Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis Benign prostatic hyperplasia
Treatment Prostate Artery Embolization
The insurer denied the Prostate Artery Embolization.
The determination is upheld.

The patient has a diagnosis of benign prostatic hyperplasia (BPH) with obstruction. His past medical history includes hypertension, diabetes, and coronary heart disease. He has urinary retention managed with self-catheterization. The prostate size is approximately 110 grams (g). At issue is whether prostate artery embolization is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The proposed health service or treatment prostate artery embolization is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The first line therapy for management of BPH includes medical therapy. This includes alpha blockers, 5 alpha reductase inhibitors, phosphodiestrase inhibitors and anticholinergic medication. The standard of care for management of patients with BPH not responding to medical therapy is transurethral resection of prostate. In patients with very large glands (greater than (>) 100 cubic centimeters (cc), as in this patient), Holep and simple prostatectomy are considered standard of care. Prostate artery embolization is a novel approach for treatment of patients with BPH. Current medical literature is limited to case series and retrospective comparisons. No randomized trial suggests improved efficacy of PAE over transurethral resection of the prostate (TURP), Holep or simple prostatectomy. in addition, the efficacy of PAE in patients with retention is largely unknown. Hence, current medical literature does not support use of PAE over standard treatments. The European Association of Urology (EAU) Guidelines do not comment on use of PAE for treatment of BPH.
The American Urological Association (AUA) Guidelines on BPH, 2019 states, "PAE is not recommended for the treatment of LUTS attributed to BPH outside the context of a clinical trial."
EAU Guidelines for non-neurogenic lower urinary tract Dysfunction, 2019 state the following, "Based on these trials a SR with meta-analysis and meta-regression showed that efficacy of PAE is inferior to standard treatment methods, including TURP or OP and concluded that PAE should still be considered an experimental approach. The selection of lower urinary tract symptoms LUTS patients who will benefit from PAE still needs to be defined. Prostatic artery embolisation is a technically demanding procedure that can be performed by interventional radiologists with the necessary experience and additional training. It is important to stress, that PAE impacts the entire prostate without the option for focused and controlled action on bladder outflow obstruction (BOO). This may explain the higher clinical failure rate compared to reference methods like TURP and commonly observed complications like acute urinary retention (AUR). A multidisciplinary team approach of urologists and radiologists is mandatory as the basis for future randomized controlled trials (RCTs) of good quality with long-term follow-up in order to integrate this treatment option into the spectrum of efficient minimally invasive treatment options."
The patient has multiple medical comorbidities and needs anticoagulation.  However, it cannot be confirmed that a prosthetic artery embolization would be more effective than standard procedures.  A patient on anticoagulation can be managed surgically using a greenlight laser or holmium laser enucleation of the prostate.  In addition there are minimally invasive procedures like the Rezum procedure which do not require anesthesia, which can be performed with anticoagulation.

The health plan's determination is upheld.