Methoxy Polyethylene Glycol-Epoetin Beta (Mircera®)
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 Indications
Mircera is indicated for the treatment of anemia associated with chronic kidney disease (CKD) in:
· Adult patients on dialysis and adult patients not on dialysis.
· Pediatric patients 5 to 17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA.
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Note: Requirements regarding hemoglobin level exclude values due to recent transfusion. All members must be assessed for iron deficiency anemia and have adequate iron stores (defined as a serum transferrin saturation [TSAT] level greater than or equal to 20% within the prior 3 months) or are receiving iron therapy before starting Mircera. Members may not use Mircera concomitantly with other erythropoiesis stimulating agents.
Anemia Due to Chronic Kidney Disease (CKD)
Authorization of 12 weeks may be granted for the treatment of anemia due to chronic kidney disease in members with pretreatment hemoglobin < 10 g/dL.
III. CONTINUATION OF THERAPY
Note: Requirements regarding current hemoglobin level exclude values due to recent transfusion. All members must be assessed for iron deficiency anemia and have adequate iron stores (defined as a serum transferrin saturation [TSAT] level greater than or equal to 20% with the prior 3 months) or are receiving iron therapy before continuation of treatment with Mircera. Members may not use Mircera concomitantly with other erythropoiesis stimulating agents.
Anemia Due to Chronic Kidney Disease (CKD)
1. Authorization of 12 weeks may be granted for continued treatment of anemia due to chronic kidney disease in members with current hemoglobin < 12 g/dL and the member has shown a response to therapy with a rise in hemoglobin of > 1 g/dL after at least 12 weeks of ESA therapy.
2. Authorization of up to 12 weeks may be granted for continued treatment of anemia due to chronic kidney disease in members who have not completed 12 weeks of ESA therapy.
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. Mircera [package insert]. St. Gallen, Switzerland: Vifor (International) Inc.; March 2023
2. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney Int. 2012;Suppl 2:279-335.
ORIGINAL EFFECTIVE DATE: 12/1/2015
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.
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