Pharmacy Medical Policy Angiotensin II Receptor Antagonists

Transcription

1 Pharmacy Medical Policy Angiotensin II Receptor Antagonists Table of Contents Policy: Commercial Information Pertaining to All Policies Endnotes Policy: Medicare References Forms Policy History Policy Number: 012 BCBSA Reference Number: None Related Policies None Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Note: All requests for outpatient retail pharmacy for indications listed and not listed on the medical policy guidelines may be submitted to BCBSMA Clinical Pharmacy Operations by completing the Prior Authorization Form on the last page of this document. Physicians may also call BCBSMA Pharmacy Operations department at (800) to request a prior authorization/formulary exception verbally. Physicians may also submit requests for retail pharmacy exceptions via the web using Express PA which can be found on the BCBSMA provider portal or directly on the web at Patients must have pharmacy benefits under their subscriber certificates. Please refer to the chart below for the formulary and step status of the medications affected by this policy. Formulary Information Drug Standard Formulary Status Step Amturnide Not Covered 3 Atacand Not Covered 3 Atacand HCT Not Covered 3 Avapro Covered 3 Avalide Covered 3 Azor Covered 2 Benicar Covered 2 Benicar HCT Covered 2 candesartan Covered 1 candesartan/hct Covered 1 Cozaar Not Covered 3 1

2 Diovan Covered 2 Diovan HCT Covered 2 Edarbi Not Covered 3 Exforge Covered 2 Exforge HCT Covered 2 Hyzaar Not Covered 3 Irbesartan Covered 1 Irbesartan/hctz Covered 1 Losartan Covered 1 losartan/hctz Covered 1 Micardis Not Covered 3 Micardis HCT Not Covered 3 Tekamlo Not Covered 3 Tekturna Not Covered 3 Tekturna HCT Not Covered 3 Telmisartan Covered 1 Telmisartan/Amlodipine Covered 1 Teveten Not Covered 3 Teveten HCT Not Covered 3 Tribenzor Covered 3 Twynsta Not Covered 3 valsartan Covered 1 valsartan-hctz Covered 1 Valturna Not Covered 3 We cover the angiotensin II receptor antagonists listed in the above chart for new starts*in the following stepped approach 1,2 : *New start is defined as no previous paid claim for the requested medication within the past 130 days Step 1: Formulary step 1 medications will be covered without prior authorization. Step 2: Formulary step 2 medications will be covered if the following criteria are met: There must be evidence of a BCBSMA paid claim or physician documented use by the patient of an Step 1 medication within the previous 130 days OR The patient must have a physician documented diagnosis of Type 1 or Type 2 Diabetes Mellitus or have evidence of a BCBSMA paid claim for either insulin or an oral hypoglycemic drug within the previous 130 days. **Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review. Step 3: Step 3 medications will be covered when a formulary exception request is submitted to BCBSMA Pharmacy Operations and the following criteria is met: There must be evidence of a BCBSMA paid claim or physician documented use by the patient of a formulary step 2 Angiotensin II receptor blocker (ARB) or ARB-diuretic combination drug within the previous 130 days. **Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review. 2

3 We do not cover the medication listed in the chart above unless the above step therapy criteria are met. Individual Consideration All our medical policies are written for the majority of people with a given condition. Each policy is based on medical science. For many of our medical policies, each individual s unique clinical circumstances may be considered in light of current scientific literature. Physicians may send relevant clinical information for individual patients for consideration to: Blue Cross Blue Shield of Massachusetts Clinical Pharmacy Department One Enterprise Drive Quincy, MA Tel: Fax: Managed Care Authorization Instructions Physicians may call BCBSMA Pharmacy Operations department to request a review for prior authorization for patients who do not meet the step-therapy criteria at the point of sale. Pharmacy Operations: (800) Physicians may also fax or mail the attached form to the address above. The Formulary Exception/Prior Authorization form is included as part of this document for physicians to submit for patients who do not meet the step therapy criteria at the point of sale. Physicians may also submit requests for retail pharmacy exceptions via the web using Express PAth which can be found on the BCBSMA provider portal or directly on the web at PPO and Indemnity Authorization Instructions Policy History Physicians may call BCBSMA Pharmacy Operations department to request a review for prior authorization for patients who do not meet the step-therapy criteria at the point of sale. Pharmacy Operations: (800) Physicians may also fax or mail the attached form to the address above. The Formulary Exception/Prior Authorization form is included as part of this document for physicians to submit for patients who do not meet the step therapy criteria at the point of sale. Physicians may also submit requests for retail pharmacy exceptions via the web using Express PAth which can be found on the BCBSMA provider portal or directly on the web at Date Action 8/2014 Updated Valsartan to step 1 of policy. 2/2014 Updated ExpressPAth language, remove Blue Value, and added Telmisartan/Amlodipine and Telmisartan to step 1. 9/2013 Update to include candesartan as step 1 and to include Tekturna and Tekturna/HCT as step 3. 1/2013 Updated 1/2013 to include ne FDA approved products valsartan-hctz, Tekamlo, Tekturna/HCT and Amturnide ; Remove ACE inhibitor medications as Step 1 eligible products. 8/2012 Updated to include coverage for newly released generics irbesartan and irbesartan/hctz as and new brand Exforge HCT. 4/2012 Reviewed - Medical Policy Group Cardiology and Pulmonology No changes to policy statements. 11/2011- Medical policy ICD 10 remediation: Formatting, editing and coding updates. 4/2012 3

4 7/2011 Updated to include coverage for new FDA approved medication Edarbi. 4/2011 Reviewed - Medical Policy Group - Cardiology and Pulmonology. 5/2011 Updated to include coverage of losartan and losartan/hctz on Step 1 based on feedback from the Pharmacy and Therapeutics Committee on 11/16/10. 12/2010 Updated to include coverage for new FDA approved medication Tribenzor. 4/2010 Reviewed - Medical Policy Group - Cardiology and Pulmonology. 4/2010 Updated to include coverage criteria for Twynsta, Valturna, losartan and losartan/hctz and to update with Express PA information. 9/2009 Policy updated to change 180 day look back period to 130 days and to remove Medicare Part D criteria from Medical Policy. 4/2009 Reviewed - Medical Policy Group - Cardiology and Pulmonology. 9/2008 Updated to include coverage for Azor and Exforge on all formularies. 4/2008 Reviewed - Medical Policy Group - Cardiology and Pulmonology. 4/1/2008 Updated to include Exforge as a Step 2 medication for the MAPD formulary; still under review for standarad and BlueValue Rx. 4/2007 Reviewed - Medical Policy Group - Cardiology and Pulmonology. 8/2003 New policy, effective 8/2003, describing covered and non-covered indications. References 1. Aamer H. Jamali, MD; W. H. Wilson Tang, MD; Umesh N. Khot, MD; Michael B. Fowler, MB, FRCP The Role of Angiotensin Receptor Blockers in the Management of Chronic Heart Failure Archives of Internal Medicine / volume:161 (page: 667) March 12, Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. J Am Coll Cardiol. 2001;38: The SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med. 1991;325: The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators. Effect of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure. Lancet. 1993;342: Kober L, Torp-Pedersen C, Carlsen JE, et al, for Trandolapril Cardiac Evaluation (TRACE) Study Group. A clinical trial of the angiotensin-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 1995;333: Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. J Am Coll Cardiol. 2001;38: The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic. JAMA. 2002;288: The Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-convertingenzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000;342: Wing LMH, Reid CM, Ryan P, et al, for Second Australian National Blood Pressure Study Group. A comparison of outcomes with angiotensin-converting-enzyme inhibitors and diuretics for hypertension in the elderly. N Engl J Med. 2003;348: American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003;26(suppl 1):S80-S National Kidney Foundation Guideline. K/DOQI clinical practice guidelines for chronic kidney disease: Kidney Disease Outcome Quality Initiative. Am J Kidney Dis. 2002;39(suppl 2):S1-S UK Prospective Diabetes Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. BMJ. 1998;317:

5 13. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic. JAMA. 2002;288: National Kidney Foundation Guideline. K/DOQI clinical practice guidelines for chronic kidney disease: Kidney Disease Outcome Quality Initiative. Am J Kidney Dis. 2002;39(suppl 2):S1-S Lewis EJ, Hunsicker LG, Bain RP, Rohde RD. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy: The Collaborative Study Group. N Engl J Med. 1993;329: The GISEN (Gruppo Italiano di Studi Epidemiologici in Nefrologia) Group. Randomised placebocontrolled trial of effect of ramipril on decline in glomerular filtration rate and risk of terminal renal failure in proteinuric, non-diabetic nephropathy. Lancet. 1997;349: PROGRESS Collaborative Group. Randomised trial of a perindopril-based blood-pressure-lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack. Lancet. 2001;358: Hunt SA, Baker DW, Chin MH, et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. J Am Coll Cardiol. 2001;38: Cohn JN, Tognoni G. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med. 2001;345: American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003;26(suppl 1):S80-S National Kidney Foundation Guideline. K/DOQI clinical practice guidelines for chronic kidney disease: Kidney Disease Outcome Quality Initiative. Am J Kidney Dis. 2002;39(suppl 2):S1-S Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001;345: Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345: Aamer H. Jamali, MD; W. H. Wilson Tang, MD; Umesh N. Khot, MD; Michael B. Fowler, MB, FRCP The Role of Angiotensin Receptor Blockers in the Management of Chronic Heart Failure Archives of Internal Medicine / volume:161 (page: 667) March 12, Endnotes A.) Based on the recommendation of the BCBSMA Pharmacy and Therapeutics Committee, 2/2003 B.) Based on the recommendation of the BCBSMA Pharmacy and Therapeutics Committee, 2/2/2008 5

6 Request for Outpatient Retail Pharmacy Prior Authorization Fax to: Clinical Pharmacy Program (800) Phone Authorization (800) or Web: To ensure that we can confirm your request (required by NCQA), please be sure to include your fax number. Patient Information (REQUIRED) Name: BCBSMA ID Number: Is the patient a BCBSMA employee? If yes, please fax request to: (617) Date of Birth: Patient s Diagnosis Physician Information (REQUIRED) Name: Medical Specialty: BCBSMA Provider number/npi number: Telephone Number: Fax Number: Is this fax number secure for PHI receipt/transmission per HIPAA requirements? (circle one) Yes No Contact Name (if different from physician) Please select one of the three following sections to complete, depending on the nature of your request for the above-named patient. Formulary Exception Request Name of non-covered drug you want to prescribe Reason for Individual Consideration Request (please check one): Treatment failure with the following covered drugs in class Documented adverse reaction to the following covered drugs Other clinical reason (please specify) Yes No Quality Care Dosing Override Request Drug name, strength and quantity requested: Clinical reason for override (please specify) Outpatient Retail Pharmacy Prior Authorization Request Drug name: Start/End date (must be one year or less): Associated Co-morbid diagnosis: MD Signature: Date: 6