Prostatic Artery Embolization for Benign Prostatic Hyperplasia: A Health Technology Assessment.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate that commonly affects older people with prostates and may lead to obstructive urinary symptoms. Symptoms may initially be mild but tend to worsen over time. Prostatic artery embolization (PAE) is an endovascular procedure to treat BPH, wherein an interventional radiologist inserts a catheter into the patient to inject tiny particles intended to reduce blood flow to the enlarged prostate, causing it to shrink in size. We conducted a health technology assessment on PAE for people with BPH, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding PAE, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk of Bias tool for randomized controlled trials (RCTs) and the Risk of Bias in Nonrandomized Studies-of Interventions (ROBINS-I) tool for observational studies. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic review of the economic literature. We then assessed the cost-effectiveness of PAE compared with alternative treatments (i.e., transurethral resection of the prostate [TURP] or open simple prostatectomy [OSP]) using a Markov microsimulation model. The analysis was conducted from the Ontario Ministry of Health perspective over a time horizon of 6.5 years. We also analyzed the budget impact of publicly funding PAE in people with moderate to severe BPH in Ontario. RESULTS: We included six studies in our systematic review. Four RCTs and one observational study compared PAE with TURP, and one observational study compared PAE with OSP. All studies had considerable risk-of-bias concerns. PAE may improve BPH symptoms and urodynamic measures, but we are uncertain whether PAE achieves better results than TURP (GRADE: Very low to Low). Compared with TURP, PAE may result in higher patient satisfaction and fewer adverse events (GRADE: Not assessed). Compared with OSP, PAE may result in smaller improvements in BPH symptoms and urodynamic measures and may lead to fewer adverse events, but the evidence is very uncertain (GRADE: Very low).We did not find any published cost-effectiveness studies in the economic literature review. Our primary economic evaluation showed that, compared with TURP, PAE has an incremental cost of $328 (95% CrI: -$686 to $1,423) and a very small incremental quality-adjusted life-year (QALY) of 0.007 (95% CrI: -0.004 to 0.018). The resulting incremental cost-effectiveness ratio (ICER) of PAE versus TURP is $44,930 per QALY gained. At the commonly used willingness-to-pay values of $50,000 and $100,000 per QALY, the cost-effectiveness of PAE is uncertain (52% and 68% probability, respectively, of being cost-effective compared with TURP). In a scenario analysis, we compared PAE with OSP for individuals with large prostates (who may be ineligible for TURP). We found that PAE is less costly (-$1,231; 95% CrI: -$2,457 to $69) and less effective (-0.12 QALYs; 95% CrI: -0.18 to -0.04). The resulting ICER of PAE versus OSP is $10,241 saved per QALY lost. At the commonly used willingness-to-pay value of $50,000 per QALY, PAE is unlikely to be cost-effective (2% probability of being cost-effective compared with OSP). Assuming a low uptake (i.e., an additional 10 to 50 procedures per year in years 1 to 5), we estimated that publicly funding PAE in Ontario would lead to an additional cost of about $11,400 over the next 5 years.People we spoke with who have lived experience with BPH reported on the negative impact it can have on their quality of life. Those who had received PAE reported a positive experience with the procedure and meaningful improvement in their symptoms. CONCLUSIONS: Prostatic artery embolization may improve BPH symptoms and urodynamic measures, but we are uncertain if the procedure results in similar outcomes to those of TURP. Based on one observational study, PAE may result in smaller improvements compared with OSP, but we are very uncertain of the evidence. Compared with TURP and OSP, PAE may result in fewer adverse events. Longer-term comparative studies are needed to assess the durability and long-term adverse events of PAE, the potential need for reintervention after PAE, and how PAE compares with other available BPH treatment options.We found the cost-effectiveness of PAE compared with TURP to be uncertain. Also, PAE is unlikely to be cost-effective compared with OSP. If PAE is publicly funded in Ontario, the budget impact is estimated to be small over the next 5 years.People who have lived experience with BPH reported that PAE improves quality of life and reduces negative symptoms of BPH.

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