See Important Reminder at the end of this policy for important regulatory and legal information.

Transcription

1 Policy: Erythropoiesis Stimulating Agents (ESAs) Reference Number: TCHP.PHAR.1813 Effective Date: Last Review Date: Line of Business: Oregon Health Plan Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Goal(s): Cover ESAs according to OHP guidelines and current literature. Cover preferred products when feasible Length of Authorization: 12 weeks initially, then up to 12 months Quantity limit of 30 day per dispense Requires PA: All ESAs require PA for clinical. Covered Alternatives: Current Trillium Preferred Drug List listed at: o Approval Criteria 1. What is the diagnosis being treated? Record ICD-10 Code 2. Is this an OHP covered diagnosis? Yes: Go to #3 not funded by the OHP 3. Is this a continuation of therapy previously Yes: Go to #12 No: Go to #4 approved by Trillium Community Health Plan? 4. Is the requested product preferred? Yes: Go to #6 No: Go to #5 5. Will the prescriber change to a preferred product? Yes: Inform prescriber of No: Go to #6 covered alternatives in class Message: Preferred products do not require PA. Preferred products are evidence-based reviewed for comparative effectiveness and safety by the Pharmacy and Therapeutics (P&T) Committee. 6. Is the diagnosis anemia due to chronic renal failure or chemotherapy? 7. Is Hgb <10 g/dl or Hct <30% Transferrin saturation >20% and/or ferritin >100 ng/ml? Page 1 of 6 Yes: Go to #7 No: Go to #8 Yes: Approve for 12 weeks with additional approval based upon adequate response. 8. Is the diagnosis anemia due to HIV? Yes: Go to #9 No: Go to #10

2 9. Is the Hgb <10 g/dl or Hct <30% Transferrin saturation >20% Endogenous erythropoietin <500 IU/L If on zidovudine, is dose <4200 mg/week? Yes: Approve for up to 12 months 10. Is the diagnosis anemia due to ribavirin treatment? Yes: Go to #11 No: Pass to RPh. Deny 11. Is the Hgb <10 g/dl or Hct <30% Is the transferrin saturation >20% and/or ferritin >100 ng/ml Has the dose of ribavirin been reduced by 200 mg/day and anemia persisted >2 weeks? Yes: Approve up to the length of ribavirin treatment 12. Has the patient responded to initial therapy? Yes: Approve for up to 12 months Page 2 of 6

3 I. Dosage and Administration Medication Indication Dosing Regimen Maximum Dose Epoetin alfa (Epogen and Procrit) Anemia due to CKD Anemia due to zidovudine in HIVinfected patients Anemia due to chemotherapy Reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery Anemia secondary to combination ribavirin and interferon-alfa therapy in patients infected with hepatitis C virus Anemia associated with MDS Anemia associated with myelofibrosis Initial dose: 50 to 100 Units/kg 3 times weekly (adults) intravenously (IV) or subcutaneously (SC) and 50 Units/kg 3 times weekly (children on dialysis) IV or SC. Individualize maintenance dose. IV route recommended for patients on hemodialysis 100 Units/kg IV or SC 3 times weekly 40,000 Units SC weekly or 150 Units/kg SC 3 times weekly (adults) until completion of a chemotherapy course; 600 Units/kg IV weekly (children 5 years) until completion of a chemotherapy course 300 Units/kg per day SC daily for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery or 600 Units/kg SC weekly in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery 40,000 units SC once weekly maintained the ribavirin dose in anemic patients with chronic hepatitis C virus; After 4 weeks, if the hemoglobin had not increased by at least 1 g/dl, the weekly dose was increased to 60,000 units SC units/kg SC 3 times weekly has been shown to improve anemia in about 20% of patients with MDS. When epoetin alfa is given in combination with granulocyte-macrophage colony stimulating or granulocyte colony stimulating factor, response increases to about 50% of MDS patients. In a clinical trial, patients initially received erythropoietin 10,000 units SC 3 days per week. Erythropoietin was increased to 20,000 units 3 days per week if a response was not obtained after 2 months and erythropoietin was discontinued in patients who did not experience a response at 3 months. Varies depending on indication and frequency of administration Page 3 of 6

4 Medication Indication Dosing Regimen Maximum Dose Darbepoetin alfa (Aranesp) Anemia due to CKD Methoxy polyethylene glycolepoetin beta (Mircera) Anemia due to chemotherapy in patients with cancer Recommended starting dose for patients with CKD on dialysis: 0.45 mcg/kg intravenously or subcutaneously weekly, or 0.75 mcg/kg intravenously or subcutaneously every 2 weeks Intravenous route is recommended for patients on hemodialysis Recommended starting dose for patients with CKD not on dialysis: 0.45 mcg/kg intravenously or subcutaneously at 4 week intervals Recommended starting dose for pediatric patients with CKD: 0.45 mcg/kg intravenously or subcutaneously weekly; patients with CKD not on dialysis may also be initiated at 0.75 mcg/kg every 2 weeks Recommended starting dose for patients with cancer on chemotherapy: 2.25 mcg/kg subcutaneously weekly, or 500 mcg subcutaneously every 3 weeks until completion of a chemotherapy course Varies depending on indication and frequency of administration. Anemia associated with MDS mcg subcutaneously every other week In some institutions, darbepoetin alfa has been administered using doses up to 500 mcg every other week Anemia due to CKD Off-label NCCN recommended use Initial treatment: 0.6 mcg/kg body weight administered SC or IV 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 Varies II. Product Availability Medication Available Formulations Epoetin alfa (Epogen) Single-dose vial: 2000, 3000, 4000, and 10,000 units/ml Multiple-dose vial containing benzyl alcohol: 20,000 units/2 ml and 20,000 units/ml Epoetin alfa (Procrit) Single-dose vial: 2000, 3000, 4000, 10,000, and 40,000 units/ml Multiple-dose vial containing benzyl alcohol: 20,000 units/2 ml and 20,000 units/ml Darbepoetin alfa Single-dose vials for injection: 25 mcg, 40 mcg, 60 mcg, 100 mcg, 200 mcg, 300 (Aranesp) mcg, and 500 mcg/1 ml, and 150 mcg/0.75 ml Single dose prefilled syringes for injection: 10 mcg/0.4 ml, 25 mcg/0.42 ml, 40 mcg/0.4 ml, 60 mcg/0.3 ml, 100 mcg/0.5 ml, 150 mcg/0.3 ml, 200 mcg/0.4 ml, Methoxy polyethylene glycol-epoetin beta (Mircera) 300 mcg/0.6 ml, and 500 mcg/1 ml Injection (single-use prefilled syringe): 50, 75, 100, 150, 200, or 250 mcg in 0.3 ml solution of Mircera Page 4 of 6

5 III. References 1. Erythropoiesis Stimulating Agents (ESAs). Oregon Health Plan Current Drug Use Criteria. Available at: Accessed March 23, Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed March 23, Reviews, Revisions, and Approvals Date P&T Approval Date Policy created Supersedes the following Centene Policies: CP.PHAR.236 Darbepoetin Alfa (Aranesp) CP.PHAR.237 Epoetin Alfa (Epogen and Procrit) CP.PHAR.238 Methoxy polyethylene glycol-epoetin beta (Mircera) Approved by Trillium Oregon Health Plan P&T Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of practice; peer-reviewed literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute advice, treatment or care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional judgment in providing the most appropriate care, and are solely responsible for the advice and treatment of Page 5 of 6

6 members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services. Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy. Page 6 of 6