Delandistrogene moxeparvovec-rokl (Elevidys®)
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
Elevidys is indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
This indication is approved under accelerated approval based on expression of Elevidys micro-dystrophin in skeletal muscle observed in patients treated with Elevidys. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
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. Genetic test results confirming the DMD diagnosis.
B. Medical records (e.g., chart notes, lab reports) documenting the member’s ambulation status.
III. EXCLUSIONS
Coverage will not be provided for members with any of the following exclusions:
A. Member has a deletion in exon 8 and/or exon 9 in the DMD gene.
B. Elevidys will not be used in combination with exon-skipping therapies (casimersen, eteplirsen, golodirsen, viltolarsen).
IV. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a physician who specializes in the treatment of Duchenne muscular dystrophy (DMD).
V. CRITERIA FOR INITIAL APPROVAL
Duchenne muscular dystrophy
Authorization of 1 month for one dose total may be granted for treatment of Duchenne muscular dystrophy when all of the following criteria are met:
A. Member is 4 to 5 years of age (inclusive).
B. Member is ambulatory (e.g., able to walk with or without assistance, not wheelchair dependent).
C. Member has a definitive diagnosis of DMD confirmed via genetic testing.
D. Member has anti-recombinant adeno-associated virus serotype rh74 (anti-AAVrh74) total binding antibody titers of < 1:400.
E. Member has not received treatment with Elevidys previously.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
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. Elevidys [package insert]. Cambridge, MA: Sarepta Therapeutics, Inc.; June 2023.
ORIGINAL EFFECTIVE DATE: 8/30/2023
MOST RECENT REVIEW DATE: 1/1/2024
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.
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