Clinical Policy: Epoetin Alfa, Epoetin Alfa-epbx - Policy Criteria for Medical Necessity

Q: 批准时通常需要哪些初始条件与关键化验阈值？

政策要求提交支持性临床资料，并在初始审批标准中给出明确门槛，例如铁储备（最近3个月血清铁蛋白≥100 mcg/L或转铁蛋白饱和度≥20%）、治疗前血红蛋白水平（多处要求 <10 g/dL），以及在特定适应证下对用药来源、专科开具（血液科/肾病科/肿瘤科等）、以及特定剂量/频次限制的要求。

Oct 13, 2026

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Clinical policy establishes medical-necessity criteria for epoetin alfa (Epogen, Procrit) and its biosimilar epoetin alfa-epbx (Retacrit). The policy outlines FDA-approved indications for ESA use, including anemia due to chronic kidney disease, zidovudine in HIV infection, chemotherapy-associated anemia, and reduction of allogeneic RBC transfusions in elective noncardiac/nonvascular surgery, plus specific limitations of use. It specifies provider documentation requirements and initial approval criteria with lab thresholds, dosing limits, approval durations, and conditional drug-selection rules.

LanguageEnglish

CategoryGeneral

FormatPDF

Pages11

Reading Time4 min

AccessFree to download

Clinical Policy Overview

Description

FDA Approved Indications

Limitations of Use

Policy/Criteria

Provider Documentation Requirements

Initial Approval Criteria

Approval Durations

Clinical Policy: Epoetin Alfa (Epogen, Procrit), Epoetin Alfa-epbx (Retacrit) Reference Number: CP.PHAR.237 Effective Date: 06.01.16 Last Review Date: 05.20 Coding Implications Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Epoetin alfa (Epogen®, Procrit®) and its biosimilar, epoetin alfa-epbx (Retacrit™), areerythropoiesis-stimulating agents (ESAs) . FDA Approved Indication(s) Epogen, Procrit, and Retacrit are indicated for: • Treatment of anemia due to: o Chronic kidney disease (CKD) in patients on dialysis and not on dialysis. o Zidovudine in patients with HIV-infection. o The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. • Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Limitation(s) of use: • Epogen, Procrit, and Retacrit have not been shown to improve quality of life, fatigue, or patient well-being. • Epogen, Procrit, and Retacrit are not indicated for use: o In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. o In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. o In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. o In patients scheduled for surgery who are willing to donate autologous blood. o In patients undergoing cardiac or vascular surgery. o As a substitute for RBC transfusions in patients who require immediate correction of anemia. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Epogen, Procrit, and Retacrit are medically necessary when the following criteria are met: I. Initial Approval Criteria A. Anemia due to Chronic Kidney Disease (must meet all): 1. Diagnosis of anemia of CKD (dialysis and non-dialysis members); 2. Prescribed by or in consultation with a hematologist or nephrologist; 3. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%; 4. Pretreatment hemoglobin level < 10 g/dL; 5. If Epogen or Procrit is requested, failure of Retacrit, unless contraindicated or clinically significant adverse effects are experienced. Approval duration: Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) B. Anemia due to Zidovudine in HIV-infected Patients (must meet all): 1. Diagnosis of zidovudine induced anemia; 2. Prescribed by or in consultation with a hematologist or HIV specialist; 3. Member is HIV-positive; 4. Dose of zidovudine is ≤ 4,200 mg/week; 5. Endogenous serum erythropoietin levels ≤ 500 mUnits/mL; 6. Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%; 7. Pretreatment hemoglobin level < 10 g/dL; 8. If Epogen or Procrit is requested, failure of Retacrit, unless contraindicated or clinically significant adverse effects are experienced. Approval duration: Medicaid/HIM – 6 months (see Appendix D for dose rounding guidelines) Commercial – 6 months or to member’s renewal period, whichever is longer (see Appendix D for dose rounding guidelines) C. Anemia due to Chemotherapy in Patients with Cancer (must meet all): 1. Request is for use in solid or non-myeloid malignancies in members receiving myelosuppressi

FAQs

批准时通常需要哪些初始条件与关键化验阈值？

政策要求提交支持性临床资料，并在初始审批标准中给出明确门槛，例如铁储备（最近3个月血清铁蛋白≥100 mcg/L或转铁蛋白饱和度≥20%）、治疗前血红蛋白水平（多处要求 <10 g/dL），以及在特定适应证下对用药来源、专科开具（血液科/肾病科/肿瘤科等）、以及特定剂量/频次限制的要求。

Oct 13, 2026

Upload by Syukur Setiap Hari