CurrentCentenePolicy CP PMN.80

Minocycline ER (Emrosi, Solodyn, Ximino, Minolira), Microspheres (Arestin), Foam (Zilxi)

Defines medical necessity criteria, prior authorization requirements, age limits, step-therapy and dosing/approval durations for minocycline extended-release products (acne), minocycline microspheres (Arestin) for periodontitis, and minocycline foam/capsule products (Zilxi, Emrosi) for rosacea across Centene lines of business (Commercial, HIM, Medicaid) with specific exclusions for Arestin on pharmacy benefit.

Policy Summary

PayerCentene

PolicyMinocycline ER (Emrosi, Solodyn, Ximino, Minolira), Microspheres (Arestin), Foam (Zilxi)

Policy CodePolicy CP PMN.80

Change TypeClarifications, additions, revisions

Effective DateJun 1, 2017

Next Review Date

Key ActionProvider must submit chart notes, lab results or other clinical information supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

Clarified that Arestin is excluded for Commercial line of business on the pharmacy benefit.

Added Emrosi to criteria with corresponding criteria set for rosacea indication.

Added step therapy bypass for Illinois HIM per IL HB 5395.

Revised requirement for IR minocycline for acne vulgaris to 'must use' language.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

3Covered Indications (Acne, Periodontitis, Rosacea)

ExcludedArestin excluded on pharmacy benefit (Commercial/HIM)

<=135 mg/dayMinocycline ER max dose

<=40 mg/dayEmrosi max dose

Coverage Summary

Coverage stance: covered_with_criteria for minocycline ER (Solodyn, Ximino, Minolira), minocycline foam/capsule products (Zilxi, Emrosi), and Arestin microspheres, with prior authorization and specific medical necessity criteria required.

Covered indications (summary and scope): Acne vulgaris (inflammatory lesions of non-nodular moderate to severe acne in patients >= 12 years) for minocycline ER products when all criteria (age, IR minocycline trial unless contraindicated, trial of an additional preferred oral tetracycline, and dose <= 135 mg/day) are met; Chronic periodontitis (adult periodontitis) for Arestin as an adjunct to scaling and root planing in adults >= 18 years (dose individualized by pocket size/number and prescribed by or in consultation with a periodontist); and Rosacea (inflammatory lesions in adults >= 18 years) for Zilxi or Emrosi after failure of two prior therapies and within stated dose limits (Zilxi <= 1 can/month, Emrosi <= 40 mg/day).

Arestin pharmacy-exclusion note: Arestin is excluded on the pharmacy benefit for Commercial and Health Insurance Marketplace (HIM) lines of business in most states (HIM exclusion applies in all states except Florida where it may be non-formulary and follow this policy); when covered as a procedure in HIM Florida, approval is for a single procedure. Prior authorization and documentation requirements still apply where Arestin coverage is allowed.

Key limits & age requirements

Age for Acne>= 12 years

Age for Periodontitis>= 18 years

Age for Rosacea>= 18 years

Minocycline ER max<= 135 mg/day

Emrosi dosing limit<= 40 mg/day

Zilxi dosing limit<= 1 can/month

Initial Therapy Criteria

Initial Approval Criteria - Acne Vulgaris

Covered when ALL of the following are met:

ALL of the following

Acne diagnosis and product
- Diagnosis of acne vulgaris
- Product requested: Request is for minocycline ER (Solodyn, Ximino) or Minolira
- Age: Member age >= 12 years>= 12 years
  Age requirement explicit for acne indication

Continuation Therapy Criteria

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Requests for listed minocycline products require prior authorization and must include supporting documentation per the policy criteria. Note that Arestin is excluded on the pharmacy benefit for Commercial and for HIM in all states except Florida (where HIM may follow this policy and approval is limited to one procedure).

Documentation Required

Support approval criteria

Submit chart notes, lab results, or other clinical information demonstrating the member meets all applicable approval criteria for the requested minocycline product.

submit chart notes, lab results or other clinical information supporting that member has met all approval criteria.

Applicable Codes

Product codes / identifiers mentionedmixed

Solodyn	Minocycline ER tablets (brand)
Ximino	Minocycline ER capsules (brand)
Minolira	Minocycline ER tablets (brand)
Arestin	Minocycline microspheres (local periodontal adjunct)
Emrosi	Minocycline ER capsule for rosacea (brand)
Zilxi	Minocycline topical foam for rosacea (brand)

Clinical Evidence & Indications

FDA-approved indications (mapped to products): Solodyn, Ximino, and Minolira are approved for treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years and older. Emrosi and Zilxi are approved for treatment of inflammatory lesions of rosacea in adults. Arestin (minocycline microspheres) is approved as an adjunct to scaling and root planing for reduction of pocket depth in patients with adult periodontitis.

Safety and dosing notes from labeling: The safety of Solodyn/Ximino/Minolira has not been established beyond 12 weeks of use. Emrosi dosing is limited to 40 mg/day and Zilxi dosing to 1 can per month. Arestin is a variable-dose unit-dose cartridge product with dose individualized based on size and number of pockets treated (clinical trials used up to 122 unit-dose cartridges in a single visit and multiple treatments at intervals).

Background

Background: Minocycline extended-release products (Solodyn, Ximino, Minolira, and Emrosi) and minocycline topical foam (Zilxi) are tetracycline-class antibiotics primarily indicated for inflammatory acne (Solodyn, Ximino, Minolira) and rosacea (Emrosi, Zilxi).

Safety/dosing nuances: Labeling states the safety of the minocycline ER acne formulations has not been established beyond 12 weeks of use. Arestin (minocycline microspheres) is a locally applied adjunct for adult periodontitis and is a variable dose unit-dose cartridge product; dosing is individualized depending on the size and number of pockets treated and clinical trials have used multiple unit-dose cartridges and repeat treatments at intervals.

Definitions

HIMHealth Insurance Marketplace

IRImmediate-release

Revision History

2025-07-14addedLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 07.14.25).

2024-12-04added

RT4: Added Emrosi to criteria with corresponding criteria set for rosacea indication.

2024-01-11clarified

2Q 2024 annual review clarified that Arestin is excluded for Commercial line of business on the pharmacy benefit; references reviewed and updated.

Policy Summary

PayerCentene

PolicyMinocycline ER (Emrosi, Solodyn, Ximino, Minolira), Microspheres (Arestin), Foam (Zilxi)

Policy CodePolicy CP PMN.80

Change TypeClarifications, additions, revisions

Effective DateJun 1, 2017

Next Review Date

Key ActionProvider must submit chart notes, lab results or other clinical information supporting that member has met all approval criteria.

On This Page

Step therapy/IR requirement

IR minocycline use: Member must use immediate-release (IR) minocycline unless contraindicated or clinically significant adverse effects are experienced
Step therapy requirement; exception when contraindicated or significant adverse effects
Preferred tetracycline trial: Failure of a 2-4 week trial of one additional preferred oral tetracycline antibiotic (e.g., immediate-release doxycycline), unless clinically significant adverse effects are experienced2-4 weeks
Preferred alternative trial requirement

Dose limit: Dose does not exceed 135 mg per day<= 135 mg/day

Initial Approval Criteria - Periodontitis (Arestin)

Covered when ALL of the following are met:

ALL of the following

Diagnosis and product
- Diagnosis of chronic periodontitis (adult periodontitis)
- Product requested: Request is for Arestin
- Prescriber: Prescribed by or in consultation with a periodontist
- Periostat intolerance: Intolerance or contraindication to oral doxycycline hyclate at a sub-antimicrobial dose (20 mg PO twice daily) (e.g., unable to swallow capsules, allergic to doxycycline excipient, history of gastrointestinal disease)
  Must document intolerance/contraindication to Periostat
- Age: Member age >= 18 years>= 18 years
  Age requirement explicit for periodontitis
Adjunct and dosing
- Adjunct to SRP: Prescribed as an adjunct to a scaling and root planing procedure to reduce pocket depth (applied during procedure)
- Individualized dose: Dose is individualized depending on size and number of pockets being treated
  Arestin is a variable dose product

Step Therapy

IR minocycline / tetracycline trial requirement for acne

Step therapy requires use of immediate-release (IR) minocycline for acne unless contraindicated or clinically significant adverse effects occur. The member must also fail a 2–4 week trial of one additional preferred oral tetracycline (for example, immediate-release doxycycline) unless contraindicated or adverse effects. For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 (step therapy bypass added).

must use IR minocycline unless contraindicated
failure of 2-4 week trial of one additional preferred oral tetracycline (e.g., immediate-release doxycycline) unless contraindicated/adverse effects.
step therapy bypass applies for Illinois HIM per IL HB 5395 (effective 1/1/2026).

Billing Rule

Arestin dosing individualized and procedure-based

Arestin dosing is individualized and procedure-based; it is supplied as unit-dose cartridges and applied as an adjunct during scaling and root planing. For Florida HIM, approval is limited to one procedure; documentation should specify the size and number of pockets treated and that application was adjunctive to scaling and root planing.

unit-dose cartridge; approval in Florida HIM for 1 procedure; document size/number of pockets and adjunct to scaling/root planing.

Denial Risk

Dose and indication limits

Claims may be denied if dose, age, indication, or required documentation do not meet policy limits. Examples include exceeding maximum doses (minocycline ER >135 mg/day; Emrosi >40 mg/day), requests for indications or ages not meeting criteria, or missing supporting documentation.

dose exceedances (>135 mg/day for minocycline ER, >40 mg/day Emrosi)
age/indication not met (e.g., acne <12 years, periodontitis <18 years, rosacea <18 years)
missing required documentation (chart notes, labs, procedure details)

2022-04-27revised

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less (recorded 04.27.22; P&T 08.22).

2021-03-01revised

2Q 2021 annual review revised requirement for immediate‑release (IR) minocycline for acne vulgaris to 'must use' language (recorded 03.01.21).