Erectile dysfunction agents (viagra, levitra, cialis, staxyn, muse, caverject, and edex) and cialis for benign prostatic hyperplasia

CLINICAL POLICY
ERECTILE DYSFUNCTION AGENTS (VIAGRA,
LEVITRA, CIALIS, STAXYN, MUSE, CAVERJECT,
EDEX, STENDRA) AND CIALIS FOR BENIGN
PROSTATIC HYPERPLASIA
Policy Number: PHARMACY 195.9 T2
Effective Date: July 1, 2013
Table of Contents
Related Policies:
…………………………………. The services described in Oxford policies are subject to the terms, conditions and limitations of the
Member's contract or certificate. Unless otherwise stated, Oxford policies do not apply to Medicare
Advantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary without
prior written notice unless otherwise required by Oxford's administrative procedures or applicable state law.
The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these
policies.

Certain policies may not be applicable to Self-Funded Members and certain insured products. Refer to the
Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or if there
are any exclusions or benefit limitations applicable to any of these policies. If there is a difference between
any policy and the Member’s plan of benefits or Certificate of Coverage, the plan of benefits or Certificate of
Coverage will govern.

CONDITIONS OF COVERAGE

Applicable Lines of Business/
This policy applies to Oxford Commercial plan Products
Benefit Type
Referral Required
(Does not apply to non-gatekeeper products) Authorization Required
(Precertification always required for inpatient
admission)
Precertification with Medical
Director Review Required
Applicable Site(s) of Service
(If site of service is not listed, Medical
Director review is required)
Special Considerations
1Providers must call Oxford's Pharmacy Benefit Manager 2New Jersey Small and Individual Commercial Members should refer to their certificate of coverage for precertification guidelines and quantity limit guidelines. Erectile Dysfunction Agents (Viagra, Levitra, Cialis, Staxyn, Muse, Caverject, and Edex) and Cialis for Benign Prostatic 1 Hyperplasia: Clinical Policy (Effective 07/01/2013) 1996-2013, Oxford Health Plans, LLC

COVERAGE RATIONALE

Oxford will provide coverage for Erectile Dysfunction Agents: Sildenafil citrate (Viagra), Vardenafil
HCl (Levitra, Staxyn), Tadalafil (Cialis), Alprostadil (Muse, Caverject and Edex), and Avanafil
(Stendra), and coverage for Tadalafil (Cialis) for the treatment of benign prostatic hypertrophy
(BPH) as indicated below.
For coverage of Sildenafil (Revatio) and Aadalafil (Adcirca) for pulmonary arterial hypertension,
refer to:
Criteria

Alprostadil (Muse/Caverject/Edex)
Oxford will provide coverage for Alprostadil (Muse, Caverject or Edex) when all of the following
criteria are met:
• Member is male and is 18 years of age or older; and
• The member has an organic cause of erectile dysfunction; conditions include: neurological disease including stroke, seizure disorder, demyelinating disease, spinal cord injury or tumor, endocrine disorder including hypogonadism, vascular or neurologic disease affecting the genitalia history of male genital surgery (including prostatectomy), trauma, or irradiation. Caverject® 5 mcg, 10 mcg, 20 mcg, and 40 mcg vials
Edex™ 5 mcg, 10 mcg, 20 mcg, and 40 mcg vials
Muse® 125 mcg, 250 mcg, 500 mcg, and 1000 mcg pellets
Sildenafil Citrate/Vardenafil HCL/Avanafil (Viagra/Levitra/Staxyn/Stendra)
Oxford will provide coverage for Sildenafil citrate (Viagra), Vardenafil HCl (Levitra, Staxyn), or
Avanafil (Stendra) when all of the following criteria are met:
• Member is male and is 18 years of age or older; and
• The member has an organic cause of erectile dysfunction; conditions include: neurological disease including stroke, seizure disorder, demyelinating disease, spinal cord injury or tumor, endocrine disorder including hypogonadism, vascular or neurologic disease affecting the genitalia history of male genital surgery (including prostatectomy), trauma, or irradiation, • The member is not receiving any form of nitrate therapy; and
• For Staxyn only: **Member has tried and failed the following medication: Levitra
Erectile Dysfunction Agents (Viagra, Levitra, Cialis, Staxyn, Muse, Caverject, and Edex) and Cialis for Benign Prostatic 2 Hyperplasia: Clinical Policy (Effective 07/01/2013) 1996-2013, Oxford Health Plans, LLC
** Does not apply to New Jersey Products and Plans. Levitra® 2.5 mg, 5 mg, 10 mg and 20 mg tablets Viagra® 25 mg, 50 mg, and 100 mg tablets Staxyn 10mg orally disintegrating tablets Tadalafil (Cialis)
Oxford will provide coverage for tadalafil (Cialis) when all of the following criteria are met:
• Member is male and > 18 years of age; and
• The Member has an organic cause of erectile dysfunction; conditions include: neurological disease including stroke, seizure disorder, demyelinating disease, spinal cord injury or tumor endocrine disorder including hypogonadism vascular or neurologic disease affecting the genitalia history of male genital surgery (including prostatectomy), trauma, or irradiation; • The Member is not receiving any form of nitrate therapy. • Requested dose is for tadalafil 2.5 or 5mg strength tablet; and
• Member is male and > 18 years of age; and
• The member is not receiving any form of nitrate therapy; and
• The member has benign prostatic hyperplasia; and
**Trial and failure after a 4-week trial of an alpha-adrenergic blocking medication
[e.g.: Cardura (doxazosin), Flomax (tamsulosin), Hytrin (terazosin), Rapaflo
(silodosin), Uroaxatrol (alfuzosin)] for the treatment of the signs and symptoms of
benign prostatic hyperplasia, or
**Patient experiences intolerable adverse effects to an alpha-adrenergic blocking medication [e.g.: Cardura (doxazosin), Flomax (tamsulosin), Hytrin (terazosin), Rapaflo (silodosin), Uroaxatrol (alfuzosin)] for the treatment of the signs and symptoms of benign prostatic hyperplasia
**Does not apply to New Jersey Products and Plans.

Cialis® 2.5mg, 5 mg, 10 mg and 20 mg tablets
Approval Period for Cialis for Treatment of BPH: 12 months at a quantity not to exceed 1
tablet/day.
For information regarding any quantity level limitations, refer to policy:
*Examples (not all-inclusive): spironolactone, thiazide diuretics (e.g. chlorthalidone,
chlorothiazide, hydrochlorothiazide), methyldopa, clonidine, guanfacine, reserpine, beta-blockers
(e.g. propranolol, metoprolol), digoxin, tricyclic antidepressants (e.g. amitriptyline, doxepin,
imipramine, nortriptyline, protriptyline), selective serotonin reuptake inhibitors (e.g. citalopram,
Erectile Dysfunction Agents (Viagra, Levitra, Cialis, Staxyn, Muse, Caverject, and Edex) and Cialis for Benign Prostatic 3 Hyperplasia: Clinical Policy (Effective 07/01/2013) 1996-2013, Oxford Health Plans, LLC
escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), duloxetine, venlafaxine, cimetidine,
phenytoin, carbamazepine, phenobarbital, primidone, lithium carbonate, chlorpromazine,
thioridazine, fluphenazine, trifluoperazine, finasteride, dutasteride, chronic use opioids, estrogens,
anti-androgens (e.g. bicalutamide, flutamide, nilutamide), luteinizing hormone releasing hormone
agonists (leuprolide, histrelin, goserelin, triptorelin)

BENEFIT CONSIDERATIONS
• Not all Oxford Members have a pharmacy benefit. For coverage of and specific exclusions, exceptions, and dispensing limitations, refer to the Member's pharmacy plan, if applicable. • Refer to the Member's specific Certificate of Coverage, health benefits plan, and/or summary of benefits documentation for additional information. • Oxford's pharmacy benefit manager (PBM) provides a nationwide network of participating pharmacies that administers prescription drugs on a retail level. Groups that purchase the Pharmacy Rider will have their retail pharmacy benefit administered by the PBM. • New York Individual products and Healthy New York products: Coverage is not provided for drugs used in the treatment of erectile dysfunction when provided to, or prescribed for use by, a person who is required to register as a sex offender pursuant to article 6-C of New York Correction Law. • For information regarding any quantity level limitations, refer to policy: • For coverage of sildenafil (Revatio) and tadalafil (Adcirca) for pulmonary arterial BACKGROUND

Erectile Dysfunction
Alprostadil (Caverject®, Edex™, and Muse®) is approved by the Food and Drug Administration
(FDA) for use in the treatment of erectile dysfunction in males 18 years of age and older. Erectile
dysfunction can be caused by an underlying medical condition such as heart disease, high blood
pressure, and high cholesterol. Other causes of erectile dysfunction include stress, depression
and as a side effect of certain medications. Alprostadil (Caverject®, Edex™, and Muse®) is
contraindicated for use in men for whom sexual activity is inadvisable or contraindicated.
Tadalafil (Cialis®), vardenafil HCl (Levitra®, Staxyn) and sildenafil citrate (Viagra) are approved by
the Food and Drug Administration (FDA) for use in the treatment of erectile dysfunction in males
18 years of age and older. Erectile dysfunction can be caused by an underlying medical condition
such as heart disease, high blood pressure, and high cholesterol. Other causes of erectile
dysfunction include stress, depression, and as a side effect of certain medications. Caution
should be used in patients with preexisting cardiovascular disease.
Tadalafil (Cialis®), vardenafil hcl (Levitra®, Staxyn), and sildenafil citrate (Viagra®) are
contraindicated in the presence of concurrent nitrate therapy (taken regularly and/or
intermittently) as they potentiate the hypotensive effects of nitrates which can result in a
potentially fatal fall in blood pressure. It is unknown when nitrates can be safely administered in
patients who have taken tadalafil (Cialis®), vardenafil hcl), (Levitra®. Staxyn), or sildenafil citrate
(Viagra®). Because the co-administration of alpha-blockers with tadalafil (Cialis®) or vardenafil
(Levitra®) can produce hypotension, tadalafil (Cialis®) and vardenafil (Levitra®) are also
contraindicated in patients taking alpha-blockers.
Benign Prostatic Hyperplasia (BPH)
Step therapy programs are utilized to encourage use of lower cost, preferred alternatives for
certain therapeutic classes. This program requires a member to try and fail an alpha-adrenergic
blocking agent for the signs and symptoms of benign prostatic hyperplasia (BPH) before
providing coverage for tadalafil.
Erectile Dysfunction Agents (Viagra, Levitra, Cialis, Staxyn, Muse, Caverject, and Edex) and Cialis for Benign Prostatic 4
Hyperplasia: Clinical Policy (Effective 07/01/2013) 1996-2013, Oxford Health Plans, LLC

Benign prostatic hyperplasia is a histologic diagnosis that refers to the proliferation of smooth
muscle and epithelial cells within the prostate. The enlarged gland has been proposed to
contribute to the overall lower urinary tract symptoms (LUTS) through direct bladder outlet
obstruction (BOO) from enlarged tissue and from increase smooth muscle tone and resistance
within the enlarged gland. The current standard of care includes the use of alpha-adrenergic
blocking medications in treating moderate to severe BPH-LUTS and the use of a 5-alpha-
reductase inhibitor (5-ARI) in men with an enlarged prostate.
Tadalafil is a phosphodiesterase 5 (PDE-5) inhibitor indicated for the treatment of erectile
dysfunction, the signs and symptoms of BPH, and the combination of erectile dysfunction and the
signs and symptoms of BPH.
The alpha-adrenergic blocking agents, alfuzosin (Uroaxatrol), doxazosin (Cardura), tamsulosin
(Flomax), and terazosin (Hytrin) are indicated for the treatment of patients with signs and
symptoms of BPH. In addition, doxazosin and terazosin are indicated for the treatment of
hypertension, however, use of doxazosin and terazosin as monotherapy for the treatment of
hypertension is not recommended. BPH and hypertension should be managed separately.
An adequate trial of an alternative agent is defined as treatment with an alpha-adrenergic
blocking medication lasting a minimum of four weeks15.
Although tadalafil is indicated for the treatment of erectile dysfunction with or without BPH,
patients using tadalafil solely for the treatment of erectile dysfunction will not be subject to the
step therapy criteria.
DEFINITIONS

For all of the definitions below, copayment/cost share will vary based on the members plan
design. Refer to the Member's specific certificate of coverage, contract and/or prescription drug
rider as applicable.
Mail Order Pharmacy: A network pharmacy contracted to provide up to a 90-day supply of
certain prescription medications (new or refill) by mail.
Specialty Pharmacy: A network pharmacy contracted to provide coverage for specialty
medications at an in network benefit level for members enrolled on NY and NJ LOBs.
Retail Pharmacy: A network non-mail order pharmacy contracted to provide prescription
medications (new or refill). Note: For members enrolled on NY LOBs new and renewing on or
after 01/12/12, if a retail pharmacy has contracted with the PBM, in advance, for the same rates
and terms and conditions as the mail order or specialty pharmacy, covered prescriptions will be
available at the same co-payment or other reimbursement level that would apply to the mail-order
or non-retail specialty pharmacies (should any of these pharmacies be available in the service
area).

REFERENCES

The foregoing Oxford policy has been adapted from an existing UnitedHealthcare Pharmacy
Clinical Pharmacy Program that was researched, developed and approved by the
UnitedHealthcare National Pharmacy & Therapeutics Committee.
1. Viagra® [prescribing information]. New York, NY: Pfizer Inc; January 2011. 2. Cialis® [prescribing information]. Indianapolis, IN: Eli Lilly and Company; October 2011. 3. Levitra® [prescribing information]. Wayne, NJ: Bayer HealthCare Pharmaceuticals. May 2010. 4. Staxyn (prescribing information). Wayne, NJ. Bayer HealthCare Pharmaceuticals, Inc. June Erectile Dysfunction Agents (Viagra, Levitra, Cialis, Staxyn, Muse, Caverject, and Edex) and Cialis for Benign Prostatic 5 Hyperplasia: Clinical Policy (Effective 07/01/2013) 1996-2013, Oxford Health Plans, LLC
5. Caverject® [prescribing information]. New York, NY: Pfizer Inc.; September 2006. 6. Edex® [prescribing information]. Smyrna, GA: Schwarz Pharma, LLC; July 2009. 7. Muse® [prescribing information]. Mountain View, CA: Vivus, Inc.; March 2009. 8. Stendra™ [prescribing information]. Mountain View, CA: Vivus, Inc.; October 2012 9. Guay AT, Spark RF, Bansal S, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Male Sexual Dysfunction: A Couple's Problem - 2003 update. Endocr Pract 2003;9(1):77-95. 10. Drugs That May Cause Male Sexual Dysfunction. Pharmacist's Letter. Detail Document 11. Drug-Induced Sexual Dysfunction. Drugdex® Consults. Micromedex® Healthcare Series. Last Modified: January 4, 2007. Available at Accessed May 14, 2013. 12. Montague DK, Jarow JP, Broderick GA, et al. Erectile Dysfunction. The Management of Erectile Dysfunction: An Update. American Urological Assocation. 2005 (Reviewed and validity confirmed, 2009.) Available at Accessed January 27, 2011. 13. American Urological Association. Guideline on the Management of Benign Prostatic 14. Flomax Prescribing Information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. 15. Roehrborn, CG, et al. Tadalafil Administered Once Daily for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Dose Finding Study. J of Urology. 2008 Oct;180:1228-34 16. Effects of Tadalafil on Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men With or Without Erectile Dysfunction. Broderick, GA, et al. Urology. 2010:75; 1452-59 POLICY HISTORY/REVISION INFORMATION

Action/Description
• Updated description of services to reflect most current clinical • Updated drug availability information for tadalafil (Cialis) to • Archived previous policy version PHARMACY 195.8 T2 Erectile Dysfunction Agents (Viagra, Levitra, Cialis, Staxyn, Muse, Caverject, and Edex) and Cialis for Benign Prostatic 6 Hyperplasia: Clinical Policy (Effective 07/01/2013) 1996-2013, Oxford Health Plans, LLC

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