Annual Review of Antihypertensives - Fiscal Year 2009

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Annual Review of Antihypertensives - Fiscal Year 2009 Oklahoma HealthCare Authority April 2010 Current Prior Authorization Criteria There are 7 categories of antihypertensive medications currently included in the Product Based Prior Authorization program: 1. Calcium Channel Blockers (CCBs) 2. Angiotensin I Converting Enzyme Inhibitors (ACEIs) 3. ACE/CCBs Combination Products 4. ACE inhibitor and hydrochlorathiazide combination products (ACEI/HCTZs) 5. Angiotensin II Receptor Blockers (ARBs) 6. ARB and hydrochlorathiazide combination products (ARB/HCTZs) 7. Direct Renin Inhibitors (DRIs) and DRI Combination products General Criteria for Authorization To qualify for a Tier 2 medication, there must be one of the following: documented inadequate response to two Tier 1 drugs of the same class contraindication to all available Tier 1 drugs previous stabilization on the Tier 2 drug a unique indication for the Tier 2 drug which the Tier 1 drugs lack To qualify for a Tier 3 medication, there must be one of the following: documented inadequate response to two Tier 1 drug of the same class and all available Tier 2 medications contraindication to all available Tier 2 drugs previous stabilization on the Tier 3 drug a unique indication for the Tier 3 drug which the lower tiered drugs lack Criteria for DRIs Authorization FDA approved indication. Recent trial, within the previous 6 months and at least 4 weeks in duration, of an ACE Inhibitor (or an ARB if previous trial of an ACEI) and a diuretic, used concomitantly at recommended doses, that did not yield adequate blood pressure control. May be used in either monotherapy or combination therapy.

Tier Charts of the Antihypertensive PBPA Category Calcium Channel Blockers (CCB medications) amlodipine (Norvasc ) diltiazem (Cardizem LA) diltiazem (Cardizem ) nicardipine (Cardene SR) diltiazem (Tiazac, Taztia XT ) verapamil (Covera-HS ) diltiazem CD (Cardizem CD) nisoldipine (Sular ) diltiazem ER (Cartia XT, Diltia XT ) amlodipine/atorvastatin (Caduet ) diltiazem SR (Cardizem SR) diltiazem XR (Dilacor XR) felodipine (Plendil ) isradipine ( Dynacirc, Dynacirc CR ) nicardipine (Cardene ) nifedipine (Adalat, Procardia ) nifedipine CC (Adalat CC) nifedipine ER nifedipine XL (Nifedical XL, Procardia XL ) nimodipine (Nimotop ) verapamil (Calan, Isoptin, Verelan ) verapamil SR (Calan SR, Isoptin SR, Verelan PM) ACE and ARB Combination Medications Any Tier-1 ACE Inhibitor: amlodopine / valsartan (Exforge ) amlodipine / olmesartan (Azor ) benazepril (Lotensin ) amlodopine / valsartan (Exforge HCT ) candesartan (Atacand ) captopril (Capoten ) irbesartan (Avapro ) candesartan / HCTZ (Atacand HCT) enalapril (Vasotec ) irbesartan / HCTZ (Avalide ) losartan (Cozaar ) enalaprilat (Vasotec IV) telmisartan (Micardis ) losartan / HCTZ (Hyzaar ) fosinopril (Monopril ) telmisartan / HCTZ (Micardis HCT) eprosartan (Teveten ) lisinopril (Prinivil, Zestril ) valsartan (Diovan ) eprosartan / HCTZ (Teveten HCT) moexipril (Univasc ) valsartan / HCTZ (Diovan HCT ) quinapril (Accupril ) olmesartan (Benicar ) trandolapril (Mavik ) olmesartan / HCTZ (Benicar HCT ) ramipril (Altace ) Direct Renin Inhibitors (DRIs) Tier-1 ACE Inhibitor + Diuretic ARB + Diuretic Aliskiren (Tekturna ) Aliskiren/HCTZ (Tekturna HCT ) Aliskiren/valsartan (Valturna )

ACE Inhibitors Any Tier-1 ACE Inhibitor: perindopril erbumine (Aceon ) benazepril (Lotensin ) captopril (Capoten ) enalapril (Vasotec ) enalaprilat (Vasotec IV) fosinopril (Monopril ) lisinopril (Prinivil, Zestril ) moexipril (Univasc ) quinapril (Accupril ) trandolapril (Mavik ) ramipril (Altace ) ACE Inhibitor / CCB Combinations Tier-1 Tier-1 Tier-1 Tier-1 ACE + Tier 1 CCB trandolapril / verapamil (Tarka ) benazepril / amlodipine (Lotrel ) enalapril / felodipine (Lexxel ) ACE Inhibitor / HCTZ Combinations Tier-1 Tier-1 Tier-1 benazepril/hctz (Lotensin HCT) captopril/hctz (Capozide ) enalapril/hctz (Vasoretic ) fosinopril/hctz (Monopril-HCT ) lisinopril/hctz (Prinzide, Zestoretic ) moexipril/hctz (Uniretic ) quinapril/hctz (Accuretic ) Utilization of Medication or Class Trends in Utilization of Antihypertensives Fiscal Year Members Claims Paid Paid/Claim Perdiem Units Days 2008 20,869 114,714 $3,773,131.38 $32.89 $0.85 5,335,159 4,450,731 2009 22,682 120,354 $3,245,475.97 $26.97 $0.70 5,694,594 4,611,357 % Change 8.70% 4.90% -14.00% -18.00% -17.60% 6.70% 3.60% Change 1,813 5,640 -$527,655.41 -$5.92 -$0.15 359,435 160,626

Demographics of Members Utilizing Antihypertensives: FY 2009 7000 Number of People 6000 5000 4000 3000 2000 1000 0 00-09 10-19 20-34 35-49 50-64 65-79 80-94 95 > Age Groups Male Female Top Prescribers of Antihypertensives by Number of Claims: FY 2009 0 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 45,000 50,000 Family Practitioner Internist General Practitioner PRESCRIBER ONLY Cardiologist Nurse Practitioner (Other) Physician Assistant General Pediatrician DDSD-NFM Obstetrician/Gynecologist

Prior Authorization of Antihypertensives There were a total of 2,150 petitions submitted for this PBPA category during fiscal year 2009. Please note that for this PBPA category the system will automatically search Tier 1 medications in member s claims history within a certain timeframe and if detected, the member can automatically get the Tier 2 medication without submitting a prior authorization form. The bottom chart shows the details of the petition submitted. Status of Petitions for Antihypertensives: FY 2009 Incomplete, 601, 28% Approved, 690, 32% Denied, 859, 40% Market News and Update Exforge HCT (amlodipine, valsartan, hydochlorothiazide) i was approved April 30, 2009, and has been added to the ARB Combination category as a Tier 3 medication. However, the manufacturer has participated in the supplemental rebate program so this agent is currently available as a Tier 2 agent. The existing criteria for that category apply. ii Cleviprex (clevidipine) was approved August 1, 2008 o Cleviprex is an intravenous, very short acting calcium channel blocker for severely elevated blood pressure in the hospital setting when oral medication cannot be taken. o Supplied as 0.5 mg/ml injection in 50 and 100mL single use vials. o Dosing should start at 1-2mg/hr and increase by 1-2mg/hr every 90 seconds. The interval to increase should be lengthened as the maximum rate is approached. The maximum rate is 16mg/hr. No dose adjustment is needed for patients with renal or hepatic impairment. o The patient has to be transferred to another hypertension treatment to prevent rebound hypertension. o Side effects include atrial fibrillation, headache, and nausea. o Pregnancy Category C.

Conclusion and Recommendations The College of Pharmacy recommends continued monitoring of this class of medications and reevaluation if warranted after the new JNC-VIII Guidelines are made available by the National Institutes of Health. i Exforge HCT monograph. Lexi-Comp ONLINE. Hudson, OH: 2009. ii Clevidipine monograph. E-Facts and comparisons. Indianapolis, IN: October 2008.