​Last Review Date: 06/04/2024

Date of Origin: 01/06/2015

Dates Reviewed: 01/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 09/2020, 05/2021, 05/2022, 05/2023, 05/2024, 06/2024

1. Length of Authorization

• Coverage will be provided for 45 days and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Mircera 30 mcg prefilled syringe: 1 syringe every 14 days
• Mircera 50 mcg prefilled syringe: 1 syringe every 14 days
• Mircera 75 mcg prefilled syringe: 1 syringe every 14 days
• Mircera 100 mcg prefilled syringe: 1 syringe every 14 days
• Mircera 120 mcg prefilled syringe: 1 syringe every 14 days
• Mircera 150 mcg prefilled syringe: 1 syringe every 14 days
• Mircera 200 mcg prefilled syringe: 1 syringe every 28 days
• Mircera 250 mcg prefilled syringe: 1 syringe every 28 days
• Mircera 360 mcg prefilled syringe: 1 syringe every 28 days

B. Max Units (per dose and over time) [HCPCS Unit]:

• 360 billable units every 28 days

3. Initial Approval Criteria ¹

    Coverage is provided in the following condition(s):

Universal Criteria ^1-6

• Lab values are obtained within 30 days of the date of administration (unless otherwise indicated); AND
• Patient has adequate iron stores as demonstrated by serum ferritin ≥ 100 ng/mL (mcg/L) and transferrin saturation (TSAT) ≥ 20% (measured within the previous 3 months for renewal)*; AND
• Other causes of anemia (e.g., hemolysis, bleeding, vitamin deficiency, etc.) have been ruled out; AND
• Patient does not have uncontrolled hypertension; AND

Anemia Due to Chronic Kidney Disease (Non-Dialysis Patients) † ^1-6

• Initiation of therapy Hemoglobin (Hb) < 10 g/dL and/or Hematocrit (Hct) < 30%; AND
  • Patient is at least 18 years of age; OR
• Patient is converting from another erythropoietin stimulating agent (ESA) (i.e., epoetin or darbepoetin) after their hemoglobin level was stabilized with an ESA; AND
  • Patient is at least 3 months of age

† FDA Approved Indications; ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,5

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Previous dose was administered within the past 60 days; AND
• Disease response with treatment as defined by improvement in anemia compared to pretreatment baseline; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: pure red cell aplasia, severe allergic reactions (anaphylaxis, angioedema, bronchospasm, etc.), severe cutaneous reactions (erythema multiforme, Stevens-Johnson Syndrome [SJS]/Toxic Epidermal Necrolysis [TEN], etc.), severe cardiovascular events (stroke, myocardial infarction, congestive heart failure, thromboembolism, etc.), uncontrolled hypertension, seizures, etc.; AND

Anemia Due to Chronic Kidney Disease (Non-Dialysis Patients):

• Pediatric patients (3 months to 17 years of age): Hemoglobin (Hb) < 12 g/dL and/or Hematocrit (Hct) < 36%
• Adult patients: Hemoglobin (Hb) <11 g/dL and/or Hematocrit (Hct) <33%

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J0888 – Injection, epoetin beta, 1 microgram, (for non-ESRD use); 1 billable unit = 1 mcg

NDC(s):

• Mircera 30 mcg/0.3 mL single-dose prefilled syringe: 59353-0400-xx
• Mircera 50 mcg/0.3 mL single-dose prefilled syringe: 59353-0401-xx
• Mircera 75 mcg/0.3 mL single-dose prefilled syringe: 59353-0402-xx
• Mircera 100 mcg/0.3 mL single-dose prefilled syringe: 59353-0403-xx
• Mircera 120 mcg/0.3 mL single-dose prefilled syringe: 59353-0407-xx
• Mircera 150 mcg/0.3 mL single-dose prefilled syringe: 59353-0404-xx
• Mircera 200 mcg/0.3 mL single-dose prefilled syringe: 59353-0405-xx
• Mircera 250 mcg/0.3 mL single-dose prefilled syringe: 59353-0406-xx
• Mircera 360 mcg/0.6 mL single-dose prefilled syringe: 59353-0408-xx

7. References

1. Mircera [package insert]. St. Gallen, Switzerland; Vifor (International) Inc. April 2024. Accessed May 2024.
2. Levin NW, Fishbane S, Cañedo FV, et al. MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: A randomised non-inferiority trial (MAXIMA). Lancet 370: 1415–1421, 2007.
3. Sulowicz W, Locatelli F, Ryckelynck JP, et al. PROTOS Study Investigators. Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol 2: 637–646, 2007.
4. Fischbach M, Wühl E, Reigner SCM, et al. Efficacy and Long-Term Safety of C.E.R.A. Maintenance in Pediatric Hemodialysis Patients with Anemia of CKD [published correction appears in Clin J Am Soc Nephrol. 2019;14(6):907] Clin J Am Soc Nephrol. 2018;13(1):81-90.
5. Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int Suppl. 2012;2(suppl):279-335. https://kdigo.org/guidelines/anemia-in-ckd/. Published August 2012.
6. Mikhail, A., Brown, C., Williams, J.A. et al. Renal association clinical practice guideline on Anaemia of Chronic Kidney Disease. BMC Nephrol 18, 345 (2017).Upd 2020. https://doi.org/10.1186/s12882-017-0688-1.
7. Pamletto GBA. Local Coverage Article (LCA): Billing and Coding: Erythropoiesis Stimulating Agents (ESA) (A58982). Centers for Medicare & Medicaid Services, Inc. Updated on 02/16/2024 with effective dates 03/01/2024. Accessed April 2024.
8. Wisconsin Physicians Service Insurance Corporation. Local Coverage Article (LCA): Billing and Coding: Erythropoiesis Stimulating Agents (ESA) (A56795). Centers for Medicare & Medicaid Services, Inc. Updated on 05/23/2023 with effective dates 06/01/2023. Accessed April 2024.

Appendix 1 – Covered Diagnosis Codes

Dual coding requirements:

• Anemia due to CKD (not on dialysis): must bill D63.1 AND I12.9, I13.0, I13.10, N18.30, N18.31, N18.32, N18.4, or N18.5

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.