ModifiedCentenePolicy CP.PMN.188

Omadacycline (Nuzyra)

Defines medical necessity and prior authorization criteria for omadacycline (Nuzyra) for adults with ABSSSI or CABP and guidance for other uses and continuity/continuation of therapy for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyOmadacycline (Nuzyra) coverage

Policy CodePolicy CP.PMN.188

Change TypeStep therapy bypass added for IL HIM (per IL HB 5395)

Effective DateMar 1, 2019

Next Review DateN/A

Key ActionSubmit prior authorization with supporting documentation (chart notes, lab results, C&S when available) showing diagnosis of ABSSSI or CABP and criteria for approval.

SourceLink

POLICY UPDATE CHANGES

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

2FDA indications

≥18Min age

7-14Duration (days)

J0121, J8499HCPCS

YesMedicaid precedence

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Other Diagnoses/Off-label

Other indications (non-listed uses) require one of the following

Other Indications: 1) If the drug has had a label change within the last 6 months not yet reflected in this policy, follow the appropriate no-coverage/non-formulary policy for the relevant line of business (see policy references). OR 2) If the requested use (diagnosis, age, dosing) is not listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

References to specific Centene policies provided for commercial, HIM, and Medicaid.

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless coverage for the use is supported by the member’s evidence of coverage documents.

For Medicaid members, when a state Medicaid coverage provision conflicts with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules that apply to this policy.

Requests for omadacycline (Nuzyra) for non‑FDA approved indications that lack sufficient documentation of efficacy and safety per the referenced off‑label use policies are considered not authorized (not medically necessary) under this clinical policy.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be required for Nuzyra (omadacycline). Providers should verify member benefits and obtain prior authorization when required by the member's health plan before initiating therapy.

Prior authorization may be requested based on the Health Plan's medical necessity criteria and benefit design.
For Illinois Health Insurance Marketplace (HIM) requests, step therapy requirements do not apply per IL HB 5395 effective 1/1/2026.

Documentation Required

Documentation Expectations

Providers must submit supporting clinical documentation to demonstrate that the member meets all approval criteria. Expect to provide office chart notes, relevant laboratory results, culture and sensitivity (C&S) reports when available, and medication history documenting prior antibiotic trials, adverse reactions, or contraindications.

Chart notes describing diagnosis, clinical findings, and response to therapy.
Lab results and microbiology/C&S reports for the current infection when feasible.
Medication history showing prior formulary antibiotic trials, dates, doses, and reasons for failure or discontinuation (adverse effects or contraindications).
Discharge summary when request is for continuation of therapy initiated in an acute care hospital.

Step Therapy

Step Therapy and IL HIM Bypass

Step therapy requirements apply except where explicitly bypassed by law or program rules. For Illinois HIM requests, the step therapy requirements do not apply per IL HB 5395 (effective 1/1/2026). When step therapy is applicable, documentation should demonstrate failure of or contraindication to required formulary agents as specified in the clinical criteria.

When C&S available: failure of ≥2 formulary antibiotics to which the isolated pathogen is susceptible, unless contraindicated or clinically intolerable.
When C&S not feasible: failure of ≥2 formulary antibiotics indicated for the diagnosis, unless contraindicated or clinically intolerable.
Illinois HIM: step therapy bypass in effect as of 2026-01-01 per IL HB 5395.

Denial Risk

Provider Action Reminder — Denial Risk and Administrative Requirements

Failure to submit required supporting documentation may result in delay or denial of the request. Coverage decisions are subject to the member's benefit contract, plan-level administrative policies, and applicable state and federal requirements.

If required documentation (e.g., chart notes, labs, C&S reports) is missing, the request may be denied or returned for more information.
Decisions remain subject to contract terms, exclusions, limits, and Health Plan administrative policies.

Definitions

ABSSSI definition

ABSSSI abbreviationAcute bacterial skin and skin structure infections

ContextListed in Appendix A as an abbreviation used in this policy

Use in criteriaABSSSI is one of the FDA-approved indications referenced in coverage criteria

CABP definition

CABP abbreviationCommunity-acquired bacterial pneumonia

ContextDefined in Appendix A as an abbreviation used in this policy

Use in criteriaCABP is one of the FDA-approved indications referenced in coverage criteria

Health Plan definition

Health Plan definitionA 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

Policy purposeProvides a guide to medical necessity to assist in coverage decisions and benefit administration

Scope and limitationsCoverage decisions are subject to terms, conditions, exclusions, limitations of coverage documents and applicable law/regulation

OpenPayer

Omadacycline (Nuzyra)

Coverage Criteria for Omadacycline (Nuzyra)

Coding and Therapy Duration

Provider Actions, Prior Authorization, and Documentation

Background

Definitions

J0121	Injection, omadacycline, 1 mg
J8499	Prescription drug, oral, non chemotherapeutic, nos