ daily. |
3TC = lamivudine; ABC = abacavir; ARTs = antiretroviral therapies; ATV = atazanavir; COBI = cobicistat; DHHS = Department of Health and Human Services; DRV = darunavir; DTG = dolutegravir; EVF = efavirenz; EVG = elvitegravir; FDC = fixed-dose combination; FTC = emtricitabine; HIV-1 = human immunodeficiency virus type 1; INSTI = integrase strand transfer inhibitor; PI = protease inhibitor; q.d. = once daily; RAL = raltegravir; RNA = ribonucleic acid; RPV = rilpivirine; STR = single-tablet regimen; TAF = tenofovir alafenamide fumarate; TDF = tenofovir disoproxil fumarate.
TDF/FTC + a third drug included the following: EVG/COBI/FTC/TDF, EFV/FTC/TDF, ATV/co + FTC/TDF and ATV/r + TDF.
The manufacturer conducted a cost comparison analysis for the full population (i.e., adolescent and adult patients). As reported in Table 5, the daily cost of EVG/COBI/FTC/TAF ($▬) is ▬ to the daily cost of DTG/ABC/3TC. Moreover, it is less costly than similar ARV regimen, STR EVG/COBI/FTC/TDF, with cost savings of $▬ per day, as well as other recommended ARV regimens (DTG + FTC/TDF; RAL + FTC/TDF; and DRV + FTC/TDF), with cost savings ranging from $▬ to $▬ per day.
Manufacturer’s Base-Case Analysis Results.
As reported in Table 6, the daily cost of EVG/COBI/FTC/TAF ($▬) is less costly than alternative ARV regimens (costs savings ranging from $▬-$▬).
Manufacturer’s Sensitivity (Alternate) Analysis Results.
CADTH Common Drug Review (CDR) identified no concerns with the manufacturer’s base-case cost comparison for the adult population.
CDR considered the adolescent population separately given potential differences in the ARV regimens used. CDR compared EVG/COBI/FTC/TAF to other ARV regimens, reported as daily cost per patient (Table 7). Patients aged 12 years to 18 years may be prescribed ARV regimens based on the pediatric guidelines,13 or may be treated with STRs. The three STRs included here are used most often in adolescent patients in clinical practice, based on clinical expert opinion. The daily cost of STR EVG/COBI/FTC/TAF is ▬ to the daily cost of STR DTG/ABC/3TC and is less costly than STRs EFV/TDF/FTC and FTC/RPV/TDF, with cost savings ranging from $▬ to $▬ per day.
CADTH Common Drug Review Cost Comparison Analysis in Adolescent Patients.
Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/
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