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ABSTRACT
Objective: To evaluate the cost-effectiveness of bedaquiline plus background drug regimens (BR) for multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) in Italy.
Methods: A Markov model was adapted to the Italian setting to estimate the incremental cost-effectiveness ratio (ICER) of bedaquiline plus BR (BBR) versus BR in the treatment of MDR-TB and XDR-TB over 10 years, from both the National Health Service (NHS) and societal perspective. Cost-effectiveness was evaluated in terms of life-years gained (LYG). Clinical data were sourced from trials; resource consumption for compared treatments was modelled according to advice from an expert clinicians panel. NHS tariffs for inpatient and outpatient resource consumption were retrieved from published Italian sources. Drug costs were provided by reference centres for disease treatment in Italy. A 3% annual discount was applied to both cost and effectiveness. Deterministic and probabilistic sensitivity analyses were conducted.
Results: Over 10 years, BBR vs. BR alone is cost-effective, with ICERs of €16,639/LYG and €4081 /LYG for the NHS and society, respectively. The sensitivity analyses confirmed the robustness of the results from both considered perspectives.
Conclusion: In Italy, BBR vs. BR alone has proven to be cost-effective in the treatment of MDR-TB and XDR-TB under a range of scenarios.
ARTICLE HISTORY
Received 7 November 2016
Revised 15 December 2016
Accepted 22 December 2016
KEYWORDS
Bedaquiline; cost-effectiveness; MDR tuberculosis; XDR tuberculosis; Italy
List of abbreviations
AIFA = Italian National Agency for Drugs
BR = background regimens
BBR = bedaquiline plus background regimen
DST = drug susceptibility testing
EMA = European Medicines Agency
HIV = human immunodeficiency virus
ICER = incremental cost-effectiveness ratio
Iv = intravenous
LBR = linezolid plus background regimen
LN = natural logarithm
LYG = life-year gained
MDR-TB = multidrug-resistant tuberculosis
miTT = modified intent-to-treat
NHS = Italian National Healthcare System
PSA = probabilistic sensitivity analysis
QALY = quality adjusted life year
SE = standard error
TB = tuberculosis.
XDR-TB = extensively drug-resistant tuberculosis
Introduction
Multidrug-resistant tuberculosis (MDR-TB) is a disease caused by strains of mycobacterium tuberculosis resistant to treatment with isoniazid and rifampicin; extensively drug-resistant tuberculosis (XDR-TB) is caused by multidrug-resistant strains which are also resistant to treatment with fluoroquinolone and any of the injectable drugs used in second-line defence, such as amikacin, capreomycin, and kanamycin.[1-3] MDR-TB and XDR-TB...