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 Form. Class Drug Statu Restriction Cost Per Rx¥ (Blank = No restriction) s Thiazide Diuretics Hydrochlorothiazide 12.5mg, 25mg, 50mg -- (Microzide) $3.39 Chlorthalidone 25mg, 50mg One tablet per day QL (Thalitone) $26.19 Metolazone 2.5mg, 5mg, 10mg -- (Zaroxolyn) $34.46 Loop Diuretics Torsemide 5mg, 10mg, 20mg, 100mg -- (Demadex) $24.09 Ethacrynic Acid 25mg Restricted to patients with (Edecrin) documented sulfa allergy or PA treatment failure of furosemide, $507.02* torsemide, bumetanide. Bumetanide (Bumex) 0.5, 1mg, 2mg -- $34.99 Furosemide (Lasix) 20mg, 40mg, 80mg, -- 10mg/5mL, 40mg/5mL $2.81 Carbonic Acetazolamide (IR, 125mg, 250mg, 500mg (ER) -- Anhydrase ER) $129.21 Inhibitors Methazolamide 25mg, 50mg -- (Neptazane) $150.02 Potassium Sparing Spironolactone 25mg, 50mg, 100mg -- Diuretics (Aldactone) $11.67 Triamterene 50mg, 100mg -- (Dyrenium) -- Angiotensin Captopril (Capoten) 12.5mg, 25mg, 50mg, 100mg -- $43.07 Converting Enalapril (Vasotec) 2.5mg, 5mg, 10mg, 20mg -- $8.01 Enzyme Inhibitors (ACEi) Quinapril (Accupril) 5mg, 10mg, 20mg, 40mg -- $9.78 Lisinopril (Prinivil) 2.5mg, 5mg 10mg, 20mg, -- 30mg, 40mg $2.65 Ramipril (Altace) 1.25mg, 2.5mg, 5mg, 10mg -- $9.60 Benazepril 5mg, 10mg, 20mg, 40mg -- (Lotensin) $4.47 Angiotensin Irbesartan (Avapro) 75mg, 150mg, 300mg QL Restricted to 1 tablet per day $13.64 Receptor Blockers Losartan (Cozaar) 25mg, 50mg, 100mg -- $4.08 (ARB) Valsartan (Diovan) 40mg, 80mg, 160mg, 320mg Reserved for heart failure PA patients intolerant of ACE $28.98 inhibitors. Calcium Channel Nifedipine (Procardia IR: 10mg, 20mg Blockers IR or XL and Adalat ER: 30mg, 60mg, 90mg -- (Dihydropyridine) CC) CR: 30mg, 60mg, 90mg $34.40 XL: 30mg, 60mg, 90mg Felodipine (Plendil 2.5mg, 5mg, 10mg -- ER) $8.72
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Amlodipine 2.5mg, 5mg, 10mg QL Limited to 1 tablet per day (Norvasc) $2.65 Calcium Channel Diltiazem (IR, LA, 24 IR: Blockers (Non- hr ER, CD, XT) 30mg, 60mg, 90mg, 120mg Dihydropyridine) LA: 120mg, 180mg, 240mg, 300mg, 360mg, 420mg 24 hr ER: 60mg, 90mg, 120mg, 180mg, -- $32.85 240mg, 300mg, 360mg, 420mg CD: 360mg XT: 120mg, 180mg, 240mg, 300mg, 360mg Diltiazem (12 hr ER) 12 hr ER capsules: NF 60mg, 90 mg, 120mg $94.85 Verapamil (IR, ER, IR: PM, SR) 40mg, 80mg, 120mg ER: 120mg, 180mg, 240mg, 360mg -- PM: $23.60 100mg, 200mg, 300mg SR: 120mg, 180mg, 240mg Selective Beta- Nebivolol (Bystolic) 2.5mg, 5mg, 10mg, 20mg Reserved for intolerance or Blockers PA; treatment failure of Metoprolol QL and Carvedilol. Restricted to 1 $114.62 tablet per day. Betaxolol (Kerlone) 10mg, 20mg NF $173.61 Metoprolol Succinate Metoprolol Succinate (ER): $19.41 or Tartrate (Toprol 25mg, 50mg, 100mg, 200mg -- XL or Lopressor) Metoprolol Tartrate: (ER) 25mg, 50mg, 100mg $3.41 (IR) Atenolol (Tenormin) 25mg, 50mg -- 100mg $3.41 Bisoprolol Fumarate 5mg, 10mg -- (Zebeta) $20.94 Non-Selective Carvedilol (Coreg) 3.125mg, 6.25mg, 12.5mg, (3.125mg = 2 per day, 6.25mg = Beta-Blockers 25mg QL 2 per day, 12.5mg = 2 per day, $3.96 25 mg = 4 per day) Propranolol (IR or IR: XL) 10mg, 20mg, 40mg, 60mg, 80mg ER: -- $14.74 60mg, 80mg, 120mg, 160mg Oral Soln: 20mg/5mL 40mg/5mL 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 Alpha-Blockers Clonidine (IR and IR: IR: $4.95 24Hr Patch) 0.1mg, 0.2mg, 0.3mg 0.1mg/24Hr patch: -- 0.1mg/24hr, 0.2mg/24hr, Patch: 0.3mg/24hr $159.24 Methyldopa 250mg, 500mg -- (Aldomet) $18.22
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Guanfacine (Tenex) 1mg, 2mg -- $8.83 Antihypertensive Valsartan/ 80mg/12.5mg, 160mg/25mg, Reserved for heart failure Combinations Hydrochlorothiazide 160mg/12.5mg 320mg/25mg, PA patients intolerant of ACE $33.26 (Diovan HCT) 320mg/12.5mg inhibitors. Losartan/ 50mg/12.5mg, Hydrochlorothiazide 100mg/12.5mg, -- $6.55 (Hyzaar) 100mg/25mg Irbesartan/ 150mg/12.5mg, Hydrochlorothiazide 300mg/12.5mg, 300mg/25mg -- $22.61 (Avalide) Benazepril/ 5mg/6.25mg, 10mg/12.5mg, Hydrochlorothiazide 20mg/12.5mg, -- $37.04 (Lotensin HCT) 20mg/25mg Enalapril/ 5mg/12.5mg, Hydrochlorothiazide 10mg/25mg -- $9.49 (Vaseretic) Captopril/ 25mg/15mg, 25mg/25mg, Hydrochlorothiazide 50mg/15mg, 50mg/25mg -- $113.07 (Capozide) Lisinopril/ 10mg/12.5mg, Hydrochlorothiazide 20mg/12.5mg, -- $4.38 (Zestoretic) 20mg/25mg Atenolol/ 50mg/25mg, Chlorthalidone 100mg/25mg -- $8.01 (Tenoretic) Spironolactone/ 25mg/25mg, 50mg/50mg Hydrochlorothiazide -- $28.97* (Aldactazide) Triamterene/ 37.5mg/25mg, Hydrochlorothiazide 50mg/25mg, 75mg/25mg -- $9.01* (Dyazide) Methyldopa/ 250mg/15mg, 250mg/25mg Hydrochlorothiazide -- $55.12* (Adoril) 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 Form. Cost Per Class Drug Restriction Status (Blank = No restriction) Rx¥ Alpha-Agonist Midodrine 2.5mg, 5mg, 10mg Reserved for symptomatic (ProAmatine) orthostatic hypotension in PA; QL patients with documented $115.14 autonomic failure. PA = Prior Authorization required. QL = Quantity Limit; ¥based on claims data from 8/2014-7/2015
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.
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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 Hydrochlorothiazide, Metolazone Coverage Criteria: None Limits: None Required Information for Approval: N/A Chlorthalidone Coverage Criteria: None Limits: 30 tablets per 30 days. Required Information for Approval: N/A
Loop Diuretics Torsemide (Demadex), Furosemide (Lasix), Bumetanide (Bumex) Coverage Criteria: None Limits: None Required Information for Approval: N/A
Ethacrynic Acid (Edecrin) Coverage Criteria: Restricted to patients with documented sulfa allergy or treatment failure of furosemide, torsemide, bumetanide. Limits: None 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 Coverage Criteria: None Limits: None Required Information for Approval: N/A
Potassium Sparing Diuretics Spironolactone, Triamterene Coverage Criteria: None Limits: None Required Information for Approval: N/A
Angiotensin Converting Enzyme Inhibitors Captopril, Enalapril, Quinapril, Ramipril, Benazepril Coverage Criteria: None Limits: None Required Information for Approval: N/A
Angiotensin Receptor Blockers Losartan (Cozaar), Irbesartan (Avapro) Coverage Criteria: None Limits: None Required Information for Approval: N/A
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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. Limits: None 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 Coverage Criteria: None Limits: None Required Information for Approval: N/A Diltiazem, Verapamil (All Formulations) Coverage Criteria: None Limits: None Required Information for Approval: N/A Non-Formulary: Diltiazem 12-hour SR capsules
Beta-Blockers Metoprolol (Succinate or Tartrate), Atenolol, Bisoprolol Coverage Criteria: None Limits: None Required Information for Approval: N/A
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, Coverage Criteria: None Limits: None Required Information for Approval: N/A
Carvedilol (Coreg) Coverage Criteria: None Limits: 3.125mg = 2 per day, 6.25mg = 2 per day, 12.5mg = 2 per day, 25 mg = 4 per day Required Information for Approval: N/A
Alpha-Blockers Clonidine, Clonidine Patch, Methyldopa, Guanfacine Coverage Criteria: None Limits: None Required Information for Approval: N/A
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Antihypertensive Combinations Valsartan/Hydrochlorothiazide (Diovan HCT), Losartan/Hydrochlorothiazide (Hyzaar), Irbesartan/Hydrochlorothiazide (Avalide), Benazepril/Hydrochlorothiazide (Lotensin HCT), Enalapril/Hydrochlorothiazide (Vaseretic), Captopril/Hydrochlorothiazide (Capozide), Lisinopril/Hydrochlorothiazide (Zestoretic), Atenolol/Chlorthalidone (Tenoretic), Spironolactone/Hydrochlorothiazide (Aldactazide), Triamterene/Hydrochlorothiazide (Dyazide), Methyldopa/Hydrochlorothiazide (Adoril) Coverage Criteria: None Limits: None Required Information for Approval: N/A
REFERENCES
1. James PA; Oparil S; Carter BL, et al. 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. doi:10.1001/jama.2013.284427
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_2013-2-19.docx 2/2013 Allen Shek PharmD BCPS Update to Policy Monograph - Cardiovascular - Midodrine 9/2015 Jonathan Szkotak, PharmD 2015-09.docx; BCACP Formulary Realignment 09-23-2015.xlsx Update to Policy HPSJ Coverage Policy – Cardiovascular – 9/2015 Jonathan Szkotak, PharmD Hypertension 2015-09.docx BCACP Update to Policy HPSJ Coverage Policy – Cardiovascular – 5/2017 Johnathan Yeh, PharmD Blood Pressure 2017-05.docx Note: All changes are approved by the HPSJ P&T Committee before incorporation into the utilization policy
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