Effective Date

Date of Origin 

7/1/2023

Cialis® ^* 

(tadalafil)

Tablet

Treatment of erectile dysfunction (ED)

Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)^

Treatment of ED and the signs and symptoms of BPH (ED/BPH)

^Limitation of Use: If Cialis is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of Cialis decreases from 4 weeks until 26 weeks, and the incremental benefit of Cialis beyond 26 weeks is unknown.

* generic available

1

Levitra®^*

(vardenafil)

Tablet 

Treatment of erectile dysfunction (ED)

* generic available

2

Staxyn®^*

(vardenafil)

Orally Disintegrating Tablet

Treatment of erectile dysfunction (ED)

* generic available

4

Stendra®

(avanafil)

Tablet

Treatment of erectile dysfunction (ED)

7

Viagra®^*

(sildenafil)

Tablet

Treatment of erectile dysfunction (ED)

* generic available

3

Erectile Dysfunction (ED)

Erectile Dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance. The Panel also endorses the Fourth International Consultation on Sexual Medicine's ED definition as the consistent or recurrent inability to attain and/or maintain penile erection sufficient for sexual satisfaction.(5)

The American Urological Association (AUA) guideline on ED (2018) states the following:(5)

• There is insufficient literature to constitute an evidence base for diagnosis of ED in clinical practice
• Any type of treatment for ED is a valid choice
• Oral medications are the least invasive option. Oral phosphodiesterase type 5 inhibitors (PDE5i) have the highest graded level evidence (Grade B) for recommendation in use of ED treatment
• PDE5i’s have similar efficacy in the general ED population

The American Family Physician guideline on the management of ED states the following:(6)

• There is no preferred, first-line diagnostic test for ED, and routine screening is not recommended
• History and physical examination are sufficient in making an accurate diagnosis of ED in most cases
• PDE5i’s are the most effective oral drugs in the treatment of ED and should be considered first-line therapy
• PDE5i’s are considered to be relatively similar in effectiveness and there is no rigorous data to suggest that one is superior to another

Sexual behavior studies indicate that commonly prescribed PDE5 inhibitor quantities range from 3 to 6 tablets per patient per month.(5)

Efficacy

PDE5i have similar efficacy in the general ED population. Examination of data reported by trials that evaluated PDE5i revealed that these medications had similar efficacy among men in the general ED population, defined as men with a variety of underlying conditions that potentially contributed to ED symptoms.(5)

Benign Prostatic Hyperplasia (BPH)

As men age, benign prostatic hyperplasia (BPH) becomes increasingly common. BPH can lead to urinary symptoms of increased frequency of urination, nocturia, hesitancy, urgency, and weak urinary stream. Symptomatic patients may benefit from medical or surgical treatment. The American Urological Association Symptom Index (AUA-SI) and the International Prostate Symptom Score (I-PSS) are nearly identical, validated short, self-administered questionnaires, used to assess the severity of three storage symptoms (frequency, nocturia, urgency) and four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream). The scores range from 0 to 35 with higher numeric scores representing greater severity. In patients with mild (AUA-SI/I-PSS <8) to moderate (AUA-SI/I-PSS 8-19) symptoms of BPH, the suggested initial treatment is alpha-1-adrenergic antagonist monotherapy. Alpha-1-adrenergic antagonists provide immediate therapeutic benefits. Alternative agents that may be used to treat lower urinary tract symptoms (LUTS) associated with BPH include 5-alpha-reductase inhibitors (5-ARIs), anticholinergics, and phosphodiesterase-5 inhibitors (PDE5i).(9)

The AUA guideline on BPH (2021) states that more recently, treatment has also been focused on the alteration of disease progression and prevention of complications that can be associated with BPH/LUTS. The pharmacologic classes used to treat LUTS attributed to BPH include alpha-adrenergic antagonists (alpha-blockers), beta adrenergic agonists, 5-ARIs, anticholinergics, vasopressin analogs, and PDE-5 inhibitors.(9)

Alpha-adrenergic receptor blockers are use as initial pharmacologic agents in most patients with BPH/LUTS. Treatment effects are seen within days. Bladder outlet obstruction (BOO) is primarily mediated by alpha-1 adrenergic receptors located on prostatic smooth muscle, which are upregulated in the stromal glandular hyperplasia seen in BPH. Blocking signaling through the alpha-adrenergic receptors leads to relaxation of the smooth muscle of the bladder neck and the prostatic urethra.(12)

PDE5 inhibitors have been shown in several randomized trials to be beneficial in improving symptom scores in patients with LUTS/BPH, although no significant changes in urine flow rates have been demonstrated.(12)

Efficacy

The efficacy and safety of Cialis (tadalafil) for once daily use for the treatment of the signs and symptoms of BPH was evaluated in 3 randomized, double-blinded, placebo-controlled, efficacy and safety studies of 12 weeks duration. Two of these studies were in men with BPH and one study was specific to men with both ED and BPH. The first study randomized 1058 patients to receive either Cialis 2.5 mg, 5 mg, 10 mg or 20 mg for once daily use or placebo. The second study randomized 325 patients to receive either Cialis 5 mg for once daily use or placebo. The primary efficacy endpoint in the two studies that evaluated the effect of Cialis on lower urinary tract symptoms (LUTS) of BPH was the International Prostate Symptom Score (IPSS), a four week recall questionnaire that was administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. The IPSS assesses the severity of irritative (frequency, urgency, nocturia) and obstructive symptoms (incomplete emptying, stopping and starting, weak stream, and pushing or straining), with scores ranging from 0 to 35; higher numeric scores representing greater severity. In each of these 2 trials, Cialis 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo.(1,5) 

Preservation of Erectile Function following Prostatectomy

Sexual dysfunction associated with radical retropubic prostatectomy (RRP) may start before the surgery. Men undergoing RRP frequently have some degree of sexual dysfunction. In addition to the psychological stress of the diagnosis, the biopsy may itself have a detrimental effect. After surgery, all men will experience loss of ejaculate, because the organ responsible for ejaculate has been removed. Penile sensation and the ability to have an orgasm are preserved even if the erectile nerves are removed during radical prostatectomy, leaving several options for treatment of erectile dysfunction. These include the use of oral phosphodiesterase-5 inhibitors, vacuum-assisted erection devices, penile self-injection (prostaglandin E1, papaverine, phentolamine), and intraurethral alprostadil.  Phosphodiesterase inhibitors are most helpful in men who have undergone a nerve-sparing procedure.(10)

Efficacy

In one study of 91 men presenting with erectile dysfunction following radical prostatectomy, the response rates to sildenafil in men who had undergone bilateral nerve-sparing, unilateral nerve-sparing, and a non-nerve sparing approach were 72, 50, and 15 percent, respectively. The response to sildenafil increases with time following radical prostatectomy. In a study in which 95 percent of men had undergone nerve-sparing procedures, 60 percent reported benefit from sildenafil at 18 to 24 months after surgery, significantly higher than the 29 percent who reported benefit in the first six months after surgery.(10)

A study of 174 men showed a response rate to sildenafil in men who had undergone bilateral nerve-sparing, unilateral nerve-sparing, and non-nerve-sparing were 76%, 53.5%, and 14.2% respectively. The recovery of erectile function can require as long as 18 to 24 months.  Initial failures of therapy might be followed by successful re-challenge at 18 to 24 months postoperatively.(11)

Safety

Cialis is contraindicated in the following:(1)

• Administration of Cialis to patients using any form of organic nitrate is contraindicated. Cialis was shown to potentiate the hypotensive effect of nitrates.
• History of known serious hypersensitivity reaction to Cialis or Adcirca
• Administration with guanylate cyclase (GC) stimulators, such as riociguat

Levitra is contraindicated in the following:(2)

• Administration with nitrates and nitric oxide donors
• Administration with guanylate cyclase (GC) stimulators, such as riociguat

Staxyn is contraindicated in the following:(4) 

• Administration with nitrates and nitric oxide donors
• Administration with guanylate cyclase (GC) stimulators, such as riociguat

Stendra is contraindicated in the following:(7)

• Administration of Stendra to patients using any form of organic nitrate is contraindicated
• Hypersensitivity to any component of the Stendra tablet
• Administration with guanylate cyclase (GC) stimulators, such as riociguat

Viagra is contraindicated in the following:(3) 

• Administration of Viagra to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Viagra was shown to potentiate the hypotensive effect of nitrates.
• Known hypersensitivity to sildenafil or any component of tablet
• Administration with guanylate cyclase (GC) stimulators, such as riociguat

1

Cialis prescribing information. Eli Lilly and Company. April 2022.

2

Levitra prescribing information. GlaxoSmithKline. August 2017.

3

Viagra prescribing information. Pfizer Inc. December 2017.

4

Staxyn prescribing information. Bayer HealthCare Pharmaceuticals Inc. August 2017.

5

Erectile Dysfunction: American Urological Association (AUA) Guideline (2018). Available at https://www.auanet.org/guidelines-and-quality/guidelines/erectile-dysfunction-(ed)-guideline.

6

Heidelbaugh JJ. Management of Erectile Dysfunction. Am Fam Physician 2010;81(3):305-312. Available at https://www.aafp.org/pubs/afp/issues/2010/0201/p305.html

7

Stendra prescribing information. Metuchen Pharmaceuticals, LLC. October 2022.

8

Bortnick E, Brown C, Simma-Chiang V, Kaplan SA. Modern best practice in the management of benign prostatic hyperplasia in the elderly. Ther Adv Urol. 2020;12:1756287220929486. Published 2020 May 27. doi:10.1177/1756287220929486. - Reference no longer used. 

9

American Urological Association Guidelines. Management of Benign Prostatic Hyperplasia/ Lower Urinary Tract Symptoms: American Urological Association (AUA) Guideline (2021). Published 2021. Available at: https://www.auanet.org/guidelines-and-quality/guidelines/benign-prostatic-hyperplasia-(bph)-guideline

10

McCullough AR. Sexual dysfunction after radical prostatectomy. Rev Urol. 2005;7 Suppl 2(Suppl 2):S3-S10. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1477599/.

11

Raina R, Lakin MM, Agarwal A, et al. Efficacy and factors associated with successful outcome of sildenafil citrate use for erectile dysfunction after radical prostatectomy. Urol J 2004;63(5):960-966.

12

McVary K. Medical Treatment of Benign Prostatic Hyperplasia. UpToDate. Last updated August 2022. Literature review current through October 2022.

vardenafil hcl orally disintegrating tab

10 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

Vardenafil HCl Orally Disintegrating Tab 10 MG

10 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

Cialis

Tadalafil Tab 10 MG

10  ; 10 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

Cialis

Tadalafil Tab 2.5 MG

2.5  ; 2.5 MG

30

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 6 doses per month. The quantity of 6 doses per month is cumulative.

Cialis

Tadalafil Tab 20 MG

20  ; 20 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

Cialis

Tadalafil Tab 5 MG

5  ; 5 MG

30

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 6 doses per month. The quantity of 6 doses per month is cumulative.

Levitra

vardenafil hcl tab

10 MG ; 2.5 MG ; 20 MG ; 5 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

Stendra

avanafil tab

100 MG ; 200 MG ; 50 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

Viagra

sildenafil citrate tab

100 MG ; 25 MG ; 50 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

Viagra

Sildenafil Citrate Tab 100 MG

100 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

Viagra

Sildenafil Citrate Tab 25 MG

25 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

Viagra

Sildenafil Citrate Tab 50 MG

50 MG

8

Tablets

30

DAYS

Quantity of 30 tablets per month is cumulative for Cialis/tadalafil 2.5 mg and 5 mg.  All agents (except for Cialis/tadalafil 2.5 mg and 5 mg) are limited to 8 doses per month. The quantity of 8 doses per month is cumulative. Some groups cover less than or more than 8 tablets per month. Group specific policies will supersede this policy when applicable. Please refer to member's benefit plan. Only 1 oral agent will be covered per month.

vardenafil hcl orally disintegrating tab

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Vardenafil HCl Orally Disintegrating Tab 10 MG

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Cialis

Tadalafil Tab 10 MG

10  ; 10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Cialis

Tadalafil Tab 2.5 MG

2.5  ; 2.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Cialis

Tadalafil Tab 20 MG

20  ; 20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Cialis

Tadalafil Tab 5 MG

5  ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Levitra

vardenafil hcl tab

10 MG ; 2.5 MG ; 20 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Stendra

avanafil tab

100 MG ; 200 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Viagra

sildenafil citrate tab

100 MG ; 25 MG ; 50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Viagra

Sildenafil Citrate Tab 100 MG

100 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Viagra

Sildenafil Citrate Tab 25 MG

25 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Viagra

Sildenafil Citrate Tab 50 MG

50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

QL

Increased quantities will be approved when the following is met:

1. The requested agent is a phosphodiesterase type 5 (PDE5) inhibitor and ALL of the following:
   1. The patient will NOT be using the requested agent in combination with another phosphodiesterase type 5 (PDE5) inhibitor for the requested indication AND
   2. The requested agent has been prescribed for preservation of erectile function following radical retropubic prostatectomy AND
   3. The quantity requested is less than or equal to 30 tablets per month

Length of Approval:  Preservation of erectile function following a radical retropubic prostatectomy – 30 tablets per month for 12 months