Sutimlimab-jome (Enjaymo™)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indication
Enjaymo is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. For initial requests: chart notes, medical records or test results documenting:
1. Lactate dehydrogenase (LDH) level above the upper limit of normal and haptoglobin level below the lower limit of normal
2. Positive polyspecific direct antiglobulin test (DAT) result
3. Monospecific DAT result strongly positive for C3d
4. Cold agglutinin titer of 1:64 or higher measured at 4°C
5. DAT result for IgG of 1+ or less
6. Secondary CAD has been ruled out (e.g., cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy)
B. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.
III. CRITERIA FOR INITIAL APPROVAL
Cold Agglutinin Disease (CAD)
Authorization of 6 months may be granted for the treatment of cold agglutinin disease (CAD) when all of the following criteria are met:
A. Confirmed diagnosis of primary cold agglutinin disease (CAD) based on all of the following:
1. Evidence of hemolysis as indicated by both of the following:
i. Lactate dehydrogenase (LDH) level above the upper limit of normal
ii. Haptoglobin level below the lower limit of normal
2. Positive polyspecific direct antiglobulin test (DAT) result
3. Monospecific DAT result strongly positive for C3d
4. Cold agglutinin titer of 1:64 or higher measured at 4°C
5. DAT result for IgG of 1+ or less
B. Secondary CAD has been ruled out (e.g., cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy)
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when there is no evidence of unacceptable toxicity or disease progression while on the current regimen and member demonstrates a positive response to therapy (e.g., improvement in hemoglobin levels, improvement in markers of hemolysis [e.g., bilirubin, haptoglobin, lactate dehydrogenase [LDH], reticulocyte count], a reduction in blood transfusions).
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. 1. Enjaymo [package insert]. Waltham, MA: Bioverativ USA Inc.; March 2023.
2. Röth A, Barcellini W, D’Sa S, Miyakawa Y, Broome CM, Michel M, Kuter DJ, Jilma B, Tvedt THA, Fruebis J, et al. Sutimlimab in cold agglutinin disease. N Engl J Med. 2021;384(14):1323–34.
3. Jäger U, Barcellini W, Broome CM, et al. Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting. Blood Rev. 2020;41:100648.
ORIGINAL EFFECTIVE DATE: 4/30/2022
MOST RECENT REVIEW DATE: 4/9/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.