NEW ORLEANS—With a projected life expectancy of approximately 1.9 years, transcatheter aortic valve implantation (TAVI) patients compared with the non-surgical standard of care have an incremental cost-effectiveness ratio of about $50,200 for each additional year of life gained, or approximately $62,000 for each quality-adjusted life year gained, based on the cost-effectiveness analysis of cohort B of the PARTNER trial, which assessed TAVI for patients with severe aortic stenosis who are deemed inoperable patients, according to a study presented April 3 at the American College of Cardiology’s (ACC) 60th annual scientific sessions.
"For these patients who are not candidates for surgery, transcatheter aortic valve replacement significantly increases life expectancy at an incremental cost per life year gained well within the range of other commonly utilized cardiovascular technologies," said the study’s lead author Matthew R. Reynolds, MD, director of the Economics and Quality of Life Research Center at Harvard Clinical Research Institute (HCRI).
With 179 patients in each group of the cohort B portion of PARTNER, the patient characteristics of the two trial arms were well-matched. Cost-effectiveness results for the first year were based on detailed medical resource utilization data for all patients, and hospital billing data were collected for a subset of the patients. Long-term survival, quality-adjusted survival and costs were projected from the observed 12-month data to estimate the cost-effectiveness of TAVI over the full expected lifespan of the patients.
For the cost-effectiveness analysis, researchers assessed the cost of the TAVI procedure (the device, procedure duration and supplies), all other costs for index admission (itemized charges multiplied by department-specific cost-to-charge ratios), follow-up hospitalizations (costs from billing data or MedPAR when bills were unavailable) and resource-based costs (including rehabilitation days, SNF days, outpatient visits, ER visits, cardiac testing and medications).
The initial cost for TAVI, along with care before and after the procedure (including both hospital and physician fees), was approximately $78,540, with the commercial cost for the Sapien valve system (Edwards Lifesciences) estimated at about $30,000. Of the $78,540, the hospital costs were $73,563.
The patient days in the hospital averaged 9.1 in the TAVI arm, compared with 20.3 days in the control arm.
The standard care group was three times more likely to be hospitalized for cardiovascular reasons than the TAVI group during the first year of follow-up. As a result, follow-up costs during the first 12 months were about $23,370 higher for the standard care group, partially offsetting the initial costs of the TAVI approach.
The investigators projected a gain in life expectancy of approximately 1.9 years for the TAVI group over standard care (3.1 years vs. 1.2 years) at an incremental cost-effectiveness ratio of about $50,200 for each additional year of life gained, or approximately $62,000 per each quality-adjusted life year gained.
Currently, the device is not approved in the U.S., so how the device will be priced is unknown. In Europe, one device costs about EUR20,000 [approximately $27,700 in U.S. currency]. However, when the researchers varied the cost of the device as low as $20,000 or as high as $40,000, it did not have “much impact” on the ultimate cost-effective data, according to Reynolds.
Based on their findings, the researchers concluded that for "patients with severe aortic stenosis who are unsuitable for surgical aortic valve replacement, TAVI significantly increases life expectancy at an incremental cost per life year gained well within accepted values for commonly used cardiovascular technologies."
This study was sponsored by Edwards Lifesciences and performed by the HCRI, in collaboration with Saint Luke's Mid America Heart and Vascular Institute.