Table 10: Dermatologic Agents - Acne and Rosacea
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: Dermatological Agents
Medication Class/Individual Agents: Anti-acne and Rosacea Agents
I. Prior-Authorization Requirements
Dermatologic Agents: Acne and Rosacea – Agents Not Otherwise Classified |
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Dermatologic Agents: Acne and Rosacea – Antibiotics (Topical) |
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Dermatologic Agents: Acne and Rosacea – Benzoyl Peroxide Agents |
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Dermatologic Agents: Acne and Rosacea – Combination Products |
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Dermatologic Agents: Acne and Rosacea – Retinoids (Oral) |
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Dermatologic Agents: Acne and Rosacea – Retinoids (Topical) |
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Dermatologic Agents: Acne and Rosacea – Salicylic Acid Agents |
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# | 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
- Keratosis pilaris – azelaic acid, dapsone
- 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, tazarotene cream and foam, tretinoin, tretinoin 0.05% gel, tretinoin microspheres
- keratosis pilaris – adapalene 0.1% cream, tretinoin 0.05% cream
- perioral/periorificial dermatitis – erythromycin, metronidazole
Note: The above lists may not include all FDA-approved and non-FDA-approved indications.
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.
- 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.
- Documentation of the following is required for adapalene 0.1% cream for a diagnosis of keratosis pilaris:
- appropriate diagnosis.
Altreno for members ≥ 21 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, salicylic acid, urea, topical retinoid.
Brand-name benzoyl peroxide and clindamycin products
- Documentation of all of the following is required:
- appropriate diagnosis (e.g., acne grade II or greater, folliculitis/pseudofolliculitis, hidradenitis suppurativa, 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, hidradenitis suppurativa, 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, salicylic acid, urea, 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 ≥ 21 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 ≥ 21 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, or 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.
- Documentation of the following is required for tretinoin 0.05% cream for a diagnosis of keratosis pilaris:
- appropriate diagnosis.
isotretinoin for members ≥ 21 years of age (excludes generic Absorica and Absorica LD)
- Documentation of all of the following is required:
- appropriate diagnosis (e.g., treatment -resistant acne grade II or greater, unresponsive to conventional therapy); and
- inadequate response or adverse reaction to a topical retinoid used in combination with a topical/oral antibiotic with or without benzoyl peroxide.
isotretinoin (generic Absorica) and Absorica LD for all ages
- Documentation of all of the following is required:
- appropriate diagnosis (e.g., treatment-resistant acne grade II or greater, unresponsive to conventional therapy); and
- inadequate response or adverse reaction to a topical retinoid used in combination with a topical/oral antibiotic with or without benzoyl peroxide; and
- medical records documenting an inadequate response or adverse reaction to an oral isotretinoin agent available without PA for members < 21 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, azelaic acid, 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 Fabior and Finacea Foam)
- Documentation of all of the following is required:
- appropriate diagnosis (e.g., acne grade II or greater, cutaneous warts, folliculitis/pseudofolliculitis, hidradenitis suppurativa, keratosis pilaris, perioral/periorificial dermatitis, 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: 10/2024
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Last updated 11/19/24