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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
DESCRIPTIONFungal infections can be classified into different categories based on either the site of infection (mucocutaneous/local, systemic) or etiology (primary, opportunistic). Fungal pathogens may be a mold, yeast, or dimorphic fungus. Local infections typically occur on the skin, mouth, or vagina and are not usually severe while systemic fungal infections are more severe and can result in death. Primary fungal infections are caused by organisms found in the environment (e.g., coccidioidomycosis, histoplasmosis, blastomycosis) and are most commonly acquired by inhalation after exposure to certain endemic areas. Opportunistic infections are caused by organisms found in the normal human flora in individuals who are immunocompromised (e.g. candidiasis, aspergillosis, zygomycosis, etc).
There are several catergories of antifungal medications – allylamine (e.g terbinafine), azoles (e.g ketoconazole, itraconazole), echinocandins (caspofungin), pyrimidines (flucytosine), polyenes (amphotericin B), and griseofulvin. Topical agents are either allylamines or azoles and are effective for candida (azoles only) and tinea infections; systemic agents are used based on their antifungal spectrum and safety profile.
Specifically, the azoles, which are the most commonly used antifungal, vary in their spectrum of activity, bioavailability, pharmacokinetic profiles, and toxicities. They are all hepatically metabolized, and many of them are potent CYP450 inhibitors. Fluconazole is very active against yeast but no activity against mold infections. Itraconazole has a more extended spectrum compared to fluconazole against most Candida sp. as well as Cryptococcus neoformans, dimorphic fungi, dematiaceous molds, dermatophytes, Aspergillus sp. and sporothrix schenckii. Onmel® is brand name itraconazole 200mg tablet approved for the treatment of onychomycosis of the toenail due to Trichophyton rubrum or T. mentagrophytes in non-immunocompromised patients. Voriconazole is considered the first line agent against invasive aspergillus, more resistant strains of candida sp., fusarium sp., Scedosporium apiospermum, Trichosporon sp. and various molds. It is not active against mucorales. Posaconazole has a wide spectrum of activity as well but is unique in its activity against zygomycetes.
Noxafil is considered medically necessary for patients who meet all of the following criteria:
Vfend is considered medically necessary for patients who meet all of the following criteria:
Length of approval: one month for oropharyngeal and esophageal candidiasis; 6 months for all other indications.
For patients with a diagnosis of oropharyngeal candidiasis see Initial Evaluation criteria.
Vfend (voriconazole) will be approved when ALL of the following is met:
Length of approval: one month for esophageal candidiasis; 6 months for all other indications.
POLICY EXCEPTIONSNoxafil/Vfend prior authorization is not required for Federal Employee Program (FEP) and State Health Plan members.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY01/01/2014: New policy added.
SOURCE(S)Noxafil® Prescribing Information
Vfend® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.