Cost-effectiveness analysis of first-line administration of tenofovir alafenamide (TAF), a novel nucleotide reverse transcrip-tase inhibitor (NRTI), for the management of chronic hepatitis b (CHB) in the united states (us).
Dusheiko G, Lim J, Liou I, Tafazzoli A, Deniz B, Saint-Laurent Thibault C, Gordon S, and Nguyen MH. Cost-effectiveness analysis of first-line administration of tenofovir alafenamide (TAF), a novel nucleotide reverse transcrip-tase inhibitor (NRTI), for the management of chronic hepatitis b (CHB) in the united states (us). Value Health 2017; 20(5):A78.
OBJECTIVES: To estimate the health and economic value of TAF versus tenofovir disoproxil fumarate (TDF) or entecavir (ETV) in the management of patients with CHB from the third-party US payer perspective. METHODS: A lifetime cost-effectiveness model was developed using discretely integrated condition event (DICE) simulation. Health and cost outcomes for the overall population and patient subgroups (e.g. treatment-naive and treatment-experienced) were analyzed separately. Inputs were obtained from published randomized trials and epidemiological/outcome studies, real-world database analyses and expert opinions. Model structure/assumptions/inputs were agreed by a group of clinical experts and health economists. As observed in the two pivotal trials, the model assumed similar HBV suppression and resistance rates between TAF and TDF, and improved ALT reduction and bone/renal safety with TAF. Efficacy and safety data for ETV were obtained from published studies. RESULTS: Over a lifetime, initiation of TAF was associated with fewer hepatic complications (cirrhosis, hepatocellular carcinoma, liver transplantation), renal and bone related events and deaths when compared to TDF and ETV, which resulted in higher quality-adjusted life years (QALYs) per patient (0.02-0.34) on long-term projection. Total costs per patient with TAF were lower (-0.35% to -1.15%) compared with TDF and higher (3.1% to 4.0%) compared with ETV. The model suggested that TAF usage dominated versus TDF in the overall population with greater cost saving and better clinical outcomes in the TE population. Compared with ETV, incremental cost-effectiveness ratios (ICERs) were below the commonly accepted threshold of $50,000/QALY in the overall population. Sensitivity analyses showed that results were robust. CONCLUSIONS: Driven by its favorable efficacy, safety, and resistance profile, TAF is projected to lead to better health outcomes and to be cost effective compared to TDF and ETV, leading to either dominance or generally favorable cost-effectiveness ratio (i.e., ICER< $50,000/QALY).