Renal denervation using radiofrequency energy is a cost-effective and high-quality intervention for the treatment of uncontrolled hypertension from the US health care perspective, according to a recently published online analysis in JSCAI suggests.

Over the life course, costs for patients treated with this procedure will be higher than those for established standard care that includes effective antihypertensive medications and lifestyle modification ($96,416 versus $85,141), with approximately $20,000 of this cost for the first procedure. Denervation was associated with an estimated increase in quality-adjusted life years (QALYs) from 12.49 to 12.83.

This corresponds to an incremental cost-effectiveness ratio (ICER) of $32,732 per QALY, report David Kandzari, MD (Piedmont Heart Institute, Atlanta, GA) and colleagues. An ICER below $50,000 per QALY indicates a high-value intervention based on standard thresholds.

“Renal denervation therapy falls into that category, considering that hypertension is the leading cause of death and disability worldwide, and we can achieve quite significant reductions in blood pressure with renal denervation therapy,” Kandzari told TCTMD. “As long as the cost of the procedure and the device and the safety of the procedure are acceptable and appropriate, which of course they all are, you can call this therapy a dominant or high-value, cost-effective therapy.”

Commentary for TCTMD: Rajesh Swaminathan, MD (Duke University Medical Center and Durham VA Medical Center, NC), lead author of a Society for Cardiovascular Angiography and Interventions Statement on renal denervationsaid: “We have shown in several studies that this technology is safe, effective and now also cost-effective.”

Studies have shown that lowering blood pressure through this procedure is associated with a lower risk of death, stroke and heart attack, as well as a reduction in medication burden, he noted.

However, there are still some unanswered questions about renal denervation, Swaminathan said, stressing the need to continue enrolling patients in ongoing post-marketing registry studies to study the procedure’s effects in larger patient groups.

In addition, he said the main interest is in predicting which patients will respond to the procedure. Previous studies have shown that 20 to 30 percent of patients do not experience a reduction in blood pressure after denervation.

And there is still no randomized trial of renal denervation that has been able to determine an impact on concrete clinical outcomes, which should be possible given the number of patients with uncontrolled hypertension, says Swaminathan.

“Now that the FDA has approved the drug, it’s in people’s hands, and they’re using it, I think it’s not far off to do further outcome studies in specific disease states.”

Consistency of results

After a long research journey with ups and downs, US clinicians gained access to renal denervation in November 2023 when the Food and Drug Administration approved two systems – first the ultrasound-based Paradise system (Recor Medical) and then the radiofrequency-based Symplicity Spyral System (Medtronic) – based on several positive sham-controlled studies. Both have broad indications for the treatment of hypertension when lifestyle changes and medications fail to control blood pressure.

Previous studies have suggested that the procedure is cost-effective. However, at least in the context of the US health care system, there is a lack of analyses that look at more recent data, says Kandzari.

For the current analysis, he and his colleagues used a decision-analytic Markov model to predict costs, QALYs, and clinical events for a group of patients treated with radiofrequency-based renal denervation and control subjects treated only with standard blood pressure medications. Patient demographics and treatment effects were derived from the SPYRAL HTN-ON MED Study showing a decrease in systolic blood pressure in the office of 9.9 mmHg after 6 months with denervation, i.e. 4.9 mmHg more than with the sham intervention, against the background of antihypertensive medication.

The impact of this reduction in blood pressure on clinical events was then estimated based on a meta-regression of 47 randomized trials of hypertension treatment. The researchers calculated that renal denervation would lead to an absolute reduction in the risk of heart attack of 1.7%, the risk of stroke of 3.3% and the risk of cardiovascular death of 3.7% over 20 years, with corresponding numbers needed to treat of 59, 31 and 27.

The overall cost-effectiveness of the procedure was relatively consistent across a variety of scenarios and sensitivity analyses. For example, ICERs ranged from $33,040 to $70,846 per QALY for patients aged 45 to 80 years and from $31,884 to $41,524 per QALY for office-based baseline systolic blood pressure values ​​between 140 and 175 mmHg. Cost-effectiveness decreased in older patients and those with lower baseline systolic blood pressure values.

Nevertheless, 91.3% of simulations produced a high ICER below the threshold of USD 50,000 per QALY, with all simulations producing an ICER below USD 150,000 per QALY, suggesting at least an intermediate value.

According to Kandzari, these are conservative estimates because they are based on sham-corrected differences rather than absolute blood pressure reductions. In addition, the study population included both patients who did not respond to treatment and those who did. “Nevertheless, the benefits of renal denervation are very cost-effective,” says Kandzari.

However, he and his colleagues acknowledge several limitations of the analysis, including the assumption that treatment effects seen in trials at 6 months are sustained long-term, the use of disease-specific mortality data that are at least 5 years old, and the lack of information on cost-effectiveness in various subgroups defined by race/ethnicity and socioeconomic status. In addition, they say there is little data to shed light on the resource use and cost of performing renal denervation in current practice.

Dealing with reimbursement issues

The release of this document is timely as the Centers for Medicare & Medicaid Services (CMS) will hold a hearing next month to discuss Current Procedural Terminology (CPT) coding for renal denervation.

“We’re at a point in U.S. practice where it’s quite a dilemma,” Kandzari said. “We have FDA approval for renal denervation technologies, but we don’t have adequate reimbursement, particularly in the outpatient setting, where this is most commonly used.”

In this context, “we are hopeful that CMS will view such data favorably for cost-effectiveness reasons and thus support reimbursement for this procedure for hospitals and health programs,” he said.

He noted that private insurers typically follow suit when CMS develops new codes for procedures such as renal denervation.

What is the role of renal denervation?

If these reimbursement issues can be resolved, renal denervation will provide a complementary approach to treating hypertension alongside lifestyle changes and drug therapy, Kandzari said. Several documents – including a Position paper And Comprehensive guidelines from the European Society of Hypertension – have proposed the procedure as a third option when patients cannot control their blood pressure by conventional means.

The safety and efficacy of denervation have been proven, Kandzari said, adding: “We also know from patient preference studies that a significant number of patients have a strong desire for additional therapies to treat their high blood pressure rather than just increasing the dose of medication.”

In fact, patients will play a key role in the application of renal denervation, Swaminathan explained, pointing to the broad indications that the FDA has listed on the device labels. “I think that means we need to make decisions together with patients about what their expectations are of this procedure and what the benefit-risk ratio is.”

Patients best suited for the procedure are those who are already taking several medications and who may have difficulty taking additional medications or who are intolerant to certain medications due to side effects, he said.

Renal denervation, says Swaminathan, “deserves practical application outside of clinical trials. We know it is a very safe procedure.”

In an accompanying editorial, Dr. Lucas Lauder (University Hospital Basel, Switzerland) and colleagues explain that despite some limitations of the analysis, these results are “reassuring, as the cost-effectiveness of the procedure is one of the key questions regarding the clinical introduction of renal denervation.”

They add that while it may be difficult to conduct studies to provide a definitive answer to the question of whether renal denervation improves clinical outcomes, it would be “desirable” to do so.

“Although it may be impractical and expensive to conduct outcome studies of renal denervation in hypertensive or at-risk patients, we should accept the challenge and work toward overcoming the barrier to conducting cardiovascular outcome studies using modern study designs and methodologies,” they write.