CurrentCentenePolicy CP.PMN.62

Tedizolid (Sivextro) (PDF)

Defines medical necessity criteria, dosing limits, continuity/renewal requirements, exclusions, coding implications, and pediatric extensions for tedizolid (Sivextro) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyTedizolid (Sivextro) (PDF)

Policy CodePolicy CP.PMN.62

Change TypePediatric extension; step therapy bypass; coding update

Effective DateMar 1, 2015

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results, C&S reports) supporting that member meets all approval criteria; include C&S when feasible.

SourceLink

POLICY UPDATE CHANGES

Added pediatric extension to include use in members at least 26 weeks gestational age and weight at least 1 kg.

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

Added HCPCS code J8499 for oral Sivextro (Commercial line of business).

Removed specific requirement for trial of linezolid in legacy WCG policy.

1Covered Indication (ABSSSI)

2Pediatric eligibility thresholds

200 mg/dayAdult max dose

120 mg/dayPediatric <35kg max dose

J3090,J8499Key HCPCS codes

Coverage Summary

Coverage stance: covered_with_criteria for acute bacterial skin and skin structure infections (ABSSSI) for Tedizolid (Sivextro). Scope: Defines medical necessity criteria, dosing limits, continuity/renewal requirements, exclusions, coding implications, and pediatric extensions for tedizolid (Sivextro) across Commercial, HIM, and Medicaid lines of business. Policy subject: Tedizolid (Sivextro). Effective date: 03.01.15. Last review: 08.25.2025. Pediatric extension: one-line summary — pediatric use added for patients ≥ 26 weeks gestational age and ≥ 1 kg with weight‑based dosing. Step therapy bypass: one-line summary — Illinois HIM step therapy bypass per IL HB 5395 effective 1/1/2026.

Key Thresholds

Pediatric minimum gestational age≥ 26 weeks gestational age

Pediatric minimum weight≥ 1 kg

Tablet use weight threshold≥ 35 kg

Adult/pediatric ≥35 kg max dose200 mg/day (1 tablet or 1 vial per day)

Pediatric <35 kg max doseWeight-based dosing not to exceed 120 mg/day (1 vial per day)

Continuation therapy maximum prior daysMember must have received less than 6 days of therapy for current infection to qualify for continuation

Initial Approval Criteria - ABSSSI

Initial Approval Criteria - Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Sivextro is medically necessary when ALL of the following are met:

ALL of the following

Request justification
- Diagnosis of ABSSSI
- Pediatric age/weight requirements (if request is for pediatrics)
  - Member is at least 26 weeks gestational age
    applies to pediatric requests
  - Member weighs at least 1 kg
    applies to pediatric requests

Continuation (Renewal) Criteria - ABSSSI

For continuation of therapy, ALL of the following must be met:

ALL of the following

Eligibility for continuation
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
- Request is for continuation of therapy initiated in an acute care hospital from which member was discharged

Other Indications & Exclusions

Other diagnoses/indications

Coverage for other uses permitted only if one of the following applies:

ANY of the following

If drug recently (within last 6 months) underwent a label change not yet reflected in this policy, refer to no coverage criteria or non-formulary policy for the relevant line of business (CP.CPA.190, HIM.PA.33, CP.PMN.255; or CP.CPA.190, HIM.PA.103, CP.PMN.16)
If requested use is NOT listed under section III AND criterion 1 (label change) does not apply, refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

Non-FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

Applicable Codes

HCPCS / Injectable tedizolidHCPCS

J3090	Injection, tedizolid phosphate, 1 mg
J8499	Prescription drug, oral, non chemotherapeutic, nos (used for oral Sivextro)

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required with step therapy requirements

Prior authorization is required. Approval requires demonstration of prior step therapy per the criteria (e.g., failure of ≥ 2 formulary antibiotics or C&S–based exceptions) unless the request qualifies for continuation from an acute care hospital. For Illinois HIM requests, the step therapy requirements do not apply beginning 1/1/2026 per IL HB 5395.

Provider action type: prior_auth
Step therapy bypass for Illinois HIM per IL HB 5395 effective 1/1/2026

Documentation Required

Submit supporting clinical documentation

Submit supporting clinical documentation with the prior authorization request. Documentation should include office chart notes, laboratory results, and culture and sensitivity (C&S) reports when feasible to demonstrate that the member meets the approval criteria.

Clinical Evidence & References

Tedizolid is an oxazolidinone-class antibacterial indicated for treatment of ABSSSI caused by susceptible gram-positive organisms including MRSA and select Streptococcus species and Enterococcus faecalis. Guidance states to use culture and susceptibility (C&S) information when available and to reserve Sivextro for infections proven or strongly suspected to be caused by susceptible bacteria to reduce development of resistance.

Key evidence/references:

• FDA Prescribing Information: Sivextro PI April 2025.

• Guideline sources: IDSA and SSTI practice guidelines (2011, 2014).

Note: metric cards not required unless additional numerical trial data are present in the source.

Definitions

Definitions:

• ABSSSI: acute bacterial skin and skin structure infections.

• C&S: culture and sensitivity.

Revision History

08.25.2025material_changeLatest

Added pediatric extension to include use in members at least 26 weeks gestational age and weighing at least 1 kg; updated to include pediatric-specific weight-based dosing and dosing limits (pediatric <35 kg weight-based dosing not to exceed 120 mg/day).

04.21.2025material_change

Added step therapy bypass for Illinois HIM per IL HB 5395 effective 1/1/2026 (step therapy requirements do not apply for Illinois HIM requests).

04.12.2023material_change

Policy Summary

PayerCentene

PolicyTedizolid (Sivextro) (PDF)

Policy CodePolicy CP.PMN.62

Change TypePediatric extension; step therapy bypass; coding update

Effective DateMar 1, 2015

Next Review Date

Key ActionProvider must submit documentation (office notes, lab results, C&S reports) supporting that member meets all approval criteria; include C&S when feasible.

SourceLink

On This Page

If request is for Sivextro tablets, member is ≥ 35 kg

ANY of the following

Request is for continuation of therapy initiated in an acute care hospital from which member was discharged
ALL of the following
- Culture and sensitivity (C&S) report for the current infection shows isolated pathogen is a gram-positive bacteria susceptible to tedizolid, unless provider documents obtaining a C&S report is not feasible
- One of
  - 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
    Step therapy bypass for IL HIM per IL HB 5395 as of 1/1/2026
  - C&S report shows resistance or lack of susceptibility of the isolated pathogen to all formulary antibiotics FDA-approved for member's diagnosis
  - If obtaining a C&S report is not feasible: Failure of ≥ 2 formulary antibiotics indicated for member's diagnosis (if available), unless clinically significant adverse effects are experienced or all are contraindicated
    Step therapy bypass for IL HIM per IL HB 5395 as of 1/1/2026

Dose must not exceed

Adults and pediatrics ≥ 35 kg: 200 mg per day; 1 tablet or 1 vial per day200 mg/day
Pediatrics < 35 kg: Weight-based dosing (see Section V), not to exceed 120 mg per day; 1 vial per day120 mg/day

Member is responding positively to therapy

Member has not received ≥ 6 days of therapy for current infection< 6 days

If request is for dose increase, new dose must not exceed

Adults and pediatrics ≥ 35 kg: 200 mg per day; 1 tablet or 1 vial per day200 mg/day
Pediatrics < 35 kg: Weight-based dosing (see Section V), not to exceed 120 mg per day; 1 vial per day120 mg/day

Provider action type: documentation
Include office notes
Include lab results
Include C&S reports when feasible

Billing Rule

Dose and unit limits

Observe dose and unit limits when submitting claims. Adults and pediatrics ≥ 35 kg: maximum 200 mg per day — do not exceed 1 tablet or 1 vial per day. Pediatrics < 35 kg: weight-based dosing per policy (see dosing table) not to exceed 120 mg per day; unit limit is 1 vial per day. Use HCPCS codes J3090 (injection, tedizolid phosphate, 1 mg) and J8499 (prescription drug, oral, non chemotherapeutic, nos) as applicable.

Provider action type: billing_rule
HCPCS codes: J3090, J8499
Adults and pediatrics ≥ 35 kg: 200 mg/day; 1 tablet or 1 vial per day
Pediatrics < 35 kg: weight-based dosing, max 120 mg/day; 1 vial per day

Denial Risk

Non-FDA uses require off-label policy adherence

Requests for non‑FDA approved indications will be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies or evidence of coverage documents.

Provider action type: denial_risk

Added HCPCS code J8499 for oral Sivextro (Commercial line of business) and added Commercial line of business.

09.27.2021administrative_update

Template and references updated across reviews; removed specific requirement for trial of linezolid in legacy WCG policy (administrative/templating updates during 2021-2024).