ModifiedConnectiCarePolicy C9351-A

Dalvance (dalbavancin) Coverage Criteria

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This policy governs prior authorization and medical-necessity coverage for intravenous Dalvance (dalbavancin) used to treat acute bacterial skin and skin structure infections and adult osteomyelitis. It applies to providers requesting coverage, subject to member benefit eligibility and the clinical criteria in the policy.

Policy Summary

PayerConnectiCare

PolicyDalvance (dalbavancin) Coverage Criteria

Policy CodePolicy C9351-A

Change TypeModified

Effective DateApr 1, 2026

Next Review DateJan 1, 2027

Key ActionSubmit prior authorization documenting the applicable indication, clinical criteria, infectious disease prescriber involvement, and requested initial authorization period.

SourceLink

POLICY UPDATE CHANGES

The policy revision history identifies revisions to continuation of therapy and FDA-approved uses.

The policy revision history identifies revisions to background information, required medical information, age restrictions, quantity, drug class, diagnosis, and available dosage forms.

2Covered infection indications

1 monthInitial authorization duration

18+Minimum age for osteomyelitis coverage

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ModifiedConnectiCarePolicy C9351-A

Dalvance (dalbavancin) Coverage Criteria

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Policy Summary

PayerConnectiCare

PolicyDalvance (dalbavancin) Coverage Criteria

Policy CodePolicy C9351-A

Change TypeModified

Effective DateApr 1, 2026

Next Review DateJan 1, 2027

Key ActionSubmit prior authorization documenting the applicable indication, clinical criteria, infectious disease prescriber involvement, and requested initial authorization period.

SourceLink

POLICY UPDATE CHANGES

The policy revision history identifies revisions to continuation of therapy and FDA-approved uses.

The policy revision history identifies revisions to background information, required medical information, age restrictions, quantity, drug class, diagnosis, and available dosage forms.

2Covered infection indications

1 monthInitial authorization duration

18+Minimum age for osteomyelitis coverage

IV infusionRoute of administration

1500 mg x 2Osteomyelitis dose schedule

Covered Indications and Coverage Rules

ABSSSI — Initial Coverage

Covered when ALL of the following are met:

ALL of the following

Documentation that the member has an infection caused by, or strongly suspected to be caused by, a type of pathogen and site of infection within the FDA label.
ONE of the following
- Documentation of an FDA-labeled contraindication to vancomycin.
- Documentation of inadequate treatment response, serious side effects, or a nonsusceptibility report for the current infection to vancomycin.
- Prescriber provides a detailed medical necessity rationale against outpatient parenteral antimicrobial therapy with vancomycin.
- Request is for continuation of therapy started in an inpatient setting within the last 14 days, and the member is transitioning to an outpatient site of care at the time of request.
  Discharge documentation is required and must include the infectious disease prescriber consultation, duration of therapy, and start and end dates.

Osteomyelitis — Initial Coverage

Covered when ALL applicable criteria are met:

ALL of the following

Documented diagnosis of osteomyelitis with a suspected gram-positive source of infection.
ONE of the following
- Inadequate response, serious side effects, nonsusceptibility, or contraindication to all applicable agents
  - For MSSA: inadequate treatment response, serious side effects, a nonsusceptibility report for the current infection, or an FDA-labeled contraindication to all of the following: nafcillin, cefazolin, or oxacillin.
  - For MRSA: inadequate treatment response, serious side effects, a nonsusceptibility report for the current infection, or an FDA-labeled contraindication to all of the following: vancomycin or daptomycin.
- Medical necessity rationale against outpatient parenteral antimicrobial therapy

FDA-Approved Use — ABSSSI

Covered for the FDA-approved treatment indication when ALL of the following are met:

ALL of the following

Treatment of acute bacterial skin and skin structure infections (ABSSSI).
The member is an adult or pediatric patient.
The infection is caused by, or strongly suspected to be caused by, designated susceptible strains of Gram-positive microorganisms.
Eligible designated susceptible microorganisms
- Staphylococcus aureus, including methicillin-susceptible and methicillin-resistant isolates.
- Streptococcus pyogenes.

Compendial Approved Off-Label Use — Adult Osteomyelitis

Covered for the compendial approved off-label use when the following is met:

Treatment of osteomyelitis in adults.

All other uses of Dalvance (dalbavancin) are considered experimental or investigational and are subject to the applicable off-label policy.

Known hypersensitivity to dalbavancin is a contraindication to Dalvance (dalbavancin).

Billing and Coding

HCPCS CodeHCPCS

J0875

Injection, dalbavancin, 5 mg

Prior Authorization and Documentation

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required. Submit documentation supporting the requested indication, applicable infection and pathogen, all clinical criteria, and the prescriber requirement. Initial authorization is approved for 1 month; continuation of therapy is not applicable.

Document an infection caused by, or strongly suspected to be caused by, a pathogen and site of infection within the FDA label.
For ABSSSI, document the qualifying vancomycin alternative-therapy requirement or provide the applicable inpatient-to-outpatient transition documentation.
For osteomyelitis, document the diagnosis, suspected gram-positive source, and qualifying failure, intolerance, nonsusceptibility, or contraindication to all applicable alternatives.
Dalvance must be prescribed by or in consultation with an infectious disease specialist.

Step Therapy

ABSSSI Alternative-Therapy Requirement

For ABSSSI requests, document why vancomycin is not appropriate for the current infection or why outpatient parenteral antimicrobial therapy with vancomycin is not appropriate.

Drug and Indication Background

Dalvance (dalbavancin) is an intravenous glycopeptide antibacterial used for acute bacterial skin and skin structure infections caused by susceptible Gram-positive organisms. The policy also recognizes adult osteomyelitis as a compendial approved off-label use. For the FDA-approved indication, designated susceptible organisms include Staphylococcus aureus, Streptococcus species, and vancomycin-susceptible Enterococcus faecalis.

Covered Condition Definitions

Definitions

TermABSSSI

ConditionAcute bacterial skin and skin structure infections

Causative organismsDesignated susceptible strains of Gram-positive microorganisms

Definitions

TermOsteomyelitis covered condition

ConditionDocumented osteomyelitis

Required sourceSuspected gram-positive source of infection

Initial Therapy Requirements

ABSSSI Initial Therapy

ABSSSI coverage requires all of the following.

ABSSSI requirements

FDA-labeled infection: The infection is caused or strongly suspected to be caused by a pathogen and the site is within the FDA label.
Vancomycin-related condition: At least one of the following applies: an FDA-labeled contraindication; inadequate response, serious side effects, or nonsusceptibility to vancomycin; a detailed rationale against outpatient parenteral vancomycin therapy; or a qualifying inpatient-to-outpatient transition.
The transition pathway requires therapy to have started inpatient within the last 14 days and requires discharge documentation.

Osteomyelitis Initial Therapy

Osteomyelitis coverage requires all of the following.

Continuation of Therapy

Continuation Therapy

Continuation therapy is not applicable.

New review for each infection: Each new infection treatment should be submitted as a new review.

Continuation of therapy is listed as not applicable.

Alternative Therapy Requirements

Step	Indication	Coverage	Qualification requirement
1	Acute bacterial skin and skin structure infection (ABSSSI)	Covered with criteria	Documentation must show an infection caused by, or strongly suspected to be caused by, a pathogen and site within the FDA label, plus at least one of the following: an FDA-labeled contraindication to vancomycin; inadequate treatment response, serious side effects, or nonsusceptibility to vancomycin for the current infection; a detailed medical-necessity rationale against outpatient parenteral vancomycin therapy; or transition to an outpatient site of care after inpatient therapy started within the last 14 days. Discharge documentation is required for the inpatient-to-outpatient transition pathway.

Step	Indication	Coverage	Qualification requirement
1	Osteomyelitis with a suspected gram-positive source of infection	Covered with criteria	Document inadequate treatment response, serious side effects, a nonsusceptibility report for the current infection, or an FDA-labeled contraindication to all applicable alternatives: nafcillin, cefazolin, and oxacillin for MSSA; or vancomycin and daptomycin for MRSA. Alternatively, provide a detailed medical-necessity rationale against outpatient parenteral therapy with the applicable alternatives.

Dose and Quantity Limits

Quantity Limits

PopulationAdults with ABSSSI

Single-dose option1500 mg as a single dose

Two-dose option1000 mg followed one week later by 500 mg

Quantity Limits

PopulationPatients younger than 6 years with ABSSSI

Weight-based dose22.5 mg/kg

Maximum dose1500 mg, single-dose regimen

Administration Location

Billing Rule

Use an eligible infusion-center setting

Administer the infused medication in a place of service that is a non-inpatient hospital facility-based location.

Policy Summary

PayerConnectiCare

PolicyDalvance (dalbavancin) Coverage Criteria

Policy CodePolicy C9351-A

Change TypeModified

Effective DateApr 1, 2026

Next Review DateJan 1, 2027

Key ActionSubmit prior authorization documenting the applicable indication, clinical criteria, infectious disease prescriber involvement, and requested initial authorization period.

SourceLink

On This Page

For MSSA: prescriber provides a detailed medical necessity rationale against outpatient parenteral antimicrobial therapy with nafcillin, cefazolin, or oxacillin.
For MRSA: prescriber provides a detailed medical necessity rationale against outpatient parenteral antimicrobial therapy with vancomycin or daptomycin.

Streptococcus agalactiae.

Streptococcus dysgalactiae.

Streptococcus anginosus group, including S. anginosus, S. intermedius, and S. constellatus.

Enterococcus faecalis, vancomycin-susceptible isolates.

FDA-labeled contraindication to vancomycin.
Inadequate treatment response, serious side effects, or a nonsusceptibility report for the current infection.
Detailed prescriber medical-necessity rationale against outpatient parenteral antimicrobial therapy with vancomycin.
If continuing therapy started during an inpatient stay, use the discharge-documentation pathway described below.

Step Therapy

Osteomyelitis Alternative-Therapy Requirement

For osteomyelitis, document that the member has a diagnosis of osteomyelitis with a suspected gram-positive source and that all applicable alternatives are unsuitable.

For MSSA: document inadequate treatment response, serious side effects, a nonsusceptibility report for the current infection, or an FDA-labeled contraindication to all of nafcillin, cefazolin, and oxacillin; or provide a detailed rationale against outpatient parenteral therapy with those agents.
For MRSA: document inadequate treatment response, serious side effects, a nonsusceptibility report for the current infection, or an FDA-labeled contraindication to both vancomycin and daptomycin; or provide a detailed rationale against outpatient parenteral therapy with those agents.

Documentation Required

Submit Complete Medical Records

Submit sufficient medical-necessity documentation for review. ConnectiCare may request additional information and may deny reimbursement or take other action when records do not support medical necessity, non-investigational status, benefit eligibility, or appropriate practice.

Patient medical records and relevant test results.
Credentials of the provider ordering or performing the drug or service.
Weight, body surface area, or other member-specific measurement when dosing uses that information.
Any additional documentation requested for adequate case-by-case review.

Documentation Required

Discharge Documentation Required

For ABSSSI continuation of therapy started during an inpatient stay within the last 14 days, submit discharge documentation showing the transition to an outpatient site of care.

Discharge documentation must include the infectious disease prescriber consultation, duration of therapy, and treatment start and end dates.

Documentation Required

Submit Infectious Disease Consultation Notes

Dalvance must be prescribed by or in consultation with an infectious disease specialist. When the prescriber is acting in consultation with a specialist, submit the consultation notes with the initial request.

Include infectious disease consultation notes with the initial prior authorization request when applicable.

Denial Risk

Insufficient Supporting Documentation May Result in Denial

Requests may be denied when the submitted documentation does not support that Dalvance is medically necessary, non-investigational or experimental, and within the member’s benefit eligibility, or when documentation indicates inappropriate or excessive billing or practice.

Provide records and other requested evidence sufficient to support the coverage determination.

Denial Risk

Clinical Criteria Not Met

Requests may be denied when the applicable infection, pathogen, and required clinical criteria are not documented.

Document an FDA-labeled infection and site of infection caused by, or strongly suspected to be caused by, a qualifying pathogen.
Document the applicable ABSSSI or osteomyelitis alternative-therapy requirement and supporting clinical evidence.
Document all other required criteria, including the infectious disease prescriber requirement.

Denial Risk

Unapproved or Unsupported Indication

Coverage may be denied for uses outside FDA-approved indications or approved compendial off-label indications. All other uses are considered experimental or investigational and are subject to the applicable off-label policy.

Submit documentation tying the request to a covered FDA-approved or applicable compendial off-label indication.

Denial Risk

Known Dalbavancin Hypersensitivity

Dalvance is contraindicated in patients with known hypersensitivity to dalbavancin.

Do not request or administer Dalvance when known dalbavancin hypersensitivity is present.

Denial Risk

Susceptible Bacteria Required

Use Dalvance only for infections proven or strongly suspected to be caused by susceptible bacteria, consistent with antimicrobial stewardship requirements.

For ABSSSI, document the infection and susceptibility support for designated susceptible Gram-positive microorganisms, when available.
Requests may be denied when the bacterial cause is not proven or strongly suspected to be susceptible.

Osteomyelitis requirements: Document osteomyelitis with a suspected gram-positive source and either qualifying failure, intolerance, nonsusceptibility, or contraindication to all applicable alternatives, or a detailed rationale against outpatient parenteral therapy with those alternatives.

MSSA alternatives: nafcillin, cefazolin, oxacillin. MRSA alternatives: vancomycin, daptomycin.

Quantity Limits

PopulationPatients 6 years of age to less than 18 years with ABSSSI

Weight-based dose18 mg/kg

Maximum dose1500 mg, single-dose regimen

Quantity Limits

ConditionOsteomyelitis

Dose1500 mg per dose

Schedule2 doses, 1 week apart