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Table 28: Antifungal Agents - Topical


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Drug Category: Dermatological

Medication Class/Individual Agents: Antifungal

I. Prior-Authorization Requirements

 Antifungal Agents: Topical – Allymines

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

naftifine Naftin PA   A90

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • Dermatophyte infections routinely affect otherwise healthy individuals. 
  • Immunocompromised members are particularly susceptible to fungal infections.
  • Topical antifungals are considered first-line therapy for most dermatophyte infections.
  • Products are usually applied once or twice daily for two to four weeks (depending on the location).
  • Combination products may prolong treatment and delay disease resolution.
  • Onychomycosis requires 48 weeks of topical ciclopirox treatment.
  • Ciclopirox nail lacquer demonstrates a minimally better cure rate versus placebo.
 

 Antifungal Agents: Topical – Benzylamine

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

butenafine Mentax test  

 Antifungal Agents: Topical – Imidazoles

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

clotrimazole test   *, A90
clotrimazole / betamethasone cream test   A90
clotrimazole / betamethasone lotion PA   A90
econazole 1% cream test   A90
efinaconazole Jublia PA   BP
fluconazole powder PA  
ketoconazole cream, shampoo test   A90
ketoconazole foam Extina PA   A90
luliconazole Luzu PA   BP
miconazole test   *, A90
miconazole / zinc oxide ointment Vusion test   BP, A90
miconazole nitrate powder PA  
oxiconazole cream Oxistat PA   BP, A90
oxiconazole lotion Oxistat PA  
sertaconazole Ertaczo test  
sulconazole Exelderm PA   BP, A90

 Antifungal Agents: Topical – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

ciclopirox 0.77% cream Loprox test   # , A90
ciclopirox 0.77% gel, suspension Loprox PA   A90
ciclopirox 1% shampoo Loprox PA   A90
ciclopirox 8% nail lacquer test   A90
ciclopirox powder PA  
griseofulvin powder PA  
itraconazole powder PA  
tavaborole Kerydin PA   A90
terbinafine powder PA  
tolnaftate test   *, A90

 Antifungal Agents: Topical – Polyenes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

nystatin / triamcinolone cream, ointment test   A90
nystatin cream, ointment, 100,000 powder test   A90
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Onychomycosis – Jublia and tavaborole
  • Seborrheic dermatitis – ciclopirox and ketoconazole
  • Superficial tinea or candida (fungal) infections
  • Vulvovaginal candidiasis – vaginal formulations only

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis (see below).

 

ciclopirox gel

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response (within the last 90 days) or adverse reaction to two different topical antifungals that do not require PA; or
      • contraindication to all topical antifungals that do not require PA; and
    • inadequate response (within the last 90 days), adverse reaction, or contraindication to ciclopirox cream.

Please note: Unless a contraindication to all medications available without PA exists, two agents must be tried.

SmartPA: Claims for ciclopirox gel will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for two different topical antifungals that do not require PA and ciclopirox cream within the most recent 90 days.

 

ciclopirox shampoo, ketoconazole foam, luliconazole, naftifine, oxiconazole, sulconazole

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response (within the last 90 days) or adverse reaction to two different topical antifungals that do not require PA; or
      • contraindication to all topical antifungals that do not require PA.

Please note: Unless a contraindication to all medications available without PA exists, two agents must be tried.

SmartPA: Claims for ciclopirox shampoo, ketoconazole foam, luliconazole, naftifine, oxiconazole, and sulconazole will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for two different topical antifungals that do not require PA within the most recent 90 days.

 

ciclopirox suspension

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response (within the last 90 days), adverse reaction, or contraindication to ciclopirox cream.

SmartPA: Claims for ciclopirox suspension will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for ciclopirox cream within the most recent 90 days.

 

ciclopirox powder, fluconazole powder, griseofulvin powder, itraconazole powder, miconazole nitrate powder, terbinafine powder

  • Documentation of the following is required:                              
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives cannot be used.

 

clotrimazole/betamethasone lotion

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response (within the last 90 days), adverse reaction or contraindication to clotrimazole/betamethasone cream.

SmartPA: Claims for clotrimazole/betamethasone lotion will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for clotrimazole/betamethasone cream within the most recent 90 days.

 

Jublia, tavaborole

  • Documentation of the following is required:                              
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response or adverse reaction to terbinafine oral tablets; or
      • medical necessity for topical formulation and inadequate response to 24 consecutive weeks of therapy or adverse reaction to ciclopirox nail solution; or
      • contraindication to terbinafine oral tablets and ciclopirox nail solution; and
    • if the request is for tavaborole, medical records documenting inadequate response to 48 weeks of therapy, adverse reaction, or contraindication to Jublia.  

 

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 01/2005

Last Revised Date: 09/2022


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Last updated 09/19/22

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