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
The requested drug will be covered with prior authorization when the following criteria are met:
· The patient has a diagnosis of severe combined immunodeficiency disease (SCID) due to adenosine deaminase (ADA) deficiency
AND
o The request is for initiation of therapy
OR
· The patient has a diagnosis of severe combined immunodeficiency disease (SCID) due to adenosine deaminase (ADA) deficiency
AND
o The patient is currently receiving treatment with Revcovi
AND
o The patient has experienced disease stabilization or improvement while on therapy with Revcovi
AND
o The patient has NOT experienced unacceptable toxicity from treatment with the requested medication
LENGTH OF AUTHORIZATION
Coverage is provided for 12 months and may be renewed.
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. Revcovi [package insert]. Cary, NC; Chiesi USA, Inc.; 2020. Accessed August 2024.
2. Elapegademase. In: Clinical Pharmacology. Tampa (FL): Elsevier. Revised September 2023. Accessed August 2024.
3. Lexi-Comp Online. (2024, August). AHFS DI. Revcovi. Retrieved August 2024 from Lexi-Comp Online with AHFS.
4. MICROMEDEX Healthcare Series. Drugdex Evaluations. (2023, September). Elapegademase-lvir. Retrieved August 2024 from MICROMEDEX Healthcare Series.
ORIGINAL EFFECTIVE DATE:3/2/2019
MOST RECENT REVIEW DATE: 10/8/2024
ID_BT
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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