Subject: Mircera 1618-A SGM P2023
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MIRCERA
(methoxy polyethylene glycol-epoetin beta)
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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:
1. Adult patients on dialysis and adult patients not on dialysis.
2. 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 pretreatment hemoglobin level
exclude values due to a 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 a 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.
Place of Service:
Outpatient
The above policy is based on the following references:
- Mircera [package insert]. St. Gallen, Switzerland: Vifor (International) Inc.; March 2023.
- 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.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
February 11, 2024
