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202201-145858

2022

CVS Caremark

Self-Funded

Cardiac/ Circulatory Problems

Pharmacy/ Prescription Drugs

Formulary Exception

Upheld

Case Summary

Diagnosis: Erectile Dysfunction (ED)

Treatment Stendra (avanafil)

The insurer denied coverage for Stendra (avanafil)

The denial is upheld

This is a male with history of benign prostatic hypertrophy (BPH), erectile dysfunction (ED), diabetes, hypertension, irritable bowel syndrome (IBS), hyperlipidemia, varicose veins. The patient suffered from nocturia / erectile dysfunction - physician office received continuing on Cialis. He received Stendra for treatment of ED.

As per the clinical records, on progress note states the patient has used Cialis, Viagra in the past but got headaches from each of these medications. However, progress note stated that "Cialis 5 mg (milligrams) oral has helped lower urinary tract symptoms (LUTS) and erectile dysfunction both." The clinical documentation supports efficacy of Cialis 5 mg oral for treatment of benign prostatic hypertrophy / erectile dysfunction. Stendra usage also reports 5-10% (percent) risk of headache, very similar to the headache side effects of sildenafil, tadalafil.

As summarized in Up to Date "All four phosphodiesterase type 5 (PDE5) inhibitors (avanafil, sildenafil, vardenafil, and tadalafil) work to sustain levels of cyclic guanosine monophosphate (GMP) within the penile corpora cavernosa to allow men with ED to achieve erections in response to appropriate sexual stimuli. Sildenafil, vardenafil, tadalafil, and avanafil result in similarly high rates of successful sexual intercourse (68 to 69 percent compared with 33 to 35 percent for placebo) and similar side-effect profiles" (3)

Request for formulary exception for Stendra is denied. Medical records do not support failure of Cialis tab to successfully treatment erectile dysfunction. No evidence that the requested drug is more effective than the formulary drug. It has similar risk of headache, may be slightly faster acting. Formulary drugs have been effective, caused the same side effective as the requested drug.

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

The insurer's denial of coverage for Formulary Exception for Stendra (avanafil) is upheld.

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