Pharmacoeconomic review report: Dolutegravir/Lamivudine (Dovato) (ViiV healthcare ULC) indication: as a complete regimen for the treatment of human immunodeficiency virus type1 (HIV-1) infection in adults and asolescents 12 years of age and older and weighing at least 40 kg

The Markov health states captured disease progression according to CD4+ cell count, as well as the occurrence of clinical events (i.e., adverse treatment events, AIDS-defining events, and long-term toxicities). The decision tree captured treatment discontinuation to stratify subsequent therapy lines...

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Bibliographic Details
Corporate Author: Canadian Agency for Drugs and Technologies in Health
Format: eBook
Language:English
Published: Ottawa (ON) CADTH October 2019, 2019
Edition:Version: final
Series:CADTH common drug review
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Description
Summary:The Markov health states captured disease progression according to CD4+ cell count, as well as the occurrence of clinical events (i.e., adverse treatment events, AIDS-defining events, and long-term toxicities). The decision tree captured treatment discontinuation to stratify subsequent therapy lines. The manufacturer sponsored network meta-analysis (NMA) informed the relative efficacy inputs in terms of virologic (viral load) and immunological response (CD4+ T-cell count), as well as the safety inputs, for all first-line therapies. The analysis was conducted over a lifetime time horizon (up to 80 additional years), from the Canadian public health care payer perspective with costs and QALYs discounted at 1.5%. In the manufacturer's base case, DTG/3TC was associated with fewer costs and higher QALYs than all comparator regimens. As a result, it was dominant and, across all willingness-to-pay thresholds, it would be considered the most likely cost-effective strategy.
The manufacturer submitted a cost-utility analysis based on a hybrid decision tree and Markov state transition model that assessed the costs and quality-adjusted life-years (QALYs) of treatment with DTG/3TC in comparison with current standard single-tablet regimens (STRs) (DTG/ abacavir [ABC]/3TC [Triumeq], elvitegravir/cobicistat/tenofovir alafenamide/emtricitabine [FTC] [Genvoya], and bictegravir/FTC/tenofovir alafenamide [Biktarvy]) and multi-tablet drug regimens (DTG/tenofovir disoproxil fumarate [TDF]/FTC [Tivicay + Truvada]). Health states were defined based on viral load, CD4+ (cluster of differentiation 4 positive) T-cell count and treatment line with the model allowing patients to receive up to two additional lines of antiretroviral therapy (ART) before moving on to salvage therapy (on which they would remain until death).
The manufacturer stated the results were driven by the drug acquisition costs
Dolutegravir/lamivudine (DTG/3TC; Dovato) is a fixed-dose combination of two drugs indicated as a complete regimen for the treatment of adults and children 12 years of age and older who weigh at least 40 kg and have HIV-1 infection. DTG/3TC consists of a single tablet containing 50 mg DTG, an integrase inhibitor, and 300 mg 3TC, a nucleoside reverse transcriptase inhibitor, to be taken once daily. At the manufacturer-submitted price of $30.44 per tablet, the annual cost of treatment is approximately $11,110. The manufacturer's reimbursement request was in accordance with the Health Canada indication.
Physical Description:1 PDF file (31 pages) illustrations