Sutimlimab-jome (Enjaymo) (ARCHIVED)

Policy ID: I-251-007

Section: Injections

Effective Date: April 01, 2022

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-251-007

Section: Injections

Effective Date: April 01, 2022

Revised Date: October 16, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Sutimlimab-jome (Enjaymo) is a humanized monoclonal antibody selectively targeting complement component 1s (C1s) which inhibits the classical complement pathway. This inhibits hemolysis in individuals with cold agglutinin disease (CAD).

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Sutimlimab-jome (Enjaymo) may be considered medically necessary when ALL of the following criteria are met:

Individual is 18 years of age or older; and
Individual has diagnosis of primary CAD as defined by ONE of the following:
- Chronic hemolysis (e.g., high reticulocytes, high LDH, high indirect bilirubin, low haptoglobin); or
- Polyspecific direct antiglobulin test (DAT) positive; or
- Monospecific DAT strongly positive for C3d; or
- IgG direct antiglobulin test less than or equal to 1+; or
- Cold agglutinin titer of greater than or equal to 64 at 4 degrees Celsius; and
Individual has hemoglobin level of less than or equal to 10 g/dL; and
Individual has bilirubin level above the normal reference range (1.2mg/dL); and
Individual has presence of at least ONE of the following CAD-related signs or symptoms within three (3) months of screening:
- Symptomatic anemia defined by ONE of the following:
  - Fatigue; or
  - Weakness; or
  - Shortness of breath; or
  - Palpitations/ Tachycardia; or
  - Light headedness; or
  - Chest pain; or
- Acrocyanosis; or
- Raynaud's syndrome; or
- Hemoglobinuria; or
- Disabling circulatory symptoms; or
- Major adverse vascular event (including thrombosis); and
Secondary causes of CAD have been ruled out (e.g., infection, rheumatologic diseases, overt hematologic malignancies, other autoimmune disorders etc.); and
Individual has been vaccinated against encapsulated bacteria (e.g., Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae serogroup b, etc.) at least two (2) weeks prior to initiation; and
Individual has not received rituximab within three (3) months of initiation and will not be using rituximab with sutimlimab-jome (Enjaymo); and
Sutimlimab-jome (Enjaymo) is being prescribed by or in consultation with a hematologist; and
Initial authorization will be for a period of six (6) months.

Reauthorization Criteria

Continuation of therapy with sutimlimab-jome (Enjaymo) may be considered medically necessary for the treatment of an individual with CAD when ALL of the following criteria are met:

Individual has an increase in hemoglobin level of 1.5 g/dL or more from baseline; or
Individual has normalization of hemoglobin level to 12 g/dL or higher; or
Individual has normalization of bilirubin levels to less than 1.2 mg/dL; or
Individual has decreased number of blood transfusions since initiation of therapy.

The use of sutimlimab-jome (Enjaymo) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J1302

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

D59.12

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 3-23-2022 - Effective April 01, 2022

Adopted new precertification drug policy

Internal Medical Policy Committee 7-21-2022 - Effective July 01, 2022

Added new code, C9094, to the policy

Internal Medical Policy Committee 9-28-2022 - Effective October 01, 2022

Added new code, J1302, and
Removed code, C9094, from the policy

Internal Medical Policy Committee 5-23-2023 - Effective July 1, 2023

Updated initial and reauthorization criteria
Updated E/I statement

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Added additional criteria for definition of diagnosis of primary CAD

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Our Partners in Health:
Members
Employers
Producers

Fargo (Headquarters)
4510 13th Ave. S.
Fargo, N.D., 58121

Medical Policies Quick Search