ModifiedmhnPolicy CP.PMN.188

Omadacycline (Nuzyra) clinical coverage policy

Medical necessity and prior authorization criteria for omadacycline (Nuzyra) for treatment of adult CABP and ABSSSI, and guidance for other/ off-label uses and continuation therapy for members of the payer lines of business.

Policy Summary

Payermhn

PolicyOmadacycline (Nuzyra) clinical coverage policy

Policy CodePolicy CP.PMN.188

Change TypeStep therapy bypass addeddosing revised

Effective Date03.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation (chart notes, lab results, C&S or step-therapy failure evidence) showing member meets initial approval criteria.

SourceLink

POLICY UPDATE CHANGES

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

Added initial Day 1 oral dosing and quantity limits for CABP per updated prescribing information.

2FDA-approved indications

>=18Minimum age for coverage

7-14Recommended duration (days)

18Document chunks

Coverage Criteria for Omadacycline (Nuzyra)

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Continuation Therapy

Covered when ALL of the following are met:

Continuation Therapy - ABSSSI or CABP: 1. Member meets ONE of the following: (a) currently receiving medication via the 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; (c) request is for continuation of therapy initiated in an acute care hospital from which the member was discharged. 2. Member is responding positively to therapy. 3. Member has not received ≥ 14 days of therapy for the current infection. 4. If the request is for a dose increase, the new dose does not exceed: (a) 100 mg IV (1 vial) per day; or (b) 300 mg PO (2 tablets) per day.< 14 days total therapy

Non‑FDA approved (off‑label) indications not explicitly addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies. Refer to CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) for the specific documentation requirements and evidentiary standards that must accompany requests for off‑label use.

When coverage provisions in this clinical policy conflict with state Medicaid coverage provisions, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any specific coverage rules or exceptions that apply to Medicaid members.

Requests for omadacycline used for non‑FDA indications are considered off‑label and will be reviewed only when the submission includes adequate clinical documentation per the payer's off‑label use policies. If supporting evidence of efficacy and safety consistent with CP.CPA.09, HIM.PA.154, or CP.PMN.53 is not provided, the use is not authorized and will be denied as not covered.

Coding, Dosing, and Treatment Duration

HCPCS Codes referencedHCPCS

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

Maximum dosing regimens — loading and maintenance (by indication and route)

ABSSSI — Loading (IV)200 mg IV on Day 1 (2 vials)

ABSSSI — Loading (PO)450 mg PO per day on Days 1 and 2 (3 tablets/day)

ABSSSI — Maintenance100 mg IV once daily or 300 mg PO once daily

CABP — Loading200 mg IV or 600 mg PO on Day 1 (IV: 2 vials; PO: 4 tablets)

CABP — Maintenance100 mg IV once daily or 300 mg PO once daily

Treatment duration

Recommended total duration7-14 days

Continuation constraintMember has not received ≥14 days of therapy for current infection (for renewal)

Duration applies to both ABSSSI and CABPTotal duration of treatment: 7-14 days for both indications

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests will be reviewed against the Health Plan's coverage documents and this clinical policy; approval is granted only when all applicable criteria are met.

Prior authorization is governed by the member's plan documents and Evidence of Coverage (EOC).
Coverage decisions and benefit administration are subject to plan terms, exclusions, limitations, and state/federal requirements.

Documentation Required

Required Documentation

Providers must submit supporting clinical documentation to establish that the member meets all approval criteria.

Acceptable documentation includes office chart notes, diagnostic test results, laboratory reports, culture and sensitivity (C&S) reports, hospital discharge records, and other pertinent clinical information.
Failure to submit required documentation may result in denial or delayed decision.

Denial Risk

Denial Triggers

Prior authorization may be denied if required information or documentation is not provided, or if requested therapy does not meet the criteria in this policy and the member's coverage documents.

Common triggers for denial: missing or incomplete clinical records, lack of C&S when required (or inadequate justification that C&S is not feasible), dose exceeds policy limits, or failure to meet step therapy criteria where applicable.
Denials are also possible when the requested indication is not covered by the member's plan or is an exclusion under the Evidence of Coverage.

Note

Coverage and Administrative Governance

Coverage decisions are made in accordance with this clinical policy and the member's coverage documents; providers must follow both the clinical policy and Health Plan administrative rules when submitting requests.

This clinical policy is a guide to medical necessity only and does not guarantee payment.
Providers should follow applicable Health Plan-level administrative policies and procedures when requesting prior authorization.

Step Therapy

Step Therapy Requirements and IL HIM Bypass

Step therapy requirements apply as specified in the clinical criteria. For Illinois Health Insurance Marketplace (IL HIM) members, the step therapy requirements do not apply (bypass) effective 01/01/2026 per IL HB 5395.

When step therapy applies, documentation must show trials and failures of the required formulary antibiotics (or clinical rationale for exemption such as adverse effects or contraindications).
For IL HIM requests on or after 01/01/2026, do not apply the step therapy requirement; document plan type and applicable request date.

Note

Provider Obligations and Policy Limitations

Providers are reminded that this clinical policy was developed by licensed clinicians and is effective as of the Health Plan-determined date; it does not replace or override the member's coverage contract.

If there is a conflict between this clinical policy and legal/regulatory requirements, law governs.
The Health Plan may change, amend, or withdraw this clinical policy at any time.

Definitions

ABSSSI and CABP definitions

ABSSSIAcute bacterial skin and skin structure infections (ABSSSI)

CABPCommunity-acquired bacterial pneumonia (CABP)

Indication linkageDosing regimens and duration differ by indication (see dosing section)

C&S (culture and sensitivity) definition

C&SCulture and sensitivity testing — report demonstrating the isolated pathogen is susceptible to omadacycline

When not feasibleProvider may document that obtaining a C&S report is not feasible; other criteria apply

Use in criteriaC&S is required to show susceptibility unless documentation indicates infeasibility; used to determine step-therapy exceptions

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 roleThis clinical policy provides guidance to assist in making coverage decisions and administering benefits but is not a contract or guarantee of payment

Subject to coverage documentsCoverage decisions are subject to terms, conditions, exclusions, and limitations of the coverage documents and applicable law/regulation

OpenPayer

Omadacycline (Nuzyra) clinical coverage policy

Coverage Criteria for Omadacycline (Nuzyra)

Coding, Dosing, and Treatment Duration

Provider Actions, Prior Authorization, and Documentation

Background on Omadacycline

Definitions