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Table 10: Dermatologic Agents - Acne and Rosacea


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Drug Category: Dermatological Agents

Medication Class/Individual Agents: Anti-acne and Rosacea Agents

I. Prior-Authorization Requirements

 Dermatologic Agents: Acne and Rosacea – Agents Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

azelaic acid foam Finacea PA  

Prior Authorizations:

  • Brand name, combination topical acne products, and convenience delivery systems (e.g., foams, kits, pads, pledgets) require prior authorization.
  • Prior authorization is also required for generic topical acne products for members 22 years of age.

 

Azelaic Acid Products:

  • Exhibits antimicrobial activity and has comedolytic properties
 
azelaic acid gel Finacea PA   BP
brimonidine topical gel, 0.33% Mirvaso PA  
dapsone 5% gel Aczone PA  
dapsone 7.5% gel Aczone PA   BP
ivermectin cream Soolantra PA  
oxymetazoline cream Rhofade PA  

 Dermatologic Agents: Acne and Rosacea – Antibiotics (Topical)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

clindamycin foam Evoclin PA  

Prior Authorizations:

  • Brand name, combination topical acne products, and convenience delivery systems (e.g., foams, kits, pads, pledgets) require prior authorization.
  • Prior authorization is also required for generic topical acne products for members 22 years of age.

 

Topical Antibiotics:

  • Used in moderate-severe acne (Types 2 and 3) as part of a combination therapy.
  • Also possesses anti-inflammatory activity.
  • Long-term use is discouraged due to increased emergence of P. acnes resistance.
  • Combination therapy with another topical medication decreases resistance emergence.
  • Metronidazole is approved for rosacea only.
  • Sulfacetamide products are used for mild inflammatory acne. These products are contraindicated in sulfonamide allergic patients.
 
clindamycin gel, lotion, solution Cleocin T PA   - ≥ 22 years #
clindamycin gel-Clindagel Clindagel PA  
clindamycin pledgets Cleocin T PA  
erythromycin / ethanol pads, pledgets PA  
erythromycin gel Erygel PA   - ≥ 22 years #
erythromycin solution PA   - ≥ 22 years
metronidazole 0.75% cream Metrocream test   #
metronidazole 0.75% gel test  
metronidazole 1% cream Noritate PA  
metronidazole 1% gel Metrogel PA  
metronidazole lotion Metrolotion test   #
minocycline foam Amzeeq PA  
sulfacetamide Klaron PA   - ≥ 22 years #

 Dermatologic Agents: Acne and Rosacea – Benzoyl Peroxide Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

benzoyl peroxide PA   - ≥ 22 years *

Prior Authorizations:

  • Brand name, combination topical acne products, and convenience delivery systems (e.g., foams, kits, pads, pledgets) require prior authorization.
  • Prior authorization is also required for generic topical acne products for members 22 years of age.

 

Benzoyl Peroxide Products:

  • Often used alone for noninflammatory, mainly comedonal acne (Type 1).
  • Used as an adjunctive therapy for mild-moderate inflammatory acne (Type 2) with a retinoid.
  • Part of a three-drug regimen (plus retinoid and topical antibiotic) for moderate-severe acne (Type 3).
  • Demonstrates antibacterial activity and some comedolytic activity.
  • A trial of two to three months is usually required to establish efficacy or treatment failure of any topical product.
  • High incidence of local irritation is evident with most topical treatments.
 
benzoyl peroxide 7% microspheres Benzepro PA  
benzoyl peroxide 9.8% foam PA  
benzoyl peroxide foaming cloth Benzepro PA  

 Dermatologic Agents: Acne and Rosacea – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

adapalene / benzoyl peroxide Epiduo PA  

Prior Authorizations:

  • Brand name, combination topical acne products, and convenience delivery systems (e.g., foams, kits, pads, pledgets) require prior authorization.
  • Prior authorization is also required for generic topical acne products for members 22 years of age.
 
benzoyl peroxide / erythromycin Benzamycin PA  
clindamycin / benzoyl peroxide-Acanya Acanya PA  
clindamycin / benzoyl peroxide-Benzaclin Benzaclin PA  
clindamycin / benzoyl peroxide-Duac Duac PA  
clindamycin / benzoyl peroxide-Onexton Onexton PA  
clindamycin / tretinoin-Veltin Veltin PA  
clindamycin / tretinoin-Ziana Ziana PA  

 Dermatologic Agents: Acne and Rosacea – Retinoids (Oral)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

acitretin Soriatane test   #

Contraindicated in Pregnancy:

  • Isotretinoin and acitretin
  • Isotretinoin – prescribers must comply with the manufacturer's iPLEDGE program (see manufacturer's product information for full details)

 

Retinoids and Photosensitivity Reactions:

  • Minimize exposure to ultraviolet light or sunlight. Quinolones, sulfonamides, thiazide diuretics, and phenothiazines are some other drugs which may also increase sensitivity to the sun.
 
isotretinoin PA   - ≥ 22 years
isotretinoin micronized Absorica LD PA  
isotretinoin-Absorica Absorica PA  

 Dermatologic Agents: Acne and Rosacea – Retinoids (Topical)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

adapalene Differin PA   BP

Prior Authorizations:

  • Brand name, combination topical acne products, and convenience delivery systems (e.g., foams, kits, pads, pledgets) require prior authorization.
  • Prior authorization is also required for generic topical acne products for members 22 years of age.

 

Contraindicated in Pregnancy:

  • Tazarotene

 

Retinoids and Photosensitivity Reactions:

  • Minimize exposure to ultraviolet light or sunlight. Quinolones, sulfonamides, thiazide diuretics, and phenothiazines are some other drugs which may also increase sensitivity to the sun.
 
alitretinoin Panretin PA  
tazarotene cream, gel Tazorac PA  
tazarotene foam Fabior PA  
tazarotene lotion Arazlo PA  
tretinoin 0.05% gel Atralin PA  
tretinoin 0.05% lotion Altreno PA  
tretinoin microspheres Retin-A Micro PA  
tretinoin-Avita Avita PA   - ≥ 22 years #
tretinoin-Retin-A Retin-A PA   - ≥ 22 years BP
trifarotene Aklief PA  

 Dermatologic Agents: Acne and Rosacea – Salicylic Acid Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

salicylic acid test   o

Salicylic acid products:

  • Topical salicylic acid products may be used for the treatment of acne vulgaris, psoriasis, removal of warts, or other hyperkeratotic skin disorders.
 
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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 
o Prior-authorization status depends on the drug's formulation.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Acne vulgaris – adapalene, Aklief, Altreno, Amzeeq, Arazlo, Avita, benzoyl peroxide, clindamycin, dapsone, erythromycin, Fabior, sulfacetamide, salicylic acid, tazarotene cream and gel, tretinoin, tretinoin 0.05% gel, tretinoin microspheres
  • AIDS-related Kaposi's sarcoma (cutaneous lesions) – Panretin
  • Nodulocystic acne (severe), recalcitrant – Absorica, Absorica LD, isotretinoin
  • Psoriasis – acitretin, tazarotene cream and gel, salicylic acid
  • Rosacea – azelaic acid gel, Finacea foam, metronidazole, Mirvaso, Rhofade, Soolantra, tazorotene gel

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).

  

Absorica and Absorica LD for all ages, and oral retinoids (isotretinoin) for members  22 years of age

  • Documentation of all of the following is required:                 
    • appropriate diagnosis (e.g., acne grade II or greater); and
    • inadequate response, adverse reaction, or contraindication to a topical retinoid used in combination with benzoyl peroxide and topical/oral antibiotics; and
    • if the request is for Absorica or Absorica LD, medical records documenting an inadequate response or adverse reaction to an oral isotretinoin agent that does not require PA for members < 22 years of age; and
    • if the request is for Absorica LD, medical records documenting an inadequate response or adverse reaction to Absorica.

 

adapalene, Aklief, Altreno, tretinoin 0.05% gel, and tretinoin microspheres

  • Documentation of all of the following is required for a diagnosis of acne:
    • appropriate diagnosis (e.g., acne grade II or greater); and
    • medical records documenting an adverse reaction or inadequate response to a topical tretinoin agent.

 

adapalene, Altreno, tretinoin 0.05% gel, and tretinoin microspheres

  • Documentation of all of the following is required for a diagnosis of rosacea:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to all of the following:
      • benzoyl peroxide with a concurrent topical antibiotic; and
      • topical metronidazole.

  

Amzeeq

  • Documentation of all of the following is required:                 
    • diagnosis of acne (grade II or greater); and
    • medical records documenting inadequate response, adverse reaction, or contraindication to a benzoyl peroxide agent used in combination with a topical antibiotic agent; and
    • medical records documenting inadequate response or adverse reaction to one or contraindication to all other FDA-approved alternatives - oral tetracycline (i.e., tetracycline, doxycycline, minocycline), sulfacetamide 10% lotion, topical adapalene, topical azelaic acid, topical tretinoin.

 

Arazlo

  • Documentation of all of the following is required for a diagnosis of acne:
    • appropriate diagnosis (e.g., acne grade II or greater); and
    • medical records documenting an inadequate response or adverse reaction to a topical tretinoin agent; and
    • medical records documenting inadequate response or an adverse reaction to a topical tazarotene agent.

 

azelaic acid gel

  • Documentation of all of the following is required for a diagnosis of acne:
    • appropriate diagnosis (e.g., acne grade II or greater); and
    • inadequate response, adverse reaction, or contraindication to benzoyl peroxide with a concurrent topical antibiotic.

 

  • Documentation of all of the following is required for a diagnosis of rosacea:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to topical metronidazole; and

 

  • Documentation of all of the following is required for a diagnosis of keratosis pilaris:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to three of the following:
      • benzoyl peroxide; or
      • salicylic acid; or
      • lactic acid; or
      • urea; or
      • topical retinoid.

  

Brand-name benzoyl peroxide and clindamycin products, and clindamycin gel (generic Clindagel)

  • Documentation of all of the following is required:                
    • appropriate diagnosis (e.g., acne grade II or greater, rosacea); and           
    • medical records documenting an inadequate response or adverse reaction to at least two clinically appropriate generic products with the same active ingredient.

  

Combination products

  • Documentation of all of the following is required:                
    • appropriate diagnosis (e.g., acne grade II or greater, rosacea); and              
    • compelling clinical rationale that the combination product would offer a therapeutic advantage over the commercially available separate agents.

 

dapsone gel

  • Documentation of all of the following is required for a diagnosis of acne:
    • appropriate diagnosis (e.g., acne grade II or greater); and
    • inadequate response, adverse reaction, or contraindication to benzoyl peroxide with a concurrent topical antibiotic.

 

  • Documentation of all of the following is required for a diagnosis of keratosis pilaris:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to three of the following:
      • benzoyl peroxide; or
      • salicylic acid; or
      • lactic acid; or
      • urea; or
      • topical retinoid.

 

Generic benzoyl peroxide agents (excludes branded agents, unique dosage forms, and combination agents) for members ≥ 22 years of age

  • Documentation of the following is required:
    • appropriate diagnosis (e.g., acne grade II or greater, rosacea).

  

Generic topical antibiotic agents (excludes branded agents, unique dosage forms, and combination agents) for members ≥ 22 years of age

  • Documentation of the following is required:
    • appropriate diagnosis (e.g., acne grade II or greater, rosacea, folliculitis, pseudofolliculitis, chemotherapy- or radiation-induced rash/topical wound care, hidradenitis suppurativa).

  

Generic single-entity sulfacetamide agents for members ≥ 22 years of age

  • Documentation of the following is required:
    • appropriate diagnosis (e.g., acne grade II or greater, rosacea).

  

Generic topical retinoids (excludes adapalene, Aklief, Altreno, tretinoin 0.05% gel, and tretinoin microspheres) for members ≥ 22 years of age

  • Documentation of the following is required for a diagnosis of acne:
    • appropriate diagnosis (e.g., acne grade II or greater).

 

  • Documentation of all of the following is required for a diagnosis of rosacea:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to all of the following:
      • benzoyl peroxide with a concurrent topical antibiotic; and
      • topical metronidazole.

  

ivermectin cream

  • Documentation of all of the following is required:
    • appropriate diagnosis (e.g., rosacea); and 
    • inadequate response, adverse reaction, or contraindication to a topical metronidazole agent.

 

metronidazole 1% gel and Noritate

  • Documentation of the following is required:
    • medical records documenting inadequate response to one metronidazole 0.75% agent.

   

Mirvaso

  • Documentation of all of the following is required:
    • appropriate diagnosis (e.g., rosacea); and 
    • inadequate response, adverse reaction, or contraindication to one topical metronidazole agent and azelaic acid agent.

  

Panretin

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • lesions are not responding to systemic antiretroviral therapy; and
    • local radiation therapy and chemotherapy are not appropriate treatment options.

  

Rhofade

  • Documentation of all of the following is required:
    • appropriate diagnosis (e.g., rosacea); and 
    • inadequate response, adverse reaction, or contraindication to all of the following:
      • topical metronidazole; and
      • azelaic acid; and
      • topical brimonidine.

 

tazarotene cream, gel

  • Documentation of all of the following is required for a diagnosis of acne:
    • appropriate diagnosis (e.g., acne grade II or greater); and
    • medical records documenting an inadequate response or adverse reaction to a topical tretinoin agent.

 

  • Documentation of all of the following is required for a diagnosis of psoriasis:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to a topical corticosteroid agent.

 

  • Documentation of all of the following is required for a diagnosis of rosacea:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to all of the following:
      • benzoyl peroxide with a concurrent topical antibiotic; and
      • topical metronidazole.

 

Unique dosage forms (i.e., foams, kits, pads, pledgets)

  • Documentation of all of the following is required:
    • appropriate diagnosis (e.g., acne grade II or greater, rosacea); and
    • medical records documenting an inadequate response or adverse reaction to at least two clinically appropriate products with the same active ingredient; and
    • medical necessity for the requested dosage form.


Original Effective Date: 09/2005

Last Revised Date: 08/2020


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Last updated 08/13/20

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