This study reports the cost-effectiveness of treating resistant hypertension in a 50-year old cohort using a novel surgically implanted device and reports at which SBP to begin treatment. The ICER for Rheos® falls in a grey area between too expensive (>$100,000 per QALY) and an acceptable price (<$50,000 per QALY). Rheos® performs as well as, if not better, than the base case assumptions. The base case incorporated a 20 mmHg SBP decrease because most achieved this decrease at two years (average: 35 ± 8 from initial SBPs of 191 ± 32).3
Current Rheos® performance suggests that the device may lower SBP by an average of 304
mmHg. These alternatives were included in the sensitivity analyses and were cost-effective. Rheos® would also be an adoptable technology at higher initial SBPs or when individuals have a risk profile similar to the ASCOT-BPLA cohort.
The costs of the actual device or the surgery have not been definitively established. The estimated hospital cost for implantation of a carotid baroreflex activation device is $8,400 (ICD-9 procedure code 39.8).50
Our base case cost for the procedure and the device is $20,000, approximately the 2007$ hospital cost for a deep brain stimulator (18,800).50
The one-way sensitivity analysis showed that doubling the cost of the procedure generates an ICER of $99,500 (). Here, the costs total $30,000 for the device ($10,000) and the procedure ($20,000).
The ICER for aliskiren was explored as a comparable treatment for resistant hypertension. The ICER of $90,000 per QALY also falls within a grey area as an acceptable price for a new medication. Lastly, comparing Rheos® to aliskiren still showed that the surgically implanted device should still be adopted as a cost-effective treatment.
The cost-effectiveness of Rheos® was comparable to other implantable devices analyzed within the setting of US health care. The base case ICER of $64,400 for Rheos® was close to the ICER for deep brain stimulation for Parkinson’s Disease treatment and within the range of values for implantable cardiac defibrillators ().51, 52
A United Kingdom-based study showed that left ventricular-assist devices as destination therapy had considerably higher costs per QALY gained.53
Lastly, a Canadian study demonstrated the cost-effectiveness of losartan as an alternative to an atenolol-based regimen using data from the LIFE study.54
Adding or switching certain medications for hypertension treatment remains the first treatment option. For resistant hypertension, Rheos® had a favorable cost-effectiveness profile to other surgically implanted devices.
Incremental cost-effectiveness ratios for hypertension treatment and other surgically implanted devices (2007$).
This analysis of resistant hypertension is consistent with other cost-effectiveness analyses of new medications to manage traditional hypertension.6, 7
Treating resistant hypertension becomes more cost-effective in those with a higher cardiovascular risk including those with diabetes. Contrary to other literature, the cost-effectiveness of Rheos® does not improve beyond 60 years or improve with male gender. Rheos® therapy was more cost-effective in hypertensive females than males. The prediction equations have a higher relative risk of stroke or MI associated with female gender, thus supporting the observation that treating hypertension in females is more cost-effective than treating hypertension in males.9, 10
The use of prediction equations for adverse events rather than event rates based on a clinical trial is a limitation to this study. Framingham-based prediction equations allow a broad look at many endpoints but may lack the accuracy of the device’s performance in its specific patient population. This limitation has been addressed, in part, by also modeling probabilities from ASCOT-BPLA trial. Another limitation is the use of direct costs and utilities from the literature rather than incorporating indirect patient costs. The strengths of this study are the inclusion of heart failure and dialysis dependent renal disease with the common disease states of MI and stroke.
One important question is whether the SBP reductions achieved in the Rheos® phase I trials are maintained throughout the Rheos® Pivotal Trial (clinicaltrials.gov
id: NCT00442286). With a finite pool of health care dollars, new effective technology or medications must have reasonable cost to justify wide-spread use. The cost-effectiveness of Rheos® is dependent on the starting SBP, performance of the device and the risks of the target population. Decreases of 30 mmHg3, 4
or more support the use of Rheos® as a cost-effective treatment for resistant hypertension regardless of the initial SBP.