CurrentCignaPolicy N/A

Topical Antifungals Drug Quantity Management Policy - Per Days

Defines quantity limits (retail per 28 days and home delivery per 84 days), approved indications/dosing, and rationale for quantity management for a range of topical antifungal products covered by Cigna. Applies to utilization review and coverage determinations for topical antifungals to prevent stockpiling/misuse and to allow additional quantities via coverage review when treatment area/duration exceed default limits.

Policy Summary

PayerCigna

PolicyTopical Antifungals Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeAdministrative and product-specific edits; one past material quantity update noted

Effective Date

Next Review Date

Key ActionIf patient requires treatment for larger surface area or longer duration than default quantity limits, submit a coverage review/one-time override with product, indication, and justification matching the product-specific criteria.

POLICY UPDATE CHANGES

Annual revision noted 'No criteria changes' for most updates.

Clotrimazole 1% cream one-time override quantities were updated previously from 45 g/90 g to 90 g/180 g.

Naftin 2% cream reference to brand removed (generic only); Vusion ointment generics added.

~9% BSADefault treatment area covered

14 daysDefault treatment duration (BID)

28/84 daysQuantity timeframes

Coverage Summary & Scope

Scope: This policy defines product-specific quantity limits for topical antifungals with retail limits per 28 days and home delivery limits per 84 days, lists approved indications and dosing drawn from product labeling, and explains the rationale for quantity management to prevent stockpiling/misuse. It applies to utilization review and coverage determinations for topical antifungals and allows additional quantities through a one-time override (coverage review) when treatment area or duration exceed default limits.

Key thresholds/points: Standard quantity coverage is sufficient to treat ~9% BSA applied up to BID for 14 days (≈63 g); a clotrimazole 1% cream exception uses ~7% BSA coverage and allows overrides at 90 g/28 days retail or 180 g/84 days home delivery; general override eligibility is for patients with > 9% BSA (or > 7% for clotrimazole 1% cream) or treatment duration > 14 days and a listed product-specific indication.

Quantity Management — General Criteria

General Policy Statement

Coverage when Drug Quantity Management rule met at point of sale; if not met, coverage determined by criteria below:

ALL of the following

Drug Quantity Management program prevents stockpiling, misuse and/or overuse of topical antifungals
If quantity limit rule is not met at point of service, coverage will be determined by the Criteria (coverage review) and approvals are provided for the duration noted

Quantity limit rationale

Quantity limits set to cover approximately 9% BSA applied BID for 14 days (exceptions noted):

ANY of the following

Standard quantity limits allow treatment of ~9% BSA applied up to BID for 14 days (1 g covers ~4% BSA; 63 g sufficient to apply to 9% BSA BID for 14 days)
Prescription clotrimazole 1% cream quantity limit sufficient to treat ~7% BSA when applied up to BID for 14 days (3.2 g/day)

General Quantity Limit Override Criteria

Per product: approve a one-time override of specified quantity per 28 days at retail or specified quantity per 84 days at home delivery when ALL of the following are met:

ALL of the following

Patient needs to treat greater than 9% body surface area or requires treatment for longer than 14 days> 9% for most products; > 7% for clotrimazole 1% cream; > 14 days
Patient meets one of the product-specific indication criteria listed below (product-specific OR lists)

Product-specific Quantity Overrides

Products, Packaging & Quantity Limits (by product)

Products and availability listed (by active ingredient / brand)mixed

butenafine HCl 1% cream	Mentax (Mylan) - availability 15 g and 30 g tubes; retail max 30 g/28 days; home delivery max 90 g/84 days; FDA dosing QD for 2 weeks for tinea (pityriasis) versicolor
ciclopirox olamine 0.77% cream	Loprox (Medimetriks) - availability 90 g tube; retail max 90 g/28 days; home delivery max 270 g/84 days; FDA indications include tinea pedis/cruris/corporis, cutaneous candidiasis, tinea (pityriasis) versicolor; dosing BID
ciclopirox 0.77% gel	Generic - multiple tube sizes (30/45/100/300 g); retail/home limits correspond to listed package sizes; dosing BID for dermotophyte infections and seborrheic dermatitis (4 weeks)
ciclopirox 1% shampoo	Loprox - 120 mL bottle; retail max 120 mL/28 days; home delivery max 360 mL/84 days; dosing twice per week for 4 weeks for seborrheic dermatitis
ciclopirox olamine 0.77% suspension	Loprox suspension/kit - 30 mL, 60 mL, 180 mL bottle sizing; retail/home limits provided per package; dosing BID
clotrimazole 1% solution	Generic - 10/30/60/180 mL bottles; dosing BID or as indicated; retail/home limits per size with override option 120 mL/28 days retail or 360 mL/84 days home delivery for larger BSA/longer duration
clotrimazole 1% cream	Generic - 15 g and 30 g tubes; retail max 45 g/28 days (quantity limit) with one-time override of 90 g/28 days retail or 180 g/84 days home delivery if treating >7% BSA or >14 days; dosing BID
clotrimazole 1%/betamethasone 0.05% cream	Generic - 15 g tube common; retail quantity guidance and one-time override up to 180 g/28 days retail (90 g noted as packaged) /540 g/84 days home delivery for specified indications; dosing: tinea corporis/cruris BID for 1 week (do not use >2 weeks), tinea pedis BID for 2 weeks (do not use >4 weeks); label limits not to exceed 45 g/week
clotrimazole 1%/betamethasone 0.05% lotion	Generic - 30/60/180 mL bottles; dosing BID; amounts >45 mL/week should not be used; one-time override options specified per product
econazole nitrate 1% cream	Generic - 15/30/85 g tubes and larger; retail max 85 g/28 days with home delivery max 255 g/84 days; dosing QD or BID depending on indication (tinea pedis may require 1 month)

1–10 of 21

1/3

Provider Actions & Prior Authorization

Prior Authorization

Coverage review for additional quantities

If patient requires treatment for larger surface area or longer duration than the default quantity limits, submit a coverage review request that specifies the topical product, the clinical indication, and justification that the patient needs treatment for greater than 9% body surface area (or greater than 7% BSA for clotrimazole 1% cream) or for longer than 14 days. Requests must include the product name, the indication being treated, and a clinical rationale for the excess quantity.

Specify product
Specify clinical indication
Provide justification for >9% BSA (or >7% BSA for clotrimazole 1% cream) or >14 days

Prior Authorization

One-time override approval required for excess quantity

Background & Definitions

Background: Topical antifungals are used for superficial fungal infections including tinea (dermatophyte infections), cutaneous candidiasis, diaper dermatitis complicated by candidiasis, and seborrheic dermatitis. Typical administration frequency is QD to BID, and initial treatment duration is commonly about 2 weeks, though duration varies by condition and product (some indications recommend up to 4–6 weeks).

Clinical Evidence & Rationale

Clinical rationale: The Drug Quantity Management program is intended to prevent stockpiling, misuse, and overuse of topical antifungals; quantity limits were chosen to approximately cover an expected treatment area and duration (namely ~9% BSA BID for 14 days). The brief contains no trial or evidence study entries (evidence list is empty); product dosing and duration guidance used to determine quantities is taken from FDA-approved labeling as summarized in the policy's code table and references.

Revision History

09/25/2024annual_revisionLatest

Annual revision noted No criteria changes

prior_revisionmaterial_change

Clotrimazole 1% cream one-time override quantities updated from 45 g/90 g to 90 g/180 g (retail/home delivery)

prior_revisionadministrative_update

Naftin 2% cream brand reference removed (generic only); Vusion ointment generics added