Cost-Effectiveness and Budget Impact Analysis of Radiofrequency Renal Denervation for Uncontrolled and Resistant Hypertension in Italy.

introductionRadiofrequency renal denervation (RF RDN) has achieved meaningful clinical benefit as an adjunct treatment for uncontrolled and resistant hypertension.

aimThis analysis evaluated the cost-effectiveness and budget impact of RF RDN in Italy.

methodsA previously published and validated Markov model was adapted to project strategy-specific costs, quality-adjusted life years (QALY), and clinical events over a lifetime horizon for RF RDN and standard of care (SOC) cohorts. The model consisted of seven primary health states, with state transitions informed by multivariate risk equations. Italian costs, utilities, and survival data informed key model inputs. Clinical data from the SPYRAL HTN-ON MED trial informed the base case treatment effect (- 4.9 mmHg reduction in office systolic blood pressure vs. sham), with alternative effect sizes explored in sensitivity analyses. Cost-effectiveness was evaluated against a threshold of €25,000 per QALY gained. The ten-year budget impact was evaluated.

resultsOver ten years, RF RDN was associated with meaningful reductions in relative risk for: myocardial infarction (0.88), stroke (0.80), and heart failure (0.72). Over lifetime, RF RDN added €3,418 in costs and 0.41 QALYs, resulting in an incremental cost-effectiveness ratio of €8282 per QALY gained. RF RDN was cost-effective across all scenarios explored. At ten years, RF RDN uptake among resistant hypertension patients was associated with per-patient cost savings of - €4302 (€8526 RF RDN vs. €12,829 SOC) from avoided clinical events.

conclusionRF RDN was cost-effective over a lifetime horizon, with the associated increase in ten-year budget impact justified by corresponding reductions in clinical events.