Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document.

Transcription

1 ERYTHROPOIESIS-STIMULATING AGENTS (ESAs) Epoetin alfa (Epogen, Procrit ) Darbepoetin alfa (Aranesp ) Methoxy polyethylene glycol (PEG) epoetin-beta (Mircera ) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. O docx Page 1 of 9

2 Description: Erythropoietin is a glycoprotein manufactured in the kidneys in response to changes in the blood oxygen concentration. When the oxygen level in the blood is detected to be low, the body is prompted to begin production of erythropoietin which acts on the bone marrow to stimulate production of red blood cells and raise the blood hemoglobin levels. Suppression of the production of erythropoietin or the bone marrow response to the erythropoietin may be caused by certain diseases, including chronic kidney disease (CKD) and cancer as well as some cancer treatments, resulting in anemia. Synthetic erythropoiesis-stimulating agents (ESAs), produced using recombinant DNA technology, may be administered to stimulate red blood cell production and treat anemia. ESAs include epoetin alfa (Epogen, Procrit ), also referred to as erythropoietin or EPO, darbepoetin alfa (Aranesp ). Pegylated (PEG)-epoetin beta (Mircera ) is a long-acting epoetin that is FDA-approved for individuals with anemia due to CKD. Definitions: Anemia: Hemoglobin and hematocrit are low for individual s age and sex. Criteria: See Resources section for FDA-approved dosage. Epogen, Procrit and Aranesp: Epogen, Procrit, or Aranesp for the treatment of anemia with a hemoglobin less than 10g/dL, utilizing the lowest dose in order to avoid red blood cell transfusion and not raise the hemoglobin level above 11 g/dl, is considered medically necessary with documentation of ALL of the following: 1. ANY of the following: ZDV (zidovudine) therapy in an HIV-infected individual 8 months or older with documentation that the individual s endogenous serum erythropoietin level is less than or equal to 500 munits/ml (Epogen/Procrit) Chronic kidney disease (CKD) in an individual on dialysis 1 month of age and older (Epogen, Procrit) or 1 year of age or older (Aranesp) CKD with symptomatic anemia in an adult individual not on dialysis (Epogen, Procrit) or 1 year of age or older not on dialysis (Aranesp) O docx Page 2 of 9

3 Criteria: (cont.) Epogen, Procrit and Aranesp: (cont.) Epogen, Procrit, or Aranesp for the treatment of anemia with a hemoglobin less than 10g/dL, utilizing the lowest dose in order to avoid red blood cell transfusion and not raise the hemoglobin level above 11 g/dl, is considered medically necessary with documentation of ALL of the following: (cont.) 1. ANY of the following: (cont.) Treatment of anemia in cancer for individuals with non-myeloid malignancy 5 years of age and older (Epogen, Procrit) or 18 years of age or older (Aranesp) with ALL of the following: a. Anemia is the result of chemotherapy b. Individual will receive concomitant chemotherapy for a minimum of 2 months and ESA is being used to decrease the need for transfusions c. Treatment with ESAs should be discontinued following the completion of a myelosuppressive chemotherapy course To reduce the need for allogeneic blood transfusion for an individual with documentation of ALL of the following: a. Scheduled to undergo elective, non-cardiac, non-vascular surgery b. At high risk for a perioperative transfusion with significant, anticipated blood loss Treatment following allogeneic stem cell (bone marrow) transplant Treatment of myelodysplastic syndromes to reduce dependency on blood transfusions Hepatitis C individuals with anemia associated with ribavirin and/or interferon therapy for an initial 3 month course. Continuation of additional 3 month courses with documentation that hemoglobin and hematocrit performed within the past 30 days and results within normal limits or no greater than 5% below 1 laboratory s normal range for individual s age and gender. O docx Page 3 of 9

4 Criteria: (cont.) Epogen, Procrit and Aranesp: (cont.) Epogen, Procrit, or Aranesp for the treatment of anemia with a hemoglobin less than 10g/dL, utilizing the lowest dose in order to avoid red blood cell transfusion and not raise the hemoglobin level above 11 g/dl, is considered medically necessary with documentation of ALL of the following: (cont.) 2. Absence of ALL of the following contraindications: Uncontrolled hypertension Pure red cell aplasia (PRCA) that begins after treatment with erythropoietin protein drugs Serious allergic reaction to erythropoietin protein drugs For Procrit/Epogen - use of multi-dose vial that contains benzoyl alcohol in neonates, infants, pregnant women, and nursing mother Continuation of Epogen, Procrit or Aranesp for the treatment of Hepatitis C individuals with anemia associated with ribavirin and/or interferon therapy is considered not medically necessary and not eligible for coverage when ribavirin combination therapy has been discontinued. Epogen, Procrit, and Aranesp for all other uses not previously listed or if above criteria not met are considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives. These uses include, but are not limited to: Treatment of chronic anemia of cancer for individuals not receiving chemotherapy Treatment of individuals following high-dose chemotherapy with autologous stem cell transplant Individuals with cancer receiving chemotherapy when the anticipated outcome is cure Other cancer associated anemia not listed above. O docx Page 4 of 9

5 Criteria: (cont.) Mircera: Mircera is considered medically necessary for the treatment of anemia associated with chronic kidney disease in an adult individual with documentation of ALL of the following: 1. A hemoglobin less than 10g/dL, utilizing the lowest dose in order to avoid red blood cell transfusion and not raise the hemoglobin level above 11 g/dl 2. Absence of ALL of the following contraindications: Uncontrolled hypertension Pure red cell aplasia (PRCA) that begins after treatment with Mircera or other erythropoietin protein drugs History of serious allergic reactions to Mircera including anaphylaxis Mircera for all other uses not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives. 1 Results greater than 5% below laboratory s normal range for individual s age and gender will be reviewed by the clinical pharmacist(s) and/or medical director(s) and/or clinical advisor(s). Resources: Literature reviewed 11/14/17. We do not include marketing materials, poster boards and nonpublished literature in our review. The BCBS Association Medical Policy Reference Manual (MPRM) policy is included in our guideline review. References cited in the MPRM policy are not duplicated on this guideline BCBS Association Medical Policy Reference Manual. Erythropoiesis-Stimulating Agents. Re-issue date 10/12/2017, issue date 12/01/1992. O docx Page 5 of 9

6 Resources: (cont.) Epogen, Procrit Package Insert: - FDA-approved indication and dosage: Indication Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis Treatment of anemia due to Zidovudine in patients with HIV-infection Treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery Recommended Dose Patients with CKD: Initial dose: 50 to 100 Units/kg 3 times weekly (adults) and 50 Units/kg 3 times weekly (children on dialysis). Individualize maintenance dose. Intravenous route recommended for individuals on hemodialysis. Patients on Zidovudine due to HIV-infection: 100 Units/kg 3 times weekly. Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (children 5 years). Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly. Pediatric Use: Safety and effectiveness have not been established in CKD patients undergoing dialysis who are less than 1 month old, pediatric patients with cancer less than 5 years old, pediatric patients with CKD not on dialysis. O docx Page 6 of 9

7 Resources: (cont.) Aranesp Package Insert: - FDA-approved indication and dosage: Indication Adults with anemia due to chronic kidney disease (CKD) in patients on dialysis Recommended Dose Recommended starting dose 0.45 mcg/kg intravenously or subcutaneously weekly, or mcg/kg intravenously or subcutaneously every 2 weeks Intravenous route is recommended for patients on hemodialysis. Adults with anemia due to chronic kidney disease (CKD) in patients not on dialysis Pediatric patients with chronic kidney disease (CKD) The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy Recommended starting 0.45 mcg/kg intravenously or subcutaneously at 4 week intervals. Recommended starting dose for pediatric patients (less than 18 years) is 0.45 mcg/kg body weight administered as a single subcutaneous or intravenous injection once weekly; patients not receiving dialysis may also be initiated at a dose of 0.75 mcg/kg once every 2 weeks. Recommended starting dose on chemotherapy 2.25 mcg/kg subcutaneously weekly, or 500 mcg subcutaneously every 3 weeks. Mircera Package Insert: - FDA-approved indication and dosage: Indication Anemia associated with chronic kidney disease (CKD) in adult patients on dialysis and patients not on dialysis Recommended Dose Mircera is administered by subcutaneous (SC) or intravenous (IV) injection Initial Treatment: 0.6 mcg/kg body weight administered once every two weeks Conversion from Another ESA: dosed once monthly or once every two weeks based on total weekly epoetin alfa or darbepoetin alfa dose at time of conversion. Pediatric Use: Safety and efficacy of Mircera not established in pediatric patients. O docx Page 7 of 9

8 Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) for Spanish and (877) for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ , (602) , TTY/TDD (602) , crc@azblue.com. You can file a grievance in person or by mail or . If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, , (TDD). Complaint forms are available at Multi-Language Interpreter Services: O docx Page 8 of 9

9 Multi-Language Interpreter Services: (cont.) O docx Page 9 of 9