CurrentCentenePolicy CP.PHAR.351

Daptomycin (Cubicin, Cubicin RF) (PDF)

Clinical policy defining medical necessity criteria, dosing limits, prior authorization requirements, indications covered and not covered, and coding implications for daptomycin (including Cubicin RF) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyDaptomycin (Cubicin, Cubicin RF) (PDF)

Policy CodePolicy CP.PHAR.351

Change TypeAnnual reviews and revisions (2022-2025)

Effective Date11.01.17

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

3Q 2025 annual review: removed references to Cubicin and Dapzura RT as these branded products are discontinued; added 350 mg strength to Section VI; added step therapy bypass for IL HIM per IL HB 5395.

3Q 2024 annual review: no significant changes; references reviewed and updated.

3Q 2023 annual review: added HCPCS code J0877; references reviewed and updated.

3Q 2022 annual review: added requirement for use of generic daptomycin if request is for brand Cubicin/Cubicin RF; removed left-sided endocarditis from Section III and added requirements to allow use after failure of vancomycin per AHA 2015 Infective Endocarditis Scientific Statement.

2FDA Approved Major Indication Groups (skin/skin structure; bloodstream/endocarditis)

1Age minimum (years)

14Max days - skin infections

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Max days - bloodstream/endocarditis

Coverage Summary

This clinical policy defines medical necessity criteria, dosing limits, prior authorization requirements, and coding implications for daptomycin (including Cubicin RF) across Commercial, HIM, and Medicaid lines of business. Coverage stance: covered_with_criteria — daptomycin is authorized when the policy's specific initial or continued therapy criteria are met.

Indications covered under the policy: complicated skin and skin structure infections in patients ≥ 1 year, and Staphylococcus aureus bloodstream infections (bacteremia) including right-sided infective endocarditis in adults (and pediatric bacteremia as specified). The policy explicitly does not authorize treatment of pneumonia and excludes non‑FDA approved indications not addressed by the policy unless supported by off‑label evidence or the off‑label use policy.

Daptomycin thresholds

Minimum age for use≥ 1 year (not recommended < 1 year due to potential neonatal risks)

Maximum therapy duration - complicated skin and skin structure infectionsUp to 14 days

Maximum therapy duration - bloodstream infection / infective endocarditisUp to 42 days

Initial Therapy Criteria

Initial Approval Criteria

Cubicin RF and daptomycin are medically necessary when the following criteria are met:

ALL of the following

A. Skin and Skin Structure Infection (must meet all)
- Diagnosis of complicated skin and skin structure infection caused by susceptible isolates of one of: Staphylococcus aureus; Streptococcus pyogenes; Streptococcus agalactiae; Streptococcus dysgalactiae subsp. equisimilis; Enterococcus faecalis (vancomycin-susceptible isolates only)
- Prescribed by or in consultation with an infectious disease specialist
- Age ≥ 1 year
- Failure of vancomycin, unless contraindicated, clinically significant adverse effects are experienced, or culture and sensitivity report indicates pathogen not susceptible to vancomycin

Continuation Therapy Criteria

Continued Therapy

Criteria to approve continuation of therapy

ALL of the following

A. Skin and Skin Structure Infection (must meet all)
- Currently receiving medication
- Member has not yet received 14 days of therapyUp to 14 days
- If request is for brand Cubicin RF, member must use generic daptomycin, unless contraindicated or clinically significant adverse effects are experienced
- ALL of the following

Unapproved Indications / Exclusions

Diagnoses/Indications Not Authorized

Coverage is not authorized for the following

ALL of the following

Non-FDA approved indications not addressed in this policy unless sufficient documentation of efficacy and safety per off-label use policy or evidence of coverage
Treatment of pneumonia

Denial Risk

Excluded indication - pneumonia

Requests for treatment of pneumonia are not authorized and are at risk for denial.

Requests for pneumonia are at risk for denial.

Applicable Codes

HCPCS codes for daptomycin (informational)HCPCS

J0872	Injection, daptomycin (Xellia), unrefrigerated, not therapeutically equivalent to J0878 or J0873, 1 mg
J0873	Injection, daptomycin (Xellia) not therapeutically equivalent to J0878 or J0872, 1 mg
J0874	Injection, daptomycin (Baxter), not therapeutically equivalent to J0878, 1 mg
J0877	Injection, daptomycin (Hospira), not therapeutically equivalent to J0878, 1 mg
J0878	Injection, daptomycin, 1 mg

HCPCS codes for daptomycin (informational)HCPCS

J0872	Injection, daptomycin (Xellia), unrefrigerated, not therapeutically equivalent to J0878 or J0873, 1 mg
J0873	Injection, daptomycin (Xellia) not therapeutically equivalent to J0878 or J0872, 1 mg
J0874	Injection, daptomycin (Baxter), not therapeutically equivalent to J0878, 1 mg
J0877	Injection, daptomycin (Hospira), not therapeutically equivalent to J0878, 1 mg
J0878	Injection, daptomycin, 1 mg

Provider Actions & Requirements

Documentation Required

Support clinical necessity

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

Prior Authorization

Prescriber specialty requirement

Requests must be prescribed by or in consultation with an infectious disease specialist for covered indications.

Prior Authorization

Brand vs generic requirement

If request is for brand Cubicin RF, member must use generic daptomycin unless contraindicated or clinically significant adverse effects are experienced.

Clinical Evidence & References

Primary source: Cubicin Prescribing Information, Merck, November 2022 (listed in policy references).

Guideline referenced: AHA 2015 Infective Endocarditis Scientific Statement (cited in the policy references).

Background

Daptomycin is a lipopeptide antibacterial indicated for complicated skin and skin structure infections and for Staphylococcus aureus bloodstream infections, including right‑sided infective endocarditis. The drug is not indicated for the treatment of pneumonia, and left‑sided infective endocarditis is not an authorized indication except in limited off‑label circumstances after vancomycin failure per the policy and guideline considerations.

Revision History

2025-08-25revisedLatest

2024-08-24revised

3Q 2024 annual review: no significant changes; references reviewed and updated.

2023-08-23revised

Policy Summary

PayerCentene

PolicyDaptomycin (Cubicin, Cubicin RF) (PDF)

Policy CodePolicy CP.PHAR.351

Change TypeAnnual reviews and revisions (2022-2025)

Effective Date11.01.17

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

*For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395

If request is for brand Cubicin RF, member must use generic daptomycin, unless contraindicated or clinically significant adverse effects are experienced

Dose does not exceed age-specific maximums

Age 1 to < 2 years: 10 mg per kg per day10 mg/kg/day
Age 2 to 6 years: 9 mg per kg per day9 mg/kg/day
Age 7 to 11 years: 7 mg per kg per day7 mg/kg/day
Age 12 to 17 years: 5 mg per kg per day5 mg/kg/day
Age ≥ 18 years: 4 mg per kg per day4 mg/kg/day

B. Bloodstream Infection and Infective Endocarditis (must meet all)

Diagnosis of bloodstream infection (bacteremia) including infective endocarditis caused by Staphylococcus aureus
Prescribed by or in consultation with an infectious disease specialist
Age ≥ 1 year
If concurrent infective endocarditis, age ≥ 18 years
If request is for left-sided infective endocarditis (off-label), failure of vancomycin unless contraindicated, clinically significant adverse effects are experienced, or culture and sensitivity report indicates pathogen not susceptible to vancomycin
*For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395
If request is for brand Cubicin RF, member must use generic daptomycin, unless contraindicated or clinically significant adverse effects are experienced
Dose does not exceed age-specific maximums
- Age 1 to 6 years: 12 mg per kg per day12 mg/kg/day
- Age 7 to 11 years: 9 mg per kg per day9 mg/kg/day
- Age 12 to 17 years: 7 mg per kg per day7 mg/kg/day
- Age ≥ 18 years: 6 mg per kg per day or 10 mg per kg per day for infective endocarditis6 or 10 mg/kg/day

C. Other diagnoses/indications (must meet 1 or 2)

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

Age 1 to < 2 years: 10 mg per kg per day10 mg/kg/day

Age 2 to 6 years: 9 mg per kg per day9 mg/kg/day

Age 7 to 11 years: 7 mg per kg per day7 mg/kg/day

Age 12 to 17 years: 5 mg per kg per day5 mg/kg/day

Age ≥ 18 years: 4 mg per kg per day4 mg/kg/day

B. Bloodstream Infection and Infective Endocarditis (must meet all)

Currently receiving medication
Member has not yet received 42 days of therapyUp to 42 days
Approval duration: Up to 42 days
If request is for brand Cubicin RF, member must use generic daptomycin, unless contraindicated or clinically significant adverse effects are experienced
ALL of the following
- Age 1 to 6 years: 12 mg per kg per day12 mg/kg/day
- Age 7 to 11 years: 9 mg per kg per day9 mg/kg/day
- Age 12 to 17 years: 7 mg per kg per day7 mg/kg/day
- Age ≥ 18 years: 6 mg per kg per day or 10 mg per kg per day for infective endocarditis6 or 10 mg/kg/day

C. Other diagnoses/indications (must meet 1 or 2)

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

Step Therapy

Vancomycin failure required

For most covered indications, prior failure of vancomycin is required unless vancomycin is contraindicated, causes clinically significant adverse effects, or culture/sensitivity shows non‑susceptibility; IL HIM requests bypass this requirement per IL HB 5395 effective 2026-01-01.

IL HB 5395 bypasses step therapy for Illinois HIM requests — effective 2026-01-01.

Billing Rule

Dose limit enforcement

Approvals will be denied if dose exceeds age-specific mg/kg/day maximums detailed in the policy.

J0872
J0873
J0874
J0877
J0878

3Q 2023 annual review: added HCPCS code J0877; references reviewed and updated.

2022-08-22revised