Prior Auth Protocol

FDA Approved Indications:

Cialis, Viagra, Levitra, Staxyn, Stendra

Treatment of erectile dysfunction (ED)

Cialis Only

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

Health Net Approved Indications and Usage Guidelines:

Benign Prostatic Hyperplasia (Cialis request only)

Patient is male

AND

Patient is NOT on nitrates or guanylate cyclase stimulators (e.g., Adempas (riociguat))

AND

Failure or clinically significant adverse effects to ONE alpha blocker (terazosin, doxazosin, tamsulosin, alfuzosin, Rapaflo^R) AND ONE 5-alpha reductase inhibitor (finasteride or Avodart^R)

Erectile Dysfunction

Diagnosis of erectile dysfunction

AND

Patient is male

AND

Patient is NOT on nitrates or guanylate cyclase stimulators (e.g., Adempas (riociguat))

AND

For EHB/IEX (Exchange) plans failure or clinically significant adverse effects to Staxyn

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
Patients taking nitrates (e.g., Nitrodur^R, Nitrobid^R, Nitrostat^R, Isordil^R, Ismo^R)
Patients taking guanylate cyclase stimulators (e.g., Adempas (riociguat))
Members without sexual dysfunction coverage (for diagnosis of ED)
Daily dosing of Cialis 2.5 mg or 5 mg strengths for diagnosis of ED

General Information:

PDE5 inhibitors should not be used in patients who have conditions that might predispose them to priapism, such as sickle cell anemia, multiple myeloma, or leukemia, or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease.
Cialis is not recommended for use in combination with alpha blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering.
PDE5 inhibitors are not recommended for use in combination with guanylate cyclase stimulators, such as Adempas (riociguat) as PDE5 inhibitors may potentiate the hypotensive effects of guanylate cyclase stimulators.
For diagnosis of ED: for HNCA commercial members, the members Evidence of Coverage states "These Prescription Drugs are covered for up to a number of doses or tablets specified in the Recommended Drug List."

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
doxazosin (Cardura^R/Cardura XL)	BPH Immediate Release 1 mg PO QD, titrate to 2 mg QD and thereafter to 4 mg QD and 8 mg QD Dosing range: 1 - 8 mg Extended Release 4 mg PO QD Dosing range: 4 - 8 mg	8 mg/day
terazosin (Hytrin^R)	BPH 1 mg PO QD; increase the dose to 2 mg, 5 mg, or 10 mg QD in a stepwise fashion Dosing Range: 1 - 20 mg	20 mg/day
tamsulosin (Flomax^R)	BPH 0.4 - 0.8 mg PO QD	0.8 mg/day
alfuzosin (Uroxatral^R)	BPH 10 mg PO QD	10 mg/day
Rapaflo^R(silodosin)	BPH 4 - 8 mg PO QD	8 mg/day
finasteride (Proscar^R)*	BPH 5 mg PO QD	5 mg/day
Avodart^R (dutasteride)*	BPH 0.5 mg PO QD	0.5 mg/day
Jalyn^R(dutasteride/ tamsulosin)*	BPH 0.5/0.4 mg PO QD	0.5/0.4 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Viagra	ED 50 mg PO 1 hour (0.5-4 hours) before sexual activity. Dosing range: 25 -100 mg The maximum recommended dosing frequency is ONCE per day.	Benefit Renewal Date (Quantity limits are plan specific)
Cialis	BPH 2.5-5 mg PO QD (maximum 5 mg/day) ED Daily for ED 2.5 - 5 mg PO QD* PRN for ED 10 mg PO before sexual activity Dosing range: 5 - 20 mg. The maximum recommended dosing frequency is ONCE per day. *NOTE: daily therapy for ED is a benefit exclusion. Refer to the member's evidence of coverage for plan specific quantity limits.	BPH Length of Benefit ED Benefit Renewal Date (Quantity limits are plan specific)
Levitra	ED 10 mg PO 60 minutes before sexual activity. Dosing range: 5 - 20 mg The maximum recommended dosing frequency is ONCE per day.	Benefit Renewal Date (Quantity limits are plan specific)
Staxyn	ED Place 1 tablet (10 mg) on the tongue 60 minutes before sexual activity. The maximum recommended dosing frequency is ONCE per day.	Benefit Renewal Date (Quantity limits are plan specific)
Stendra	ED 100 mg PO 30 minutes before sexual activity. Dosing range: 50 - 200 mg. The maximum recommended dosing frequency is ONCE per day.	Benefit Renewal Date (Quantity limits are plan specific)

Product Availability:

Cialis Tablet: 2.5 mg, 5 mg, 10 mg, and 20 mg

Viagra Tablet: 25 mg, 50 mg, and 100 mg

Levitra Tablet: 2.5 mg, 5 mg, 10 mg, and 20 mg
Staxyn ODT (not scored): 10 mg

Stendra: 50 mg, 100 mg and 200 mg

References:

1. Cialis [package insert]. Indianapolis, IN: Eli Lilly; September 2015.

2. Viagra [package insert]. New York, NY: Pfizer, Inc.; September 2015.

3. Levitra [package insert]. Wayne, NJ: Bayer Pharmaceuticals Corporation; September 2015.

4. Staxyn [package insert]. Wayne, NJ: Bayer Pharmaceuticals Corporation; September 2015.

5. Stendra [package insert]. Mountain View, CA: Vivus;September 2015.

6. Guay, AT, et al. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Evaluation and Treatment of Male Sexual Dysfunction: A Couples Problem-2003 Update. Endocrine Practice, 2003; 9(1): 77-95

7. Lue TF. Drug therapy: Erectile dysfunction. N Engl J Med 2000;342:1802.

8. Steele, D. Drugs causing sexual dysfunction and their alternatives: A Reference Tool. Urol Nurs. 1989 Oct-Dec;9(6):10-12.

9. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 27, 2015.

10. American Hospital Formulary Service Drug Information [Internet database]. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed May 27, 2015.