Darbepoetin Alfa:
Darbepoetin Alfa (brand name Aranesp by Amgen), also known as novel erythropoiesis stimulating protein (NESP), is an erythropoiesis stimulating protein closely related to erythropoietin that is produced in Chinese hamster ovary cells by recombinant technology. It binds to the same receptor as endogenous erythropoietin and exerts the same erythropoietic action.

Darbepoetin Alfa (Aranesp) differs from Epoetin Alfa (Epogen or Procrit) in that the former contains 5 sialic-acid containing carbohydrate chains and the latter only 3. The additional sialic acid in Darbepoetin Alfa significantly increases its in vivo biological activity and extends its serum half-life three times longer than Epoetin alfa. This results in reduced dosing frequency for Darbepoetin Alfa compared to Epoetin Alfa.

Pegylated (PEG)-epoetin Beta:
Pegylated (PEG)-epoetin Beta (brand name Mircera by Roche), is a recombinant form of erythropoietin that is different from epoetin alfa in isoform compositions. Pegylated (PEG)-epoetin Beta contains a greater proportion of more basic isoforms, a greater proportion of EPO binding to Erythrina cristagalli agglutinin (which binds N-glycans with nonsialylated outer Gal beta1-4GlcNAc moieties), and isoforms with higher in-vivo:in-vitro bioactivity ratios.
[INFORMATIONAL NOTE: Pegylated (PEG)-epoetin Beta (brand name Mircera by Roche),is commercially available in the USA.]

Peginesatide:
Peginesatide (brand name Omontys by Affymax and Takeda), approved March 27,2012, differs from the other ESA agents in that it only needs to be administered once a month, instead of frequent injections. This drug has been taken off the US market since 2013.

[INFORMATIONAL NOTE: On February 23, 2013 Affymax, Inc. and Takeda Pharmaceutical Company Limited decided to voluntarily recall all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. The companies issued a letter to health care professionals indicating that no new or existing patients should receive OMONTYS. To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of OMONTYS. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received OMONTYS in the postmarketing setting. The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.]

[INFORMATIONAL NOTES: In Februrary 2010, the FDA is requiring erythropoiesis-stimulating agents (ESAs) (e.g. Epogen, Procrit, Aranesp) to be prescribed and used under a risk management program known as a Risk Evaluation and Mitigation Strategies (REMS) program. This program was required because studies showed that these agents can increase risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also showed that these agents may increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions. As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. In addition, APPRISE (assisting providers and cancer patients with risk information for the safe use of ESAs) oncology program for healthcare professionals was implemented to ensure that only healthcare professionals who have enrolled and completed training in this program will prescribe and dispense ESAs to patients with cancer.

In April 2017, the FDA determined that the ESA Risk Evaluation and Mitigation Strategy (REMS) is no longer necessary to ensure that the benefits of Epogen/Procrit and Aranesp outweigh its risks of shortened overall survival and/or increased risk of tumor progression or recurrence in patients with cancer. The FDA made this determination based on an evaluation of the results of the REMS Assessments submitted by Amgen, Inc., and additional FDA analyses to understand the impact of the various regulatory and other actions on the use of ESAs.

While the REMS is no longer necessary to ensure the benefits outweigh the risks, the serious risks of shortened overall survival and/or increased risk of tumor progression or recurrence associated with these drugs remain. The prescribing information continues to note an increased risk of tumor progression or recurrence, as well as death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Health care providers are encouraged to discuss the risks and benefits of using ESAs with each patient before initiating use]

[INFORMATIONAL NOTE: The FDA-approved epoetin alfa, epoetin alfa-epbx, darbepoetin alfa and methoxy polyethylene glycol-epoetin beta package inserts have the following BLACK BOX WARNINGS: Increased mortality, serious cardiovascular events, thromboembolic events, stroke and increased risk of tumor progression or recurrence.

• Chronic Kidney Disease: patients experience greater risk for death, serious cardiovascular events and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. The lowest dose sufficient to reduce the need for red blood cell (RBC) transfusion should be used.
• Cancer:
  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
  • Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.
• Perisurgery: Epoetin alfa increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Deep venous thrombosis prophylaxis is recommended.
  

The requirements of the Horizon BCBSNJ Erythropoietin Therapy: Epoetin Alfa, Epoetin Alfa-epbx, Darbepoetin Alfa, and Pegylated (PEG)-epoetin Beta Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).

I. As per the FDA approved package inserts, prior to initiating erythropoietin therapy with epoetin alfa, epoetin alfa-epbx, pegylated (PEG)-epoetin beta, or darbepoetin alfa, appropriate diagnostic work-up must be done. Rule out other causes for anemia such as iron deficiency, folate deficiency, hemolysis, or gastrointestinal bleeding.

II. As per the FDA approved package inserts, prior to initiating erythropoietin therapy with epoetin alfa, epoetin alfa-epbx, pegylated (PEG)-epoetin beta, or darbepoetin alfa, the member's iron stores must be evaluated. Transferrin saturation should be at least 20% and ferritin at least 100 ng/ml. For members who do not have adequate iron stores, iron therapy is recommended.

III. As per the FDA approved package inserts, prior to initiating erythropoietin therapy with epoetin alfa, epoetin alfa-epbx, pegylated (PEG)-epoetin beta, or darbepoetin alfa, blood pressure should be adequately controlled and must be closely monitored and controlled during therapy. Lab values must be obtained within 30 days of request and administration.

[INFORMATIONAL NOTE: As per the FDA approved package inserts, uncontrolled hypertension is a contraindication to therapy.]

1. Anemia associated with chronic kidney disease (CKD):
A. Erythropoietin therapy (epoetin alfa, epoetin alfa-epbx, and darbepoetin alfa) is medically necessary for the treatment of anemia due to chronic kidney disease in members aged ≥1 month regardless of whether they are on dialysis.
• Prior to using epoetin alfa (Procrit, Epogen), member must try and have an inadequate response or adverse event to epoetin alfa-epbx (Retacrit)

B. Pegylated (PEG)-epoetin beta is medically necessary in adult members who are or are not on dialysis, and pediatric members 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level has been stabilized with an ESA (i.e. epoetin alfa, epoetin beta, or darbepoetin alfa) when ALL of the following criteria are met:

• At the initiation of the supplemental erythropoietin treatment, members with CKD must have a documented anemia with a hemoglobin (Hgb) < 10 g/dL and either glomerular filtration rate less than 60 mL/min or one or more of the following markers of kidney damage: albuminuria, urine sediment abnormalities, electrolyte and other abnormalities due to tubular disorders, abnormalities detected by histology, structural abnormalities detected by imaging or history of kidney transplantation.
• Per the updated 2018 FDA labeling, ESA therapy should be started in patients with CKD when the hemoglobin is below 10 g/dL and to stop or reduce ESA therapy dosing when the hemoglobin level is above 10 g/dL. In dialysis patients, a 10- to 11-g/dL hemoglobin range has been recommended, with initiation of therapy when the hemoglobin falls below 10 g/dL. The consideration of the rate of fall is largely again focused on the avoidance of transfusion in these patients.

[INFORMATIONAL NOTE:
• Current clinical practice guidelines from the National Kidney Foundation Kidney Dialysis Outcomes Quality Initiatives (NKF-K/DOQI) recommends that an anemia work-up should be initiated in patients with chronic kidney disease when the
  - Hemoglobin <13.5 g/dL in males.
  - Hemoglobin <12.0 g/dL in females.
• Prior to beginning erythropoietin therapy, the evaluation of anemia should consist of measurements of the following:
  - Hemoglobin and or hematocrit;
  - Red blood cell indices;
  - Reticulocyte count;
  - Iron parameters: serum iron, total iron binding capacity, percent transferrin saturation, serum ferritin;
  - Test for occult blood in stool.
• The benefits of increasing hematocrit values from below 30 percent to 36 percent in patients undergoing dialysis with erythropoietin include a decrease in the need for transfusion and an improvement in the quality of life, cognitive function, cardiac function, exercise capacity, and immune function. In retrospective studies in patients with end-stage renal disease, the mortality rate among patients with hematocrit values below 30 percent was higher than that among patients with hematocrit of 30 to 35 percent. Hematocrit in excess of 35 to 42 percent were not associated with greater improvements.
• Erythropoietin therapy is not intended for patients who require immediate correction of severe anemia.
• Erythropoietin therapy may obviate the need for maintenance transfusions but is not a substitute for emergency transfusions.]
  
2. Severe anemia associated with zidovudine therapy in human immunodeficiency virus (HIV) infected members: Erythropoietin therapy (epoetin alfa, epoetin alfa-epbx) is medically necessary for the treatment of anemia related to Zidovudine ( AZT) therapy in doses less than or equal to 4200 mg/week in HIV-infected members.
A. Therapy may be initiated when hemoglobin declines to <10 g/dL or hematocrit is < 30%; AND
B. Endogenous serum erythropoietin level is ≤500 mUnits/mL; AND
[INFORMATIONAL NOTE:
Peer-reviewed literature supporting that Epoetin alfa, at a dose of 100 U/kg three times weekly (TIW), is effective in decreasing the transfusion requirement and increasing the red blood cell level of anemic, HIV-infected patients treated with zidovudine, when the endogenous serum epoetin alfa level is ≤500 mUnits/mL and when patients are receiving a dose of zidovudine ≤4200 mg/week. (The recommended dose of zidovudine is 600 mg per day or 4200 mg per week.)]
C. Prior to using epoetin alfa (Procrit, Epogen), member must try and have an inadequate response or adverse event to epoetin alfa-epbx (Retacrit)

3. Anemia associated with chemotherapy in cancer members: Erythropoietin therapy (epoetin alfa, epoetin alfa-epbx, and darbepoetin alfa) is medically necessary for the treatment of anemia due to concomitant myelosuppressive chemotherapy in members aged ≥5 years of age (epoetin alfa, epoetin alfa-epbx only) or ≥ 18 years of age (darbepoetin alfa). ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure. There should be a minimum of two additional months of planned chemotherapy.
A. Therapy may be initiated only in patients with hemoglobin levels < 10 g/dL; AND
B. Prior to using epoetin alfa (Procrit, Epogen), member must try and have an inadequate response or adverse event to epoetin alfa-epbx (Retacrit)

[INFORMATIONAL NOTES:
• American Society of Clinical Oncology and the American Society of Hematology 2010 guidelines recommend the following:
  - Use of erythropoietin therapy is recommended as a treatment option for patients with chemotherapy associated anemia and Hgb that has decreased to less than 10 g/dL. Red blood cell transfusion is also an option depending upon the severity of the anemia or clinical circumstances.
  - An optimal level at which to initiate ESA therapy in patients with anemia and Hgb between 10 and 12 g/dL cannot be definitively determined from the available evidence. Under these circumstances, whether or not to initiate ESA treatment should be determined by clinical judgment, consideration of the risks and benefits of ESAs, and patient preferences. Red blood cell transfusion is also a treatment option when warranted by clinical conditions.
The National Comprehensive Cancer Network (NCCN) recommends in the Cancer and Chemotherapy-Induced Anemia 2018 guidelines that erythropoietin therapy should be considered for the following:
- Patients with terminal cancer who are not receiving chemotherapy should not be treated with ESAs.
- For cancer treatment goals with a curative intent, ESA therapy is not indicated. These include primary and adjuvant chemotherapy for malignancies such as early-stage breast cancer and NSCLC, lymphomas, and testicular cancer, among others. An exception to this may be SCLC, for which there are trials demonstrating no negative impact on survival or disease progression.
- For cancer treatment goals without curative intent risk/benefit ratio should be carefully assessed on an individual basis. ESA therapy may be appropriate based on a thorough risk/benefit discussion and patient preferences.
- Patients with previous risk factors for thrombosis may be at higher risk for thrombosis with the use of ESAs. If considering use of ESAs, evaluate the risk factors for thrombosis: history of thromboembolism, heritable mutation, hypercoagulability, elevated pre-chemotherapy platelet counts, hypertension, steroids, prolonged immobilization, recent surgery, certain therapies for multiple myeloma, hormonal agents, etc.
- For treatment of cancer-related anemia in patients with solid tumors who are not undergoing chemotherapy, transfusion is recommended.
- For immediate correction of anemia, transfusion of packed red blood cells (PRBCs) is recommended.
- For symptomatic chemo-therapy induced anemia that does not require immediate attention, PRBCs (curative or non-curative intent) or ESA (non-curative intent) are recommended.
- For asymptomatic patients with factors for development of symptomatic anemia required transfusion include observation or consideration of ESA therapy, based on risks/benefits.
- It is recommended to measure serum iron parameters and iron supplementation is indicated.

The NCCN guidelines also discussed adverse effects of ESA therapy. They are as follows:
- Recent studies have reported decreased survival in cancer patients receiving erythropoietic drugs for correction of anemia. Analyses of eight studies in patients with cancer found decreased survival in cancer patients receiving erythropoietic drugs for correction of anemia and target hemoglobin levels of >12 g/dL. Until new research evidence changes current benefit:risk estimates, physicians should be advised not to administer ESAs to patients outside of the treatment period of cancer-related therapy (radiation therapy, chemotherapy).
- A treatment period is defined as anemia following initiation of therapy and continuing approximately 6 weeks after the completion of treatment
- Five meta-analyses of 51 to 91 randomized controlled trials confirmed worsened health outcomes associated with the use of ESAs when targeting Hb levels above 12 g/dL. Analyses reported statistically significant increased mortality in patients receiving ESAs; although two other meta-analyses by Ludwig et al and Glaspy et al reported no statistically significant effect of ESAs on mortality or progression.
- The risks of shortened survival and tumor progression have not been excluded when ESAs are dosed to a target hemoglobin of < 12 g/dL.
- Because of the above issues, providers should inform patients of risks and benefits of ESA therapy versus red blood cell transfusion.]
4. Reduction of allogeneic blood transfusions in anemic surgery members: Erythropoietin therapy (epoetin alfa, epoetin alfa-epbx) is medically necessary for the reduction of allogeneic blood transfusion in anemic members (hemoglobin greater than 10 and less than or equal to 13 g/dL), who are at high risk for perioperative transfusions with significant anticipated blood loss and are scheduled to undergo elective, non cardiac, nonvascular surgery. Member is unwilling or unable to participate in an autologous blood donation program prior to surgery.

A. Prior to using epoetin alfa (Procrit, Epogen), member must try and have an inadequate response or adverse event to epoetin alfa-epbx (Retacrit)

[INFORMATIONAL NOTE: Erythropoietin therapy (epoetin alfa, epoetin alfa-epbx) is not indicated for anemic patients who are able and willing to donate autologous blood. An epoetin dose of 600 IU/kg SC once per week for 3 weeks prior to surgery and on the day of surgery has been found to be as effective as 300 IU/Kg SC for 10 days prior to surgery, on the day of surgery, and 4 days postoperatively. Supplemental iron is important for optimal benefit.]

5. The following non-oncology “off-label” indications may be considered medically necessary for erythropoietin therapy (epoetin alfa and darbepoetin alfa):
A. To maintain optimal ribavirin dosing in members that experience symptomatic anemia associated with the treatment of ribavirin and interferon alfa-2b or peg-interferon alfa for chronic hepatitis C.
a. Therapy may only be initiated in members on ribavirin and interferon or peg-interferon therapy when the Hgb declines to <10 g/dL


B. Anemia secondary to Rheumatoid Arthritis (Epoetin only)
a. Initiation of therapy may be considered when hemoglobin declines to <10 g/dL in members

C. Anemia secondary to prematurity (Epoetin only)
a. Initiation of therapy may be considered when hemoglobin declines to <10 g/dL in members; AND
b. Must be used in combination with iron supplementation

6. Epoetin Alfa, Darbepoetin Alfa, Pegylated (PEG)-epoetin Beta, and Epoetin Alfa-epbx are considered medically necessary for the oncology off-label indications that have in effect a rating of ‘Category 1’ or ‘Category 2A’ in the current recommendations in the National Comprehensive Cancer Network (NCCN) compendium. Refer to National Comprehensive Cancer Network: Drugs and Biologics Compendium - Epoetin Alfa, Darbepoetin Alfa, Pegylated (PEG)-epoetin Beta, or Epoetin Alfa-epbx. Available at: https://www.nccn.org/professionals/drug_compendium/content/

[INFORMATIONAL NOTE: Based on the ASCO 2010 guidelines, epoetin alfa and darbepoetin alfa treatment beyond 6-8 weeks in absence of response (1-2 g/dL rise in Hgb or no diminution of transfusion requirements), does not appear to be beneficial and therapy should be discontinued. NCCN guidelines from 2007 state that if patient has no response in Hgb at 8-12 weeks of therapy, epoetin alfa and darbepoetin alfa should be discontinued.]

• Last dose less than 60 days ago; AND
• Disease response (e.g.: insignificant increase in Hgb of >1 g/dL or decrease in the duration or number of transfusions; AND
• Absence of unacceptable toxicity from the drug (e.g.: cardiovascular events, tumor progression/recurrence, thrombosis, hypertension, seizures, pure red blood cell aplasia, serious allergic reactions including anaphylactic reactions, severe cutaneous reactions); AND
• Lab values are obtained within 30 days of request and administration; AND
• Adequate iron stores measured within the previous 3 months with a ferritin of at least 100 ng/mL and a TSAT of at least 20%; AND
Anemia secondary to myelodysplastic syndrome (MDS):
• Hemoglobin (Hb) <12 g/dL and/or Hematocrit (Hct) <36%
Reduction of allogenic blood transfusions in elective, non-cardiac, non-vascular surgery:
• Hemoglobin(Hb)between 10 g/dL and 13 g/dL and/or Hematocrit(Hct) between 30% and 39%
Anemia secondary to chemotherapy treatment:
• Hemoglobin (Hb)<10 g/dL and/or Hematocrit (Hct)<30%; AND
• Patient is receiving concurrent myelosuppressive chemotherapy; AND
• There is a minimum of two additional months of planned chemotherapy
Anemia secondary to zidovudine treated, HIV-infected patients:
• Hemoglobin (Hb)<12 g/dL and/or Hematocrit (Hct)<36%
Anemia of chronic inflammation:
• Hemoglobin (Hb)<12 g/dL and/or Hematocrit (Hct)<36%
Anemia secondary to Hepatitis C treatment:
• Hemoglobin (Hb) <11 g/dL and/or Hematocrit (Hct) <33%; AND
• Patient is receiving interferon AND ribavirin
Anemia secondary to chronic kidney disease, pediatric patients (Aranesp and Procrit):
• Hemoglobin (Hb)<12 g/dL and/or Hematocrit (Hct)<36%
Anemia secondary to myeloproliferative neoplasms:
• Hemoglobin (Hb)<10 g/dL and/or Hematocrit (Hct)<30%
All other indications:
• Hemoglobin (Hb) <11 g/dL and/or Hematocrit (Hct) <33%

A. To enhance physical performance and energy level.
B. For members who merely have concerns with safety issues surrounding the use of blood products.
C. In managing immediate correction of acute anemia.

A. Anemia associated with acute renal failure
B. Anemia associated with congestive heart failure
C. Anemia in a woman with postpartum iron deficiency anemia
D. Anemia secondary to autologous blood donation.
E. Cardiac or vascular surgery
F. Castleman disease
G. Gaucher disease
H. Multiple sclerosis
I. Non-critically ill individual requiring correction of anemia
J. Optic neuritis
K. Paroxysmal nocturnal hemoglobinuria (PNH)
L. Pruritis (uremic) in the absence of anemia
M. Scoliosis surgery
N. Sickle-cell anemia
O. Traumatic brain injury

Erythropoiesis Stimulating Agents (ESAs) are covered when given by injection for end stage renal disease. Additionally, ESA treatment for the anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia is covered under specified conditions per NCD 110.21. For additional information and eligibility, refer to National Coverage Determination (NCD) for Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions (110.21). Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx. For step therapy criteria, Medicare Advantage product will follow the Horizon policy.

On June 16, 2011, CMS issued a Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG-00413N) noting that CMS was not issuing a national coverage determination at that time for Erythropoiesis Stimulating Agents (ESAs) for Treatment of Anemia in Adults with CKD Including Patients on Dialysis and Patients not on Dialysis (CAG-00413N).

Medicaid Coverage

For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Erythropoietin Therapy
Anemia, Treatment with Epoetin Alfa
Aranesp
Darbepoetin Alfa
EPO (Erythropoietin)
Epoetin Alfa
Epogen
Hematopoietic Growth Factors, Erythropoietin
NESP
Novel Erythropoiesis Stimulating Protein
Procrit
Peginesatide
Omontys
Pegylated (PEG)-epoetin Beta
Mircera
Epoetin alfa-epbx
Retacrit
Epoetin Alfa-epbx

References:

1. 2004 Physicians' Desk Reference. 58th Edition. Medical Economics Publishing Company.

2. Micromedex® 2.0, (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com. Accessed 3/2019.

3. AHFS Drug Information. 2018. Bethesda, MD :American Society of Health-System Pharmacists, Inc. Accessed 3/2019.

4. Henry DH. Epoetin alfa and high-dose chemotherapy. Semin Oncol. June 1998;25(3 Suppl 7):54-57.

5. Ohls RK, Harcum J, Schibler KR, Christensen RD. The effect of erythropoietin on the transfusion requirements of preterm infants weighing 750 grams or less: a randomized, double-blind, placebo-controlled study. J Pediatr. November 1997;131(5):661-665.

6. Goldberg MA. Perioperative epoetin alfa increases red cell mass and reduces exposure to transfusions: results of randomized clinical trials. Semin Hematol. July 1997;34(3 Suppl 2):41-7.

7. Adamson J. Epoetin alfa as an adjunct to autologous blood donation in patients with a low hematocrit scheduled for elective orthopedic surgery. Semin Hematol. April 1997;33(2 Suppl 2):15-6.

8. Beris P. Epoetin alfa as an adjuvant to autologous blood donation. Semin Hematol. April 1997;33(2 Suppl 2):27-9.

9. Henry D. Haematological toxicities associated with dose-intensive chemotherapy, the role for and use of recombinant growth factors. Annals of Oncology 1997;8(Suppl 3):S7-S10.

10. National Comprehensive Cancer Network: Cancer and Chemotherapy-Induced Anemia. Version 2.2018. [Available at: http://www.nccn.org/professionals/physician_gls/PDF/anemia.pdf (accessed 3/2018)]

11. Garton JP, Gertz MA, Witzig TE, Greipp PR, Lust JA, Schroeder G, Kyle RA. Epoetin alfa for the treatment of the anemia of multiple myeloma. A prospective, randomized, placebo-controlled, double-blind trial. Arch Intern Med. October 23, 1995;155(19):2069-74.

12. Shannon KM, Keith JF, Mentzer WC, Ehrenkranz RA, et al. Recombinant human erythropoietin stimulates erythropoiesis and reduces erythrocyte in very low birth weight preterm infants. Pediatrics. January 1995;95(1):1-8.

13. Markham A, Bryson HM. Epoetin Alfa: A Review of its Pharmacodynamic and Pharmacokinetic Properties and Therapeutic Use in Nonrenal Applications. Drugs. 1995;49(2):232-254.

14. Evidence Report/Technology Assessment #30: Uses of Epoetin for Anemia in Oncology. Agency for Healthcare Research and Quality. June 2001. Publication No. 01-E009.

15. Evidence Report/Technology Assessment #29: Use of Epoetin for Anemia in Chronic Renal Failure. Agency for Healthcare Research and Quality. August 2001. Publication No. 00-E015.

16. FDA website: Product Approval Information for Darbepoetin alfa. http://www.fda.gov/cber/approvltr/darbamg071902L.htm (accessed 07/23/03).

17. Cella D, Dobrz D, Glaspy J. Control of cancer-related anemia with erythropoietic agents: a review of evidence for improved quality of life and clinical outcomes. Ann Oncol. 2003 Apr;14(4):511-9.

18. Vansteenkiste J, Rossi G, Foote M. Darbepoetin alfa: a new approach to the treatment of chemotherapy-induced anaemia. Expert Opin Biol Ther. 2003 Jun;3(3):501-8.

19. Macdougall IC, Matcham J, Gray SJ: NESP 960245/246 Study Group. Correction of anaemia with darbepoetin alfa in patients with chronic kidney disease receiving dialysis. Nephrol Dial Transplant. 2003 Mar18(3):576-81.

20. Empire Medicare Services LMRP #I-7L: Erythropoietin (Epoetin Alpha, EPO). http://www.empiremedicare.com/Newjpolicy/policy/i7final.htm (accessed 07/23/03).

21. Amgen Inc. Epogen Package Insert. Thousand Oaks, CA; 7/2018. Available from: URL: https://pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/epogen/epogen_pi_hcp_english.pdf

22. Amgen Inc. Procrit Package Insert. Thousand Oaks, CA: 7/2018. Available from: URL: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/PROCRIT-pi.pdf

23. National Kidney Foundation. KDOQI. KDOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis 2007 Sep;50(3):471-530.

24. Rizzo JD, Lichtin AE, Woolf SH. 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 2010;100(7):2303-2320.

25. Volberding P and the Anemia in HIV Working Group. Consensus Statement: Anemia in HIV Infection-Current Trends, Treatment Options, and Practice Strategies. Clinical Therapeutics 2000,22(9):1005-1020.

26. Saag MS, Levine AM, Leitz GJ, et al. Once-weekly epoetin alfa increases hemoglobin and improves quality of life in anemic HIV+ patients. Presented at the 39th Annual Meeting of the Infectious Diseases Society of America. San Francisco 2001. Abstract 708.

27. Information provided by Ortho-Biotech. Procrit (epoetin alfa): Use in HIV-Associated Anemia. Revised 5/2003.

28. Abrams DI, Steinhart C, and Frascino R. Epoetin alfa therapy for anaemia in HIV-infected patients: impact on quality of life. International Journal of STD & AIDS 2000;11:659-665.

29. Henry DH, Beall GN, Benson CA, et al. Recombinant human erythropoietin in the treatment of anemia associated with Human Immunodeficiency Virus (HIV) infection and zidovudine therapy. Annals of Internal Medicine 1992;117:739-748.

30. Moore RD. Human Immunodeficiency Virus infection, anemia, and survival. Clinical Infectious Disease 1999;29:44-49.

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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS

J0881
J0882
J0885
Q4081
J0887
J0888

Q5106
Q5105