Medication Prior Authorization Form

Transcription

1 Procrit, Aranesp and (Epoetin Alfa) Policy Number: 1043 Policy History Approve Date: 12/11/2015 Effective Date: 12/11/2015 Preauthorization All Plans Benefit plans vary in coverage and some plans may not provide coverage for certain service(s) listed in this policy. Decisions for authorization are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations as well as applicable state and/or federal laws. Please review the benefit plan descriptions for details. We utilize a combination of MCG and internally developed evidence-based clinical guidelines to support our prior authorization work. All internally developed prior authorization guidelines follow a rigorous process including, but not limited to, review by clinical pharmacist, clinical nurse manager, Chief Medical Officer, independent 3 rd party physician review agency and WEA Trust s Medical Advisory Committee. Prior authorization guidelines are reviewed at least annually, or when there are significant labeling changes made by FDA or peer-reviewed clinical outcomes (via Cochrane or Hayes). INSTRUCTIONS: Please review section I and complete sections II, III, and IV (type or print clearly). Prescribers are asked to submit this form along with supporting clinical documentation to the WEA Trust for review. Submission of form does not guarantee approval. Submit preauthorization (PA) by fax to the WEA Trust at (608) or by mail to WEA Trust, Pharmacy Services Prior Authorization, PO Box 21538, Eagan MN Section I Approval Criteria I. Approval Duration A. Initial therapy: two months (eight weeks) B. Continued use: two months (eight weeks) C. Requests will NOT be approved for longer than two months (eight weeks) at a time II. and Aranesp are medically necessary when individual has tried and failed or is intolerant to Procrit or and meets all of the following criteria: A. The individual has a hemoglobin (Hgb) levels less than 10 g/dl, prior to initiation of therapy AND B. Prior to initiation of therapy, evaluation of the individual s iron status reveals: i. Transferrin saturation is at least 20% OR ii. Ferritin is at least 80 ng/ml OR

2 Page 2 iii. Bone marrow demonstrates adequate iron stores AND C. For individuals with hypertension, blood pressure is adequately controlled before initiation of therapy and closely monitored and controlled during therapy AND D. The individual meets as least one of the following: i. Anemia associated with chronic kidney disease (CKD), for individuals on dialysis, to achieve and maintain hemoglobin levels within the range of 10 to 11 g/dl OR ii. Anemia associated with chronic kidney disease (CKD) for individuals not on dialysis, to achieve and maintain hemoglobin levels of 10g/dL OR iii. Cancer chemotherapy known to produce anemia (myelosuppressive) when ALL of the following are met: 1. Chemotherapy is planned for a minimum of two months AND 2. The individual has a diagnosis of non-myeloid cancer and the anticipated outcome is not cure OR iv. Myelodysplastic syndrome with an endogenous erythropoietin level less than 500 mu/ml OR v. Zidovudine in human immunodeficiency virus (HIV)-infected individuals when the endogenous serum erythropoietin level is less than or equal to 500 mu/ml and when the dose of Zidovudine is less than or equal to 4200 mg/week OR vi. Hepatitis C virus infection in individuals who are being concomitantly treated with the combination of ribavirin and interferon alfa, or ribavirin and peginterferon alfa OR vii. Myelosuppressive drugs (for example, disease modifying anti-rheumatic drugs) known to produce anemia in individuals with a diagnosis of a chronic inflammatory disease or Allogeneic Bone Marrow Transplantation III. Epoetin alfa is medically necessary for elective, non-cardiac, non-vascular surgery to reduce the need for allogeneic blood transfusion when the individual meets all of the following criteria: A. Individual s hemoglobin levels are greater than 10 to less than or equal to 13 g/dl AND B. Individual is at high risk for perioperative transfusions with significant, anticipated blood loss AND C. Individual is unable or unwilling to donate autologous blood AND D. Antithrombotic prophylaxis has been considered AND E. For individuals with hypertension, blood pressure is adequately controlled before initiation of therapy and closely monitored and controlled during therapy AND F. Prior to initiation of therapy, evaluation of the individual s iron status reveals: i. Transferrin saturation is at least 20% OR ii. Ferritin is at least 80 ng/ml OR iii. Bone marrow demonstrates adequate iron stores IV. Continued use of epoetin alfa may only be approved beyond eight weeks if the hemoglobin does not exceed 11 g/dl and iron stores (including transferrin saturation and ferritin) are adequately maintained and monitored periodically during therapy; Epoetin alpha is not medically necessary for the following: A. When above criteria are not met B. Used to treat anemia in any indication not listed above, including but not limited to anemia of prematurity C. Continued use when the hemoglobin level exceeds 11 g/dl unless otherwise specified above (except when the dose of epoetin alfa is adjusted to achieve and maintain target hemoglobin not to exceed 11 g/dl) D. Use beyond 12 weeks in the absence of response in individuals with chronic kidney disease E. Use beyond eight weeks in the absence of response in individuals with myelodysplastic syndrome (MDS) F. Use beyond eight to nine weeks in the absence of response or if transfusions are still required in individuals with metastatic, non-myeloid cancer being treated with myelosuppressive chemotherapy agents known to produce anemia G. To treat anemia in individuals due to other factors such as iron deficiency, folate deficiency or B12 deficiency, hemolysis, gastrointestinal bleeding, other active or occult bleeding, or underlying hematologic diseases (such as sickle cell anemia, thalassemia, and porphyria)

3 Page 3 H. As a treatment in the presence of sudden loss of response with severe anemia and low reticulocyte count I. To treat anemia in individuals with cancer receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy J. To treat anemia in individuals with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure K. Continued use beyond six weeks after therapy with myelosuppressive chemotherapy known to produce anemia is completed L. Pre-operative use for individuals who are willing to donate autologous blood V. Erythropoiesis-stimulating agents (ESAs) have black box warnings related to the increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. Individuals with chronic kidney disease (CKD) are at a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target hemoglobin (Hgb) levels greater than 11 g/dl in clinical studies. No trial has identified a target Hgb level, ESA dose, or dosing strategy that does not increase these risks. Use of ESAs in individuals with certain tumor types (i.e., breast, non-small cell lung, head and neck, lymphoid, cervical), shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies. Recommended to use the lowest ESA dose needed to avoid RBC transfusions and serious cardiovascular and thromboembolic reactions. ESAs should only be used for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course. Individuals receiving myelosuppressive chemotherapy should not be treated with ESAs when the anticipated outcome is cure. Deep venous thrombosis prophylaxis should be considered when epoetin alfa is used perisurgically. Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense epoetin alfa to individuals with cancer. Renewal Criteria I. All renewals will be for six months References 1. FDA approved product labeling and Lexicomp 2. Tonia T, Mettler A, Robert N, Schwarzer G, Seidenfeld J, Weingart O, Hyde C, Engert A, Bohlius J Erythropoietin or darbepoetin for patients with cancer. Cochrane Database Syst Rev. 2012;12: CD Grant MD, Piper M, Bohlius J, et al. Comparative Effectiveness Review Number 113: Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment: Comparative Effectiveness Update http: //effectivehealthcare.ahrq.gov/ehc/products/170/1480/cancer-anemia-treatment-report pdf 4. NCCN guidelines v Cancer and Chemotherapy Induced Anemia 5. Rizzo JD, Brouwers M, Hurley P, Seidenfeld J, Arcasoy MO, Spivak JL, Bennett CL, Bohlius J, Evanchuk D, Goode MJ, Jakubowski AA, Regan DH, Somerfield MR; American Society of Clinical Oncology; American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. American Society of Hematology. J Clin Oncol 2010 Nov 20;28(33): Epub 2010 Oct Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney inter., Suppl. 2012; 2: http: // 7. NCCN guidelines Myelodysplastic Syndromes v

4 Page 4 Section II Member Information Name (Last, First, Middle Initial) Date of Birth WEA Trust Subscriber Number Diagnosis 1. MEDICATION 2. STRENGTH 3. DIRECTIONS 4. QUANTITY PER 30 DAYS (epoetin alfa) Specify: 5. DIAGNOSIS: 6. APPROVAL CRITERIA: CHECK ALL BOXES THAT APPLY NOTE: Any areas not filled out are considered not applicable to your patient and MAY AFFECT THE OUTCOME of this request. No Individual has tried, failed or is intolerant to Procrit OR Aranesp No Individual is continuing therapy with the requested drug If yes: No The hemoglobin (Hgb) level exceeds 11.0 g/dl. Please specify current Hgb: g/dl No Iron stores (including transferrin saturation and ferritin) are adequately maintained and monitored periodically during therapy No Individual has Hgb levels less than 10.0 g/dl, prior to initiation of therapy No Individual s iron status, prior to initiation of therapy, includes transferrin saturation or ferritin or bone marrow evaluation If yes: No Transferrin saturation is at least 20% No Ferritin is at least 80ng/ml No Bone marrow demonstrates adequate iron stores No The individual has hypertension If yes: No Blood pressure will be adequately controlled before initiation of therapy and closely monitored and controlled during therapy

5 Page 5 Diagnosis: (please respond to all) No Anemia associated with chronic kidney disease No Individual is on dialysis No Anemia associated with cancer chemotherapy No If yes, Individual is using the requested medication to achieve and maintain hemoglobin levels within the range of 10.0 to 11.0 g/dl No If no, Individual is using the requested medication to achieve and maintain hemoglobin levels of 10.0g/dL No Chemotherapy is planned for a minimum of two months No Patient has a diagnosis of non-myeloid cancer and anticipated outcome is not cure No Myelodysplastic syndrome with endogenous erythropoietin level < 500mUnits/ml No Zidovudine therapy for human immunodeficiency virus (HIV)-infected patients No Individual s endogenous serum erythropoietin level is less than or equal to 500 m Units/ml and the dose of zidovudine is less than or equal to 4200 mg/week No Elective, non-cardiac non-vascular surgery to reduce the need for allogeneic blood transfusions when the individual meets the following: No Individual s hemoglobin levels are greater than 10.0 to less than or equal to 13.0g/dL No Individual is unable or unwilling to donate autologous blood No Antithrombotic prophylaxis has been considered No Hepatitis C virus infection No Individual is being concomitantly treated with the combination of ribavirin and interferon alfa, or ribavirin and peg-interferon alfa No Myelosuppressive drugs (e.g. disease modifying anti-rheumatic drugs) known to produce anemia in individuals with a diagnosis of chronic inflammatory disease No Individual is following allogeneic bone marrow transplantation

6 Page 6 Section III Physician Information Physician Name National Provider Identification (NPI) Number Clinic Name Address (Street, City, State, Zip Code) Physician Telephone Number Physician Fax Number Physician Signature Date Section IV For WEA Trust Use Only Plan: Copay Tiers: Date of Receipt: Remarks: Approve Deny More information is needed Incomplete form Submission and review of this form does not guarantee approval of this request. Unless approved, payment of the brand-name medication will be limited to the amount the Trust would have paid for the generic equivalent. Insureds and providers will be informed of the decision in writing within approximately 30 days. Fax to: Pharmacy Services (608) Mail to: WEA Trust Pharmacy Services Prior Authorization PO Box Eagan MN