Oscar Erectile Dysfunction (CG037) Form

The Plan

Members who have erectile dysfunction (ED), also known as impotence, may be eligible for treatments to assist with sexual function. ED is a type of sexual dysfunction where a man cannot get or maintain an erection adequate for sexual intercourse. It can occur due to a variety of different conditions and is commonly associated with diabetes, heart disease, Peyronie’s Disease or surgery/radiation to the pelvic region. ED can be distressful for both the member and his partner.

Treatment is typically performed for members when physiological impotence, which is a physical process, rather than psychological impotence, which is an emotional process, is the primary cause. First line treatment is typically with oral medications. Failure to respond to these oral medications leads to a regimen of injectable medications, external devices, and/or surgical implants.

The medical necessity criteria in this guideline are based on a combination of expert recommendations, such as those from the American Urological Association, and primary literature review.

Please refer to the drug formulary, pharmacy clinical guideline, and pharmacy benefit manager for additional information and clinical criteria for oral medications.

Definitions

• Erectile Dysfunction (i.e., ED, Impotence) is a sexual dysfunction where a man cannot achieve or maintain an erection for sexual intercourse. Possible causes include the following:
  • diseases affecting the blood supply to the penis (e.g., diabetes, heart disease, injury)
  • nerve damage (e.g., spinal cord injury, diabetic neuropathy)
  • Peyronie’s Disease (fibrous scar and plaque under the skin of the penis)
  • psychogenic causes (e.g., an abnormal thought process)
  • certain medications which can impair erectile function
• Injectable medications for erectile dysfunction are typically titrated in the office under direct physician supervision and then self-administered by patients to achieve erection.
• Oral medications are taken by mouth.
• Penile Implants or penile prostheses are surgically implanted devices to assist with erection. They can be semi-rigid or inflatable depending on preference and specific member conditions.
• Postage Stamp Testing refers to a test for nocturnal erection where a line of postage stamps are placed on the flaccid penis. Should nocturnal erection occur, the line of stamps will break at the perforated edges. It is used to distinguish between psychogenic and organic causes of impotence.
• Snap Gauge Testing refers to a device worn on the penis overnight with small plastic tabs that will break if a nocturnal erection is achieved. It is used to distinguish between psychogenic and organic causes of impotence.
• Vacuum Pump devices assist with erection by creating a vacuum to improve blood flow into the penis.

Clinical Indications

General Criteria

Prior to the initiation of treatment for suspected erectile dysfunction, the following diagnostic workup elements may be performed:

1. Comprehensive history and physical exam
2. Psychosocial evaluation
3. Duplex ultrasound with intracorporeal papaverine
4. Applicable only to members meeting criteria and planning to undergo for revascularization:
   1. Dynamic infusion cavernosometry and cavernosography
   2. Pudendal artery angiography (same revascularization)
5. All patients should have other etiologies of erectile dysfunction ruled out and/or adequately treated prior to initiation of therapy, including but not limited to:
   • Testosterone deficiency
   • Pituitary or hypothalamic dysfunction
   • Psychogenic impotence
6. Lab tests that may be medically necessary as part of the erectile dysfunction work-up:
   • Blood glucose
   • Complete blood count
   • Liver function tests
   • Creatinine
   • Lipid panel
   • PSA
   • Testosterone, with tests for pituitary dysfunction if abnormal
   • Thyroid function tests
   • Urinalysis

Medications

The Plan considers injectable medications (papaverine, alprostadil, or phentolamine) into the corpus cavernosum or intraurethral medications [Medical Urethral System for Erection (MUSE) for intra-urethral medication delivery] medically necessary for the treatment of erectile dysfunction when ALL of the following criteria are met:

1. The member has documented physiologic erectile dysfunction with other reversible causes as documented above ruled out and/or adequately treated; and
2. The member has tried and failed, has contraindications, or refuses to take oral medications for erectile dysfunction; and
3. An in-office test should be performed to demonstrate efficacy.

Vacuum Erectile Devices

The Plan considers vacuum erectile devices medically necessary when ALL of the following criteria are met:

1. The member has documented physiologic erectile dysfunction with other reversible causes as documented above ruled out and/or adequately treated; and
2. The prescribed erectile device meets criteria as durable medical equipment; and
3. The member has tried and failed conservative management, as defined by ALL of the following:
   • Sexual activity with adequate stimulation is attempted within the timeframe of drug efficacy; and
   • The member has had an adequate trial of oral medications, as defined by ONE of the following:
     • Tried and failed the maximum dosage of at least ONE medication, e.g., 20 mg of tadalafil (Cialis), 20 mg of vardenafil (Levitra, Staxyn), 100 mg of sildenafil (Viagra), or 200 mg of avanafil (Spedra); or
     • Unable to tolerate a dosage less than the maximum dosage of TWO medications due to adverse effects; or
     • Oral medications are contraindicated or refused.

Penile Prosthetic Surgery

The Plan considers penile prosthetic surgery and implant or reimplantation medically necessary when ALL of the following criteria are met:

1. The member has documented physiologic erectile dysfunction with other reversible causes as documented above ruled out and/or adequately treated; and
2. The member has tried and failed conservative management, as defined by ALL of the following:
   • The member has had an adequate trial of oral medications, as defined by ONE of the following:
     • Tried and failed the maximum dosage of at least ONE medication, e.g., 20 mg of tadalafil (Cialis), 20 mg of vardenafil (Levitra, Staxyn), 100 mg of sildenafil (Viagra), or 200 mg of avanafil (Spedra); or
     • Unable to tolerate a dosage less than the maximum dosage of TWO medications due to adverse effects; or
     • Oral medications are contraindicated or refused;
   • Sexual activity with adequate stimulation is attempted within the timeframe of drug efficacy; and
   • The member has tried and failed a vacuum erectile device for at least 1 month and applied for a maximum of 30 minutes per use; and
   • The member has tried and failed injectable or intraurethral medications at least 1 time on an appropriate dose, unless contraindicated.
3. The member meets at least ONE of the following:
   • Documented neurogenic impotence for greater than 1 year duration (i.e., diabetic neuropathy, fractured pelvis, major surgery of the pelvis or retroperitoneum, prostatectomy, or colorectal surgery, multiple sclerosis, spina bifida, spinal cord injury, disease or surgery, including syringomyelia); or
   • Documented vasculogenic impotence for greater than 1 year duration (i.e., hypertension, arterial microvascular disease, penile contusion or fracture, Peyronie's disease, cavernosal infection, major vascular surgery involving the aorta or femoral blood vessels, renal failure); or
   • Documented impotence for greater than 1 year duration due to radiation to the pelvis or retroperitoneum.
4. There is no evidence of drug induced impotence related to ANY of the following substances:
   • Anticholinergics
   • Antidepressants
   • Antipsychotics
   • CNS depressants
   • Anabolic steroids
5. The member is not actively abusing alcohol or substances; and
6. The member has had any depression or psychiatric illness adequately treated and/or ruled out; and
7. The member has no current urinary tract, cutaneous, or systemic infection at the time of surgery; and
8. If the member has comorbidities such as diabetes, documentation must show proper management. Any risks that would cause potential complications or intolerance to healing post surgery should be evaluated prior to surgery; and
9. The member has been assessed for normal hormone levels (e.g., testosterone, prolactin, and thyroid hormone) or there are specific, long-term contraindications to treating the underlying hormone disorder.

Removal of Penile Implant

The Plan considers removal of penile implant medically necessary for any ONE of the following indications:

1. Infected prosthesis; or
2. Intractable pain directly related to prosthesis; or
3. Mechanical failure; or
4. Urinary obstruction.

Experimental or Investigational / Not Medically Necessary

The Plan considers the following erectile dysfunction treatments and indications experimental, investigational, unproven, and/or not medically necessary:

1. Any procedure not meeting the above criteria
2. The following genetic tests:
   • Angiotensin-converting enzyme (ACE) insertion/deletion polymorphism testing
     Rationale: The existing studies have shown some potential utility of using ACE polymorphism to predict response to oral medications to treat erectile dysfunction, however these genetic tests are currently undergoing further research and have not been validated in randomized, controlled trials.
   • Endothelial nitric oxide synthase polymorphism testing.
3. Cavernous nerve mapping
   Rationale: The existing literature is limited the small studies and those on non-human subjects. Further randomized, clinical evidence is needed to determine any potential benefit of this procedure.
4. Corpora cavernosal electromyography
   Rationale: CMS released a decision memo stating that this procedure would not be covered. Furthermore, a clinical trial looking into the technique was terminated due to lack of enrollment. Further randomized, clinical evidence is needed to determine any potential benefit of this procedure.
5. Dorsal nerve conduction latency testing or evoked potential measurement
   Rationale: The current evidence is limited to small, single institution studies with limited numbers of patients. Further randomized, clinical evidence is needed to determine any potential benefit of this procedure
6. Extracorporeal shock wave therapy (ESWT):
   Rationale: Extracorporeal shock wave therapy (ESWT) is considered investigational as per 2018 AUA Guideline statement 23: For men with ED, low-intensity extracorporeal shock wave therapy (ESWT) should be considered investigational. (Conditional Recommendation; Evidence Level: Grade C). Based on review of trials, the treatment's ability to restore normal erectile function is unproven, the duration of treatment effects is not well-established, and increased financial burden associated with obtaining the treatment when comparing the availability of other treatments that are less burdensome and known to be effective.
7. Penile plethysmography
   Rationale: The current literature supports doppler ultrasound as the gold standard in assessing cavernous artery blood-flow, and notes inherent limitations of penile plethysmography. Further research is needed to identify any potential benefit of this technique.
8. Crural ligation
   Rationale: The current evidence is limited to small, single institution studies with limited numbers of patients. Further randomized, clinical evidence is needed to determine any potential benefit of this procedure.
9. Venous ligation
   Rationale: The AUA has stated in their consensus, expert guidelines, that “there has been no new substantial evidence to support a routine surgical approach in the management of veno-occlusive ED”. Further evidence is needed to evaluate any potential benefit of this treatment.
10. Lumbar ganglionic block or sympathectomy
    Rationale: The current evidence is limited to small, single institution studies with limited numbers of patients. Further randomized, clinical evidence is needed to determine any potential benefit of this procedure.
11. Acupuncture
    Rationale: Authors of one study on acupuncture for erectile dysfunction state “no definite conclusions can be drawn from this pilot study. A controlled and blinded study including more patients will be needed before any definitive conclusion can be reached”, while another concluded that “Further controlled studies are needed to determine whether acupuncture might be a feasible and useful treatment option for erectile dysfunction in patients.”
12. Percutaneous electrostimulation of the perineum
    Rationale: The current evidence is limited to small, single institution studies with limited numbers of patients. Further randomized, clinical evidence is needed to determine any potential benefit of this procedure.
13. Statin therapy
    Rationale: Statin therapy has shown some potential benefit in erectile dysfunction treatment, however further randomized, clinical trials are needed to better characterize the efficacy of this treatment. Furthermore, meta-analyses of randomized data have shown that statins increased erectile function scores by only one-third to one-half that of the current oral PDE-5 inhibitors used for ED.
14. Stem cell therapy
    Rationale: Stem cell therapy for erectile dysfunction has been primarily researched in non-human models and has not yet been validated in randomized clinical trials for human use. Further research is needed to determine a potential benefit. Additionally, the 2018 AUA guidelines list ESWT as an investigational treatment.
15. Penile arterial revascularization
    Rationale: The AUA expert consensus guidelines state: “The efficacy of this surgery remains unproven and controversial, largely because the selection criteria, outcome measurements, and microsurgical techniques have not been objective or standardized.” “To demonstrate that penile arterial reconstructive surgery is efficacious, a large study of hundreds of patients who meet the demographic, selection, surgical, and outcome criteria of the Arterial Occlusive Disease Index Patient is needed. Such a study should focus on men who meet the criteria listed above, who have failed medical therapy, and who are followed with objective measures of sexual function.”
16. Nocturnal penile tumescence or rigidity testing, including rigiscan device
    Rationale: AUA expert consensus guidelines state nocturnal penile or rigidity testing is prone to false negatives in the workup or treatment of erectile dysfunction. Furthermore, the techniques used to test for nocturnal erections (e.g., stamp test, snap gauge test) have historically been highly operator dependent and difficult to reproduce.
17. Biothesiometry
    Rationale: A biothesiometer is a test that uses electromagnetic vibrations to measure sensitivity and neuropathies, as seen in diabetics and groin trauma. The AUA and other sources conclude that data is limited on the clinical utility of this device.
18. Uncontrolled Diabetes
    Rationale: As per 2018 AUA guidelines, erectile dysfunction (ED) is one of the most common complications of diabetes mellitus and approximately 20% of men with ED also had diabetes. Diabetes as well as other risk factors such as age, smoking, cardiovascular disease show an increased correlation to ED. In some cases, the underlying cause of ED may be related to undiagnosed diabetes and therefore, proper screening and management of diabetes should be performed.
    Furthermore, patients with diabetes show increased infection risk related to penile prosthetic surgery compared to patients without diabetes as reflected in multiple studies (Adamsky et al., 2018; Gross et al., 2019; Lipsky et al., 2019). Therefore, when a member has uncontrolled diabetes, the request for penile prosthetic surgery should be considered not medically necessary.