Prior Auth Protocol

FDA Approved Indications:

Cialis, Staxyn, Viagra

Cialis Only

Health Net Approved Indications and Usage Guidelines:

Benign Prostatic Hyperplasia (Cialis requests only)

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 (ED is a benefit exclusion except for Aon Active)

AND

AND

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

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
Members without sexual dysfunction coverage (for diagnosis of ED)
Daily dosing of Cialis 2.5 mg or 5 mg strengths for diagnosis of ED
Patients taking nitrates (e.g., Nitrodur^R, Nitrobid^R, Nitrostat^R, Isordil^R, Ismo^R)
Patients taking guanylate cyclase stimulators (e.g., Adempas (riociguat))

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.
Cialis for once daily use is approved for BPH and should be used up to a maximum dose of 5 mg PO QD.

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
Cialis	BPH 2.5-5 mg PO QD 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.	Length of benefit
Staxyn	ED Place 1 tablet (10 mg) on the tongue 60 minutes before sexual activity. The maximum recommended dosing frequency is ONCE per day.	Length of Benefit
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.	Length of Benefit

Product Availability:

Cialis Tablet: 2.5 mg, 5 mg (10 mg and 20 mg tablets are a benefit exclusion)

Staxyn ODT (not scored): 10 mg

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

References:

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

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

3. Staxyn [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September 2015.

4. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 09, 2015.

5. American Hospital Formulary Service Drug Information [Internet database]. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 09, 2015.