Cost-Effectiveness Study in Europe Evaluates Neovasc's Reducer for Refractory Angina

 

May 28, 2019—Neovasc Inc. announced that a study of the cost-consequences and cost-effectiveness of the company's Reducer device for patients with refractory angina were published online ahead of print by Guglielmo Gallone, MD, et al in European Heart Journal: Quality of Care and Clinical Outcomes.

According to the company, the study's main findings were (1) that Reducer decreases the health care burden of patients with refractory angina and the associated costs across a range of European health care system perspectives and (2) that Reducer is cost-effective as a therapy for refractory angina according to the cost-effectiveness thresholds of the World Health Organization (WHO). The Reducer device was shown to reduce health care resource utilization and associated costs in patients with severe angina that is refractory to optimal medical therapy and not amenable for further revascularization.

Neovasc stated that in a limited 1-year time frame, the Reducer device was consistently cost-effective across the considered countries and range of cost-effectiveness thresholds. Under the assumptions of a Reducer effect duration of 2 and 3 years from implantation with a 30% per year efficacy decrease, the device yielded cost-effectiveness ratios that suggest high value from all the considered perspectives.

According to Neovasc, the study indicates that Reducer significantly improves quality of life for patients and improves quality-adjusted life-year (QALY) values. Reducer also resulted in statistically significant savings in health care costs related to angina-driven hospitalizations, outpatient visits, coronary angiography, and percutaneous coronary interventions (PCIs) per patient-year. At the second year, the incremental cost-effectiveness ratio for patients was well below the levels established by the WHO and the even stricter Dutch threshold.

The study considered cost-consequence (a comparison of patient care before and after Reducer implantation) and cost-effectiveness (a measure of total cost of the procedure and ongoing care against a combined measure of quality of life and life expectancy).

As summarized by Neovasc, the study collected usage of angina-related health care resources and quality-of-life data for 215 consecutive patients with refractory angina who were undergoing Reducer implantation in Belgium, the Netherlands, and Italy.

For the cost-consequence analysis, costs were assessed in each country's health care system. Data from the date of refractory angina diagnosis until Reducer implantation, the standard-of-care period (SoC time period), and from Reducer implantation to follow-up (the Reducer time period) were compared, with each patient serving as his or her own control. The investigators observed significant reductions in angina-driven hospitalizations, outpatient visits, coronary angiograms, and PCIs per patient-year during the Reducer time period, translating into significantly reduced costs per patient-year.

This translated into a significant reduction of the associated costs per patient-year from all three health care system perspectives during the SoC and Reducer time periods, respectively:

  • Belgium: €4,143 (€1,970–€9,347) versus €312 (€97–3,209); P < .001
  • The Netherlands: €3,079 (€1,441–€6,990) versus €121 (€37–€2,342); P < .001
  • Italy: €4,175 (€2,009–€3,210) vs €194 (€58–€2,786); P < .001

The cost-effectiveness of Reducer was expressed in the incremental cost-effectiveness ratio (ICER), defined as the difference in cumulative costs of Reducer and SoC time periods divided by the difference in cumulative QALYs of Reducer and SoC time periods.

The associated simulations under the WHO cost-effectiveness thresholds were 99.9%, 100%, and 93.3%, respectively, meaning that within 1 year, the Reducer nearly met or exceeded the WHO guidelines and that these effects further improved over 2- and 3-year estimates in the study. Costs and utilities during a 1-year SoC time period were compared with those of a 1-year Reducer time period to assess cost-effectiveness. Several Reducer efficacy duration assumptions were explored with modeled projections.

The investigators found the following:

  • The Reducer device was associated with higher QALYs (0.665 vs 0.580; P < .001) and incremental costs, yielding ICERs of €53,197, €34,948, €63,146 per QALY gained in Belgium, the Netherlands, and Italy, respectively.
  • Under the assumption of both a 2- and 3-year Reducer effect duration, modeling a 30% per year efficacy decrease, the device yielded ICERs in the range of €1,977 to €20,796 per QALY gained.

The Reducer device has received European CE Mark approval for the treatment of refractory angina. It is not approved for commercial use in the United States but was granted the FDA Breakthrough Device Designation in October 2018.

 

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