CurrentConnectiCarePolicy C15974-A

Seysara (sarecycline) for moderate to severe acne vulgaris

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This policy governs pharmacy benefit coverage and prior authorization for oral Seysara (sarecycline) in patients age 9 years and older with inflammatory lesions of non-nodular moderate to severe acne vulgaris. Coverage requires documented topical and oral antibiotic treatment failure, serious adverse effects, or contraindications, and is limited to an initial 12-week authorization.

Policy Summary

PayerConnectiCare

PolicySeysara (sarecycline) for moderate to severe acne vulgaris

Policy CodePolicy C15974-A

Change TypeNo material clinical or coverage changes

Effective DateApril 1, 2026

Next Review DateJanuary 1, 2027

Key ActionDocument the diagnosis, medical necessity, required topical and oral antibiotic treatment history, age, and weight-based dosing limits for initial Seysara authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age 9+Minimum patient age

12 weeksMaximum approved treatment duration

2 classesRequired formulary topical acne classes

2 drugs

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CurrentConnectiCarePolicy C15974-A

Seysara (sarecycline) for moderate to severe acne vulgaris

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Policy Summary

PayerConnectiCare

PolicySeysara (sarecycline) for moderate to severe acne vulgaris

Policy CodePolicy C15974-A

Change TypeNo material clinical or coverage changes

Effective DateApril 1, 2026

Next Review DateJanuary 1, 2027

Key ActionDocument the diagnosis, medical necessity, required topical and oral antibiotic treatment history, age, and weight-based dosing limits for initial Seysara authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age 9+Minimum patient age

12 weeksMaximum approved treatment duration

2 classesRequired formulary topical acne classes

2 drugs

Required generic oral antibiotics

1 tablet/dayMaximum quantity

3Available tablet strengths

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Seysara therapy

Clinical diagnosis: Documentation of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Medical necessity: The prescriber attests that Seysara is medically necessary and is not provided only for convenience
Topical therapy prerequisite: Documented failure, serious side effects, or contraindications to TWO formulary topical acne product classes selected from benzoyl peroxide, topical retinoid, or topical antibioticFor treatment failure, continuous use for 30 days without improvement or stabilization of symptoms
Two topical classes are required
Oral antibiotic prerequisite: Documented failure, serious side effects, or contraindication to both generic minocycline and doxycyclineFor treatment failure, continuous use of each drug for 30 days without improvement or stabilization of symptoms
Both drugs are required
Age: Patient is 9 years of age or older>= 9 years
Duration: Initial authorization is limited to 12 weeks12 weeks
Weight-based dose and quantity: The prescribed dose is within the applicable weight-based dosing limits and does not exceed the maximum quantity33-54 kg: 60 mg once daily; 55-84 kg: 100 mg once daily; 85-136 kg: 150 mg once daily; maximum 1 tablet per day of any one strength

Continuation Therapy

Continuation beyond the initial authorization is not covered.

Continuation limitation: Continuation of Seysara therapy past the initial authorization will not be approvedMaximum duration: 12 weeks

Continuation of therapy is not available under this policy

Continuation of Seysara therapy beyond 12 weeks is not covered. The initial authorization is limited to 12 weeks, and continuation authorization is not available under this policy.

There are no compendial approved off-label uses for Seysara (sarecycline) under this policy.

All other uses of Seysara (sarecycline) are considered experimental or investigational and are subject to the applicable off-label policy.

Coverage and Dosing Parameters

Minimum age

Minimum age9 years of age and older

Covered indicationInflammatory lesions of non-nodular moderate to severe acne vulgaris

TreatmentSeysara (sarecycline)

Topical treatment trial

Required duration30 continuous days

Treatment requirementTopical acne therapy trial

Failure criterionNo improvement or stabilization of symptoms

Prior Authorization and Documentation

Prior Authorization

Initial Seysara Authorization

Initial authorization for Seysara (sarecycline) requires documentation supporting the covered diagnosis, age, required treatment history, weight-based dosing, and the authorization duration.

Diagnosis: non-nodular moderate to severe acne vulgaris with documented inflammatory lesions.
Member is 9 years of age or older.
Required prior topical and oral antibiotic treatment history is documented.
Initial authorization is limited to 12 weeks.
Dose must follow the member's weight-based dosing range and quantity limit.

Step Therapy

Topical Acne Class Step Therapy

Before Seysara is authorized, document failure, serious side effects, or a contraindication to two formulary topical acne product classes. For treatment failure, each trial must be continuous use for 30 days without improvement or stabilization of symptoms.

Clinical Background

Acne vulgaris is a multifactorial inflammatory disease of the pilosebaceous follicles. Its pathophysiology involves follicular hyperkeratinization, microbial colonization, sebum production, and immune-mediated inflammation. Moderate to severe acne may cause psychological morbidity and permanent scarring.

Key Definitions

Acne vulgaris

TermAcne vulgaris

DefinitionA multifactorial inflammatory disease affecting the pilosebaceous follicles of the skin

Affected structuresPilosebaceous follicles

Initial Therapy

Initial Therapy for Acne Vulgaris

Initial therapy is covered when ALL of the following clinical, step-therapy, age, and dosing criteria are met:

Initial therapy for non-nodular moderate to severe acne vulgaris

Clinical diagnosis: Documentation of inflammatory lesions of non-nodular moderate to severe acne vulgaris
Medical necessity attestation: The prescriber attests that Seysara is medically necessary and is not provided only for convenience
Topical step therapy: Failure, serious side effects, or contraindications to TWO formulary topical acne product classes: benzoyl peroxide, topical retinoid, or topical antibioticFor treatment failure, continuous use for 30 days without improvement or stabilization of symptoms

Continuation Therapy

No Continuation Authorization

Continuation therapy is not available under this policy.

No continuation authorization: Continuation of Seysara therapy past 12 weeks will not be approved12 weeks maximum

Continuation of therapy: N/A

Required Prior Treatment

Step	Therapy prerequisite	Requirement
1	Two formulary topical acne product classes: benzoyl peroxide, topical retinoid, or topical antibiotic	Document failure, serious side effects, or contraindication. For treatment failure, document continuous use for 30 days without improvement or stabilization of symptoms.

Step	Therapy prerequisite	Requirement
2	Generic minocycline and doxycycline	Document failure, serious side effects, or contraindication to both drugs. For treatment failure, document continuous use of each drug for 30 days without improvement or stabilization of symptoms.

Seysara Dose and Quantity Limits

Seysara 60 mg

Weight range33–54 kg

Daily dose60 mg once daily

Maximum quantity1 tablet per day of any one strength

Seysara 100 mg

Weight range55–84 kg

Daily dose100 mg once daily

Maximum quantity1 tablet per day of any one strength

Pharmacy Benefit and Administration

Billing Rule

Use the pharmacy benefit and self-administration setting

Oral Seysara is recommended for pharmacy benefit coverage and patient self-administration.

Route of administration: oral.
Site of care: patient self-administration.

Policy Summary

PayerConnectiCare

PolicySeysara (sarecycline) for moderate to severe acne vulgaris

Policy CodePolicy C15974-A

Change TypeNo material clinical or coverage changes

Effective DateApril 1, 2026

Next Review DateJanuary 1, 2027

Key ActionDocument the diagnosis, medical necessity, required topical and oral antibiotic treatment history, age, and weight-based dosing limits for initial Seysara authorization.

SourceLink

On This Page

Oral antibiotic treatment trial

Required duration30 continuous days of each drug

Required drugsGeneric minocycline and doxycycline

Failure criterionNo improvement or stabilization of symptoms

Maximum duration

Initial authorization12 weeks

ContinuationContinuation of therapy past 12 weeks will not be approved

Efficacy limitationEfficacy of Seysara beyond 12 weeks has not been established

Weight-based dosing

33–54 kg60 mg once daily

55–84 kg100 mg once daily

85–136 kg150 mg once daily

Maximum quantity

Maximum quantity1 tablet per day

Applies toAny one strength

Quantity basisMaximum quantity limits

Applicable formulary classes: benzoyl peroxide, topical retinoid, and topical antibiotic.
Two different classes must be documented.
Document the product or class, dates and duration of use, response, and the reason treatment was discontinued or unsuitable.

Step Therapy

Generic Oral Tetracycline Step Therapy

Seysara requires documented failure, serious side effects, or a contraindication to both generic minocycline and doxycycline. Treatment failure requires 30 days of continuous use of each medication without improvement or stabilization of symptoms.

Both generic minocycline and doxycycline are required trials unless a serious side effect or contraindication is documented.
Document the medication, dates and duration of use, response, and reason treatment was discontinued or unsuitable.

Documentation Required

Diagnosis and Inflammatory Lesions

The covered diagnosis is non-nodular moderate to severe acne vulgaris, and the record must document inflammatory lesions associated with that diagnosis.

Document the diagnosis and clinical findings supporting inflammatory lesions.
Nodular acne or an unsupported diagnosis does not meet this criterion.

Documentation Required

Medical Necessity Attestation

The prescriber must attest that Seysara is medically necessary and is not being provided only for convenience.

Include the medical-necessity and non-convenience attestation with the authorization request.

Documentation Required

Topical Acne Therapy History

Document the required history for two formulary topical acne product classes before requesting Seysara.

Choose two classes from benzoyl peroxide, topical retinoid, and topical antibiotic.
For each class, document continuous use for 30 days without improvement or stabilization, or document a serious side effect or contraindication.

Documentation Required

Oral Antibiotic Therapy History

Document treatment history for both generic minocycline and doxycycline, including the outcome and reason each therapy was not continued.

For treatment failure, document 30 days of continuous use of each drug without improvement or stabilization of symptoms.
If not failed, document the serious side effect or contraindication for the applicable drug.

Unsupported block type: documentation

Denial Risk

Required Documentation Not Established

Authorization may be denied when the required diagnosis, prescriber attestation, or treatment history is not documented.

No documented non-nodular moderate to severe acne vulgaris with inflammatory lesions.
No attestation that Seysara is medically necessary and not provided only for convenience.
No qualifying history for two formulary topical acne classes and both generic minocycline and doxycycline.

Denial Risk

Treatment Exceeds 12 Weeks

Continuation of Seysara beyond the policy's maximum 12-week duration will not be approved.

Initial authorization: 12 weeks.
Continuation of therapy: not applicable.
Do not request or dispense treatment beyond 12 weeks under this policy.

Denial Risk

Quantity or Dose Exceeds Policy Limit

Requests exceeding the policy's weight-based dose or the maximum quantity of one tablet per day of any one strength may be denied.

33–54 kg: 60 mg once daily.
55–84 kg: 100 mg once daily.
85–136 kg: 150 mg once daily.
Maximum quantity: one tablet per day of any one strength.

Denial Risk

Supporting Documentation Is Insufficient

Insufficient supporting documentation may prevent a favorable coverage determination. ConnectiCare may request additional records and may deny reimbursement if the documentation does not support medical necessity, non-investigational status, benefit eligibility, or appropriate billing.

Submit complete clinical records and test results when requested.
Provider credentials and other documentation supporting the ordering or dispensing of the drug may also be required.
Inappropriate or excessive billing patterns may result in denial or other action.

Denial Risk

Non-Covered or Investigational Use

Uses of Seysara other than the covered indication are considered experimental or investigational and are subject to the applicable off-label policy.

Coverage is limited to non-nodular moderate to severe acne vulgaris meeting the policy criteria.
Unsupported uses follow the applicable Off-Label policy.

Denial Risk

Tetracycline Hypersensitivity

Seysara is contraindicated for persons who have demonstrated hypersensitivity to any tetracycline.

Document and evaluate any history of tetracycline hypersensitivity before prescribing.

Two topical classes are required

Oral antibiotic step therapy: Failure, serious side effects, or contraindication to both generic minocycline and doxycyclineFor treatment failure, continuous use of EACH drug for 30 days without improvement or stabilization of symptoms

Both drugs are required

Age requirement: Patient is 9 years of age or older>= 9 years

Initial authorization duration: Authorization is limited to an initial 12-week course12 weeks

Weight-based dosing: Prescribed dose corresponds to the patient's weight33-54 kg: 60 mg once daily; 55-84 kg: 100 mg once daily; 85-136 kg: 150 mg once daily

Quantity limit: The quantity does not exceed one tablet per day of any one strength1 tablet per day of any one strength

Seysara 150 mg

Weight range85–136 kg

Daily dose150 mg once daily

Maximum quantity1 tablet per day of any one strength