CurrentDelaware First HealthPolicy CP.PMN.188

Omadacycline (Nuzyra) coverage

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Defines medical necessity criteria, dosing limits, and authorization requirements for omadacycline (Nuzyra) for adults with CABP or ABSSSI and guidance for other/ off-label uses within Delaware First Health lines of business.

Policy Summary

PayerDelaware First Health

PolicyOmadacycline (Nuzyra) coverage

Policy CodePolicy CP.PMN.188

Change TypeNo material change

Effective DateMar 1, 2019

Next Review DateAug 25, 2025

Key ActionProvider must submit documentation (office notes, lab results, or other clinical information) showing the member meets all approval criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentDelaware First HealthPolicy CP.PMN.188

Omadacycline (Nuzyra) coverage

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Policy Summary

PayerDelaware First Health

PolicyOmadacycline (Nuzyra) coverage

Policy CodePolicy CP.PMN.188

Change TypeNo material change

Effective DateMar 1, 2019

Next Review DateAug 25, 2025

Key ActionProvider must submit documentation (office notes, lab results, or other clinical information) showing the member meets all approval criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Coverage Criteria for Omadacycline (Nuzyra)

Initial Therapy (CABP, ABSSSI)

Covered when ALL of the following are met

Initial Approval for CABP or ABSSSI: 1) Diagnosis of ABSSSI or CABP; 2) Age ≥ 18 years; 3) Member meets one of the following: a) Request is for continuation of therapy initiated in an acute care hospital from which member was discharged; OR b) BOTH: i) Culture and sensitivity (C&S) report for the current infection shows the isolated pathogen is susceptible to omadacycline, unless provider documents that obtaining a C&S report is not feasible; AND ii) one of: (a) Failure of ≥ 2 formulary antibiotics to which the isolated pathogen is susceptible (if available) per C&S report, unless clinically significant adverse effects are experienced or all are contraindicated; (b) C&S report shows resistance or lack of susceptibility of the isolated pathogen to all formulary antibiotics FDA‑approved for the member's diagnosis; (c) If obtaining a C&S report is not feasible: failure of ≥ 2 formulary antibiotics indicated for the member's diagnosis (if available), unless clinically significant adverse effects are experienced or all are contraindicated; 4) Requested dose does not exceed the dosing limits for the indication (see dosing specifics). Approval duration: up to 14 days of total treatment.

See dosing specifics for IV and PO loading and maintenance doses

Continuation Therapy (CABP, ABSSSI)

Covered for continuation when ALL of the following are met

Continued Therapy: 1) Member meets one of: a) currently receiving medication via Centene benefit or member 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 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 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. Approval duration: up to 14 days of total treatment.

Approval duration: up to 14 days total treatment

Other Indications / Off-label

Other/Off-label uses

Other indications: 1) If the drug has had a label change within the last 6 months not yet reflected in this policy, follow the applicable formulary or non‑formulary policy for the relevant line of business; OR 2) If the requested use (e.g., diagnosis, age, dosing) is not listed in 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).

Non‑FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety per off‑label use policies or evidence of coverage documents

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 applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy. Providers must consult the applicable state Medicaid manual for coverage rules that supersede this policy.

Use of omadacycline for non‑FDA approved indications is not authorized unless the request is supported by the off‑label use policies referenced above or other evidence of coverage documents demonstrating adequate efficacy and safety.

Coding and Quantity Limits

HCPCS CodesHCPCS

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

Policy identifier / coding implicationsmixed

CP.PMN.188

Policy identifier referenced under Coding Implications

inv-09: Maximum treatment duration — Up to 14 days

Maximum treatment durationUp to 14 days of total treatment

Applicable indicationsCABP and ABSSSI per policy dosing and criteria

Approval applies to adultsMinimum age ≥ 18 years per coverage criteria

inv-25: Omadacycline — Up to 14 days (quantity limits)

Quantity limit (course)Omadacycline limited to up to 14 days of total treatment per course

Dosing referenceFollow loading and maintenance doses in policy (see IV/PO regimens for ABSSSI and CABP)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required for CABP or ABSSSI (adults)

Prior authorization is required for omadacycline (Nuzyra) for adults with CABP or ABSSSI. Submit a PA request with documentation showing the member meets all approval criteria. Approval duration is up to 14 days of total treatment.

Applies to adults (age ≥ 18 years) with a diagnosis of ABSSSI or CABP.
Dose and duration must not exceed the policy limits (see dosing): approval up to 14 days.

Billing Rule

Prior authorization / coding note

The policy notes coding implications (including HCPCS codes J0121 and J8499) and documents that a step therapy bypass for Illinois HIM was added; the excerpt does not provide a complete list of PA form fields or exact PA submission procedure.

Key Definitions

inv-19: ABSSSI — ABSSSI: acute bacterial skin and skin structure infections

DefinitionABSSSI: acute bacterial skin and skin structure infections

ContextOne of the FDA-indicated infections covered by this policy

Related dosing sectionSee policy dosing for ABSSSI loading and maintenance regimens

inv-20: CABP — CABP: community-acquired bacterial pneumonia

DefinitionCABP: community-acquired bacterial pneumonia

ContextOne of the FDA-indicated infections covered by this policy

Related dosing section

Initial Therapy Criteria and Dosing Limits

Initial Therapy

Initial therapy criteria and dosing limits for CABP and ABSSSI

Dosing and Limits for Initial Therapy: ABSSSI dosing: Loading dose Day 1: 200 mg IV (2 vials) on Day 1 OR 450 mg PO per day on Days 1 and 2; Maintenance: 100 mg IV once daily or 300 mg PO once daily. CABP dosing: Loading dose Day 1: 200 mg IV (2 vials) OR 600 mg PO (4 tablets) on Day 1; Maintenance: 100 mg IV once daily or 300 mg PO once daily. Total duration of treatment: up to 14 days (prescribing information total duration typically 7–14 days). Dose requests must not exceed the listed loading and maintenance doses above.Up to 14 days

See Appendix V for administration details (IV infusion times and alternative loading regimens)

Criteria for Continued Therapy

Continued Therapy

Criteria for continued therapy for CABP or ABSSSI

Continued Therapy — dosing and duration: 1) Member meets continuation criteria (currently receiving via Centene benefit or previously met initial approval criteria; or enrolled in a state/product with continuity of care regulations; or continuation from acute care hospital); 2) Member is responding positively to therapy; 3) Member has not yet received ≥ 14 days of therapy for the current infection; 4) If a dose increase is requested, the new dose must not exceed 100 mg IV per day or 300 mg PO per day. Approval duration for continuation is up to 14 days total treatment.Up to 14 days

Approval limited to total course ≤ 14 days

Step Therapy Requirements

Requirement	Details
Documentation of culture & sensitivity (C&S)
C&S report for the current infection shows the isolated pathogen is susceptible to omadacycline unless provider documents that obtaining a C&S is not feasible
Step therapy failure requirement
Failure of ≥ 2 formulary antibiotics to which the isolated pathogen is susceptible (if available) per C&S, unless clinically significant adverse effects or all are contraindicated; if C&S not feasible, failure of ≥ 2 formulary antibiotics indicated for the diagnosis (if available)
Illinois HIM exception (effective 1/1/2026)
For Illinois Health Improvement Matters requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

Coverage label	Policy change / note
Step therapy bypass for Illinois HIM
Added step therapy bypass for Illinois Health Improvement Matters per IL HB 5395

Site of Care Provisions

Note

Allow continuation of hospital‑initiated therapy

Continuation of omadacycline therapy is allowed when therapy was initiated in an acute care hospital from which the member was discharged; include documentation that therapy was hospital‑initiated when requesting continuation coverage.

This permits hospital outpatient continuation of therapy begun during an inpatient or acute care stay.

Background

Omadacycline is a tetracycline‑class antibacterial indicated for adult patients with community‑acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Use should be limited to infections proven or strongly suspected to be caused by susceptible organisms, consistent with the prescribing information and to reduce development of resistance.