ZILXI (minocycline 1.5% foam)

SELF ADMINISTRATION-TOPICAL

Indication for Prior Authorization:
  • Treatment of inflammatory lesions of rosacea in adults
  • Limitations of Use:
    • This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Zilxi™ should be used only as indicated
Coverage Criteria:
  • Patient is 18 years of age or older, AND
  • Patient has inflammatory lesions of rosacea as confirmed by chart note documentation, AND
  • Patient has tried and failed 2 of the preferred agents (e.g. topical metronidazole, azelaic acid, ivermectin) within the past 180 days, AND
  • Patient has tried and failed oral generic minocycline capsules
Reauthorization Criteria:
  • Patient had a positive response to therapy as confirmed by chart note documentation
Dosing:

Apply to affected areas once daily

Coverage Duration:
  • Initial: 3 months
  • Renewal: 1 year
Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:
  • Avoid giving tetracycline-class drugs in conjunction with penicillin
  • Tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage
  • Pregnancy: Available data with Zilxi™ use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic absorption of Zilxi™ in humans is low following once daily topical administration of Zilxi™ under maximal clinical use conditions. Because of low systemic exposure, it is not expected that maternal use of Zilxi™ will result in significant fetal exposure to the drug. Tetracycline-class drugs may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered orally during pregnancy
  • Lactation: Tetracycline-class drugs, including minocycline, are present in breast milk following oral administration. It is not known whether minocycline is present in human milk after topical administration to the nursing mother. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with Zilxi™
Review History:
  • 11/17/20- New review
References:
  • Amzeeq [package insert], Bridgewater, NJ: Foamix Pharmaceuticals, Inc.; October 2019.
  • Baldwin HE, Harper J, Baradaran S, Patel V. Erythema of rosacea affects health-related quality of life: results of a survey conducted in collaboration with the National Rosacea Society. Dermatol Ther. 2019;9:725-734.
  • Chang YS, Huang YC. Role of Demodex mite infestation in rosacea: a systematic review and meta-analysis. J Am Acad Derm. 2017;77:441-447.
  • Dahl MV. Rosacea: pathogenesis, clinical features, and diagnosis. UpToDate Web site. Updated February 7, 2020. www.uptodate.com. Accessed August 7, 2020.
  • Del Rosso JQ, Tanghetti E, Webster G, et al. Update on the management of rosacea from the American Acne & Rosacea Society (AARS). J Clin Aesthet Dermatol. 2019;12(6):17-24.
  • Gallo RL, Granstein RD, Kang S, et al. Standard classification and pathophysiology of rosacea: the 2017 update by the National Rosacea Society expert committee. J Am Acad Derm. 2018;78:148-155.
  • Stein Gold LS, Del Rosso JQ, Kircik L, et al. Minocycline 1.5% foam for the topical treatment of moderate to severe papulopustular rosacea: results of 2 phase 3, randomized, clinical trials. J Am Acad Derm. 2020;82(5):1166-1173.
  • Maier LE. Management of rosacea. UpToDate Web site. Updated February 24, 2020. www.uptodate.com. Accessed August 7, 2020.
  • Schaller M, Almeida LMC, Bewley A, et al. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea Consensus 2019 panel. Br J Derm. 2020:182:1269-1276.
  • Thiboutot D, Anderson R, Cook-Bolden F, et al. Standard management options for rosacea: the 2019 update by the National Rosacea Society expert committee. J Am Acad Derm. 2020;82(6):1501-1510.
  • van Zuuren EJ, Fedorowicz Z, Tan J, et al. Interventions for rosacea based on phenotype approach: an updated systematic review including GRADE assessments. Br J Derm. 2019;181:65-79.
  • Zilxi [package insert], Bridgewater, NJ: Foamix Pharmaceuticals, Inc.; May 2020.
     

Last review date: November 17, 2020