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Table 63: Dermatologic Agents - Topical Chemotherapy, Genital Wart Treatment, and Miscellaneous Dermatologic Agents


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


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

Drug
Notes

aminolevulinic acid Ameluz test   MB
diclofenac 3% gel test   A90
fluorouracil 0.5% cream Carac test   BP, A90

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

Drug
Notes

imiquimod 2.5%, 3.75% cream Zyclara PA   BP, A90

 Dermatologic Agents – Actinic Keratosis and Superficial Basal Cell Carcinoma

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

fluorouracil 5% cream Efudex test   BP, A90
fluorouracil solution test   A90

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

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

imiquimod 5% cream test   A90

 Dermatologic Agents – Genital Wart Treatment

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

podofilox Condylox test   # , A90
sinecatechins Veregen PA  

 Dermatologic Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

aluminum chloride Drysol PA  
cantharidin Ycanth PA   MB
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. PA 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.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 

II. Therapeutic Uses

FDA-approved, for example: 

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

non-FDA approved, for example: 

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

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

 

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.

    

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 both of the following: aluminum chloride solution, and 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 specialist 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.


Original Effective Date: 05/2012

Last Revised Date: 03/2024


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Last updated 04/01/24

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