Background: The EMILIA trial demonstrated T-DM1 significantly increased in median profession-free (3.2 months) and overall (5.8 months) survival relative to combination therapy with lapatinib plus capecitabine (LC) in patients with HER2-positive ABC previously treated with trastuzumab and a taxane. We performed an economic analysis of T-DM1 compared to LC and monotherapy with capecitabine (C) from both US payer and societal perspectives. Methods: We developed 4 possible Markov models to compare the projected lifetime costs and outcomes of T-DM1 and LC, and C. Markov models 1 and 2 have four health states (progression-free, response to therapy, disease-progression, and death), and Markov models 3 and 4 have three health states (progression-free, disease-progression, and death). In models 1 and 3, the possibility of death can occur in any health state; while in models 2 and 4, death can only occur in disease-progressing health state. Transition probabilities were estimated from published relevant trials. Six-week cycle time was modeled to follow the assessment time interval in the trials. Direct costs of the therapies, major adverse events, laboratory tests, and disease progression, indirect costs (productivity losses due to morbidity and mortality), and health utilities were obtained from published sources. The models used 3% discount rate and reported in 2014 US dollars. One-way and probabilistic sensitivity analyses were performed in the study. Results: When incorporating both model structural and parameter uncertainty, the resulting incremental cost-effectiveness ratios (ICER) comparing T-DM1 to LC and T-DM1 to C were $172,152 per quality-adjusted life year (QALY) and $126,251/QALY from the US societal perspective, respectively. From the US payer perspective, the ICERs were $205,598/QALY (T-DM1 vs. LC) and $164,628/QALY (T-DM1 vs. C). (See Table) Conclusions: From the US societal perspective, T-DM1 may be cost-effective relative to C. However, T-DM1 is not clearly cost-effective when comparing to LC from both perspectives.
Treatment Regimen | Lifetime Direct Cost ($) | Lifetime Indirect Cost ($) | QALYs |
---|---|---|---|
T-DM1 | 270,630 | 27,335 | 2.04 |
LC | 180,202 | 42,046 | 1.60 |
C | 101,966 | 66,653 | 1.01 |
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