Aetna considers the diagnosis and treatment of erectile dysfunction (impotence) medically necessary according to the criteria outlined below.

1. Diagnosis

   Aetna considers the following diagnostic workup of erectile dysfunction medically necessary:

   • Comprehensive history and physical examination (including medical and sexual history and psychosocial evaluation)
   • Duplexscan (Doppler and ultrasound) in conjunction with intracorporeal papaverine
   • Dynamic infusion cavernosometry and cavernosography only for members who are to undergo revascularization procedures and meet medical necessity criteria for penile revascularization (see below)
   • Pharmacological response test (PRT) for erectile dysfunction (using vasoactive drugs, e.g., papaverine HCl, phentolamine mesylate, prostaglandin E1)
   • Pudendal arteriography (angiography) only for members who are to undergo penile revascularization and meet the medical necessity criteria for penile revascularization (see below).

   Aetna considers the following laboratory tests medically necessary for the diagnosis of erectile dysfunction:

   • Blood glucose
   • Complete blood count
   • Creatinine
   • Hepatic panel
   • Lipid profile
   • Prostate specific antigen

   • Serum testosterone

     • Tests for evaluation of pituitary dysfunction (e.g., measurement of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prolactin levels) if serum testosterone level is below normal

   • Thyroid function studies
   • Urinalysis
   • Biothesiometry (Note: biothesiometry is considered an integral part of the comprehensive history and physical examination).

   Note: Routine nocturnal penile tumescence (NPT) and/or rigidity testing has no proven value.  NPT testing using the postage stamp test or the snap gauge test is rarely medically necessary; it is considered medically necessary where clinical evaluation, including history and physical examination, is unable to distinguish psychogenic from organic impotence and any identified medical factors have been corrected.  Nocturnal penile tumescence testing using the RigiScan is considered medically necessary only where NPT testing is indicated, and the results of postage stamp or snap gauge testing are equivocal or inconclusive.

   Aetna considers the following workup/laboratory tests for the diagnosis of erectile dysfunction experimental and investigational:

   • Corpora cavernosal electromyography (EMG)
   • Dorsal nerve conduction latencies
   • Evoked potential measurements
   • Penile plethysmography
   • Iron binding capacity
   • Prostatic acid phosphatase.

   • Cavermap cavernous nerves electrical stimulation with penile plethysmography (also referred to as cavernosal nerve mapping).  This policy is based upon an assessment by the Centers for Medicare and Medicaid Services (CMS, 2006).

2. Treatments

   Aetna considers the following therapies for the treatment of erectile dysfunction medically necessary:

   1. Injectable Medications

      Aetna considers self-administered injectable medications for the treatment of erectile dysfunction medically necessary.* Medically necessary self-administered medications for erectile dysfunction include:

      1. Injections into the corpus cavernosa to cause an erection (papaverine, alprostadil, phentolamine) and,

      2. MUSE (Medicated Urethral System for Erection) method of treatment for erectile dysfunction that involves inserting medication through a small catheter into the urethra.

      Titrating doses of injectable impotence medications that are administered in a physician's office and the accompanying office visits are considered medically necessary.  This includes in office titrating doses of papaverine, alprostadil (prostaglandin E1 or Caverject) and phentolamine. Except for phentolamine, which is not generally used alone, these drugs can be used alone or in combination.  The drug MUSE, a pellet from of alprostadil, is also used as an alternative to alprostadil injections.

      Diagnostic injections of impotence medications by the treating physician are also considered medically necessary.

      *Note: Coverage of injectable medications is subject to the terms of the member’s benefit plan.  Please check benefit plan descriptions for details.

   2. Oral and Transdermal Medications

      Aetna considers exogenous testosterone replacement therapy, including transdermal preparations, experimental and investigational for the treatment of non-hypogonadal impotence because its effectiveness in non-hypogonadal impotence has not been established.  (See CPB 345 - Implantable Hormone Pellets.)

      Aetna considers topical cream or gel containing vasodilators, such as verapamil cream, experimental and investigational for the treatment of erectile dysfunction because their effectiveness for this indication has not been established.

      Note: Many Aetna pharmacy benefit plans exclude coverage of drugs for lifestyle enhancement or performance.  Please check benefit plan descriptions for details.  Under these plans, sildenafil citrate (Viagra), vardenafil hydrochloride (Levitra) and tadalafil (Cialis) are covered only when required by state regulation or when a plan sponsor has elected an optional rider under the pharmacy plan, or, for indemnity or PPO plans without a separate pharmacy benefit, when the plan sponsor has added optional coverage under the medical plan. 

   3. External Devices

      Aetna considers the external penile vacuum pump device medically necessary durable medical equipment (DME) when it is prescribed by a physician as an alternative to other therapies for erectile dysfunction. External penile pumps are considered experimental and investigational for other indications including for the prevention of erectile dysfunction following prostatectomy.

   4. Implantable Devices

      Aetna considers implantation of semi-rigid penile prostheses or inflatable penile prostheses (implantable penile pumps) medically necessary for members with documented physiologic erectile dysfunction who have failed medical therapy or for whom medical therapy is contraindicated. Implantable penile prostheses are considered experimental and investigational for other indications.

   5. Surgical Revascularization

      Aetna considers penile revascularization for vasculogenic erectile dysfunction medically necessary only in men less than 55 years old who meet all of the following criteria:

      1. The erectile dysfunction is the direct result of an arterial injury caused by blunt trauma to the pelvis and/or perineum; and 
      2. A focal blockage of arterial inflow is demonstrated by duplex Doppler ultrasonography or arteriography; and 
      3. Diagnostic work-up reveals normal corporeal venous function; and 
      4. Member is not diabetic and has no evidence of systemic vascular occlusive disease; and 

      5. Member is not actively smoking. 

      Penile revascularization is considered experimental and investigational for other indications. Consistent with clinical guidelines of the American Urological Association, Aetna considers arterial reconstructive procedures, dorsal vein arterialization procedures, or penile venous occlusive surgery (e.g., venous ligation, dorsal vein ligation) in men with erectile dysfunction secondary to arteriosclerotic occlusive disease experimental and investigational because such procedures have not been proven to be effective.

   6. Peyronie's Disease

      1. Plaque Excisions and Venous Graft Patching

         Aetna considers surgical correction of Peyronie’s disease (e.g., plaque excisions and venous graft patching, tunica plication, Nesbit tuck procedure) medically necessary for the treatment of members with Peyronie's disease for 12 or more months with significant morbidity who have failed conservative medical treatment. Surgical correction of Peyronie's disease is considered experimental and investigational when criteria are not met.

      2. Extracorporeal Shock Wave Therapy (ESWT)

         Aetna considers extracorporeal shock wave therapy (ESWT) experimental and investigational for Peyronie’s disease because of a lack of evidence from prospective randomized controlled clinical studies of the effectiveness of ESWT for this indication. 

      3. Interferon Alpha

         For interferon alpha for Peyronie’s disease, see CPB 404 - Interferons.

      4. Verapamil Iontophoresis

         Aetna considers verapamil iontophoresis experimental and investigational for Peyronie’s disease because of a lack of evidence from prospective randomized controlled clinical studies of the effectiveness of this approach for this indication.

      5. Testosterone Injection

         Aetna considers testosterone injection experimental and investigational for Peyronie’s disease because of a lack of evidence from prospective randomized controlled clinical studies of the effectiveness of this approach for this indication.

   7. Percutaneous Electrostimulation of the Perineum

      Aetna considers percutaneous electrostimulation of the perineum experimental and investigational for the treatment of erectile dysfunction because its effectiveness has not been established.

This policy is supported by guidelines from the American Urological Association (Monatague et al, 2005; Monatague, et al, 2006).

Greenfield et al (2007) stated that while surgery remains the gold standard of therapy to correct the acquired curvature of Peyronie's disease, the search for a less invasive therapy continues.  Transdermal drug delivery was proposed to be superior to oral or injection therapy because it bypasses hepatic metabolism and minimizes the pain of injection.  After electromotive drug administration with verapamil tunica albuginea specimens were demonstrated to contain detectable levels of the drug.  Due to varying success with verapamil as injectable therapy for Peyronie's disease, these researchers performed a double-blind, placebo controlled trial to determine the effectiveness of verapamil delivered through electromotive drug administration.  A total of 42 men with Peyronie's disease volunteered to participate in this study, which was approved by the authors' institutional review board.  A genitourinary examination was performed on all patients, including plaque location, stretched penile length, objective measurement of curvature after papaverine injection and duplex ultrasound.  Each subject was randomized to receive 10 mg verapamil in 4 cc saline or 4 cc saline via electromotive drug administration.  A Mini-Physionizer (Physion, Mirandola, Italy) device was used at a power of 2.4 mA for 20 minutes.  Treatments were performed 2 times weekly for 3 months.  After 3 months each patient was re-evaluated with physical examination and duplex ultrasound by a technician blinded to the treatment received.  A modified erectile dysfunction index of treatment satisfaction questionnaire was also completed by each patient.  A total of 23 patients were randomized to the verapamil treatment group (group 1) and 19 were randomized to the saline group (group 2).  There were no significant differences between patient groups with respect to patient age, disease duration or pretreatment curvature.  In group 1, 15 patients (65 %) had measured improvement (mean 9.1 degrees, range 5 to 30), 5 (22 %) had no change and in 3 (13 %) the condition worsened.  In group 2, 11 patients (58 %) had measured improvement (mean 7.6 degrees, range 5 to 30), 7 (37 %) showed no change and in 1 (5 %) the condition worsened.  To better evaluate effectiveness the total number of patients experiencing significant improvement (20 degrees or greater) was calculated and compared.  Seven patients (30 %) in group 1 and 4 (21 %) in group 2 achieved this criterion.  Although a greater percent of patients treated with verapamil had improved curvature, the results were not statistically significant.  The authors concluded that although a greater percent of patients treated with verapamil in our electromotive drug administration protocol had a measured decrease in curvature, the results were not statistically significant.  The authors stated that further research is necessary to determine whether electric current may have a role in the treatment of Peyronie's disease as well as if verapamil delivered via electromotive drug administration may have a role as effective treatment.

Cabello Benavente et al (2005) evaluated the effects of transdermal iontophoresis with verapamil and dexamethasone in patients with Peyronie's disease of less than one year of evolution.  These researchers treated 10 patients twice a week during six consecutive weeks using iontophoresis with a Miniphysionizer dispositive.  This device generates a 2mA electric current during 20 min which triggers the transdermal penetration of medication.  In every session dexamethasone 8 mg and verapamil 5 mg were administered inside a small self-adhesive receptacle on the penile skin overlying the fibrosis plaque. T o evaluate the efficacy, penile curvature was measured by Kelami's test, while the plaque size was assessed by penile ultrasound.  Other parameters like pain, erectile function and ability for vaginal intercourse were recorded using questionnaires.  Safety parameters were also assessed during treatment.  No improvement or progression in penile curvature was evidenced in any of the patients.  The hardness of the plaque was reduced in 5 patients, becoming impalpable in 2 of them.  Decrease in plaque volume was observed by penile ultrasound in 6.  Pain improved in 8 patients, disappearing in 6 of them.  One patient recovered his erectile function at the end of the treatment; whereas 3 referred that their ability for intercourse enhanced while 2 reported that treatment improved their sexual life in general.  These researchers didn't record any significantly side effects, except for a transitory and slight dermal redness on the site of electrode placement.  The authors concluded that transdermal iontophoresis had an effect on pain control in early stages of Peyronie's disease, but efficacy in reducing penile curvature seems to be limited.  They stated that controlled clinical trials are needed, and perhaps reviewing indications in order to obtain more relevant clinical effects.

Shafik et al (2008) examined the hypothesis that percutaneous perineal stimulation evokes erection in patients with neurogenic erectile dysfunction (NED).  Percutaneous electrostimulation of the perineum (PESP) with synchronous intra-corporeal pressure (ICP) recording was performed in 28 healthy volunteers (age of 36.3 +/- 7.4 years) and 18 patients (age of 36.6 +/- 6.8 years) with complete NED.  Current was delivered in a sine wave summation fashion.  Average maximal voltages and number of stimulations delivered per session were 15 to 18 volts and 15 to 25 stimulations, respectively.  Percutaneous perineal electrostimulation of healthy volunteers resulted in an increase in ICP (p < 0.0001), which returned to the basal value upon cessation of stimulation.  The latent period recorded was 2.5 +/- 0.2 seconds.  Results were reproducible on repeated PESP in the same subject but with an increase of the latent period.  Patients with NED recorded an ICP increase that was lower (p < 0.05) and a latent period that was longer (p < 0.0001) than those of healthy volunteers.  The authors concluded that PESP resulted in ICP increase in the healthy volunteers and patients with NED.  The ICP was significantly higher and latent period shorter in the healthy volunteers than in patients with NED.  They noted that PESP may be of value in the treatment of patients with NED, provided that further studies are carried out to reproduce these results.