There are four embolization agents used for prostate artery embolization (PAE) that have received marketing authorization in the European Union:
- Embozene™ Microspheres (Boston Scientific, USA)
- Bead Block® polyvinyl alcohol hydrogel (Biocompatibles UK Ltd, UK)
- Embosphere® trisacryl microspheres (Merit Medical Systems Inc., USA),
- PVA Foam Embolisation Particles (Cook Medical, USA)
Currently, PAE is not included in the Austrian hospital benefit catalogue, and therefore is not reimbursed by the Austrian health care system.
In 2017, PAE was evaluated by the Ludwig Boltzmann Institute – Health Technology Assessment (LBI-HTA) to define whether this minimally invasive procedure can be sufficient for inclusion into benefit catalogue. Within this research work, evidence in relation to efficacy and safety of PAE were assessed in comparison to transurethral resection of the prostate (TURP) and open prostatectomy. Two RCTs comparing PAE to TURP (n = 144), and one matched-pairs study comparing PAE to open prostatectomy (n = 160), were identified for evaluation of effectiveness outcomes. Additionally, one RCT comparing PAE particle sizes, two non-randomized studies comparing different populations treated with PAE, and two single-arm studies of PAE were included for evaluation of safety outcomes.
A strength of evidence for comparison PAE with TURP and open prostatectomy in relation to effectiveness was low. The same situation with evidence for safety where a strength of available evidence was assessed as very low, low and moderate. Based on these findings LBI-HTA does not currently recommend PAE for inclusion into benefit catalogue in Austria.
However, there is potential evidence that might improve recommendations for the procedure that are based on ongoing studies:
- Five ongoing studies that have the aim to compare PAE to TURP in patients with moderate-to-severe LUTS, which are currently scheduled for completion before the 2021 year:
- Prostatic Artery Embolization vs. Conventional Transurethral Prostatectomy in the Treatment of Benign Prostatic Hyperplasia (NCT02054013, n=101, completion date – December 2022)
- Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia (NCT01789840, n=186, completion date – May 2018)
- Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment (NCT02566551, n=100, date of completion – May 2018)
- Clinical Trial to Evaluate the Efficacy and Safety of the Transarterial Supraselective Embolization of the Prostate to Treat the Urinary Symptoms (NCT01963312, n=81, completion date - November 2018)
- Prospective randomized interventional single-center study to evaluate preoperative transarterial embolization of the prostate before prostatectomy (DRKS00008079, n=100; completion date – not known)
- One RCT of comparison of PAE with medical therapy
- Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia (PARTEM) (NCT02869971, n=90, completion date – February 2021)
- One RCT compared PAE to sham procedure (NCT02074644, n=80, completion date – December 2018)
- Two patient registries compared PAE to TURP and open prostatectomy
- ROPE Registry Project to Determine the Safety and Efficacy of Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Enlargement (LUTS BPE). (UKROPE) (NCT02849522, n=300, completion date – September, 2017)
- UK ROPE Register Study (UK ROPE) (NCT02434575, n=300, completion date – December, 2017)
- Additionally, several non-comparative observational studies for assessment of PAE is planned to be completed until 2021 year
Thus, LBI-HTA recommended re-evaluating PAE procedure in the 2021 year when new potential evidence is available.
See full report here.
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