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Terbinafine (Lamisil-oral) is considered medically necessary for the treatment of Onychomycosis when
 laboratory testing confirms fungal disease and any of the following criteria are met:

-Medical records document skin involvement or infection.
-Medical records document pain.
-The member has diabetes.

-The member has vascular insufficiency to the lower extremities.
-The member has immune deficiency.

Description:

Terbinafine (Lamisil), an allylamine antifungal, is hypothesized to exert it antifungal effect through interfering with fungal sterol biosynthesis by inhibiting the enzyme squalene monooxygenase, a key enzyme in sterol biosynthesis in fungi. The accumulation of squalene weakens the cell membrane in sensitive fungi. The inhibition of squalene monooxygenase creates a deficiency in ergosterol, a component of fungal membranes necessary for normal growth. Oral terbinafine is highly effective for treating onychomycosis due to its fungicidal activity and ability to concentrate within the nail and has been found to be superior to griseofulvin and to itraconazole for the treatment of onychomycosis.

Oral dosage:
Adults and adolescents: The recommended dosage is 250 mg PO once daily. Treatment should continue for 6 weeks for treatment of fingernails, and 12 weeks for treatment of toenails. Alternatively, an intermittent dosage of 500 mg PO once daily for 7 days during the first week of each month for 3 months was found to be equivalent to the standard continuous dosage.

The most commonly reported adverse effects involve the gastrointestinal tract- diarrhea, dyspepsia and abdominal pain. Other reported adverse effects include rashes, urticaria, pruritis, taste disturbances and liver tests abnormalities.

Terbinafine (Lamisil) is pregnancy category B.

Coverage:

Itraconazole (Sporanox-oral) is considered medically necessary for the treatment of Onychomycosis

when laboratory testing confirms fungal disease and any of the following criteria are met:

-Medical records document skin involvement or infection.
-Medical records document pain.
-The member has diabetes.

-The member has vascular insufficiency to the lower extremities.
-The member has immune deficiency.

Description:

Itraconazole (Sporanox) is a synthetic triazole antifungal agent that exerts its effect by altering the fungal cell membrane. Itraconazole inhibits ergosterol synthesis by interacting with 14-alpha demethylase, a cytochrome P-450 enzyme that is necessary for the conversion of lanosterol to ergosterol, an essential component of the membrane. Inhibition of ergosterol synthesis results in increased cellular permeability, which causes leakage of cellular contents. Other antifungal effects of azole compounds have been proposed and include: inhibition of endogenous respiration, interaction with membrane phospholipids, and inhibition of yeast transformation to mycelial forms. Other mechanisms may involve inhibition of purine uptake and impairment of triglyceride and/or phospholipid biosynthesis. Azole compounds, including itraconazole, have a broad spectrum of antifungal activity against common fungal pathogens including Blastomyces dermatitidis, Candida species, Cryptococcus neoformans, Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis, and Sporothrix schenckii. Itraconazole is the only azole compound with activity against Aspergillus sp.

For fingernail involvement only:

Oral dosage:
Adults: 200 mg PO twice daily for 1 week, followed by no drug for 3 weeks, then another week of 200 mg PO twice daily.
For toenail involvement with or without fingernail involvement:
Oral dosage:
Adults: 200 mg PO once daily for 12 weeks.

Adverse effects reported during therapy with itraconazole for systemic fungal infections include nausea/vomiting (11%/5%), diarrhea (3%), abdominal pain (2%), and anorexia (1%). Other adverse effects reported during therapy with itraconazole are headache (10%), edema (4%), injection site reaction (4%), chest pain (unspecified) (3%), fatigue (3%), hypertension (3%), hypertriglyceridemia (3%), depression (2%), dizziness (2%), hypokalemia (2%), and in at least 1% of patients: albuminuria, impotence (erectile dysfunction), libido decrease, malaise, myalgia, orthostatic hypotension, vasculitis, and vertigo.

Itraconazole (Sporanox) is pregnancy category C.

Coverage:

Ciclopirox (Penlac-topical) is considered medically necessary for the treatment of Onychomycosis when laboratory testing confirms fungal disease and any of the following criteria are met:

-Medical records document skin involvement or infection.
-Medical records document pain.
-The member has diabetes.

-The member has vascular insufficiency to the lower extremities.
-The member has immune deficiency.

-Medical records document contraindication to oral therapy.

Description:

Ciclopirox olamine (Penlac) is a topical antifungal agent, which has antifungal activity similar to the imidazoles. Ciclopirox is a substituted pyridone antimycotic with activity against a broad spectrum of dermatophytes, yeasts, actinomycetes, molds, other fungi and some gram-positive and gram-negative bacteria. Although the exact cellular mechanisms are unknown, ciclopirox is thought to exert its antifungal and antibacterial activity by blocking fungal transmembrane transport, causing intracellular depletion of essential substrates (e.g., amino acids) and/or ions (e.g., potassium). Ciclopirox interferes with the synthesis of RNA and DNA. At high ciclopirox concentrations, the fungal cell membrane permeability is altered, allowing leakage of intracellular material.

Ciclopirox has fungicidal activity against in vitro isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida albicans. Ciclopirox also inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Although not used for its antibacterial properties, ciclopirox has some activity against Trichomonas vaginalis and Mycoplasma.

Topical dosage for Topical Nail Solution (Penlac 8% Nail Lacquer):
Adults and adolescents: Apply once daily (preferably at bedtime or eight hours before washing nails) to affected nails with the applicator brush provided. Ciclopirox should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, apply to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g. onycholysis). Contact with the surrounding skin may produce mild, transient irritation (redness). Apply daily over the previous coat (do not remove nail lacquer until 7 days). Remove the nail lacquer coat every 7 days with alcohol. Patients should file away (with an emery board) loose nail material and trim nails, as required, every seven days after ciclopirox is removed with alcohol. Repeat this cycle throughout the duration of therapy. The safety and efficacy of using ciclopirox daily for > 48 weeks have not been established.
Elderly: See adult dosage.
Children: Safe and effective use has not been established.

Ciclopirox is pregnancy category B.

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