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.

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 and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

ciclopirox gel

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response (within the last 90 days) or adverse reaction to two different topical antifungals or contraindication to all topical antifungals available without PA; and
  • inadequate response (within the last 90 days), adverse reaction, or contraindication to ciclopirox cream.

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 available without PA and ciclopirox cream within the last 90 days.^†

ciclopirox shampoo, ketoconazole foam, luliconazole, naftifine, oxiconazole

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response (within the last 90 days) or adverse reaction to two different topical antifungals or contraindication to all topical antifungals available without PA.

SmartPA: Claims for ciclopirox shampoo, ketoconazole foam, luliconazole, naftifine, and oxiconazole 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 available without PA within the last 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 last 90 days.^†

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 last 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
  • 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.