Fetroja (cefiderocol sulfate tosylate)

POLICY NUMBER

L.5.01.577

Fetroja (cefiderocol sulfate tosylate)

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

Fetroja (cefiderocol sulfate tosylate) is an intravenous cephalosporin antibacterial agent with a novel mechanism for transport across the outer membrane that can overcome the effect of membrane permeability mutations. Fetroja (cefiderocol sulfate tosylate) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Fetroja (cefiderocol sulfate tosylate) is also indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja (cefiderocol sulfate tosylate) and other antibacterial drugs, it should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 

Fetroja (cefiderocol sulfate tosylate) may be considered medically necessary when ALL of the following criteria are met:

1. The individual is >18 years old;

2. The individual has ONE of the following diagnoses:

   1. Complicated urinary tract infection, including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex; OR

   2. Hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens;

3. Culture and sensitivity testing has identified the pathogen and demonstrated susceptibility to the requested medication (documentation required);

4. The individual has limited or no alternative treatment alternatives;

5. The individual does not have an FDA-labeled contraindication to therapy with the requested agent; AND

6. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

 Length of Approval:

• Up to 14 days

 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

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.

Medication failure is defined as disease progression despite maximally tolerated dose (>3 months use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.

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.

Investigative  is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of 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. In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

BCBSMS determines patient medication trials and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or the requesting provider to obtain said records and submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

11/01/2020: New policy added.

09/29/2021: Code Reference section updated to add new HCPCS code J0699, effective 10/01/2021.

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.

01/31/2025: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Fetroja (cefiderocol sulfate tosylate). Policy section updated to state that the use of samples by an individual will not be considered current or stable therapy for purposes of Medical Policy review. Medically necessary criteria updated regarding diagnoses, culture and sensitivity testing, treatment alternatives, contraindications, and dose requirements. Length of approval changed from "Up to 2 weeks" to "Up to 14 days." Added statement that 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 updated. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders." Sources updated. Code Reference section updated to remove HCPCS codes C9399 and J3490.

12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy section updated to add "Prior authorization is required." Revised statement to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Sources updated.

SOURCE(S)

1. Fetroja prescribing information. Shionogi Inc. July 2025. Last accessed September 2025.

2. Letourneau AR. Cephalosporins. UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed on September 23, 2025. https://www.uptodate.com/contents/cephalosporins

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.

Medically Necessary Codes

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