CurrentCentenePolicy CP PMN.189

Sarecycline (Seysara)

Policy governing medical necessity and prior authorization criteria for sarecycline (Seysara) for treatment of non-nodular moderate to severe acne vulgaris in patients 9 years and older under Centene lines of business.

Policy Summary

PayerCentene

PolicySarecycline (Seysara)

Policy CodePolicy CP PMN.189

Change TypeNo material changes

Effective DateMar 1, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation showing age ≥9, dose ≤150 mg/day, and failure of two preferred tetracyclines when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=9minimum age for FDA-approved indication

150 mg/daymaximum daily dose

12 wksapproval duration

60/100/150 mgtablet strengths

Centenepolicy owner

Coverage Criteria

Policy Summary

PayerCentene

PolicySarecycline (Seysara)

Policy CodePolicy CP PMN.189

Change TypeNo material changes

Effective DateMar 1, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation showing age ≥9, dose ≤150 mg/day, and failure of two preferred tetracyclines when required.

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met:

Initial Approval - Acne Vulgaris: (1) Diagnosis of acne vulgaris; (2) Age >= 9 years; (3) Dose does not exceed 150 mg (1 tablet) per day; (4) Failure of two preferred oral tetracycline antibiotics (e.g., immediate-release minocycline, doxycycline), each used for 4 weeks, unless clinically significant adverse effects are experienced or all are contraindicated.

Approval duration: 12 weeks

Continuation Therapy

Covered when ALL of the following are met for continuation:

Continued Therapy - Acne Vulgaris: (1) Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; b) member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; (2) Member is responding positively to therapy; (3) If request is for a dose increase, new dose does not exceed 150 mg (1 tablet) per day.

Approval duration: 12 weeks

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the Health Plan's off‑label use policies. Refer to the Health Plan off‑label policies (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP PMN.53 for Medicaid) or applicable evidence of coverage documents when requesting coverage for an off‑label indication.

Coverage determinations made under this clinical policy are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). This clinical policy is a medical necessity guideline to assist in coverage decisions and administering benefits and does not guarantee payment or results; applicable state and federal requirements and Health Plan administrative policies also apply.

Coding and Dosing

Maximum daily dose

Maximum daily dose150 mg/day

Tablet strengths referenced100 mg and 150 mg used in weight-based dosing (see dosing guidance)

Dose frequencyOnce daily (QD)

Weight-based dosing

Weight-based dosing regimen55–84 kg: 100 mg; 85–136 kg: 150 mg

Maximum allowed per day150 mg/day

AdministrationEach dose taken once daily (QD) without regard to food

Provider Actions / Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage of sarecycline (Seysara). Approval will be granted when the member meets the initial or continued therapy criteria specified in this policy and the requested dose does not exceed 150 mg (1 tablet) per day.

Prior authorization required for initial and continued therapy
Maximum allowed dose: 150 mg (1 tablet) per day
Approval duration: 12 weeks for initial and continuation requests

Note

Medical Necessity and Prior Authorization

This clinical policy is intended to assist in making coverage decisions and administering benefits; it does not itself guarantee payment. Medical necessity determinations, including prior authorization approvals, are based on the criteria in this policy (e.g., diagnosis of acne vulgaris, age > 9 years, prior therapy failures, and response to therapy). Providers must exercise clinical judgment and submit supporting documentation.

Coverage decisions are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (e.g., EOC, certificate of coverage, policy, contract).
State and federal requirements and Health Plan-level administrative policies also apply.

Denial Risk

Off‑label / Non‑covered Indications

Requests for sarecycline to treat non–FDA‑approved indications not addressed in this policy may be denied unless the provider submits sufficient documentation of efficacy and safety in support of the off‑label use in accordance with the Health Plan's off‑label use policies and applicable evidence of coverage documents.

Follow off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), CP PMN.53 (Medicaid) as applicable
Provide supporting clinical literature, rationale, and member‑specific documentation when requesting coverage for off‑label indications

Documentation Required

Required Documentation and Coverage Compliance

Providers must submit documentation (office chart notes, laboratory results, prior therapy history, and other pertinent clinical information) demonstrating that the member meets all approval criteria. Providers are bound by their contractual terms when submitting claims and are responsible for compliance with applicable contract requirements.

Required documentation: office notes, labs, medication history showing failure of two preferred oral tetracyclines each used for 4 weeks unless contraindicated or not tolerated
Providers are bound to contract terms and the Health Plan's policies when providing services or submitting claims

Background

Sarecycline is a tetracycline‑class antibiotic approved by the FDA for the treatment of inflammatory lesions of non‑nodular moderate to severe acne vulgaris in patients 9 years of age and older. Dosing is weight‑based with recommended tablet strengths available and a maximum daily dose of 150 mg/day. Clinical evidence supporting efficacy beyond 12 weeks and safety beyond 12 months is limited, and sarecycline has not been evaluated for treatment of infections.

Definitions

FDA Approved Indication

FDA‑approved indicationTreatment of inflammatory lesions of non‑nodular moderate to severe acne vulgaris in patients 9 years of age and older

Minimum approved age>= 9 years

Scope of indicationNon‑nodular moderate to severe acne vulgaris (inflammatory lesions)

Health Plan

DefinitionHealth Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

RoleAdopts and uses the clinical policy to assist in making coverage decisions and administering benefits

Not a guaranteePolicy does not constitute a contract or guarantee regarding payment or results; coverage subject to plan documents and legal/regulatory requirements

Providers

DefinitionProviders are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control

Employment statusProviders are not employees or agents of the Health Plan

ResponsibilityProviders are solely responsible for medical advice and treatment of members