Oxiconazole (Oxistat 1%)

Oxiconazole (Oxistat 1%) is a topical antifungal agent approved by the FDA for managing superficial fungal infections of the skin caused by a variety of dermatophytes and yeast. This drug can be administered to both pediatric and adult patients and is available in two commercial formulations: cream and lotion. The most frequently observed side effects include itching and irritation at the site of application, which may manifest as pain, burning, or stinging.

Definitions

Tinea refers to a group of contagious fungal infections caused by dermatophytes, a type of fungus. These infections can manifest on various body parts and are usually named for the body area affected.

Tinea corporis

"Tinea corporis" describes a fungal infection on body surfaces not including the feet, groin, face, scalp hair, or beard hair. It's commonly known as "ringworm" due to its characteristic ring-shaped rash.

Tinea cruris

"Tinea cruris" refers to a fungal infection in the groin region, proximal inner thighs, or buttocks. It's often referred to as "jock itch."

Tinea pedis

"Tinea pedis" pertains to a fungal infection of the feet, commonly known as "athlete's foot."

Tinea versicolor

"Tinea versicolor" is a non-contagious skin condition caused by an overgrowth of certain types of yeast present on skin. This results in discoloration, with patches of skin appearing lighter or darker than the surrounding skin. These patches are most common on the trunk and shoulders.

Medical Necessity Criteria for Authorization

The Plan considers oxiconazole (Oxistat 1%) medically necessary when BOTH of the following criteria are met:

1. The member has ONE of the following as a documented diagnosis:
   • a. Tinea corporis (ringworm); or
   • b. Tinea cruris (jock itch); or
   • c. Tinea pedis (athlete's foot); or
   • d. Tinea (pityriasis) versicolor; AND
2. The member is unable to use or has tried and failed THREE (3) of the following:
   • a. butenafine cream over-the-counter (OTC); or
   • b. ciclopirox cream, gel, or suspension; or
   • c. clotrimazole cream or solution OTC; or
   • d. econazole cream; or
   • e. ketoconazole cream or shampoo; or
   • f. luliconazole cream; or
   • g. miconazole cream OTC; or
   • h. naftifine cream; or
   • i. terbinafine cream OTC; or
   • j. tolnaftate cream OTC.
   If the above prior authorization criteria are met, Oxiconazole (Oxistat 1%) will be approved for up to 6 months.

Experimental or Investigational / Not Medically Necessary

Oxiconazole (Oxistat 1%) for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. Burke D and Chi E. Tinea Versicolor. Available at: https://www.healthline.com/health/tinea-versicolor. Last Updated March 2019. Accessed Sept 2021.
2. Dermatological Therapies: American Academy of Dermatology. Available at: www.aad.org. Accessed Sept 2021.
3. Goldstein, AO and Goldstein BG. Dermatophyte (tinea) infections - UpToDate. Available at: https://www.uptodate.com/contents/dermatophyte-tinea-infections. Last Updated May 2021. Accessed Sept 2021.
4. Hoopes RR, Travers JB. Exaggerated Immune Reaction to Trichophyton Fungus Results in an Inflammatory Tinea Pedis. Arch Intern Med Res. 2020;3(3):183-185. doi:10.26502/aimr.00405.
5. Jartarkar SR, Patil A, Goldust Y, et al. Pathogenesis, Immunology and Management of Dermatophytosis. J Fungi (Basel). 2021;8(1):39. Published 2021 Dec 31. doi:10.3390/jof8010039
6. Leung AK, Lam JM, Leong KF, Hon KL. Tinea corporis: an updated review. Drugs Context. 2020;9:2020-5-6. Published 2020 Jul 20. doi:10.7573/dic.2020-5-6
7. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, CO. Available at: http://www.micromedexsolutions.com/. Accessed Sept 2021.
8. Oxistat [package insert]. Melville, NY: E. Fougera & CO; February 2019.

Clinical Guideline Revision / History Information

Original Date: 10/14/2021
Reviewed/Revised: 12/01/2021, 06/23/2022, 06/29/2023