Sporanox (itraconazole) — Blue Cross Blue Shield of Illinois

Preferred products

• itraconazole capsules (generic equivalent)

Initial criteria

• ONE of the following:
• A. The patient has a diagnosis of onychomycosis (tinea unguium) AND ALL of the following:
• 1. The requested agent is Sporanox (itraconazole) capsules AND
• 2. The patient has not received treatment for onychomycosis with the requested agent within the past 12 months AND
• 3. The patient has ONE of the following: diabetes mellitus, peripheral vascular insufficiency, immune deficiency due to medical condition or treatment (e.g., cancer chemotherapy, HIV/AIDS, anti-rejection therapy post organ transplant) AND
• 4. Treatment of the patient’s onychomycosis is medically necessary and not entirely for cosmetic reasons AND
• 5. Fungal nail infection is confirmed by laboratory testing (KOH preparation, fungal culture, periodic acid-Schiff [PAS] staining, or polymerase chain reaction [PCR] testing) [lab results are required] AND
• 6. If the request is for one of the following brand agents with an available generic equivalent (listed below), then ONE of the following:
• A. The patient has tried and had an inadequate response to the generic equivalent [chart notes are required] OR
• B. The generic equivalent was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required] OR
• C. The patient has an intolerance or hypersensitivity to the generic equivalent that is not expected to occur with the brand agent [chart notes are required] OR
• D. The patient has an FDA labeled contraindication to the generic equivalent that is not expected to occur with the brand agent [chart notes are required] OR
• E. The generic equivalent is expected to be ineffective based on the known clinical characteristics of the patient and the known characteristics of the prescription drug; OR cause a significant barrier to the patient’s adherence of care; OR worsen a comorbid condition; OR decrease the patient’s ability to achieve or maintain reasonable functional ability in performing daily activities; OR cause an adverse reaction or cause physical or mental harm [chart notes are required] OR
• F. The generic equivalent is not in the best interest of the patient based on medical necessity [chart notes are required] OR
• G. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as the generic equivalent and that prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes are required] OR
• H. There is support for the use of the requested brand agent over the generic equivalent
• B. The patient has another FDA labeled diagnosis for the requested agent and route of administration OR
• C. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
• 2. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

BCBSIL/BCBSMT: 6 months; BCBSNM: 3 months; Others: toenail 3 months, fingernail 5 weeks, oral/esophageal candidiasis 6 weeks, all other indications 12 months