Prior Auth Protocol

FDA Approved Indications:

For the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older

Health Net Approved Indications and Usage Guidelines:

Diagnosis of persistent facial erythema of rosacea papules without pustules of rosacea

OR

Diagnosis of persistent facial erythema of rosacea with papules and pustules of rosacea

AND

Failure or clinically significant adverse effects to trial of topical metronidazole, Finacea or doxycycline 50 mg.

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.

General Information:

Tetracycline agents, including doxycycline and minocycline exhibit anti-inflammatory activities at doses < 50 mg. Anti-inflammatory dose doxycycline does not exert antibiotic selection pressure and thus does not induce antibiotic resistance; its mechanism of action in rosacea appears to relate to the anti-inflammatory and biological activities of doxycycline.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
metronidazole 0.75% (Metrocream^R)	Apply topically BID	This field intentionally left blank.
metronidazole 0.75 % (Rosadan^R)	Apply topically BID	This field intentionally left blank
metronidazole 1% (Metrogel^R)	Apply topically QD	This field intentionally left blank
Finacea (azelaic acid)^R	Apply topically BID	This field intentionally left blank
doxycycline	Rosacea 40 mg or 50 mg PO QD	50 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Mirvaso	Apply a pea-size amount topically QD to each of the five areas of the face (forehead, chin, nose, each cheek) avoiding the eyes and lips	Length of Benefit

Product Availability:

Gel: 0.33% (30 gm)

References:

Mirvaso [Prescribing Information]. Fort Worth, TX: Galderma Laboratories; August 2013.
Fowler J Jr, et al. Efficacy and safety of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: results of two randomized, double-blind, and vehicle-controlled pivotal studies. J Drugs Dermatol. Jun 2013;12(6):650-6.
Micromedex^R Healthcare Series [database online]. Greenwood Village, Colorado: Thomson Healthcare. Updated periodically. Accessed June 21, 2015
Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed June 21, 2015