Daptomycin

POLICY NUMBER

L.5.01.496

Cubicin (daptomycin injection)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Cubicin (daptomycin for injection) is a cyclic lipopeptide antibacterial agent indicated in adult and pediatric patients (1 to 17 years of age) for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only). Cubicin (daptomycin for injection) is also indicated in adults and pediatric patients (1 to 17 years of age) for the treatment of Staphylococcus aureus bloodstream infections (bacteremia), and for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.

Cubicin (daptomycin for injection) is not indicated for the treatment of pneumonia, left-sided infective endocarditis (LIE) due to S. aureus, or pediatric patients younger than 1 year of age.

POLICY

Daptomycin may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The individual is 1 year of age or older and ONE of the following:

      1. The individual has a complicated skin and skin structure infection (cSSSI) caused by a susceptible Gram-positive bacteria as evidenced by culture and sensitivity report; OR

      2. The individual has a bloodstream infection (bacteremia) caused by Staphylococcus aureus; OR

   2. The individual is 18 years of age or older AND has a bloodstream infection (bacteremia) caused by Staphylococcus aureus, including those with right-sided infective endocarditis caused by methicillin-susceptible and methicillin-resistant isolates;

2. ONE of the following:

   1. The individual has clinical documentation of trial and failure (see definition of Medication Failure in Policy Guidelines section) of vancomycin for the current active infection; OR

   2. The provider has submitted a culture and sensitivity report indicating the gram positive organism is susceptible to daptomycin and resistant to vancomycin;

3. The initial prescribing/recommendation for prescribing is made by or in consultation with a board certified infectious disease provider;

4. The individual does not have any contraindication(s) to the requested agent; AND

5. The prescribed dosage is within the program quantity limit based on FDA approved labeled dosage. 

Length of Approval:

• Complicated skin and skin structure infections: up to 2 weeks

• S. aureus bacteremia: up to 6 weeks

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. 

BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Vancomycin Failure

Vancomycin failure is defined as persistent infection, emergence of resistant organism(s), superinfections, unacceptable toxicity, and/or inability to achieve therapeutic serum concentrations despite dose and interval adjustment.

POLICY HISTORY

07/01/2016: New policy L.5.01.496 added.

08/08/2016: Code Reference section updated to add ICD-10 diagnosis codes.

09/30/2016: Code Reference section updated to add new ICD-10 diagnosis code L03.213.

11/01/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.

05/16/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

03/27/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added generic drug name to policy. Policy description updated regarding indication for pediatric patients. Policy section updated to add length of approval for complicated skin and skin structure infections and S. aureus bacteremia. Source updated.

05/06/2021: Policy title changed from "Cubicin (daptomycin)" to "daptomycin." Policy description updated regarding indication for Cubicin (daptomycin for injection). Policy statement updated to change "Cubicin" to "Daptomycin" and to revise medically necessary criteria. Added statement that services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders," to add information regarding BCBSMS request for medical records, and to define Vancomycin failure. Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.

06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Cubicin (daptomycin injection). Revised medically necessary statement regarding individuals age 18 years of age or older with a bloodstream infection (bacteremia). Sources updated.

09/15/2025: Code Reference section updated to add HCPCS codes J0872, J0873, J0874, and J0877 to the Covered Codes table.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis codes L02.217, L02.227, L03.31A, and L03.32A. Revised code descriptions for ICD-10 diagnosis codes L02.212 and L02.222.

SOURCE(S)

Daptomycin prescribing information. Camber Pharmaceuticals, Inc. January 2023. Last accessed March 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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