RESUMEN
Aim: To evaluate the cost-effectiveness of ribociclib plus fulvestrant versus fulvestrant in hormone receptor-positive/human EGF receptor 2-negative advanced breast cancer. Materials & methods: A three-state Markov model was developed to evaluate the costs and effectiveness over 10 years. Direct costs and utility values were obtained from previously published studies. We calculated incremental cost-effectiveness ratio to evaluate the cost-effectiveness at a willingness-to-pay threshold of $150,000 per additional quality-adjusted life year. Results: The incremental cost-effectiveness ratio was $1,073,526 per quality-adjusted life year of ribociclib plus fulvestrant versus fulvestrant. Conclusions: Ribociclib plus fulvestrant is not cost-effective versus fulvestrant in the treatment of advanced hormone receptor-positive/human EGF receptor 2-negative breast cancer. When ribociclib is at 10% of the full price, ribociclib plus fulvestrant could be cost-effective.
Asunto(s)
Aminopiridinas/economía , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Neoplasias de la Mama/tratamiento farmacológico , Fulvestrant/economía , Purinas/economía , Aminopiridinas/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/metabolismo , Análisis Costo-Beneficio , Femenino , Fulvestrant/administración & dosificación , Humanos , Cadenas de Markov , Purinas/administración & dosificación , Receptor ErbB-2/biosíntesis , Receptores de Estrógenos/biosíntesis , Receptores de Progesterona/biosíntesisRESUMEN
OBJECTIVE: The S0226 trial demonstrated that the combination of half-dose fulvestrant (FUL) and anastrozole (ANA) (F&A) caused a significant improvement in overall survival (OS) versus ANA monotherapy for first-line treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer (PMW-MBC (HR+)). The objective of this study was to evaluate the cost-effectiveness of F&A in the first-line treatment for PMW-MBC (HR+) in China. DESIGN: We constructed a Markov model over a life-time horizon. The clinical outcomes and utility data were obtained from published literature. Cost data were obtained from official Chinese websites. Sensitivity analyses were performed to test result uncertainty. SETTING: Chinese healthcare system perspective. POPULATION: A hypothetical cohort of adult patients presenting with PMW-MBC (HR+). INTERVENTIONS: F&A compared with full-dose FUL and ANAmonotherapy. MAIN OUTCOME MEASURES: The main outcome of this study was the incremental cost-effectiveness ratio (ICER) and quality-adjusted life-years (QALY). RESULTS: ANA was estimated to have the lowest cost and minimum life-years. The ICER of F&A versus ANA was US$15 665.891/QALY with incremental cost and QALY of US$12 401.120 and 0.792, respectively, which was less than the willingness-to-pay of US$29 383/QALY. Compared with F&A, FUL yielded a higher cost and a shorter lifetime; hence, it was identified as a dominated strategy. The univariate sensitivity analysis indicated the price of FUL was the most influential factor in our study. The probability that F&A was cost-effective at a threshold of US$29 383/QALY in China was 86.5%. CONCLUSION: F&A is a cost-effective alternative to FUL and ANA monotherapy for the first-line treatment of PMW-MBC (HR+) in China. F&A is a promising first-line treatment for PMW-MBC (HR+), and more research is needed to evaluate the economy of using F&A in other countries.
Asunto(s)
Anastrozol/uso terapéutico , Antineoplásicos Hormonales/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Fulvestrant/uso terapéutico , Anastrozol/administración & dosificación , Anastrozol/economía , Antineoplásicos Hormonales/administración & dosificación , Antineoplásicos Hormonales/economía , Neoplasias de la Mama/economía , Neoplasias de la Mama/patología , Análisis Costo-Beneficio , Costos de los Medicamentos , Quimioterapia Combinada/economía , Quimioterapia Combinada/métodos , Femenino , Fulvestrant/administración & dosificación , Fulvestrant/economía , Costos de la Atención en Salud , Humanos , Cadenas de Markov , Años de Vida Ajustados por Calidad de VidaRESUMEN
PURPOSE: In a recent randomized, open-label trial (S0226), the addition of fulvestrant to anastrozole therapy decreased the risk of progression and death in patients with hormone-receptor-positive metastatic breast cancer. However, the cost-effectiveness of incorporating fulvestrant into the first-line setting is unknown. METHODS: We developed a Markov model to assess the costs and clinical outcomes of fulvestrant plus anastrozole compared with anastrozole as a first-line therapy in a cohort of patients with advanced hormone-receptor-positive breast cancer. The transition probabilities were estimated from the fitted survival curves in the S0226 trial. Health care costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated for fulvestrant plus anastrozole compared with anastrozole from US payer's perspective. RESULTS: Fulvestrant plus anastrozole led to an improvement of 0.11 QALYs compared with treatment with anastrozole alone. However, incorporating fulvestrant into the first-line therapy produced significantly higher health care costs ($72,496 vs. $38,959 for all eligible patients, and $73,728 vs. $37,239 for patients with no previous hormonal adjuvant therapy), resulting in ICERs of $300,564 and $194,450/QALY, respectively. Two-way sensitivity analysis showed that when the cost of fulvestrant decreased to $1.5/mg for all eligible patients or $3.5/mg for patients with no previous hormonal adjuvant therapy, at the perfect health in progression-free status, the ICER became $141,320 and $145,543 per QALY. CONCLUSION: Substituting fulvestrant as a first-line therapy for hormone-receptor-positive metastatic breast cancer is not cost-effective compared with anastrozole based on the willing-to-pay threshold of $150,000 per QALY.
Asunto(s)
Anastrozol/economía , Antineoplásicos Hormonales/economía , Neoplasias de la Mama/economía , Análisis Costo-Beneficio , Fulvestrant/economía , Posmenopausia , Anastrozol/uso terapéutico , Antineoplásicos Hormonales/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/metabolismo , Neoplasias de la Mama/patología , Femenino , Estudios de Seguimiento , Fulvestrant/uso terapéutico , Humanos , Pronóstico , Receptor ErbB-2/metabolismo , Receptores de Estrógenos/metabolismo , Receptores de Progesterona/metabolismoRESUMEN
BACKGROUND: Exemestane (EXE), exemestane + everolimus (EXE + EVE), toremifene (TOR), and fulvestrant (FUL) are second-line endocrine therapies for postmenopausal hormone receptor-positive (HR +)/human epidermal growth factor receptor 2-negative (HER2 -) metastatic breast cancer (mBC) in Japan. Although the efficacy of these therapies has been shown in recent studies, cost-effectiveness has not yet been determined in Japan. OBJECTIVE: This study aimed to examine the cost-effectiveness of second-line endocrine therapies for the treatment of postmenopausal women with HR + and HER2 - mBC. METHODS: A Markov model was developed to analyze the cost-effectiveness of the therapies over a 15-year time horizon from a public healthcare payer's perspective. The efficacy and utility parameters were determined via a systematic search of the literature. Direct medical care costs were used. A discount rate of 2% was applied for costs and outcomes. Subgroup analysis was performed for non-visceral metastasis. A series of sensitivity analyses, including probabilistic sensitivity analysis (PSA) and threshold analysis were performed. RESULTS: Base-case analyses estimated incremental cost-effectiveness ratios (ICERs) of 3 million and 6 million Japanese yen (JPY)/quality-adjusted life year (QALY) gained for TOR and FUL 500 mg relative to EXE, respectively. FUL 250 mg and EXE + EVE were dominated. The overall survival (OS) highly influenced the ICER. With a willingness-to-pay (WTP) threshold of 5 million JPY/QALY, the probability of TOR being cost-effective was the highest. Subgroup analysis in non-visceral metastasis revealed 0.4 and 10% reduction in ICER from the base-case results of FUL5 500 mg versus EXE and TOR versus EXE, respectively, while threshold analysis indicated EVE and FUL prices should be reduced 73 and 30%, respectively. CONCLUSION: As a second-line therapy for postmenopausal women with HR +/HER2 - mBC, TOR may be cost-effective relative to other alternatives and seems to be the most favorable choice, based on a WTP threshold of 5 million JPY/QALY. FUL 250 mg is expected to be as costly and effective as EXE. The cost-effectiveness of EXE + EVE and FUL 500 mg could be improved by a large price reduction. However, the results are highly sensitive to the hazard ratio of OS. Policy makers should carefully interpret and utilize these findings.