Sporanox (itraconazole) capsules — Blue Cross Blue Shield of Oklahoma

Preferred products

• itraconazole capsules (generic)

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, PAS staining, or PCR testing) AND (6) If the request is for a brand agent with an available generic equivalent, then ONE of the following: (A) The patient has tried and had an inadequate response to the generic equivalent OR (B) The generic equivalent was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event OR (C) The patient has an intolerance or hypersensitivity to the generic equivalent that is not expected to occur with the brand agent OR (D) The patient has an FDA labeled contraindication to the generic equivalent that is not expected to occur with the brand agent OR (E) The generic equivalent is expected to be ineffective based on known clinical characteristics of the patient or the drug; or cause a significant barrier to adherence; or worsen a comorbid condition; or decrease functional ability; or cause adverse reaction or harm OR (F) The generic equivalent is not in the best interest of the patient based on medical necessity OR (G) The patient has tried another prescription drug in the same pharmacologic class or mechanism of action as the generic equivalent and it was discontinued due to lack of efficacy or adverse event OR (H) There is support for the use of the requested brand agent over the generic equivalent; OR (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 The patient does NOT have any FDA labeled contraindications to the requested agent.
• Alternative approval for BCBS NM Fully Insured or NM HIM members: ALL of the following: (A) The patient does NOT have FDA labeled contraindications AND (B) The requested indication is a rare disease AND ONE of the following: (1) another FDA labeled indication OR (2) another indication supported in compendia OR two peer-reviewed clinical studies support use.
• Alternative approval for Ohio Fully Insured or HIM Shop (SG) members: ALL of the following: (A) Member resides in Ohio AND (B) Plan Fully Insured or HIM Shop (SG) AND (C) No FDA labeled contraindications AND ONE of the following: (1) another FDA labeled indication OR (2) another indication supported in compendia OR (3) two peer-reviewed clinical studies supporting proposed use as generally safe and effective.

Approval duration

BCBSIL and BCBSMT: 6 months; BCBSNM: 3 months; All other plans: 3 months (toenail), 5 weeks (fingernail), 6 weeks (candidiasis), other indications 12 months