Cost-effectiveness analysis of utidelone plus capecitabine for metastatic breast cancer in China.

Objective: To estimate the cost-effectiveness of utidelone plus capecitabine therapy compared to capecitabine alone in patients with metastatic breast cancer (MBC) resistant to anthracyclines and taxanes treatment in the Chinese context and provide a reference for the marketing of utidelone in China. Methods: A Markov model was developed based on the NCT02253459 clinical trial to simulate the clinical course of patients with metastatic breast cancer who had received taxanes and anthracycline therapy. The quality-adjusted life years (QALYs) and Incremental Cost Effectiveness Ratio (ICER) were then analyzed to evaluate the benefits. Two-parametric Weibull distribution was conducted to fit PFS and OS curves by using R. Sensitivity analyses were performed to evaluate the stability of the model designed. Results: The addition of utidelone increased the cost and QALYs by $13,370.25 and 0.1961, respectively, resulting in an increased ICER of $68,180.78 per QALY. The most sensitive influential parameter on ICER was the price of utidelone. At the threshold of willingness-to-pay (WTP) of $24,380 (3 per capita GDP of China), the cost of utidelone per 30 mg of less than $18.5, $33.7, and greater than $48.8 resulted in a 100%, 50%, and 0% possibility of cost-effectiveness, respectively. The addition of utidelone was not cost-effective when it was $115.4 per 30 mg-the price of its analog paclitaxel. In consideration of varied economics levels across China, cost-effectiveness could be achieved with the price of utidelone ranging from $5.2 to $35.9. Limitations: The survival curves extended beyond the follow-up time horizon, of which data were generated not from the real analyses but from our established two-parameter Weibull survival model. Conclusion: It is recommended that the price of utidelone would be less than $18.5 per 30 mg in order to obtain cost-effectiveness for metastatic breast cancer patients resistant to anthracyclines and taxanes treatment in China.

A cost effectiveness study of eribulin versus standard single-agent cytotoxic chemotherapy for women with previously treated metastatic breast cancer.

Eribulin was FDA approved in 2012 as a treatment for patients with MBC who have previously received at least two prior chemotherapy regimens. The aim of this analysis was to assess the cost effectiveness of eribulin versus the three most commonly utilized drugs (TPC) in the EMBRACE trial: vinorelbine, gemcitabine, and capecitabine (X); and to other branded FDA approved drugs: ixabepilone (I), liposomal-doxorubicin (D), and nab-paclitaxel. We created a decision-analytical and a Markov model using clinical data from the EMBRACE trial. Health utilities were derived from the published literature. Costs for drug acquisition, physician visits, and laboratory tests were obtained from Medicare Services Drug Payment Table and Physician Fee Schedule and are represented in 2012 USD. Life-years saved (LY), quality-adjusted life years (QALY), and incremental cost effectiveness ratio (ICER) were calculated. Eribulin added 0.208 LY and 0.119 QALY with an incremental cost over TPC of $25,458, and therefore an ICER of $213,742 per QALY. The main drivers of the model were drug cost, PFS, OS, and health utility values. The results of the model were robust in sensitivity analyses. Relative to I, D, A, and X, the ICER for eribulin was $76,823, $109,283, $129,773, and $167,267, respectively. Even with a more contemporary willingness-to-pay threshold of approximately $120,000 per QALY, eribulin was not found to be cost effective in the treatment of MBC relative to TPC; relative to some more expensive branded drugs, eribulin appears to be cost effective.

Budget impact analysis of ixabepilone used according to FDA approved labeling in treatment-resistant metastatic breast cancer.

BACKGROUND: Breast cancer is one of the most common forms of cancer in the United States, with approximately 10% of newly diagnosed patients presenting with metastatic disease. Limited therapy options make the successful treatment of metastatic breast cancer (MBC) difficult. Current treatment options include drugs belonging to the classes of anthracyclines and taxanes as well as the drug capecitabine. Resistance to these classes of drugs is often acquired, thus highlighting the need for newer agents capable of managing treatment resistant disease. Ixabepilone is an antineoplastic agent from the epothilone class that was FDA-approved in October 2007 for the treatment of metastatic or locally advanced breast cancer. The FDA-approved indications for ixabepilone specify (a) use of ixabepilone in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer after (resistance to) treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated; and (b) ixabepilone as a monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to an anthracycline, a taxane, and capecitabine. OBJECTIVES: To estimate the 3-year projected impact on the annual pharmacy budget for a hypothetical 1 million-member commercial plan that introduces and reimburses ixabepilone therapy for its FDA-approved indications: either as a monotherapy for patients pretreated with combined anthracyclines, taxanes, and capecitabine (ATC-p) or in combination with capecitabine for patients pretreated with anthracyclines and taxanes (AT-p). METHODS: U.S. prevalence and treatment data for MBC patients were obtained from published and nonpublished sources. The MBC population was stratified into AT-p and ATC-p populations. These 2 groups comprised the assumed study population. The model considered 2 scenarios-without (pre) and with (post) ixabepilone, either as monotherapy for ATC-p or combination therapy with capecitabine for AT-p patients. Market share data for chemotherapeutic treatment options for MBC pre-ixabepilone and in the first year post-ixabepilone were obtained from nonpublished, proprietary, real-world drug utilization data collected by IntrinsiQ LLC (Waltham, MA), for 2007 and 2008, respectively. Market shares for the second and third years post-ixabepilone were forecasted by the study authors based on IntrinsiQ data collected from January 2008 to January 2009 and the observed switching patterns in the 2007 and 2008 IntrinsiQ data. Drug costs were based on First DataBank Inc. Wholesale Acquisition Cost (accessed March 2009). The results for each indication were analyzed individually and summed to reflect the total impact of ixabepilone. Results were also considered on a per member per month (PMPM) basis to examine the relative impact on the plan. Sensitivity of the results to model assumptions was tested using univariate sensitivity analyses on the prevalence of AT-p and ATC-p, the price of ixabepilone, the price of comparator medications, and the ixabepilone market uptake. A key assumption was that ixabepilone would be used only in accordance with its current labeled indications. RESULTS: In a health plan population of 1 million members, the estimated number of female patients aged 20 years or older with recurrent MBC and previous treatment with either AT or ATC was 15 over the 3-year time horizon used in this budget impact model. For AT-p patients, the estimated incremental cost PMPM was $0.002 for each of the 3 years. The estimated incremental cost PMPM for the ATC-p population was $0.003 for year 1 and $0.004 for both year 2 and year 3. In sensitivity analyses, the PMPM impact varied between -$0.01 and $0.02 over the 3-year period. The model was most sensitive to the cost of ixabepilone. CONCLUSION: Given the poor prognosis and limited number of treatment options for patients with MBC, the need for widespread coverage of ixabepilone in accordance with FDA-approved indications can clearly be established. Assuming that ixabepilone is used only for its currently labeled indications, both the number of patients eligible for ixabepilone treatment and the expected budget impact of covering ixabepilone for this group of patients are relatively small.