OBJECTIVES:

To compare the lifetime cost-effectiveness of once-daily 25 mg Empagliflozin, 5 mg Linagliptin, and 1000 mg Metformin XR triple-fixed-dose combination (FDC) versus its dual FDC of 25 mg Empagliflozin and 5 mg Linagliptin plus Metformin and its individual components.

METHODS:

The Building, Relating, Assessing, and Validating Outcomes (BRAVO) diabetes model was used to assess costs and outcomes with an antidiabetic FDC vs. its equivalent formulations from a US national health payer perspective. Patients were assumed to receive either the triple FDC, double FDC or the three individual components for the 40-year time horizon with 3% annual discounting. Baseline characteristics, changes in clinical parameters, and rates of adverse events were derived from the 24-week results of trial NCT01422876, the ACCORD trial, and data from Boehringer Ingelheim. Medication costs were taken from Good RX. Outcomes included quality-adjusted life years (QALYs), direct medical costs per person, and the incidence of diabetes complications. One-way and probabilistic sensitivity analyses were performed with WTP threshold of $50000/QALY.

RESULTS:

Treatment with triple FDC was associated with a decrease of 0.01 life-years (LY) and an increase of 0.002 QALYs and a cost-savings of $8,596 compared with double FDC. Compared with Linagliptin, FDC led to an increase of 0.38 LY and 0.25 QALYs, and increased costs by $3,472 Compared with Empaglifozin, the triple FDC led to an increase of 0.1 LY, 0.08 QALYs, and saved $42758. The ICER compared to the double, Linglipatin, and Empaglifozin was -4306250, 13803, and -552498 respectively. At a willingness-to-pay threshold of 50,000, the triple FDC was cost-effective compared to all three alternatives. Probabilistic sensitivity analysis found that results were cost-effective 100% of the time at the $50,000/QALY threshold.

CONCLUSIONS:

The triple FDC treatment demonstrated to be a dominant alternative to double FDC + Metformin and Empagliflozin + Metformin and cost-effective compared to Linagliptin + Metformin.