OBJECTIVES: Catheter-based radiofrequency renal denervation (RF-RDN) is an interventional treatment for uncontrolled hypertension. The objective of this study was to assess the cost-effectiveness of RF-RDN in the context of the Swedish healthcare system.

METHODS: A decision-analytic Markov model based on multivariate risk equations was used to project clinical events, quality-adjusted survival and costs over 10 years and lifetime. Risk reduction associated with changes in office systolic blood pressure (oSBP) in the treatment group was estimated based on a meta-regression of 47 hypertension RCTs. The base case effect size (-4.9 mmHg, observed vs. sham oSBP) was derived from the SPYRAL HTN-ON MED full cohort results. Additional analyses were calculated using a pooled estimate of all 2^nd-generation RF-RCTs (-5.7 mmHg) and data from the Swedish registry for RDN (-16.0 mmHg vs. baseline). Effect sizes were assumed to be maintained over lifetime. The analysis was conducted from a Swedish healthcare perspective, with a 3.0% discount rate applied to costs and effects. Relative risks (RR) of 10-year clinical events were assessed and the lifetime incremental cost-effectiveness ratio (ICER) was evaluated against a willingness-to-pay threshold of SEK 500,000 per QALY gained.

RESULTS: RDN resulted in a relative risk reduction in clinical events (RR=0.80 for stroke, 0.88 for myocardial infarction, 0.72 for heart failure) and added 0.43 QALYs at a concurrent cost increase of SEK61,791 over lifetime, resulting in an ICER of SEK143,887 per QALY gained for the SPYRAL HTN-ON MED base case. All additional cohorts studied in scenario analysis were associated with further outcome improvement and lower ICERs, with the most favorable ICER of SEK54,891 per QALY gained reached for the Swedish registry cohort.

CONCLUSIONS: Based on model-based projections, radiofrequency RDN provides a cost-effective alternative in the treatment of uncontrolled hypertension in Sweden, including resistant hypertension.