CurrentMass General Brigham Health PlanPolicy N/A

Acne and Rosacea topical medication step-therapy coverage

Defines prior-authorization and step-therapy requirements for topical medications used to treat acne vulgaris and rosacea for Mass General Brigham Health Plan Commercial/Exchange members (pharmacy benefit).

Policy Summary

PayerMass General Brigham Health Plan

PolicyAcne and Rosacea topical medication step-therapy coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionIf the prescription does not meet initial step therapy requirements at point of sale, submit a prior authorization request and document diagnosis and prior trials/adverse reactions as required by the specific agent criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2-tier2-tier formulary structure

12Initial approval / reauthorization duration

26Age threshold for PA on topical retinoids

Step-Therapy and Prior Authorization Criteria

Initial Step-Therapy Rules

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Approval criteria when prior authorization required for second-line agents

Approval of specific second-line topical agents will be granted when the following criteria are met:

Aczone 7.5% gel & dapsone 5% gel

ANY of the following
- Diagnosis: acne vulgaris
- Diagnosis: rosacea
Patient has documented inadequate response, side effect, or allergy to at least two (2) different generic topical anti-infective agents (used separately or together).
Examples of generic topical anti-infectives include clindamycin, erythromycin, benzoyl peroxide, sulfacetamide, sodium sulfacetamide/sulfur

Atralin, adapalene 0.3% gel, adapalene 0.1% cream, Differin 0.1% lotion, tretinoin microsphere 0.04%/0.1% gel

ANY of the following
- Diagnosis: ichthyosis
- Diagnosis: hyperkeratosis
- Diagnosis: acne vulgaris
- Diagnosis: rosacea
Patient has documented inadequate response, side effect, or allergy to a preferred generic tretinoin cream or gel OR Differin OTC 0.1% gel

Tazorac cream/gel 0.05%, Tazorac 0.1% gel, tazarotene 0.1% cream & Fabior foam

ANY of the following
- Diagnosis: plaque psoriasis
ALL of the following
- ANY of the following
  - Diagnosis: acne vulgaris
  - Diagnosis: rosacea
- Documented inadequate response, side effect, or allergy to preferred generic tretinoin cream/gel OR Differin OTC 0.1% gel

Azelaic acid 15% gel, metronidazole 1% and ivermectin 1%

Patient has a diagnosis of rosacea
Patient has documented inadequate response, side effect, or allergy to generic metronidazole 0.75% gel, lotion, or cream

Initial approvals and reauthorizations will be granted for 12 months. All topical retinoids require PA for members >= 26 years of age.

Formulary — Covered and Criteria-Based Topical Agents

Formulary - First-line topical agents (Acne vulgaris)mixedCovered

benzoyl peroxide (OTC/generic)	Topical anti-infective - first-line
clindamycin 1% (generic)	Topical anti-infective - first-line
erythromycin 2% (generic)	Topical anti-infective - first-line
sulfacetamide 10% & sulfur 5% (generic)	Topical anti-infective - first-line
sulfacetamide 10% (generic)	Topical anti-infective - first-line
tretinoin cream 0.05% & 0.1% (generic)	Topical retinoid - first-line
tretinoin gel 0.01%, 0.025% & 0.1% (generic)	Topical retinoid - first-line
Differin OTC (adapalene) 0.1% gel	Topical retinoid - first-line

Formulary - Second-line topical agents (Acne vulgaris)mixed

Aczone 7.5% gel (dapsone)	Topical anti-infective - second-line; PA if step not met
dapsone 5% gel	Topical anti-infective - second-line
Atralin (tretinoin) 0.05% gel	Topical retinoid - second-line
adapalene 0.3% gel (RX)	Topical retinoid - second-line
adapalene 0.1% cream (RX)	Topical retinoid - second-line
Differin 0.1% lotion	Topical retinoid - second-line
tretinoin microsphere 0.04%, 0.1% gel	Topical retinoid - second-line
Fabior (tazarotene) 0.1% aerosol foam	Topical retinoid - second-line
Tazorac (tazarotene) 0.05% & 0.1% gel/cream	Topical retinoid - second-line

Formulary - First-line topical agents (Acne/Rosacea)mixedCovered

metronidazole 0.75% (generic)

Topical agent for acne/rosacea - first-line (cream, gel, lotion)

Formulary - Second-line topical agents (Rosacea)mixed

metronidazole 1% gel	Second-line topical for rosacea; PA if step not met
Noritate (metronidazole) 1% cream	Second-line topical for rosacea
azelaic acid 15% gel	Second-line topical for rosacea
ivermectin (Soolantra) 1% cream	Second-line topical for rosacea

What Providers Must Do

Prior Authorization

Submit PA when step therapy criteria not met

If the prescription does not meet the initial step therapy requirements at the point of sale, submit a prior authorization request and include the patient diagnosis plus documentation of prior trials or adverse reactions as required by the specific agent criteria. Submit the PA at point of sale to avoid denial and ensure coverage consideration for second-line agents.

Documentation Required

Document prior treatment failures/allergies/side effects

For second-line agents, document an inadequate response, side effect, or allergy to the required first-line agents; include the specific agents tried and the dates of those trials as part of the prior authorization submission.

List which first-line agents were used (e.g., clindamycin, erythromycin, benzoyl peroxide, sulfacetamide, tretinoin, Differin OTC) and the dates of use or failure.
Document whether the issue was inadequate response, side effect, or allergy.

Prior Authorization

Topical retinoid PA for adults

All prescriptions for topical retinoids require prior authorization for members 26 years of age and older; submit a PA when the member is age 26 or older regardless of agent.

Age threshold for PA: members >= 26 years.

Numeric & Operational Thresholds

Policy thresholds

Step therapy lookback window180 days — member must have filled at least two different first-line medications OR a second-line medication within the past 180 days

Approval duration12 months — initial approvals and reauthorizations will be granted for 12 months

Age threshold for PA on topical retinoids>= 26 years — all prescriptions for topical retinoids require prior authorization for members 26 years of age and older

Clinical and Administrative Context

This policy uses step therapy to encourage use of preferred first-line topical therapies—including over-the-counter and generic agents—before coverage of higher-tier topical products. Prescriptions that meet the initial step therapy requirements will adjudicate automatically at the point of sale; if they do not, the claim will deny with instruction to submit a prior authorization (PA) request. First-line agents are covered without prior authorization, while specified second-line agents are subject to additional criteria or PA when step therapy requirements are not met.

Preferred first-line topical options for acne vulgaris include OTC and generic agents such as benzoyl peroxide, generic clindamycin 1%, generic erythromycin 2%, generic sulfacetamide 10% ± sulfur 5%, generic tretinoin cream (0.05% and 0.1%), generic tretinoin gel (0.01%, 0.025%, 0.1%), and Differin OTC (adapalene) 0.1% gel. For acne/rosacea, generic metronidazole 0.75% (cream, gel, lotion) is listed as first-line.

The policy lists specific second-line/non-preferred topical formulations that will require documentation of prior trials, intolerance, or allergy for approval if step therapy is not met. Examples include Aczone (dapsone) 7.5% gel, dapsone 5% gel, higher-strength or branded retinoids (e.g., Atralin, adapalene 0.3% gel, adapalene 0.1% cream, Differin 0.1% lotion, tretinoin microsphere formulations, Tazorac and Fabior), and for rosacea metronidazole 1% gel, Noritate 1% cream, azelaic acid 15% gel, and ivermectin (Soolantra) 1% cream. When the initial step therapy requirements are not met, approval of these second-line agents is granted only when the agent-specific criteria—such as documented inadequate response, side effect, or allergy to required first-line agents—are satisfied.

Defined Terms

Definitions

First-linePreferred agents that are covered without prior authorization (examples: generic topical anti-infectives such as benzoyl peroxide, clindamycin 1%, erythromycin 2%, sulfacetamide formulations; and topical retinoids like generic tretinoin and Differin OTC 0.1% gel)

Second-lineNon-preferred agents that require documented failure, intolerance, or allergy to first-line agents or meet other agent-specific criteria for approval (examples: Aczone/dapsone gels, prescription-strength retinoids such as adapalene 0.3% and tazarotene products)

Policy Dates

Policy status: CURRENT. Effective date: 2022-01-01. Last review date: 2021-11-17. Next review date: not specified.

There are no material changes recorded in the policy changes array for this version. Initial approvals and reauthorizations under this policy are granted for 12 months, and all topical retinoid prescriptions require prior authorization for members 26 years of age and older.