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Oral Erectile Dysfunction (ED) Medications BENEFIT APPLICATION

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Oral Erectile Dysfunction (ED) Medications BENEFIT APPLICATION DRUG POLICY Oral Erectile Dysfunction (ED) Medications BENEFIT APPLICATION Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This policy may not apply to FEP. Benefits are determined by the Federal Employee Program. DESCRIPTION The intent of the oral erectile dysfunction (ED) drug policy for Cialis® (tadalafil), Levitra® (vardenafil), Staxyn® (vardenafil), Stendra® (avanafil) and Viagra® (sildenafil) is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines and clinical studies. The aforementioned drugs are all classified as phosphodiesterase type 5 (PDE5) inhibitors. PDE5 plays a role in regulating and decreasing cyclic guanosine monophosphate (cGMP), an enzyme that is released during sexual stimulation which helps to relax smooth muscle in the corpus cavernosum thereby increasing blood flow to the penis and allowing erection. Inhibiting PDE5 increases cGMP levels, which aids the erection process. The mechanism by which tadalafil reduces symptoms of benign prostatic hyperplasia (BPH) has not been fully established, though its use has been associated with an increase in cGMP in the smooth muscle of the prostate, bladder and their vasculature. Cialis®, Levitra®, Staxyn®, Stendra®, and Viagra® (and generics when market available) are all approved by the Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED). Cialis is also approved by the FDA for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH), with or without ED. POLICY I. Cialis (tadalafil), Levitra (vardenafil), Staxyn (vardenafil orally disintegrating), Stendra (avanafil), or Viagra (sildenafil) will be covered with prior authorization when the following criteria are met: The patient does NOT require nitrate therapy on a regular OR on an intermittent basis AND o Cialis 2.5 mg or 5 mg is being prescribed for daily use for symptomatic benign prostatic hyperplasia (BPH) with or without erectile dysfunction (ED) in a male that is 18 years of age or older. [Note: examples of signs and symptoms of BPH are incomplete emptying, weak stream, straining, urinary frequency, intermittency, urgency, or acute urinary retention.] OR o The drug is being prescribed for erectile dysfunction in a male patient that is 18 years of age or older. © 2016 Caremark. All rights reserved. 1 Approval will be 36 months. II. Cialis®, Levitra®, Staxyn®, Stendra®, and Viagra® (and generics when market available) are considered not medically necessary for patients who do not meet the criteria set forth above. Prior approval is required. Submit a prior approval/treatment request now. Quantity limits apply: Cialis 2.5mg & 5 mg 30 tablets/30 days, Cialis 10mg & 20mg 6 tablets/30 days, Levitra 6 tablets/30 days, Staxyn 6 tablets/30 days, Viagra 6 tablets/30days, Stendra 6 tablets/30 days PROCEDURES AND BILLING CODES To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD diagnostic codes. No applicable codes REFERENCES Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; January 2015. Levitra [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; April 2014. Staxyn [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc; April 2014. Stendra [package insert]. Mountain View, CA: VIVUS, Inc.; January 2015. Viagra [package insert]. New York, NY: Pfizer Labs; February 2015. AHFS DI (Adult and Pediatric) [database online]. Hudson, OH: Lexi-Comp, Inc.; http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed April 2015. Micromedex Solutions [database online]. Greenwood Village, CO: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed April 2015. American Urological Association Guideline on the Management of Erectile Dysfunction. 2005. http://www.auanet.org/common/pdf/education/clinical-guidance/Erectile-Dysfunction.pdf. Accessed April 2015. Eisenberg M, Shindel A, Smith J, et al. Socioeconomic, Anthropomorphic, and Demographic Predictors of Adult Sexual Activity in The United States: Data from the National Survey of Family Growth. J Sex Med. 2010;7:50-58. Lindau S, Schumm L, Laumann E, et al. A Study of Sexuality and Health among Older Adults in the United States N Engl J Med. 2007 August 23;357(8):762–774. American Urological Association Guideline Management of Benign Prostatic Hyperplasia (BPH). 2010. https://www.auanet.org/common/pdf/education/clinical-guidance/Benign-Prostatic- Hyperplasia.pdf. Accessed April 2015. POLICY HISTORY Policy #: 05.01.42 Original Effective Date: April 2006 Reviewed: September 2016 Revised: May 2016 Current Effective Date: June 11, 2016 © 2016 Caremark. All rights reserved. 2 .
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