CurrentCignaPolicy IP0093

Sarecycline (Seysara) tablets - Coverage Policy

Policy defines medical necessity criteria, continuation, authorization duration, and non-covered uses for sarecycline (Seysara) tablets for treatment of moderate to severe acne vulgaris in Cigna-administered health plans. Coverage may vary by specific benefit plan and preferred product requirements apply.

Policy Summary

PayerCigna

PolicySarecycline (Seysara) tablets - Coverage Policy

Policy CodePolicy IP0093

Change TypeNo material change

Effective DateApr 1, 2023

Next Review DateApr 1, 2024

Key ActionDocument age and failure/contraindication/intolerance to both doxycycline and minocycline before requesting coverage; prior authorization is required and sample receipt does not satisfy criteria.

POLICY UPDATE CHANGES

No material clinical/coverage changes.

2Required prior antibiotic trials (doxycycline & minocycline)

9Minimum patient age (years)

12 moAuthorization duration (max)

Coverage Summary

Sarecycline (Seysara) is a tetracycline indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years and older (indication and age threshold).

Clinical guideline context emphasizes topical therapies as the cornerstone of acne management; systemic antibiotics are reserved for moderate to severe or inflammatory acne resistant to topical treatments and should be used in combination with topical agents and limited to the shortest possible duration (generally 3-4 months) with re-evaluation at 3 to 4 months.

Applicable Codes & Policy Identifiers

Policy Identifiers / Effective Datesmixed

IP0093

Coverage Policy Number

No additional billing codes (CPT/HCPCS/NDC) were provided in the brief.

Policy number: IP0093; Effective: 2023-04-01; Last review: 2023-04-01; Next review: 2024-04-01.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required per policy

Coverage is subject to medical necessity review and plan-specific preferred product requirements; documentation must demonstrate age and documented failure/contraindication/intolerance to both doxycycline and minocycline prior to approval.

Documentation Required

Document prior antibiotic trials

Provider must document failure, contraindication, or intolerance to both doxycycline (monohydrate, hyclate or hyclate ER) and minocycline (immediate-release or extended-release).

Denial Risk

Not covered for other indications

Claims for uses other than moderate to severe acne vulgaris in patients meeting criteria (including infections) are considered experimental/investigational and may be denied.

Billing Rule

Sample product

Receipt of sample product does not satisfy criteria requirements for coverage.

Operational notes: Receipt of sample product does not satisfy criteria requirements for coverage. Coverage is subject to medical necessity review and plan-specific preferred product requirements; documentation must demonstrate age and documented failure/contraindication/intolerance to both doxycycline and minocycline prior to approval.

Clinical Evidence & Guidelines

Evidence summary: Phase 3 randomized trials demonstrated efficacy of once-daily sarecycline at 1.5 mg/kg/day for moderate to severe acne.

Guideline recommendations from the American Academy of Dermatology and the Global Alliance advise that systemic antibiotics not be used as monotherapy and should be used in combination with topical therapies and limited to approximately 3-4 months with reevaluation.

Quantitative evidence

Trial dosing (phase 3)1.5 mg/kg/day

Recommended systemic antibiotic duration (guidelines)limit to shortest possible; re-evaluate at 3-4 months

Definitions & Background

Background: Seysara (sarecycline) is a tetracycline indicated for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Limitations of use include that efficacy beyond 12 weeks and safety beyond 12 months have not been established, and the agent has not been evaluated for treatment of infections.

Guideline context: Topical retinoids and benzoyl peroxide are cornerstone therapies; systemic antibiotics (including tetracyclines) are recommended for moderate to severe acne but should not be used as monotherapy and should be limited to the shortest possible duration (generally 3-4 months) with re-evaluation.

Term	Definition
Failure
Insufficient clinical response to therapeutic trial of specified agent
Contraindication or intolerance
Documented reason patient cannot receive or tolerate specified agent

Revision History

2023-04-01effective_date

Policy effective date

2023-04-01last_review

Policy last review date

2024-04-01next_reviewLatest

Policy next scheduled review date