FDA-approved, for example: 

• Actinic keratosis (diclofenac 3% gel, fluorouracil  0.5% cream, fluorouracil 5% cream, imiquimod  3.75% cream, imiquimod 5% cream, Picato, Tolak, Zyclara)
• Diabetic neuropathic ulcers in the lower extremities (Regranex)
• External genital/perianal warts (Condylox Gel, imiquimod 3.75% cream, imiquimod 5% cream, Veregen)
• Moderate-to-severe pruritus (doxepin cream)
• Primary axillary hyperhidrosis (Qbrexza)
• Superficial basal cell carcinoma (fluorouracil 5% cream, imiquimod 5% cream)

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.
• 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 the member’s condition and requested medication (see below).

Condylox Gel for External Genital Warts

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • an inadequate response or adverse reaction to podofilox solution; or
    • clinical rationale for use of the requested agent instead of podofilox solution.

Condylox Gel for Perianal Warts

• Documentation of the following is required:
  • appropriate diagnosis.

diclofenac 3% gel, Picato

• Documentation of all the following is required:
  • diagnosis of actinic keratosis; and
  • an inadequate response, adverse reaction, or contraindication to topical fluorouracil. 

doxepin cream

• Documentation of all of the following is required:
  • diagnosis of moderate-to-severe pruritus; and
  • member is ≥ 18 years of age; and
  • an inadequate response or adverse reaction to three of the following or contraindication to all of the following:
    • capsaicin cream; and
    • lidocaine patch; and
    • one potent or superpotent topical corticosteroid; and
    • systemic therapy (antihistamines, SSRIs, SNRIs, anticonvulsants); and
    • topical calcineurin inhibitor (tacrolimus, pimecrolimus); and
  • one of the following:
    • request is for ≤ 45 grams per month; or
    • all of the following:
      • request is for > 45 grams per month; and
      • an adverse reaction or inadequate response to at least one systemic therapy; and
      • medical necessity for exceeding quantity limits.

fluorouracil 0.5% cream for Actinic Keratosis

• Documentation of the following is required:
  • appropriate diagnosis.

fluorouracil 5% cream for Actinic Keratosis and Superficial Basal Cell Carcinoma

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • an inadequate response or adverse reaction to fluorouracil 5% solution; or
    • clinical rationale for use of the requested agent instead of fluorouracil solution.

imiquimod 3.75% cream for External Genital/Perianal Warts

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • an inadequate response or adverse reaction to imiquimod 5% cream; or
    • clinical rationale for use of imiquimod 3.75% instead of imiquimod 5%; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to topical podofilox; or
    • an inadequate response, adverse reaction, or contraindication to podophyllum resin applied by a provider.

imiquimod 3.75% cream and Zyclara for Actinic Keratosis

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • an inadequate response or adverse reaction to imiquimod 5% cream; or
    • clinical rationale for use of imiquimod 2.5% or 3.75% instead of imiquimod 5%; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to topical fluorouracil; or
    • clinical rationale for use of the requested agent instead of topical fluorouracil.

imiquimod 5% cream for Actinic Keratosis and Superficial Basal Cell Carcinoma

• Documentation of the following is required:
  • appropriate diagnosis.

imiquimod 5% cream, and Veregen for External Genital/Perianal Warts

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to topical podofilox; or
    • an inadequate response, adverse reaction, or contraindication to podophyllum resin applied by a provider. 

Qbrexza

• Documentation of all of the following is required:
  • diagnosis of primary axillary hyperhidrosis; and
  • member is ≥ nine years of age; and
  • prescriber is a dermatologist; and
  • an inadequate response, adverse reaction, or contraindication to aluminum chloride solution; and
  • request is within quantity limit of 30 units/30 days.

Regranex

• Documentation of all of the following is required:
  • diagnosis of diabetic neuropathic ulcers in the lower extremities; and
  • number and size of the ulcers for treatment; and
  • duration of treatment; and
  • ulcer extends to subcutaneous tissue or beyond; and
  • lower extremities have adequate blood supply; and
  • ulcer is clear of infection; and
  • member has had a minimum of two months of good wound care without adequate ulcer healing.

Tolak for Actinic Keratosis

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • an inadequate response or adverse reaction to fluorouracil 5% solution; or
    • clinical rationale for use of the requested agent instead of fluorouracil solution.