State and School Employees' Health Insurance Plan - Nuzyra (omadacycline)

POLICY NUMBER

S.5.01.558

Nuzyra (omadacycline)

Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.

DESCRIPTION

Nuzyra (omadacycline) is a tetracycline antibiotic indicated for the treatment of adult individuals with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nuzyra (omadacycline), it should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

POLICY

Nuzyra (omadacycline) is considered not medically necessary as there is insufficient evidence of greater clinical benefit when compared to other available treatment options for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.

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 Participant’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 Participant’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 Participant, his or her Provider; and

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

POLICY HISTORY

07/01/2023: New policy added.

10/01/2024: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated to change "patients" to "individuals." Policy statements unchanged. Sources updated.

09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. PPolicy statement unchanged. Sources updated.

SOURCE(S)

Nuzyra prescribing information. Paratek Pharmaceuticals, Inc. March 2025. Last accessed July 2025.

CODE REFERENCE

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

Not Medically Necessary Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.