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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:

  • Select generic, select brand name, combination topical acne products, and convenience delivery systems (e.g., foams, kits, pads, pledgets) require prior authorization.

 

Azelaic Acid Products:

  • Exhibits antimicrobial activity and has comedolytic properties
 
azelaic acid gel Finacea PA   A90
brimonidine topical gel, 0.33% PA   A90
clascoterone Winlevi PA  
dapsone gel Aczone PA   A90
ivermectin cream PA   A90
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   A90

Prior Authorizations:

  • Select generic, select 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 sulfacetamide 10% lotion agents 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.
  • Sulfacetamide products are used for mild inflammatory acne. These products are contraindicated in sulfonamide allergic patients.
 
clindamycin gel, lotion, solution Cleocin T test   # , A90
clindamycin gel-Clindagel Clindagel PA  
clindamycin pledgets test   A90
erythromycin / ethanol pads, pledgets PA   A90
erythromycin gel Erygel test   # , A90
erythromycin solution test   A90
metronidazole 0.75% cream test   A90
metronidazole 0.75% gel test   A90
metronidazole 1% cream Noritate test  
metronidazole 1% gel PA   A90
metronidazole lotion PA   A90
sulfacetamide 10% lotion Klaron PA   - ≥ 22 years # , A90

 Dermatologic Agents: Acne and Rosacea – Benzoyl Peroxide Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

benzoyl peroxide test   *, A90

Prior Authorizations:

  • Select generic, select brand name, combination topical acne products, and convenience delivery systems (e.g., foams, kits, pads, pledgets) require prior authorization. 

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 9.8% foam PA   A90

 Dermatologic Agents: Acne and Rosacea – Combination Products

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

adapalene 0.1% / benzoyl peroxide 2.5% PA   A90

Prior Authorizations:

  • Select generic, select brand name, combination topical acne products, and convenience delivery systems (e.g., foams, kits, pads, pledgets) require prior authorization.
 
adapalene 0.3% / benzoyl peroxide 2.5% PA   A90
benzoyl peroxide / erythromycin Benzamycin PA   A90
clindamycin / benzoyl peroxide-Acanya Acanya PA   A90
clindamycin / benzoyl peroxide-Benzaclin Benzaclin PA   A90
clindamycin / benzoyl peroxide-Onexton Onexton PA   A90
clindamycin / tretinoin-Veltin Veltin PA   A90
clindamycin / tretinoin-Ziana Ziana PA   A90
clindamycin 1.2% / benzoyl peroxide 5% PA   A90

 Dermatologic Agents: Acne and Rosacea – Retinoids (Oral)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

acitretin test   A90

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 A90
isotretinoin micronized Absorica LD PA   A90
isotretinoin-Absorica Absorica PA   BP, A90

 Dermatologic Agents: Acne and Rosacea – Retinoids (Topical)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

adapalene PA   A90

Prior Authorizations:

  • Select generic, select 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 retinoid 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.
 
tazarotene 0.1% cream, gel PA   A90
tazarotene foam Fabior PA  
tazarotene lotion Arazlo PA  
tretinoin 0.05% gel Atralin PA   A90
tretinoin 0.05% lotion Altreno PA   - ≥ 22 years
tretinoin microspheres Retin-A Micro PA   A90
tretinoin-Avita Avita PA   - ≥ 22 years # , A90
tretinoin-Retin-A Retin-A PA   - ≥ 22 years BP, A90

 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, A90

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. 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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without PA.
 
o PA status depends on the drug's formulation.
 
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:

  • Acne vulgaris – adapalene, Altreno, Arazlo, Avita, benzoyl peroxide, clindamycin, dapsone, erythromycin, sulfacetamide, salicylic acid, tazarotene cream and foam, tretinoin, tretinoin 0.05% gel, tretinoin microspheres, Winlevi
  • Nodulocystic acne (severe), recalcitrant – Absorica LD, isotretinoin, isotretinoin (generic Absorica)
  • Psoriasis – acitretin, tazarotene cream, salicylic acid
  • Rosacea – azelaic acid gel, Finacea foam, ivermectin cream, metronidazole, brimonidine topical gel, Rhofade, tazarotene cream

Non-FDA-approved, for example:

  • cutaneous warts – adapalene, Altreno, Arazlo, tazarotene cream and foam, tretinoin, tretinoin 0.05% gel, tretinoin microspheres
  • folliculitis/pseudofolliculitis – adapalene, Altreno, Arazlo, benzoyl peroxide, clindamycin, erythromycin, tazarotene cream and foam, tretinoin, tretinoin 0.05% gel, tretinoin microspheres
  • perioral/periorificial dermatitis – metronidazole

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.

  

adapalene, tretinoin 0.05% gel, and tretinoin microspheres

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

 

adapalene, 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.

 

Altreno for members ≥ 22 years of age

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

 

  • 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.
    

Arazlo

  • Documentation of all of the following is required for a diagnosis of acne, cutaneous warts, folliculitis/pseudofolliculitis:
    • appropriate diagnosis (e.g., acne grade II or greater, cutaneous warts, folliculitis/pseudofolliculitis); and
    • medical records documenting 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, cutaneous warts, folliculitis/pseudofolliculitis:
    • 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.

 

  • Documentation of all of the following is required for a diagnosis of keratosis pilaris:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two or contraindication to all of the following:
      • benzoyl peroxide; or
      • salicylic 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, folliculitis/pseudofolliculitis, rosacea); and           
    • medical records documenting an inadequate response or adverse reaction to at least two clinically appropriate generic products with the same active ingredient.
  

brimonidine topical gel, 0.33%

  • 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.

 

Combination products

  • Documentation of all of the following is required:                
    • appropriate diagnosis (e.g., acne grade II or greater, folliculitis/pseudofolliculitis, rosacea); and              
    • medical necessity for the combination product instead of 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
    • 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.

 

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

    

Fabior

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


Finacea 15 % foam

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

 

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, 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 the following is required for a diagnosis of cutaneous warts, folliculitis/pseudofolliculitis:
    • appropriate diagnosis.

 

  • 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.
   

isotretinoin for members  22 years of age (excludes generic Absorica and Absorica LD)

  • 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.
   

isotretinoin (generic Absorica) and Absorica LD for all ages

  • 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
    • medical records documenting an inadequate response or adverse reaction to an oral isotretinoin agent available without PA for members < 22 years of age; and
    • for Absorica LD, medical records documenting an inadequate response or adverse reaction to isotretinoin (generic Absorica).
   

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 0.75% lotion and metronidazole 1% gel

  • Documentation of the following is required for a diagnosis of perioral/periorificial dermatitis, rosacea:
    • appropriate diagnosis; and
    • medical records documenting inadequate response to one of the following: metronidazole 0.75% gel or metronidazole 0.75% cream.
    

 

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, cutaneous warts, folliculitis/pseudofolliculitis:
    • appropriate diagnosis (e.g., acne grade II or greater, cutaneous warts, folliculitis/pseudofolliculitis); 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 formulations (i.e., foams, kits, pads, pledgets, excludes clindamycin 1 % pledgets)

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

 

Winlevi

  • Documentation of all of the following is required:
    • appropriate diagnosis (e.g., 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.


Original Effective Date: 09/2005

Last Revised Date: 03/2024


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Last updated 05/16/24

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