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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

naftifine Naftin PA  

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.

  • Brand name topical antifungal products require PA.
  • Dermatophyte infections routinely affect otherwise healthy individuals. 
  • Immunocompromised patients are particularly susceptible to fungal infections.
  • Imidazoles 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

butenafine Mentax PA  

 Antifungal Agents: Topical – Imidazoles

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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

 Antifungal Agents: Topical – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

ciclopirox 0.77% cream, suspension Loprox # test  
ciclopirox 0.77% gel PA  
ciclopirox 1% shampoo Loprox PA  
ciclopirox 8% nail lacquer Penlac # test  
tavaborole Kerydin PA  
tolnaftate * test  

 Antifungal Agents: Topical – Polyenes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

nystatin / triamcinolone cream, ointment PA   - ≥ 17 years
nystatin cream, ointment, powder test  
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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Cutaneous/mucocutaneous infections due to Candida albicans – nystatin/triamcinolone
  • Diaper dermatitis complicated by candidiasis – miconazole/zinc oxide ointment
  • Onychomycosis – Jublia and Kerydin
  • 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.
  • 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 and shampoo, Ertaczo, Exelderm, ketoconazole foam, luliconazole, Mentax, naftifine, oxiconazole

  • 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 clinically appropriate generic topical antifungals available without PA; or
      • contraindication to all clinically appropriate agents available without PA.

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

SmartPA: Claims for ciclopirox gel and shampoo, Ertaczo, Exelderm, ketoconazole foam, luliconazole, Mentax, naftifine, and oxiconazole will usually process at the pharmacy without a prior authorization request if the member has a history of paid MassHealth pharmacy claims for two different generic topical antifungals available without PA within the most recent 90 days.

  

clotrimazole/betamethasone lotion, nystatin/triamcinolone cream and ointment (members ≥ 17 years)

  • 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 and nystatin/triamcinolone cream and ointment 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.

 

fluconazole powder, miconazole nitrate powder

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

 

Jublia, Kerydin

  • 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 Kerydin, medical records documenting inadequate response to 48 weeks of therapy, adverse reaction, or contraindication to Jublia.  

 

miconazole/zinc oxide ointment

  • Documentation of all of the following is required.
    • appropriate diagnosis; and
    • inadequate response, adverse drug reaction, or contraindication to two of the following less-costly topical antifungal agents:
      • clotrimazole
      • ketoconazole
      • miconazole
      • nystatin.

 

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: 08/2019


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Last updated 11/18/19