RXMP-08 Erythropoietic Stimulating Agents for Non Cancer Conditions Form

Erythropoietic Stimulating Agents for Non Cancer Conditions

Updated on: 12/23/2025

Page 1 of 5 Policy Number RXMP-08 Line of Business Medicaid & Medicare Effective Date 1/7/2020
Revision Date 12/23/2025

Products: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa), Retacrit (epoetin alfa-epbx), Mircera (epoetin beta)

Override(s)
Approval Duration
Prior Authorization
Initial or renewal: up to 12 months Preoperative use for reduction of allogeneic blood transfusion in Members undergoing surgery: 3 months

HCPCS Description Medical Benefit: Authorization Required; Pharmacy Benefit: PA required J0881 Injection, darbepoetin alfa, 1 mcg (non-ESRD use) [Aranesp] (preferred) J0882 Injection, darbepoetin alfa, 1 mcg (for ESRD on dialysis) [Aranesp]
J0885 Injection, epoetin alfa, (for non-ESRD use), 1000 units [Procrit, Epogen] (preferred) Q4081 Injection, epoetin alfa, 100 units (for ESRD on dialysis) [Procrit, Epogen] (preferred)
Q5105 Injection, epoetin alfa-epbx, biosimilar, (Retacrit) (for ESRD on dialysis), 100 units
Q5106 Injection, epoetin alfa-epbx, biosimilar, (Retacrit) (for non-ESRD use), 1000 units
J0887 Injection, epoetin beta, 1 microgram, (for ESRD on dialysis) [Mircera] J0888 Injection, epoetin beta, 1 microgram, (for non-ESRD use) [Mircera] Medicare (new starts)/Medicaid preferred agents: Aranesp (non-ESRD), Procrit, Epogen (non-ESRD)/(ESRD)

Medicare Part B Coverage Criteria
Medicare covers Erythropoiesis Stimulating Agents (ESAs) for the treatment of anemia in patients with chronic renal failure who are on dialysis. Refer to the Medicare Benefit Policy Manual, Chapter 15, § 50.5.2- Erythropoietin (EPO).

Erythropoiesis stimulating agents (ESAs) also may be covered for patients with specific clinical indications and who meet coverage criteria. Refer to the National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions (110.21). Local Coverage Determinations (LCDs)/Local Coverage Articles (LCAs) exist; refer to the LCDs/LCAs for LCD - Erythropoiesis Stimulating Agents (ESAs) (L34633) (Accessed as of 11/25/2025).

In general, Medicare covers outpatient (Part B) drugs that are furnished "incident to" a physician's service provided that the drugs are not usually self-administered by the patients who take them. Refer to the Medicare Benefit Policy Manual, Chapter 15, §50 - Drugs and Biologicals. (Accessed August 1, 2022)

Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• For Retacrit or Mircera (new starts): The member has an inadequate response to, intolerable adverse event to, or has a contraindication to Epogen, Procrit or Aranesp.

Erythropoietic Stimulating Agents for Non Cancer Conditions

Updated on: 12/23/2025

Page 2 of 5 Approval Criteria Products Aranesp, Epogen (preferred), Mircera, Procrit (preferred), Retacrit Diagnosis Anemia due to Chronic Kidney Disease (CKD) Approval Length Initial or renewal: up to 12 months Override Type PA, QL Initial Criteria Note: Pharmacy staff: For QUEST non-ABD members with CKD/cancer, refer to ADRC.

1. Diagnosis of chronic kidney disease (CKD); AND
2. Adequate iron store as demonstrated by one of the following: a. Serum transferrin saturation is greater than or equal to 20 percent; b. Serum ferritin is greater than or equal to 100ng/mL; c. Member is receiving oral iron supplement^. AND
3. One of the following: a. Most recent or average hematocrit (Hct) over a 3-month period was 30% or less; or
   b. Most recent or average hemoglobin (Hgb) over a 3-month period was 12 g/dL or less. AND
4. One of the following (a, b, or c):
   a. Member is on dialysis;
   b. Member is NOT on dialysis and both of the following: 1) The rate of hemoglobin decline indicates the likelihood of requiring a red blood cell (RBC) transfusion
   2) Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal. c. For Mircera only, all of the following:
   1) Member is between 5 and 17 years of age;
   2) On hemodialysis; 3) Hemoglobin level has been stabilized by treatment with another erythropoietin stimulating agent (ESA) (e.g., Procrit, Epogen); and
   4) Member is converting to Mircera from another ESA (e.g., Procrit or Epogen). AND
5. For Procrit or Epogen: Ok to approve;
   OR

6. For Retacrit, Mircera, and Aranesp: trial and failure or contraindication to Procrit or Epogen AND the prescriber attests that, in their clinical opinion, the same failure, contraindication, or intolerance would not be expected to occur with Procrit or Epogen.

   Notes: ^Authorization will be given if physician is aware of iron deficiency and is taking steps to replenish iron stores.
   Renewal Criteria

7. Diagnosis of chronic kidney disease (CKD); AND
8. One of the following (a, b, or c):
   a. Member is on dialysis AND the most recent or average HCT over the last 3 months is 33% or less (Hgb 11 g/dL or less);
   b. Member is not on dialysis AND the most recent or average HCT over the last 3 months is 30% or less (Hgb 10 g/dL or less); or c. Request is for a pediatric AND the most recent or average HCT over the 3 months is 36% or less (Hgb 12 g/dL or less). AND
9. One of the following (a or b):
   a. Therapy is needed to reduce the risk of alloimmunization and/or other blood transfusion-related risk; b. Hemoglobin (Hgb) increased greater than or equal to 1g/dL from pre-treatment level. AND
10. Verification of iron evaluation for adequate iron stores; AND

Erythropoietic Stimulating Agents for Non Cancer Conditions

Updated on: 12/23/2025

Page 3 of 5

5. Adequate iron store as demonstrated by one of the following: a. Serum transferrin saturation is greater than or equal to 20 percent; b. Serum ferritin is greater than or equal to 100ng/mL; c. Member is receiving oral iron supplement^. AND
6. For Procrit or Epogen: Ok to approve; OR

7. For Retacrit, Mircera, and Aranesp: Trial and failure or contraindication to Procrit or Epogen AND the prescriber attests that, in their clinical opinion, the same failure, contraindication, or intolerance would not be expected to occur with Procrit or Epogen.

   Notes: ^Authorization will be given if physician is aware of iron deficiency and is taking steps to replenish iron stores.

   Products Epogen (preferred), Procrit (preferred), Retacrit Diagnosis Anemia in members with zidovudine in HIV-infected patients
   Approval Length Initial or renewal: 12 months Override Type PA, QL Initial Criteria Note: Pharmacy staff: For QUEST non-ABD members with CKD/cancer, refer to ADRC.

8. The member is receiving zidovudine administered at less than or equal to 4,200mg/week; AND
9. Endogenous serum erythropoietin level is less than or equal to 500mUnits/mL; AND
10. One of the following: a. Most recent or average hematocrit (Hct) over a 3-month period was 30% or less; or
    b. Most recent or average hemoglobin (Hgb) over a 3-month period was 12 g/dL or less. AND
11. Adequate iron store as demonstrated by one of the following: a. Serum transferrin saturation is greater than or equal to 20 percent; b. Serum ferritin is greater than or equal to 100ng/mL; or c. Member is on oral iron supplement^.
12. For Procrit or Epogen: Ok to approve;
    OR

13. For Retacrit: Trial and failure or contraindication to Procrit or Epogen AND the prescriber attests that, in their clinical opinion, the same failure, contraindication, or intolerance would not be expected to occur with Procrit or Epogen.

    Notes: ^Authorization will be given if physician is aware of iron deficiency and is taking steps to replenish iron stores. Renewal Criteria

14. The member is receiving zidovudine administered at less than or equal to 4,200mg/week; AND
15. Endogenous serum erythropoietin level is less than or equal to 500mUnits/mL; AND
16. The most recent or average HCT over the 3 months is 36% or less (Hgb 12 g/dL or less); AND
17. There is documentation of positive clinical response to ESA therapy; AND
18. For Procrit or Epogen: Ok to approve;
    OR

19. For Retacrit: Trial and failure or contraindication to Procrit or Epogen AND the prescriber attests that, in their clinical opinion, the same failure, contraindication, or intolerance would not be expected to occur with Procrit or Epogen.

    Products Epogen (preferred), Procrit (preferred), Retacrit Diagnosis Preoperative use for reduction of allogeneic blood transfusion in members undergoing surgery
    Approval Length Initial :3 months
    Override Type PA, QL

Erythropoietic Stimulating Agents for Non Cancer Conditions

Updated on: 12/23/2025

Page 4 of 5 Initial Criteria Note: Pharmacy staff: For QUEST non-ABD members with CKD/cancer, refer to ADRC.

1. The member is scheduled to undergo elective, non-cardiac, non-vascular surgery; AND
2. The member is at high risk of blood loss during surgery; AND
3. The member is unwilling or unable to donate autologous blood pre-operatively; AND
4. Hemoglobin (Hgb) is greater than 10 to less than or equal to 13 g/dL; AND
5. Adequate iron store as demonstrated by one of the following: a. Serum transferrin saturation is greater than or equal to 20 percent; b. Serum ferritin is greater than or equal to 100ng/mL; or c. Member is on oral iron supplement^
6. For Procrit or Epogen: Ok to approve;
   OR

7. For Retacrit: Trial and failure or contraindication to Procrit or Epogen AND the prescriber attests that, in their clinical opinion, the same failure, contraindication, or intolerance would not be expected to occur with Procrit or Epogen.

   Notes: ^Authorization will be given if physician is aware of iron deficiency and is taking steps to replenish iron stores. Exclusion ESAs are contraindicated in individuals with uncontrolled hypertension. Blood pressure should be adequately controlled prior to initiation and during treatment with ESAs.

   Agent Aranesp Epogen Mircera Procrit Retacrit Anemia due to CKD X X X X X Anemia due to zidovudine in HIV infection

   X

   X X Anemia due to myelosuppressive
   chemotherapy X X

   X X Reduction of allogenic RBC transfusions in individuals undergoing elective, non-cardiac, non-vascular surgery

   X

   X X Myelodysplastic syndrome† X X

   X X † Off-label use

   FDA Indications & Dosing Aranesp (darbepoetin alfa) 25 mcg/mL, 40 mcg/mL, 60 mcg/mL, 100 mcg/mL, 200 mcg/mL, 300 mcg/mL Vial 4 vials (4 mL) per 28 days Epogen (epoetin alfa) 2,000 Units/mL; 3,000 Units/mL; 4,000 Units/mL; 10,000 Units/mL Vial; 20,000 Units/mL Vial 12 vials (12 mL) per 28 days Epogen (epoetin alfa) 20,000 Units/2 mL Multi-Dose Vial 6 vials (12 mL) per 28 days Mircera (methoxy polyethylene glycol-epoetin beta) 30 mcg/0.3mL, 50 mcg/0.3 mL, 75 mcg/0.3 mL, 100 mcg/0.3 mL, 150 mcg/0.3 mL, 200 mcg/0.3 mL Syringe 2 syringes (0.6 mL) per 28 days Procrit (epoetin alfa) 2,000 Units/mL; 3,000 Units/mL; 4,000 Units/mL; 10,000 Units/mL; 20,000 Units/mL; 40,000 Units/mL Vial 12 vials (12 mL) per 28 days Procrit (epoetin alfa) 20,000 Units/2 mL Multi-Dose Vial 6 vials (12 mL) per 28 days Retacrit (epoetin alfa-epbx) 2,000 Units/mL; 3,000 Units/mL; 4,000 Units/mL; 10,000 Units/mL; 20,000 Units/mL, 40,000 Units/mL Vialǂ 12 vials (12 mL) per 28 days Retacrit (epoetin alfa-epbx) 20,000 Units/2 mL Multi-Dose Vialǂ 6 vials (12 mL) per 28 days Override Criteria *When Epogen (epoetin alfa) is being used to reduce the need for allogeneic red blood cell transfusions in elective, noncardiac, nonvascular surgery, may allow up to an additional 3 vials (2,000 Units/mL; 3,000 Units/mL; 4,000

Erythropoietic Stimulating Agents for Non Cancer Conditions

Updated on: 12/23/2025

Page 5 of 5 Units/mL; 10,000 Units/mL; 20,000 Units/mL; 20,000 Units/2 mL) in a rolling 28 days for completion of therapy. **When Procrit (epoetin alfa) is being used to reduce the need for allogeneic red blood cell transfusions in elective, noncardiac, nonvascular surgery, may allow up to an additional 3 vials (2,000 Units/mL; 3,000 Units/mL; 4,000 Units/mL; 10,000 Units/mL; 20,000 Units/mL; 20,000 Units/2 mL; 40,000 Units/mL) in a rolling 28 days for completion of therapy. ǂWhen Retacrit (epoetin alfa-epbx) is being used to reduce the need for allogeneic red blood cell transfusions in elective, noncardiac, nonvascular surgery, may allow up to an additional 3 vials (2,000 Units/mL; 3,000 Units/mL; 4,000 Units/mL; 10,000 Units/mL; 40,000 Units/mL) in a rolling 28 days for completion of therapy.

References

1. Bohlius J et al., Management of Cancer-Associated Anemia With Erythropoiesis-Stimulating Agents: ASCO/ASH Clinical PracticeGuideline Update. JCO 37, 1336-1351(2019). DOI:10.1200/JCO.18.02142.2.
2. Clinical Pharmacology [database online]. Philadelphia, PA: Elsevier, Inc.; URL: https://www.clinicalkey.com/pharmacology/. Updatedperiodically.
3. Epogen/Procrit [package insert]. Thousand Oaks, CA: Amgen, Inc.; April 2024.
4. Lexi-Comp ONLINE™ with AHFS™, Hudson, Ohio: Lexi-Comp, Inc. Updated periodically.
5. McMurray JJV, Parfrey PS, Adamson JW, et al. KDIGO Clinical practice guideline for anemia in chronic kidney disease.Kidney Int Suppl. 2012;2(4):279-335. http://www.kidney-international.org

6. Merative Micromedex® DRUGDEX [database online]. Ann Arbor, MI: Merative L.P.; URL: https://www.micromedexsolutions.com/. Updatedperiodically.

   Review History 9/19/2023 PH: New
   12/23/2025: New Format, updated preferred drugs