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Drug Category: Dermatologic Agents

Medication Class/Individual Agents: Topical Chemotherapy, Genital Wart Treatment, and Miscellaneous Dermatologic Agents

I. Prior-Authorization Requirements

 Dermatologic Agents – Actinic Keratosis

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

diclofenac 3% gel Solaraze PA  
fluorouracil 0.5% cream Carac PA  
fluorouracil 4% cream Tolak PA  
ingenol gel Picato 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.

  

Actinic keratosis:

  • Treatment includes destructive therapies, topical medications, and photodynamic therapy.
  •  

Basal Cell Carcinoma:

  • The NCCN guideline on Basal Cell and Squamous Cell Skin Cancers, recommends that in patients with low-risk, superficial basal cell skin cancer, where surgery or radiation is contraindicated or impractical, topical therapies such as fluorouracil, imiquimod, photodynamic therapy, or cryotherapy can be considered. The guideline does not specify any agent as preferred.1

Genital Warts:

  • Treatment involves one of three major approaches: chemical or physical destruction, immunologic therapy, or surgical excision.
  • The preferred approach depends upon the number and extent of the lesions.
  • In general, no one treatment appears to be significantly more efficacious versus another.

Moderate pruritus:

  • Doxepin cream is FDA-approved for the short-term (up to eight days) management of moderate pruritus in adults with atopic dermatitis or lichen simplex chronicus.

 

1NCCN Clinical Practice Guidelines in Oncology. Basal Cell Skin Cancer [guideline on the Internet]. 2017 Sept 18 [cited 2018 May 30]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/nmsc.pdf

 

 Dermatologic Agents – Actinic Keratosis and Genital Wart Therapy

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

imiquimod 2.5%, 3.75% cream Zyclara PA  

 Dermatologic Agents – Actinic Keratosis and Superficial Basal Cell Carcinoma

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

fluorouracil 5% cream Efudex BP PA  
fluorouracil solution test  

 Dermatologic Agents – Actinic Keratosis, Superficial Basal Cell Carcinoma and Genital Wart Therapy

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

imiquimod 5% cream Aldara PA  

 Dermatologic Agents – Genital Wart Treatment

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

podofilox gel Condylox Gel PA  
podofilox solution Condylox Solution # test  
sinecatechins Veregen PA  

 Dermatologic Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

becaplermin Regranex PA  
doxepin cream-Prudoxin Prudoxin PA  
doxepin cream-Zonalon Zonalon PA  
glycopyrronium cloth Qbrexza PA  
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.
 

II. Therapeutic Uses

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.

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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 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.


Original Effective Date: 05/2012

Last Revised Date: 08/2019


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Last updated 11/08/19