FDA-approved, for example: 

• Actinic keratosis (Ameluz, imiquimod  3.75% cream, Levulan, Zyclara)
• External genital/perianal warts (imiquimod 3.75% cream, Veregen)
• Hyperhydrosis (Drysol)
• Moderate-to-severe pruritus (doxepin cream)
• Molluscum contagiosum (Ycanth)
• Primary axillary hyperhidrosis (Sofdra, Qbrexza)

non-FDA-approved, for example: 

• Craniofacial hyperhidrosis (Sofdra, Qbrexza)
• Palmar or plantar hyperhidrosis (Sofdra, Qbrexza)

Note: The above lists may not include all FDA-approved and non-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.

Ameluz and Levulan

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a dermatologist or consult notes from a dermatologist are provided; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: topical fluorouracil, topical imiquimod, cryosurgery; and
  • requested agent will be used in conjunction with photodynamic therapy; and
  • for Ameluz, inadequate response, adverse reaction, or contraindication to Levulan used in conjunction with photodynamic therapy.
• For recertification, medical necessity for use beyond 12 weeks. 

doxepin cream

• Documentation of all of the following is required:
  • diagnosis of moderate-to-severe pruritus; and
  • member is ≥ 18 years of age; and
  • inadequate response or adverse reaction to three or contraindication to all of the following: capsaicin cream, lidocaine patch, one potent or superpotent topical corticosteroid, systemic therapy (antihistamines, SSRIs, SNRIs, anticonvulsants), topical calcineurin inhibitor (tacrolimus, pimecrolimus); and
  • one of the following:
    • requested quantity is ≤ 45 grams/30 days; or
    • all of the following:
      • requested quantity is > 45 grams/30 days; and
      • adverse reaction or inadequate response to one systemic therapy; and
      • medical necessity for exceeding the quantity limit.

Drysol

• Documentation of all of the following is required:
  • diagnosis of hyperhidrosis; and
  • inadequate response, adverse reaction, or contraindication to an OTC antiperspirant.

imiquimod 3.75% cream for External Genital/Perianal Warts

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

Sofdra

• Documentation of all of the following is required:
  • diagnosis of craniofacial hyperhidrosis, primary axillary hyperhidrosis, or palmar or plantar hyperhidrosis; and
  • member is ≥ nine years of age; and
  • inadequate response, adverse reaction, or contraindication to both of the following: aluminum chloride solution, Qbrexza; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to Botox; or
    • clinical rationale for use of the requested agent instead of Botox; and
  • one of the following:
    • requested quantity is ≤ 40.2 mL/30 days; or
    • medical necessity for exceeding the quantity limit.

Qbrexza

• Documentation of all of the following is required:
  • diagnosis of craniofacial hyperhidrosis, primary axillary hyperhidrosis, or palmar or plantar hyperhidrosis; and
  • member is ≥ nine years of age; and
  • inadequate response, adverse reaction, or contraindication to aluminum chloride solution; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to Botox; or
    • clinical rationale for use of the requested agent instead of Botox; and
  • requested quantity is ≤ one unit/day.

Veregen for External Genital/Perianal Warts

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

 Ycanth

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following:
    • itching, pain, or bleeding associated with lesions; or
    • member is immunocompromised; or
    • concomitant bacterial infection; or
    • risk of spread to contacts (i.e., siblings, daycare); and
  • member is ≥ two years of age; and
  • prescriber is a dermatologist or consult notes from a dermatologist are provided; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: cryotherapy, curettage, podofilox; and
  • requested dose is ≤ eight applicators/12 weeks.