Pharmacy Prior Authorization Criteria

Erythropoietic Agents - PA, NF

Indications for Prior Authorization

Aranesp (darbepoetin alfa)

For diagnosis of Anemia Due to Chronic Kidney Disease
Indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.
For diagnosis of Anemia Due to Chemotherapy in Patients with Cancer
Indicated for treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy. Limitations of Use:
Aranesp has not been shown to improve quality of life, fatigue, or patient well-being.
Aranesp is not indicated for use:
(1) In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy;
(2) In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure;
(3) In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion; and
(4) As a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia.
For diagnosis of Anemia in patients with Myelodysplastic Syndrome (MDS)
Has been used for the treatment of anemia in patients with MDS. [20]

Epogen (epoetin alfa), Procrit (epoetin alfa), and Retacrit (epoetin alfa-epbx)

For diagnosis of Anemia Due to Chronic Kidney Disease
Indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.
For diagnosis of Anemia Due to Zidovudine in Patients with HIV-infection
Indicated for the treatment of anemia due to zidovudine administered at less than or equal to 4200 mg/week in patients with HIV-infection with endogenous serum erythropoietin levels of less than or equal to 500 mUnits/mL.
For diagnosis of Anemia Due to Chemotherapy in Patients with Cancer
Indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy and upon initiation, there is a minimum of 2 additional months of planned chemotherapy.
Limitations of Use: Epoetin alfa has not been shown to improve quality of life, fatigue, or patient well-being. Epoetin alfa is not indicated for use: (1) In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy; (2) In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure; (3) In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion; (4) As a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia.
For diagnosis of Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery
Indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin greater than 10 to less than or equal to 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. Epoetin alfa is not indicated for patients who are willing to donate autologous blood preoperatively.
Limitations of Use: Epoetin alfa has not been shown to improve quality of life, fatigue, or patient well-being. Epoetin alfa is not indicated for use: (1) In patients scheduled for surgery who are willing to donate autologous blood; (2) In patients undergoing cardiac or vascular surgery; (3) As a substitute for red blood cell (RBC) transfusions in patients who require immediate correction of anemia.
For diagnosis of Anemia associated with HIV infection
Have been used for the treatment of anemia associated with HIV infection in patients not receiving zidovudine. [5]
For diagnosis of Anemia in Hepatitis C virus (HCV) infected patients due to combination therapy of ribavirin and interferon or peg-interferon
Have been used for the treatment of anemia in patients with hepatitis C virus (HCV) infection who are being treated with the combination of ribavirin and interferon or peginterferon alfa. [20]
For diagnosis of Anemia in patients with Myelodysplastic Syndrome (MDS)
Have been used for the treatment of anemia in patients with MDS. [5, 20]

Mircera (methoxy polyethylene glycol-epoetin beta)

For diagnosis of Anemia Due to Chronic Kidney Disease
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 3 months to 17 years of age on dialysis or not on dialysis, who are converting from another ESA after their hemoglobin level was stabilized with an ESA.
Limitations of use: Mircera is not indicated and is not recommended: (1) In the treatment of anemia due to cancer chemotherapy; or (2) As a substitute for RBC transfusions in patients who require immediate correction of anemia. Mircera has not been shown to improve symptoms, physical functioning, or health-related quality of life.

Criteria

Aranesp, Epogen, Procrit, or Retacrit

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Anemia Due to Chronic Kidney Disease (CKD)

Diagnosis of chronic kidney disease (CKD)

AND

Adequate iron stores confirmed by both of the following: [A, J]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Verification of anemia as defined by one of the following laboratory values collected within 30 days of the request: [1-3, 9, 13-17, 29, 33, B]

Hematocrit (Hct) less than 30%
Hemoglobin (Hgb) less than 10 g/dL

AND

One of the following: [1-3, 33, L]

Patient is on dialysis

All of the following:

Patient is NOT on dialysis

AND

The rate of hemoglobin decline indicates the likelihood of requiring a red blood cell (RBC) transfusion

AND

Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal

AND

History of use or unavailability of both of the following (applies to Epogen only): [O]

Aranesp
Retacrit or Procrit

Mircera

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Anemia Due to Chronic Kidney Disease (CKD)

Diagnosis of chronic kidney disease (CKD)

AND

Adequate iron stores confirmed by both of the following: [A, J]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

One of the following:

All of the following:

Patient is 18 years of age or older

AND

Verification of anemia as defined by one of the following laboratory values collected within 30 days of the request: [9, 13-17, 29, 31, B]

Hematocrit (Hct) less than 30%
Hemoglobin (Hgb) less than 10 g/dL

AND

One of the following: [31]

Patient is on dialysis

All of the following:

Patient is NOT on dialysis

AND

The rate of hemoglobin decline indicates the likelihood of requiring a red blood cell (RBC) transfusion

AND

Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal

All of the following:

Patient is between 3 months and 17 years of age

AND

Patient’s hemoglobin level has been stabilized by treatment with another erythropoietin stimulating agent (ESA) (e.g., Aranesp, Retacrit)

AND

Patient is converting to Mircera from another ESA (e.g., Aranesp, Retacrit)

AND

History of use or unavailability of both of the following: [O]

Aranesp
Retacrit or Procrit

Aranesp, Epogen, Mircera, Procrit, or Retacrit

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

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Anemia Due to Chronic Kidney Disease (CKD)

Diagnosis of chronic kidney disease (CKD)

AND

One of the following:

Both of the following:

Patient is on dialysis
Most recent or average Hct over 3 months is 33% or less (Hgb 11 g/dL or less)

Both of the following:

Patient is not on dialysis
Most recent or average (avg) Hct over 3 mo is 30% or less (Hgb 10 g/dL or less)

Both of the following:

Request is for a pediatric patient
Most recent or average Hct over 3 mo is 36% or less (Hgb 12 g/dL or less)

AND

One of the following: [1-3, 31, 33]

Decrease in the need for blood transfusion

Hemoglobin (Hgb) increased greater than or equal to 1 g/dL from pre-treatment level

AND

Adequate iron stores confirmed by both of the following: [A, J]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

Epogen, Procrit

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Anemia Due to Chronic Kidney Disease (CKD)

Diagnosis of chronic kidney disease (CKD)

AND

Submission of medical records (e.g., chart notes) confirming adequate iron stores by both of the following: [A, J]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Submission of medical records (e.g., chart notes) confirming anemia as defined by one of the following laboratory values collected within 30 days of the request: [1-3, 9, 13-17, 29, 33, B]

Hematocrit (Hct) less than 30%
Hemoglobin (Hgb) less than 10 g/dL

AND

One of the following: [1-3, 33, L]

Patient is on dialysis

All of the following:

Patient is NOT on dialysis

AND

The rate of hemoglobin decline indicates the likelihood of requiring a red blood cell (RBC) transfusion

AND

Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal

AND

Paid claims or submission of medical records (e.g., chart notes) confirming history of use or unavailability of both of the following (applies to Epogen only): [O]

Aranesp
Retacrit or Procrit

Epogen, Procrit, or Retacrit

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Anemia in Patients with HIV-infection

Adequate iron stores confirmed by both of the following: [2-3, 33]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Verification of anemia as defined by one of the following laboratory values collected within 30 days of the request:

Hemoglobin (Hgb) less than 12 g/dL [11, 25-28, K]
Hematocrit (Hct) less than 36%

AND

Serum erythropoietin level less than or equal to 500 mU/mL [2-3, 24, 26, 33]

AND

One of the following:

Patient is receiving zidovudine therapy [2-3, 33]
Diagnosis of HIV infection [off-label] [5, 11, 24-28]

AND

History of use or unavailability of Retacrit or Procrit (applies to Epogen only) [O]

Epogen, Procrit, or Retacrit

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Anemia in Patients with HIV-infection

Verification of anemia as defined by one of the following: [2, 3, 33]

Most recent or average hematocrit (Hct) over a 3-month period was below 36%
Most recent or average hemoglobin (Hgb) over a 3-month period was below 12 g/dL

AND

One of the following: [2, 3, 33]

Decrease in the need for blood transfusion

Hemoglobin (Hgb) increased greater than or equal to 1 g/dL from pre-treatment level

Epogen, Procrit

Non Formulary

Length of Approval: 6 Month(s)
For diagnosis of Anemia in Patients with HIV-infection

Submission of medical records (e.g., chart notes) confirming adequate iron stores by both of the following: [2-3, 33]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Submission of medical records (e.g., chart notes) confirming anemia as defined by one of the following laboratory values collected within 30 days of the request:

Hemoglobin (Hgb) less than 12 g/dL [11, 25-28, K]
Hematocrit (Hct) less than 36%

AND

Submission of medical records (e.g., chart notes) confirming serum erythropoietin level less than or equal to 500 mU/mL [2-3, 24, 26, 33]

AND

One of the following:

Patient is receiving zidovudine therapy [2-3, 33]
Diagnosis of HIV infection [off-label] [5, 11, 24-28]

AND

Paid claims or submission of medical records (e.g., chart notes) confirming history of use or unavailability of Retacrit or Procrit (applies to Epogen only) [O]

Aranesp, Epogen, Procrit, or Retacrit

Prior Authorization (Initial Authorization)

Length of Approval: 3 Months [C]
For diagnosis of Anemia Due to Chemotherapy in Patients with Cancer

Verification that other causes of anemia have been ruled out [1-3, 33, M]

AND

Verification of anemia as defined by one of the following laboratory values collected within the prior two weeks of the request: [1-3, 33]

Hematocrit (Hct) less than 30%
Hemoglobin (Hgb) less than 10 g/dL [N]

AND

Adequate iron stores confirmed by both of the following: [1-3, 8, 33, G]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Verification that the cancer is a non-myeloid malignancy [1-3, 33, F]

AND

Patient is receiving chemotherapy [1-3, 33, D]

AND

History of use or unavailability of both of the following (applies to Epogen only): [O]

Aranesp
Retacrit or Procrit

Aranesp, Epogen, Procrit, or Retacrit

Prior Authorization (Reauthorization)

Length of Approval: 3 Months [C]
For diagnosis of Anemia Due to Chemotherapy in Patients with Cancer

Verification of anemia as defined by one of the following laboratory values collected within the prior two weeks of the request: [1-3, 33]

Hemoglobin (Hgb) less than 10 g/dL
Hematocrit (Hct) less than 30% [10, 18-19]

AND

One of the following: [1-3, 33]

Decrease in the need for blood transfusion

Hemoglobin (Hgb) increased greater than or equal to 1 g/dL from pre-treatment level

AND

Patient is receiving chemotherapy [D]

Epogen, Procrit

Non Formulary

Length of Approval: 3 Months [C]
For diagnosis of Anemia Due to Chemotherapy in Patients with Cancer

Verification that other causes of anemia have been ruled out [1-3, 33, M]

AND

Submission of medical records (e.g., chart notes) confirming anemia as defined by one of the following laboratory values collected within the prior two weeks of the request: [1-3, 33]

Hematocrit (Hct) less than 30%
Hemoglobin (Hgb) less than 10 g/dL [N]

AND

Submission of medical records (e.g., chart notes) confirming adequate iron stores by both of the following: [1-3, 8, 33, G]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Verification that the cancer is a non-myeloid malignancy [1-3, 33, F]

AND

Patient is receiving chemotherapy [1-3, 33, D]

AND

Paid claims or submission of medical records (e.g., chart notes) confirming history of use or unavailability of both of the following (applies to Epogen only): [O]

Aranesp
Retacrit or Procrit

Epogen, Procrit, or Retacrit

Prior Authorization

Length of Approval: 1 month [2]
For diagnosis of Preoperative use for reduction of allogeneic blood transfusion in patients undergoing surgery

Patient is scheduled to undergo elective, non-cardiac, non-vascular surgery

AND

Hemoglobin (Hgb) is greater than 10 to less than or equal to 13 g/dL

AND

Patient is at high risk for perioperative transfusions

AND

Patient is unwilling or unable to donate autologous blood pre-operatively

AND

Adequate iron stores confirmed by both of the following: [2-3, 33]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

History of use or unavailability of Retacrit or Procrit (applies to Epogen only) [O]

Epogen, Procrit

Non Formulary

Length of Approval: 1 month [2]
For diagnosis of Preoperative use for reduction of allogeneic blood transfusion in patients undergoing surgery

Patient is scheduled to undergo elective, non-cardiac, non-vascular surgery

AND

Submission of medical records (e.g., chart notes) confirming hemoglobin (Hgb) is greater than 10 to less than or equal to 13 g/dL

AND

Patient is at high risk for perioperative transfusions

AND

Patient is unwilling or unable to donate autologous blood pre-operatively

AND

Submission of medical records (e.g., chart notes) confirming adequate iron stores by both of the following: [2-3, 33]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Paid claims or submission of medical records (e.g., chart notes) confirming history of use or unavailability of Retacrit or Procrit (applies to Epogen only) [O]

Aranesp, Epogen, Procrit, or Retacrit

Prior Authorization (Initial Authorization)

Length of Approval: 3 months [I]
For diagnosis of Anemia in Myelodysplastic Syndrome (MDS) patients [off-label] [4-6, 20]

Diagnosis of Myelodysplastic Syndrome (MDS) [4]

AND

One of the following: [4]

Serum erythropoietin level less than or equal to 500 mU/mL
Diagnosis of transfusion-dependent MDS

AND

Adequate iron stores confirmed by both of the following: [4, A, H]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

History of use or unavailability of both of the following (applies to Epogen only): [O]

Aranesp
Retacrit or Procrit

Aranesp, Epogen, Procrit, or Retacrit

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Anemia in Myelodysplastic Syndrome (MDS) patients [off-label]

Verification of anemia as defined by one of the following: [4, E]

Most recent or average hematocrit (Hct) over a 3-month period was less than or equal to 36%
Most recent or average hemoglobin (Hgb) over a 3-month period was less than or equal to 12 g/dL

AND

One of the following: [1-3, 33]

Decrease in the need for blood transfusion

Hemoglobin (Hgb) increased greater than or equal to 1.5 g/dL from pre-treatment level

Epogen, Procrit

Non Formulary

Length of Approval: 3 months [I]
For diagnosis of Anemia in Myelodysplastic Syndrome (MDS) patients [off-label] [4-6, 20]

Diagnosis of Myelodysplastic Syndrome (MDS) [4]

AND

One of the following: [4]

Diagnosis of transfusion-dependent MDS
Serum erythropoietin level less than or equal to 500 mU/mL

AND

Submission of medical records (e.g., chart notes) confirming adequate iron stores by both of the following: [4, A, H]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Paid claims or submission of medical records (e.g., chart notes) confirming history of use or unavailability of both of the following (applies to Epogen only): [O]

Aranesp
Retacrit or Procrit

Epogen, Procrit, or Retacrit

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s)
For diagnosis of Anemia in HCV-infected patients due to ribavirin in combination with interferon or peg-interferon [off-label] [6]

Diagnosis of hepatitis C viral (HCV) infection [12, 20]

AND

Adequate iron stores confirmed by both of the following: [2-3, 33]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Verification of anemia as defined by one of the following laboratory values collected within 30 days of the request: [P]

Hematocrit (Hct) less than 36%
Hemoglobin (Hgb) less than 12 g/dL

AND

Verification of both of the following:

Patient is receiving ribavirin

AND

Patient is receiving one of the following:

interferon alfa
peginterferon alfa

AND

History of use or unavailability of Retacrit or Procrit (applies to Epogen only) [O]

Epogen, Procrit, or Retacrit

Prior Authorization (Reauthorization)

Length of Approval: 3 Months or if patient has demonstrated response to therapy, authorization will be issued for the full course of ribavirin therapy.
For diagnosis of Anemia in HCV-infected patients due to ribavirin in combination with interferon or peg-interferon [off-label]

Verification of anemia as defined by one of the following: [35]

Most recent or average hematocrit (Hct) over a 3-month period was 36% or less
Most recent or average hemoglobin (Hgb) over a 3-month period was 12 g/dL or less

AND

One of the following: [2, 3, 33]

Decrease in the need for blood transfusion

Hemoglobin (Hgb) increased greater than or equal to 1 g/dL from pre-treatment level

Epogen, Procrit

Non Formulary

Length of Approval: 3 Month(s)
For diagnosis of Anemia in HCV-infected patients due to ribavirin in combination with interferon or peg-interferon [off-label] [6]

Diagnosis of hepatitis C viral (HCV) infection [12, 20]

AND

Submission of medical records (e.g., chart notes) confirming adequate iron stores by both of the following: [2-3, 33]

Patient's ferritin level is greater than 100 mcg/L
Patient's transferrin saturation (TSAT) is greater than 20%

AND

Submission of medical records (e.g., chart notes) confirming anemia as defined by one of the following laboratory values collected within 30 days of the request: [P]

Hematocrit (Hct) less than 36%
Hemoglobin (Hgb) less than 12 g/dL

AND

Verification of both of the following:

Patient is receiving ribavirin

AND

Patient is receiving one of the following:

interferon alfa
peginterferon alfa

AND

Paid claims or submission of medical records (e.g., chart notes) confirming history of use or unavailability of Retacrit or Procrit (applies to Epogen only) [O]

Aranesp, Epogen, Mircera, Procrit, or Retacrit

*Off-label requests will be evaluated on a case-by-case basis by a clinical pharmacist

Prior Authorization

For diagnosis of Other Off-Label Uses

Off-label guideline approval criteria have been met*

AND

Off-label requests other than those listed above for coverage in patients with Hgb greater than 10 g/dL or Hct greater than 30% will not be approved [1-3, 31, 33]

Epogen, Procrit

*Off-label requests will be evaluated on a case-by-case basis by a clinical pharmacist

Non Formulary

For diagnosis of Other Off-Label Uses

Off-label guideline approval criteria have been met*

AND

Off-label requests other than those listed above for coverage in patients with Hgb greater than 10 g/dL or Hct greater than 30% will not be approved [1-3, 31, 33]

Guideline ID
GL-157881
Formulary
EHB
Effective date
Jan 1, 2025
P&T approval date
Mar 17, 2000

P & T Revisions

2024-11-04, 2024-05-24, 2023-11-20, 2023-05-22, 2022-11-22, 2022-03-29, 2021-12-01, 2021-10-29, 2021-09-27, 2021-05-19, 2020-12-30, 2020-11-04, 2020-04-01, 2019-11-05

References

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Epogen prescribing information. Amgen Inc. Thousand Oaks, CA. April 2024.
Procrit prescribing information. Amgen Inc. Thousand Oaks, CA. April 2024.
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Rizzo JD, Lichtin AE, Woolf SH, et al. Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. Blood 2002;100(7):2303-20.
Volberding P, Levine A, Dieterich D, et al. Anemia in HIV infection: clinical impact and evidence-based management strategies. Clin Infect Dis 2004;38:1454-63.
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Revicki DA, Brown RE, Henry DA, et al. Recombinant human erythropoietin and health-related quality of life of AIDS patients with anemia. J Acquir Immune Defic Syndr. 1994;7:474-84.
Phair JP, Abels RI, McNeill MV, Sullivan DJ. Recombinant human erythropoietin treatment: investigational new drug protocol for the anemia of the acquired immunodeficiency syndrome. Arch Intern Med. 1993;153:2668-75.
Saag MS, Bowers P, Leitz GJ, Levine AM. Once-weekly epoetin alfa improves quality of life and increases hemoglobin in anemic HIV+ patients. AIDS Res Hum Retroviruses. 2004;20(10):1037-45.
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Mircera prescribing information. Vifor (International) Inc. St. Gallen, Switzerland. June 2024.
Centers for Medicare and Medicaid Services. Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies; Final Rule. Federal Register. 2014;79(215):66120-66265.
Retacrit prescribing information. Pfizer Inc. New York, NY. June 2024.
Per clinical consult with hematologist/oncologist, June 6, 2018.
EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. J Hepatol. 2011;55(2):245-64.

End Notes

Aranesp, Epogen, Mircera, Procrit, and Retacrit Prescribing Information recommend prior and during therapy, the patient's iron stores should be evaluated. Administer supplemental iron therapy when serum ferritin is less than 100 mcg/L or when serum transferrin saturation is less than 20%. The majority of patients with CKD will require supplemental iron during the course of ESA therapy. [1-3, 31, 33]
Aranesp, Epogen, Mircera, Procrit, or Retacrit Prescribing Information states that dialysis, and non-dialysis patients with symptomatic anemia considered for therapy should have a Hgb < 10 g/dL. [1-3, 31, 33]
ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen. [18]
ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure. [1-3, 33]
NCCN panel recommends MDS patients aim for a target hemoglobin level of less than or equal to 12 g/dL. [4]
The American Cancer Society definition of "non-myeloid malignancy" is any malignancy that is not a myeloid leukemia. Non-myeloid cancers include all types of carcinoma, all types of sarcoma, melanoma, lymphomas, lymphocytic leukemias (ALL and CLL), and multiple myeloma. [30]
Absolute iron deficiency is defined as ferritin <30 ng/mL and TSAT <20%. Functional iron deficiency in patients receiving ESAs is defined as ferritin 30-800 ng/mL and TSAT 20%-50%. No iron deficiency is defined as ferritin >800 ng/mL or TSAT greater or equal to 50%. [8]
Iron repletion needs to be verified before instituting Epo therapy. [4]
Detection of erythroid responses generally occurs within 6 to 8 weeks of treatment. If no response occurs in this time frame, this treatment should be considered a failure and discontinued. [4]
Iron stores evaluation is recommended to occur every month during initial erythropoietin treatment in adults with chronic kidney disease or at least every 3 months during stable ESA treatment or in patients with HD-CKD not treated with an erythropoietin. [7]
Anemia in HIV patients has been defined as hemoglobin less than 10 g/dL [11, 25-26], hemoglobin less than 11 g/dL [11, 27], or hemoglobin less than 12 g/dL. [17]
Although primarily used in patients with ESRD, ESAs such as erythropoietin and darbepoetin alfa also correct the anemia in those with CKD who do not yet require dialysis. [21, 32]
Examples of other anemias include: vitamin B12, folate or iron deficiency anemia, hemolysis, or gastrointestinal bleeding.
Data from a systematic review by the Agency for Healthcare Research and Quality (AHRQ) determined that delaying ESA treatment until hemoglobin is less than 10 g/dL resulted in fewer thromboembolic events and a reduced mortality. [8]
Per consult with hematologist/oncologist, if a patient does not respond to one short-acting ESA, switching to another short-acting agent would not provide any added benefit; instead, one would increase the dose or perhaps switch to a long-acting agent. [34]
Epoetin alfa was effective in maintaining the dose of rivabirin in anemic patients with chronic hepatitis C virus in patients with a baseline hemoglobin of 12 g/dL or less. [20]

Revision History

2024-11-04: 2024 annual review: criteria and background updates.
2024-05-24: update guideline
2023-11-20: 2023 annual review: For anemia in myelodysplastic syndromes (MDS) indication, updated reauth criterion for positive response of hemoglobin level from increase of at least 1 g/dL from pre-treatment to increase of at least 1.5 g/dL to align with NCCN guidelines.
2023-05-22: update guideline
2022-11-22: Annual review: no criteria changes.
2022-03-29: Due to an impending shortage on Retacrit, updated to remove embedded step on Procrit and added Procrit as an option wherever Retacrit exists.
2021-12-01: Added NF sections for epogen and procrit.
2021-10-29: Annual review: updated references
2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
2020-12-30: Add new GPI for Retacrit 20,000 units/mL multiple dose vial to guideline; no changes to criteria
2020-11-04: Annual Review; updated criteria
2020-04-01: April P&T update to align with Med D updates for the anemia due to chronic kidney disease (CKD) indication.
2019-11-05: Annual Review; April P&T formulary strategy update; November P&T PA criteria optimization update for anemia due to chemotherapy in cancer patients.

Erythropoietic Agents - PA, NF

Indications for Prior Authorization

Aranesp (darbepoetin alfa)

Epogen (epoetin alfa), Procrit (epoetin alfa), and Retacrit (epoetin alfa-epbx)

Mircera (methoxy polyethylene glycol-epoetin beta)

Criteria

Aranesp, Epogen, Procrit, or Retacrit

Mircera

Aranesp, Epogen, Mircera, Procrit, or Retacrit

Epogen, Procrit

Epogen, Procrit, or Retacrit

Epogen, Procrit, or Retacrit

Epogen, Procrit

Aranesp, Epogen, Procrit, or Retacrit

Aranesp, Epogen, Procrit, or Retacrit

Epogen, Procrit

Epogen, Procrit, or Retacrit

Epogen, Procrit

Aranesp, Epogen, Procrit, or Retacrit

Aranesp, Epogen, Procrit, or Retacrit

Epogen, Procrit

Epogen, Procrit, or Retacrit

Epogen, Procrit, or Retacrit

Epogen, Procrit

Aranesp, Epogen, Mircera, Procrit, or Retacrit

Epogen, Procrit

P & T Revisions

References

End Notes

Revision History

Provider Tools