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 symptoms of benign prostatic hyperplasia (BPH). He has had retention of urine. He has required intermittent self-catheterization. His prostate measured 110 grams. Review of concomitant medications included clopidogrel. He was recommended to, and did, undergo prostatic artery embolization as primary treatment of his problem. At issue is whether the proposed health service or treatment 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. Literature documents the complication rate for prostatic artery embolization is greater than 50% over a 24 month period, as compared to transurethral prostatectomy (29.8%).
Guidelines of the American Urological Association state, "PAE is a newer and largely untested modality for BPH. High level evidence remains sparse, and the overall quality of the studies remains low. Quantitative results of clinical trials do not alone constitute proof of efficacy or safety and the Panel carefully considered not only the trial results, but qualitatively appraised primary outcomes, methods of endpoint assessment, sources of potential bias, external validity (i.e. generalizability), clinical significance, rates and types of adverse events, potential placebo effects, and treatment failure rates. In the opinion of the Panel, a substantial issue is the unpredictable consequences of treating bothersome urinary symptoms with a technically demanding procedure involving vascular catheterization, substantial radiation exposures with fluoroscopy times averaging up to 50 minutes and table times up to 2 hours, and challenging learning curves for physicians who, while trained in the performance of endovascular interventions, may be less familiar with core concepts of BPH pathophysiology, diagnosis, treatment, and follow-up. Given the heterogeneity in the literature-and concerns regarding radiation exposure, post-embolization syndrome, vascular access, technical feasibility, and quality control at lower volume centers, it is the opinion of the Panel that PAE should only be performed in the context of a clinical trial until sufficient evidence from rigorously performed studies is available to indicate definitive clinical benefit and define specific indications."
Rampoldi and associates have opined that the procedure may be best suited for those patients with a chronic indwelling catheter who are unable to have traditional surgical procedures. This is not the case for this particular patient.
The patient was deemed to be a poor surgical risk. Antiplatelet therapy was required. The embolization procedure necessitated temporary cessation of anticoagulation as evidenced in the post-procedure orders to resume anticoagulation. Alternatively, the patient may have been considered for laser enucleation of the prostate which may have been done with anticoagulation, or continued with intermittent catheterization. For large prostates, such as this case, laser enucleation of the prostate may be safely performed in the anticoagulated patient. Additionally, anticoagulation is often held to achieve vascular access for an arterial embolization.

The health plan's determination is upheld.