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1 MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY: Blood Pressure P&T DATE: 5/9/2017 THERAPEUTIC CLASS: Cardiovascular Disorders REVIEW HISTORY: 9/15, 2/13, 2/08, 5/07 LOB AFFECTED: MCL (MONTH/YEAR) This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the HPSJ Pharmacy and Therapeutic Advisory Committee. OVERVIEW Table 1: Formulary Blood Pressure Lowering Agents: Available Strengths Class Drug Thiazide Diuretics Loop Diuretics Carbonic Anhydrase Inhibitors Potassium Sparing Diuretics Angiotensin Converting Enzyme Inhibitors (ACEi) Angiotensin Receptor Blockers (ARB) Calcium Channel Blockers (Dihydropyridine) (Microzide) Chlorthalidone (Thalitone) Metolazone (Zaroxolyn) Torsemide (Demadex) Ethacrynic Acid (Edecrin) 12.5mg, 25mg, 50mg 25mg, 50mg 5mg, 10mg, 20mg, 100mg 25mg Form. Statu s Restriction (Blank = No restriction) Coverage Policy Cardiovascular Disorders Blood Pressure Page 1 Cost Per Rx -- $3.39 QL One tablet per day $ $ $24.09 PA Restricted to patients with documented sulfa allergy or treatment failure of furosemide, torsemide, bumetanide. $507.02* Bumetanide (Bumex) 0.5, 1mg, 2mg -- $34.99 Furosemide (Lasix) 20mg, 40mg, 80mg, 10mg/5mL, 40mg/5mL -- $2.81 Acetazolamide (IR, 125mg, 250mg, 500mg (ER) ER) -- $ Methazolamide 25mg, 50mg (Neptazane) -- $ Spironolactone 25mg, 50mg, 100mg (Aldactone) -- $11.67 Triamterene 50mg, 100mg (Dyrenium) Captopril (Capoten) 12.5mg, 25mg, 50mg, 100mg -- $43.07 Enalapril (Vasotec), 20mg -- $8.01 Quinapril (Accupril) 5mg, 10mg, 20mg, 40mg -- $9.78 Lisinopril (Prinivil) 2.5mg, 5mg 10mg, 20mg, 30mg, 40mg -- $2.65 Ramipril (Altace) 1.25mg, -- $9.60 Benazepril 5mg, 10mg, 20mg, 40mg (Lotensin) -- $4.47 Irbesartan (Avapro) 75mg, 150mg, 300mg QL Restricted to 1 tablet per day $13.64 Losartan (Cozaar) 25mg, 50mg, 100mg -- $4.08 Valsartan (Diovan) 40mg, 80mg, 160mg, 320mg Reserved for heart failure PA patients intolerant of ACE $28.98 inhibitors. Nifedipine (Procardia 10mg, 20mg IR or XL and Adalat ER: 30mg, 60mg, 90mg CC) CR: 30mg, 60mg, 90mg -- $34.40 XL: 30mg, 60mg, 90mg Felodipine (Plendil ER) -- $8.72

2 Calcium Channel Blockers (Non- Dihydropyridine) Selective Beta- Blockers Non-Selective Beta-Blockers Alpha-Blockers Amlodipine (Norvasc) Diltiazem (IR, LA, 24 hr ER, CD, XT) Diltiazem (12 hr ER) Verapamil (IR, ER, PM, SR) Nebivolol (Bystolic) 30mg, 60mg, 90mg, 120mg LA: 120mg, 180mg, 240mg, 300mg, 360mg, 420mg 24 hr ER: 60mg, 90mg, 120mg, 180mg, 240mg, 300mg, 360mg, 420mg CD: 360mg XT: 120mg, 180mg, 240mg, 300mg, 360mg 12 hr ER capsules: 60mg, 90 mg, 120mg 40mg, 80mg, 120mg ER: 120mg, 180mg, 240mg, 360mg PM: 100mg, 200mg, 300mg SR: 120mg, 180mg, 240mg, 20mg QL Limited to 1 tablet per day $ $32.85 NF $ $23.60 PA; QL Reserved for intolerance or treatment failure of Metoprolol and Carvedilol. Restricted to 1 tablet per day. $ Betaxolol (Kerlone) 10mg, 20mg NF $ Metoprolol Succinate Metoprolol Succinate (ER): $19.41 or Tartrate (Toprol 25mg, 50mg, 100mg, 200mg -- (ER) XL or Lopressor) Metoprolol Tartrate: 25mg, 50mg, 100mg $3.41 (IR) Atenolol (Tenormin) Bisoprolol Fumarate (Zebeta) Carvedilol (Coreg) Propranolol (IR or XL) 25mg, 50mg 100mg 5mg, 10mg 3.125mg, 6.25mg, 12.5mg, 25mg 10mg, 20mg, 40mg, 60mg, 80mg ER: 60mg, 80mg, 120mg, 160mg Oral Soln: 20mg/5mL 40mg/5mL -- $ $20.94 QL (3.125mg = 2 per day, 6.25mg = 2 per day, 12.5mg = 2 per day, 25 mg = 4 per day) $ $14.74 Pindolol (Visken) 5mg, 10mg -- $43.28 Labetalol (Trandate) 100mg, 200mg, 300mg -- $30.80 Timolol (Blocadren) 5mg, 10mg, 20mg -- $45.43 Nadolol (Corgard) 20mg, 40mg, 80mg -- $59.10 Clonidine (IR and 24Hr Patch) Methyldopa (Aldomet) 0.1mg, 0.2mg, 0.3mg 0.1mg/24Hr patch: 0.1mg/24hr, 0.2mg/24hr, 0.3mg/24hr 250mg, 500mg -- $4.95 Patch: $ $18.22 Coverage Policy Cardiovascular Disorders Blood Pressure Page 2

3 Antihypertensive Combinations Guanfacine (Tenex) 1mg, 2mg -- $8.83 Valsartan/ 80mg/12.5mg, 160mg/25mg, Reserved for heart failure 160mg/12.5mg 320mg/25mg, PA patients intolerant of ACE $33.26 (Diovan HCT) 320mg/12.5mg inhibitors. Losartan/ (Hyzaar) Irbesartan/ (Avalide) Benazepril/ (Lotensin HCT) Enalapril/ (Vaseretic) Captopril/ (Capozide) Lisinopril/ (Zestoretic) Atenolol/ Chlorthalidone (Tenoretic) Spironolactone/ (Aldactazide) Triamterene/ (Dyazide) Methyldopa/ (Adoril) 50mg/12.5mg, 100mg/12.5mg, 100mg/25mg -- $ mg/12.5mg, 300mg/12.5mg, 300mg/25mg -- $ mg/6.25mg, 10mg/12.5mg, 20mg/12.5mg, 20mg/25mg -- $ mg/12.5mg, 10mg/25mg -- $ mg/15mg, 25mg/25mg, 50mg/15mg, 50mg/25mg -- $ mg/12.5mg, 20mg/12.5mg, 20mg/25mg -- $ mg/25mg, 100mg/25mg -- $ mg/25mg, 50mg/50mg -- $28.97* 37.5mg/25mg, 50mg/25mg, 75mg/25mg -- $9.01* 250mg/15mg, 250mg/25mg -- $55.12* F = Formulary, ST = Step therapy, PA = Prior Authorization required. based on claims data from 4/2016 3/2017 *based on historical data. Table 2: Formulary Blood Pressure Increasing Agents: Available Strengths Class Drug Alpha-Agonist Midodrine (ProAmatine) Form. Status PA; QL PA = Prior Authorization required. QL = Quantity Limit; based on claims data from 8/2014-7/2015 Restriction (Blank = No restriction) Reserved for symptomatic orthostatic hypotension in patients with documented autonomic failure. Cost Per Rx $ Clinical Justification: HPSJ formulary restrictions for blood pressure medications are limited, and this has not changed with the JNC8 treatment guidelines. Most restrictions are quantity limitations, which are in place to encourage dose consolidation. Dose consolidation reduces pill burden and improves patient adherence. Triage: Appropriate diagnosis Blood Pressure medications tried History blood pressure medication intolerances. Coverage Policy Cardiovascular Disorders Blood Pressure Page 3

4 EVALUATION CRITERIA FOR APPROVAL/EXCEPTION CONSIDERATION Below are the coverage criteria and required information for each agent. These coverage criteria have been reviewed approved by the HPSJ Pharmacy & Therapeutics (P&T) Advisory Committee. For conditions not covered under this Coverage Policy, HPSJ will make the determination based on Medical Necessity as described in HSPJ Medical Review Guidelines (UM06). Thiazide Diuretics, Metolazone Chlorthalidone Limits: 30 tablets per 30 days. Loop Diuretics Torsemide (Demadex), Furosemide (Lasix), Bumetanide (Bumex) Ethacrynic Acid (Edecrin) Coverage Criteria: Restricted to patients with documented sulfa allergy or treatment failure of furosemide, torsemide, bumetanide. Required Information for Approval: Chart notes documenting treatment failure of alternative diuretics or documented sulfa allergy including reaction type and severity. Carbonic Anhydrase Inhibitors Acetazolamide, Methazolamide Potassium Sparing Diuretics Spironolactone, Triamterene Angiotensin Converting Enzyme Inhibitors Captopril, Enalapril, Quinapril, Ramipril, Benazepril Angiotensin Receptor Blockers Losartan (Cozaar), Irbesartan (Avapro) Coverage Policy Cardiovascular Disorders Blood Pressure Page 4

5 Valsartan (Diovan) Coverage Criteria: Valsartan is reserved for patients with Congestive Heart Failure (CHF) who are intolerant to one formulary ACE inhibitor, such as lisinopril, benazepril or enalapril. Required Information for Approval: Chart notes documenting a diagnosis of Congestive Heart Failure, and chart notes and pharmacy fill history documenting an intolerance or adverse reaction to a formulary first line ACE inhibitor. Calcium Channel Blocker Nifedipine, Felodipine, Amlodipine Diltiazem, Verapamil (All Formulations) Non-Formulary: Diltiazem 12-hour SR capsules Beta-Blockers Metoprolol (Succinate or Tartrate), Atenolol, Bisoprolol Nebivolol (Bystolic) Coverage Criteria: Reserved for intolerance or treatment failure of dose optimized metoprolol AND carvedilol. Limits: One tablet per day Required Information for Approval: Chart notes and pharmacy fill history of Metoprolol and Carvedilol. Chart notes must describe the intolerance or adverse reaction to Metoprolol and Carvedilol. Labetalol, Propranolol, Pindolol, Nadolol, Timolol, Carvedilol (Coreg) Limits: 3.125mg = 2 per day, 6.25mg = 2 per day, 12.5mg = 2 per day, 25 mg = 4 per day Alpha-Blockers Clonidine, Clonidine Patch, Methyldopa, Guanfacine Coverage Policy Cardiovascular Disorders Blood Pressure Page 5

6 Antihypertensive Combinations Valsartan/ (Diovan HCT), Losartan/ (Hyzaar), Irbesartan/ (Avalide), Benazepril/ (Lotensin HCT), Enalapril/ (Vaseretic), Captopril/ (Capozide), Lisinopril/ (Zestoretic), Atenolol/Chlorthalidone (Tenoretic), Spironolactone/ (Aldactazide), Triamterene/ (Dyazide), Methyldopa/ (Adoril) REFERENCES 1. James PA; Oparil S; Carter BL, et al 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): doi: /jama REVIEW & EDIT HISTORY Document Changes Reference Date P&T Chairman Creation of Policy Potential Generics 2007 and 2008.doc 5/2007 Allen Shek PharmD BCPS Update to Policy ACE and ARB 2-08.doc 2/2008 Allen Shek PharmD BCPS Update to Policy Bystolic_Monograph_ docx 2/2013 Allen Shek PharmD BCPS Update to Policy Monograph - Cardiovascular - Midodrine docx; 9/2015 Jonathan Szkotak, PharmD BCACP Formulary Realignment xlsx Update to Policy HPSJ Coverage Policy Cardiovascular Hypertension docx 9/2015 Jonathan Szkotak, PharmD BCACP Update to Policy HPSJ Coverage Policy Cardiovascular Blood Pressure docx 5/2017 Johnathan Yeh, PharmD Note: All changes are approved by the HPSJ P&T Committee before incorporation into the utilization policy Coverage Policy Cardiovascular Disorders Blood Pressure Page 6

12.5mg, 25mg, 50mg. 25mg, 50mg. 250mg, 500mg, 250mg/5ml. 2.5mg, 5mg, 10mg. 5mg, 10mg, 20mg, 100mg. 25mg

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