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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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY01/01/2014: New policy added.
07/31/2015: Code Reference section updated for ICD-10.
05/27/2016: Policy number L.5.01.455 added. Policy Guidelines updated to add medically necessary and investigative definitions.
08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
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.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.