Clinical Policy: Reference Number: CP.HNMC.15 Effective Date: 11.16.16 Last Review Date: 08.17 Revision Log Line of Business: Medicaid Medi-Cal See Important Reminder at the end of this policy for important regulatory and legal information. Description The following are Angiotesin II Receptor Blockers and renin inhibitors requiring prior authorization: Amlodipine/Olmesartan (Azor ), Olemesartan (Benicar ), Olmesartan/HCTZ (Benicar HCT ), AzilsartanMedoxomil(Edarbi), Azilsartan/Chlorthalidone (Edarbyclor ), Aliskiren (Tekturna ), Aliskiren/HCTZ (Tekturna HCT ), Olmesartan/Amlodipine/HCTZ (Tribenzor ). FDA Approved Indications: Hypertension a DiabeticNephropathy b Azor Benicar O Benicar HCT Edarbi O Edarbyclor Tekturna Tekturna HCT Tribenzor = FDA Approved Indication O = Sufficient data and/or Guidelines exist to support off-label use a = Treatment of Hypertension alone or in combination with other antihypertensive agents b = Treatment of diabetic nephropathy with an elevated serum ctekreatinine and proteinuria in patients with type 2 diabetes and hypertension ^For use in pediatric hypertension as well as adult hypertension Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation Azor, Benicar, Benicar HCT, Edarbi, Edarbyclor, Tekturna, Tekturna HCT, and Tribenzor are medically necessary when the following criteria are met: I. Initial Approval Criteria A. Hypertension (must meet all): 1. Diagnosis of Hypertension; 2. Failure or clinically significant adverse effects to one of the following (a or b): Page 1 of 8
a. An angiotensin converting enzyme (ACE) inhibitor followed by a generic angiotensin II receptor blocker (ARB) or ARB combinations (i.e., losartan, candesartan, irbesartan, telmisartan); b. Two generic ARBs or ARB combinations (i.e., losartan, candesartan, irbesartan, telmisartan); 3. Dose does not exceed Drug Max Dosage Edarbi 80 Edarbyclor 40/25 Benicar 40 Benicar HCT 40/25 Azor 10/40 Tekturna 300 Tekturna HCT 300/25 Tribenzor 40/10/25 Approval duration: Length of Benefit B. Other diagnoses/indications 1. Refer to CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). II. Continued Therapy A. Hypertension (must meet all): 1. Currently receiving medication via health plan benefit or member has previously met initial approval criteria; 2. Member is responding positively to therapy. 3. If request is for a dose increase, new dose does not exceed those listed in Section I, A3 above. Approval duration: Length of Benefit B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via health plan benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to CP.PMN.53 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy CP.PMN.53 or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key RAS: renin-angiotensin system ACE: angiotensin converting enzyme Page 2 of 8
ARB: angiotensin receptor blockers AHFS DI: American Hospital Formulary Service Drug Information LVEF: left ventricular ejection fraction Appendix B: General Information Dual blockade of the renin-angiotensin system (RAS) with angiotensin receptor blockers, angiotensin converting enzyme (ACE) inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. According to the American Hospital Formulary Service Drug Information database (AHFS DI), ARBs have been shown to slow the rate of progression of renal disease in patients with diabetes mellitus and persistent albuminuria and use of ARBs is recommended in patients with modestly elevated (30 300 mg/24 hours) or higher (exceeding 300 mg/24 hours) levels of urinary albumin excretion. The 2013 ACCF/AHA practice guideline for the management of heart failure recommend ACE inhibitors as the preferred drugs for inhibition of the renin-angiotensin system in patients with heart failure and reduced left ventricular ejection fraction (LVEF); however, angiotensin II receptor antagonists may be used as an alternative in patients who are unable to tolerate ACE-inhibitors. Appendix C: Therapeutic Alternatives Drug Dosing Regimen Dose imit/ Benazepril (Lotensin ) Captopril (Capoten ) Fosinopril (Monopril ) Lisinopril (Zestril, Prinivil ) Quinapril (Accupril ) losartan (Cozaar ) Hypertension: 10-40 mg/day (single or two divided Hypertension: 25 mg PO BID/TID; titrate to blood pressure Heart Failure: 6.25-12.5 mg PO TID, titrate to blood pressure Left ventricular dysfunction s/p MI: 6.25 mg PO TID, titrated to maintenance dose of 50 mg PO TID Hypertension: 10-40 mg PO (single or two divided Heart Failure: 5-40 Hypertension: 10-40 mg PO Heart Failure: 5-40 Hypertension: 10-80 mg PO (single or two divided Heart Failure: 5-20 mg PO BID Adult Hypertension: 25-100 mg (single or two divided Maximum Dose 80 mg/day 450 mg/day 80 mg/day 40 mg/day 80 mg/day 40 mg/day 80 mg/day 40 mg/day 100 mg/day Page 3 of 8
Drug Dosing Regimen Dose imit/ Maximum Dose Pediatric Hypertension: >/= 6 years: 0.7 mg/kg (up to 50 mg) 1.4 mg/kg (up to 100 mg) Hypertension with LVH: 50-100 Nephropathy: 50-100 mg PO losartan/hctz (Hyzaar ) Hypertension: 50/12.5 100/25 100 mg/25 mg/day (single or two divided irbesartan (Avapro ) Hypertension: 150 300 mg PO 300 mg/day Nephropathy: 300 irbesartan/hctz Hypertension: 150/12.5 300/25 300/25 mg/day (Avalide ) candesartan (Atacand ) Adult Hypertension: 8-32 mg (single or two divided Pediatric Hypertension: 1 to <6 years: 0.05 0.4 mg/kg 6 to <17 years (<50 kg): 4 16 6 to <17 years (>50 kg): 4 32 32 mg/day candesartan/ HCTZ (Atacand HCT) eprosartan (Teveten)* telmisartan (Micardis) telmisartan/ amlodipine (Twynsta) telmisartan/ HCTZ (Micardis HCT) valsartan (Diovan)* Heart Failure: 4 32 Hypertension: 16/12.5 32/25 (single or two divided Hypertension: 400-800 mg PO (single or two divided Hypertension: 40 80 Cardiovascular Risk Reduction: 80 Hypertension: 40/5 80/10 mg Hypertension: 40/12.5 80/25 Hypertension: 80 320 mg PO Pediatric Hypertension: 32/25 mg/day 80 80/10 80/25 320 Page 4 of 8
Drug Dosing Regimen Dose imit/ Maximum Dose 6 to 16 years: 1.3 mg/kg (up to 40 mg) 2.7 mg/kg (up to 160 mg) Heart Failure: 40 160 mg PO BID Post-MI: 20-160 mg PO BID valsartan/ HCTZ Hypertension: 160/12.5 320/25 320/25 (Diovan HCT)* amlodipine/ valsartan (Exforge)* amlodipine/ valsartan/ HCTZ (Exforge HCT)* Hypertension: 5/160 10/320 mg Hypertension: 5/160/12.5 10/320/25 10/320 10/320/25 Therapeutic alternatives are listed as Brand name (generic) when the drug is available by brand name only and generic (Brand name ) when the drug is available by both brand and generic. V. Dosage and Administration Drug Dosing Regimen Maximum dose Edarbi Hypertension: 80 ; 80 consider 40 for patients on high doses of diuretics Edarbyclor Hypertension: 40/12.5 40/25 mg 40/25 Benicar Adult Hypertension: 20-40 mg 40 Pediatric Hypertension: 20 to <35 kg: 10-20 >/=35 kg: 20-40 Benicar HCT Hypertension: 20/12.5 40/25 40/25 Azor Hypertension: Initiate with 5/20 10/40 for 1 to 2 weeks; titrate as needed up to 10/40 mg Tekturna Hypertension: 150 300 mg PO 300 Tekturna HCT Hypertension: 150/12.5 300/25 300/25 Tribenzor Hypertension: 20/5/12.5-40/10/25 40/10/25 VI. Product Availability Drug Availability Single agent tablets Page 5 of 8
Benicar 5, 20,40 mg tablets Edarbi 40, 80 mg tablets Tekturna 150, 300 mg tablets In combination with diuretic Benicar HCT 20/12.5, 40/12.5, 40/25 mg tablets Edarbyclor 40/12.5, 40/25 mg tablets Tekturna HCT 150/12.5, 150/25, 300/12.5, 300/25 mg tablets In combination with calcium channel blocker Azor 5/20, 10/20, 5/40, 10/40 mg tablets Tribenzor 20/5/12.5, 40/5/12.5, 40/5/25, 40/10/12.5, 40/10/25 mg tablets VII. References 1. Azor Prescribing Information. Parsippany, NJ: Daiichi Sankyo; November 2016. Available at www,azor.com. Accessed January 18, 2017. 2. Benicar Prescribing Information. Parsippany, NJ: Daiichi Sankyo, Inc; November 2016. Available at www,benicar.com. Accessed January 18, 2017. 3. Benicar HCT Prescribing Information. Parsippany, NJ: Daiichi Sankyo, Inc.; November 2016. Available at www,benicar.com. Accessed January 18, 2017 4. Edarbi Prescribing Information. Atlanta, GA: Arbor Pharmaceuticals; May 2014. Available at www.edarbi.com. Accessed January 18, 2017. 5. Edarbyclor Prescribing Information. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; April 2015. Available at www,edarbi.com. Accessed January 18, 2017. 6. Micromedex 2.0, (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed January 18, 2017. 7. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed January 18, 2017. 8. Rodgers JE and Patterson JH. Angiotensin II receptor blockers: Clinical relevance and therapeutic role. Am J Health-Syst Pharm. 2001;58:671-683. 9. American Diabetes Association Clinical Practice Recommendations - 2015. Diabetes Care. 2015;38:(Suppl 1): S1-94. 10. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014; 311 (5): 507-520. 11. Dahlof B, Devereux RB, Kjeldsen SE, et al for the LIFE study group. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): A Randomized trial against atenolol. The Lancet. 2002;359:995-1003. 12. Tekturna Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2016. Available at www.tekturna,com. Accessed January 18, 2017. 13. Tekturna HCT Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2016. Available at www.tekturna.com. Accessed January 18, 2017. 14. Tribenzor Prescribing Information. Parsippany, NJ: Daiichi Sankyo, Inc.; November 2016. Available at www,tribenzor.com. Accessed January 18, 2017. Page 6 of 8
15. Yancy CW, Jessup M et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013; 128:e240-327. Reviews, Revisions, and Approvals Date P&T Approval Date Converted to new template; minor changes to verbiage and grammar. 01.18.17 08.17 References updated. Removed eprosartan and valsartan redirection as these are nonformulary products 09.20.17 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 medical practice; peer-reviewed medical 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 medical 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 medical 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 medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to Page 7 of 8
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. 2016 Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 8 of 8