Cardiovascular 2019

PA Criteria: Tier 1 products are covered with no authorization necessary.

Tier 2 authorization requires:

• documented inadequate response to two Tier 1 medications, or
• adverse drug reaction to all the Tier 1 medications, or
• previous stabilization on the Tier 2 medication, or
• a unique indication for which the Tier 1 antihypertensives are not indicated

Tier 3 authorization requires:

• documented inadequate response to two Tier 1 medications and documented inadequate response to all available Tier 2 medications, or
• adverse drug reaction to all the Tier 1 or all Tier 2 medications, or
• previous stabilization on the Tier 3 medication, or
• a unique indication for which the lower tiered antihypertensives are not indicated
• Prior Authorization form

Additional Information

• Consideration for approval of Monopril-HCT® (fosinopril/HCTZ) requires the following:
• A patient specific, clinically significant reason why the member cannot use the individual components.  
• Consideration for approval of Cardizem® CD (diltiazem CD) 360mg capsules requires the following:
• A patient specific, clinically significant reason why the member cannot use two 180mg Cardizem CD (diltiazem CD) capsules.  
• Duration and quantity limits on the use of nimodipine oral capsules and Nymalize™ (nimodipine oral solution) will apply as follows:
• A quantity limit of 252 capsules for 21 days will apply for Nimodipine oral capsules.
• A quantity limit of 2,838 mL for 21 days will apply for Nymalize™ oral solution.  
• An age restriction on the use of Epaned™ (enalapril powder for oral solution) for members aged 7 years or older will apply with the following criteria:
• Consideration for approval requires a patient specific, clinically significant reason why the member cannot swallow the oral tablet formulation even when crushed.

aliskiren oral pellets (Tekturna®) Approval Criteria:

• An FDA approved indication; AND
• A recent trial, within the previous six months and at least four weeks in duration, of an angiotensin I converting enzyme inhibitor (ACEI) [or an angiotensin II receptor blocker (ARB) if previous trial of an ACEI] and a diuretic, used concomitantly at recommended doses, that did not yield adequate blood pressure control; AND
• Member must be 6 years of age or older; AND
• A patient-specific, clinically significant reason why the member cannot use Tekturna® tablets must be provided.

lisinopril oral solution (Qbrelis™) Approval Criteria:  

• A patient-specific, clinically significant reason why the member cannot use lisinopril oral tablets in place of the oral solution formulation even when the tablets are crushed. 

metoprolol succinate extended-release (ER) capsules (Kapspargo™ Sprinkle) Approval Criteria:  

• A patient-specific, clinically significant reason why the member cannot use metoprolol succinate ER tablets, which are available without prior authorization, must be provided. 

nebivolol/valsartan (Byvalson™) Approval Criteria:  

• A patient-specific, clinically significant reason the member cannot use the individual components, nebivolol (Bystolic®) and valsartan (Diovan®); AND
• A quantity limit of 30 tablets per 30 days will apply. 

perindopril/amlodipine (Prestalia®) Approval Criteria:

• An FDA approved diagnosis; and
• Documented trials of inadequate response to two Tier-1 angiotensin converting enzyme inhibitors (ACEIs) in combination with amlodipine; and
• A patient-specific, clinically significant reason why the member cannot use the individual components separately; and
• A quantity limit of 30 tablets per 30 days will apply.

• An FDA approved diagnosis of treatment of proliferating infantile hemangioma requiring systemic therapy; and
• A patient-specific, clinically significant reason why the member cannot use the generic propranolol solutions (20mg/5mL and 40mg/5mL) which are available without prior authorization.

sotalol oral solution (Sotylize™) Approval Criteria:

• An FDA approved diagnosis of life-threatening ventricular arrhythmias or for the maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter; and
• A patient-specific, clinically significant reason why the member cannot use sotalol oral tablets in place of the oral solution formulation; and
• A quantity limit of 64mL per day or 1,920mL per 30 days will apply. 

spironolactone oral suspension (CaroSpir®) Approval Criteria:  

• An FDA approved indication; AND
• A patient-specific, clinically significant reason why the member cannot use spironolactone oral tablets must be provided.  

valsartan oral solution (Prexxartan®) Approval Criteria:   

• A patient-specific, clinically significant reason why the member cannot use valsartan oral tablets in place of the oral solution formulation even when the tablets are crushed must be provided.  

Tier 1

Tier 2

 Special PA

• quinapril (Accupril®)
• perindopril erbumine (Aceon®)
• ramipril (Altace®)
• benazepril (Lotensin®)
• trandolapril (Mavik®)
• fosinopril (Monopril®) 
• lisinopril (Prinivil®, Zestril®)
• moexipril (Univasc®)
• enalapril (Vasotec®)
• enalaprilat (Vasotec® IV)

• captopril (Capoten®)

• enalapril powder (Epaned®)
• lisinopril oral solution (Qbrelis®)

Tier 1

Tier 2

Tier 3

• quinapril/HCTZ (Accuretic®)
• benazepril/HCTZ (Lotensin® HCT)
• lisinopril/HCTZ (Prinzide®, Zestoretic®)
• moexipril/HCTZ (Uniretic®)
• enalapril/HCTZ (Vasoretic®)

• captopril/HCTZ (Capozide®)

• fosinopril/HCTZ (Monopril-HCT®)

Tier 1

Tier 2

Special PA Criteria 

• amlodipine (Norvasc®)
• diltiazem (Cardizem®)
• diltiazem (Tiazac®, Taztia® XT)
• diltiazem CD (Cardizem® CD)
• (All strengths except 360mg)
• diltiazem ER (Cartia® XT, Diltia® XT)
• diltiazem XR (Dilacor® XR)
• felodipine (Plendil®)
• nicardipine (Cardene®)
• nifedipine (Adalat®, Procardia®)
• nifedipine CC (Adalat® CC)
• nifedipine ER
• nifedipine XL (Nifedical® XL, Procardia® XL)
• nimodipine (Nimotop®)
• verapamil (Calan®, Isoptin®)
• verapamil SR (Calan® SR, Isoptin® SR)

• amlodipine/atorvastatin (Caduet®)
• diltiazem (Cardizem® LA)
• diltiazem ER (Matzim® LA)
• diltiazem SR (Cardizem® SR)
• isradipine ( Dynacirc®)
• nicardipine (Cardene® SR)
• nisoldipine (Sular®)
• verapamil (Covera® HS)
• verapamil ER (Verelan®, Verelan® PM) 

• diltiazem CD (Cardizem® CD) 360mg  

Tier 1

Tier 2

Tier 3

• Tier 1 ACE + Tier 1 CCB
• benazepril/amlodipine (Lotrel®)

         

perindopril/amlodipine (Prestalia®)

trandolapril/verapamil (Tarka®)

Tier 1

Tier 2

Tier 3

• amlodipine/olmesartan (Azor®)
• amlodopine/valsartan (Exforge®)
• amlodopine/valsartan/HCTZ (Exforge® HCT)  - Brand only
• benazepril (Lotensin®)
• enalapril (Vasotec®)
• enalaprilat (Vasotec® IV)
• fosinopril (Monopril®)
• irbesartan (Avapro®)
• irbesartan / HCTZ (Avalide®) 
• lisinopril (Prinivil®, Zestril®)
• losartan (Cozaar®)
• losartan/HCTZ (Hyzaar®)
• moexipril (Univasc®)
• olmesartan (Benicar®)
• olmesartan/HCTZ (Benicar® HCT)
• perindopril erbumine (Aceon®) 
• quinapril (Accupril®)
• ramipril (Altace®)
• telmisartan (Micardis®)
• trandolapril (Mavik®)
• valsartan (Diovan®)
• valsartan / HCTZ (Diovan HCT®)

• amlodopine/valsartan/HCTZ (Exforge® HCT)  - generic (Brand is Tier 1)
• candesartan (Atacand®)
• olmesarten med/amlodipine/HCTZ (Tribenzor®)
• telmisartan/HCTZ (Micardis® HCT)

• azilsartan/chlorthalidone (Edarbyclor®)
• azilsartan (Edarbi®)
• candesartan/HCTZ (Atacand® HCT)
• eprosartan (Teveten®)
• eprosartan/HCTZ (Teveten® HCT)
• telmisartan/amlodipine (Twynsta®)

Direct Renin Inhibitors

Tier 3 authorization requires:

• 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.

Prior Authorization form  

Tier 1

Tier 2

Tier 3

• Tier 1 ACE Inhibitor + Diuretic

• ARB + Diuretic

• aliskiren/amlodipine (Tekamlo®)
• aliskiren (Tekturna®)
• aliskiren/HCTZ (Tekturna® HCT) 

Consideration will be based on ALL of the following criteria:

PA criteria:

• An FDA approved diagnosis of moderately severe to severe essential hypertension or uncomplicated malignant hypertension; AND
• Use of at least 6 classes of medications, in the past 12 months, that did not yield adequate blood pressure control. Treatment must have included combination therapy with a diuretic, and therapy with at least a four-drug regimen. Medications can be from, but not limited to, the following classes: ACE inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers (CCBs), direct renin inhibitors (DRIs), beta blockers, alpha blockers, alpha agonists, diuretics, etc,; AND
• Prescriber must verify member does not have ANY of the following contraindications: 

a. Coronary insufficiency
b. Recent myocardial infarction
c. Rising or elevated BUN, or known renal insufficiency
d. Uremia
e. Glaucoma
f. Organic pyloric stenosis
g. Currently receiving sulfonamides or antibiotics
h. Known sensitivity to mecamylamine (Vecamyl™)  

• Prior Authorization form  

PA criteria:

Nexiclon® XR (clonidine extended release) requires prior authorization with the following criteria:

• FDA-approved indication of hypertension in adults.
• Must provide a clinically significant reason why the member cannot take clonidine immediate release tablets.

Prior Authorization form   

omega-3-acid ethyl esters A (Omtryg™)/icosapent ethyl (Vascepa®)

PA criteria:

• Laboratory documentation of severe hypertriglyceridemia (fasting triglycerides ≥ 500mg/dL), and controlled diabetes (fasting glucose < 150mg/dL at the time of triglycerides measurement and HgA1C < 7.5%); AND
• Previous failure with fibric acid medications; AND
• Use of Vascepa® or Epanova® requires a previous failure of or a patient-specific, clinically significant reason why the member cannot use omega-3-acid ethyl esters (generic Lovaza®) which is available without a prior authorization; AND
• Use of Vascepa® 0.5 gram requires a patient-specific, clinically significant reason why the member cannot use Vascepa® 1 gram.

Prior Authorization form   

lomitapide (Juxtapid^TM) mipomersen (Kynamro^TM)

PA criteria:
Consideration will be based on all of the following criteria:

• An FDA approved diagnosis of homozygous familial hypercholesterolemia defined by the presence of at least one of the following criteria:
• A documented functional mutation(s) in both LDL receptor alleles or alleles known to affect LDL receptor functionality via genetic testing; OR
• An untreated total cholesterol >500 mg/dL and triglycerides <300 mg/dL AND at least one of the following: 
• Documentation that both parents have untreated total cholesterol >250 mg/dL; OR
• Presence of tendinous / cutaneous xanthoma prior to age 10 years; AND 
• Documented tiral of high dose statin therapy (LDL reduction capability equivalent to rosuvastatin 40mg or higher) or maximally tolerated statin therapy at least 12 weeks in duration; AND
• Documented trial of Repatha® (evolocumab) at least 12 weeks in duration; AND
• Member requires additional lowering of LDL-C (baseline, current, and goal LDL-C levels must be provided); AND
• Prescriber must be certified with Juxtapid™ or Kynamro™ REMS program.

Prior Authorization form   

Tier 1 products available with no authorization necessary

PA Criteria:

Statin Medications Tier-2 Approval Criteria:

• Member must have documented trials with atorvastatin and rosuvastatin, consisting of at least 8 weeks of continuous therapy each, titrated to a dose of at least 40mg atorvastatin and 20 mg rosuvastatin, which did not yield adequate LDL reduction.; OR
• A documented adverse effect or contraindication to all available lower tiered products.

Statin Medications Special Prior Authorization (PA) Approval Criteria:

• Use of any Special PA medication will require a patient-specific, clinically significant reason why lower tiered medications with similar or higher LDL reduction cannot be used; AND
• Use of FloLipid® (simvastatin oral suspension) will require a patient specific, clinically significant reason why the member cannot use simvastatin oral tablets, even when the tablets are crushed. 

Prior Authorization form

Tier 1

Tier 2

• atorvastatin (Lipitor®)
• ezetimibe (Zetia®)
• lovastatin (Mevacor®)
• pravastatin (Pravachol®)
• rosuvastatin (Crestor®)
• simvastatin (Zocor®)

• fluvastatin (Lescol® Lescol®  XL) 
• lovastatin (Altoprev®)
• pitavastatin calcium (Livalo®)
• pitavastatin magnesium (Zypitamag™)
• pitavastatin sodium (Nikita™)
• simvastatin suspension (FloLipid®)
• simvastatin/ezetimibe (Vytorin®)

%LDL Reduction

Pravastatin (Pravachol®)

Simvastatin (Zocor®)

Atorvastatin (Lipitor®)

Rosuvastatin (Crestor®)

Pitavastatin (Livalo®)

25-32%
31-39%
37-45%
48-52%
55-60%
60-63%

5mg
10mg
20mg
40mg

1mg
2mg
4mg

Tier 1 products are available with no authorization necessary

PA criteria:

Tier 2 authorization requires:

• Laboratory documented failure of a tier one medication after 6 months trial, OR
• Documented adverse effect, drug interaction, or contraindication to tier 1 medications; OR
• Documented Prior Stabilization on the Tier 2 medication within the last 100 days.

Prior Authorization form  

Tier 1

Tier 2

• fenofibric acid (Fibricor® Tablets) 35mg
• micronized fenofibrates (Lofibra® Capsules) 67mg, 134mg
• gemfibrozil (Lopid® Tablets)
• micronized fenofibrates (Tricor® Tablets)
• fenofibrates (Triglide® Tablets)
• choline fenofibrate delayed-release (Trilipix® Capsules) 45mg

• micronized fenofibrates (Antara® Capsules)
• fenofibrate (Fenoglide® Tablets) 
• fenofibric acid (Fibricor® Tablets) 105mg
• micronized fenofibrates (Lipofen® Capsules)
• micronized fenofibrates (Lofibra® Capsules) 200mg
• choline fenofibrate delayed-release (Trilipix® Capsules) 135mg 

 PA Approval Criteria:

• An FDA approved indication for the prophylaxis of recurrent thromboembolic stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis; AND
• Member must be 18 years of age or older; AND
• A patient-specific, clinically significant reason why member cannot use immediate-release dipyridamole and over-the-counter (OTC) aspirin in place of Aggrenox® must be provided.
• A quantity limit of 60 capsules for a 30 day supply will apply.

Prior Authorization form

• An FDA approved diagnosis of one of the following:  history of myocardial infarction (MI) or peripheral arterial disease (PAD); AND
• Zontivity™ must be used in combination with aspirin and/or clopidogrel (not monotherapy); AND
• Zontivity™ will not be approved for members with the following situations: history of transient ischemic attack (TIA), stroke, or intracranial hemorrhage (ICH), or active pathological bleeding; AND
• A quantity limit of 30 tablets per 30 days will apply.

Prior Authorization form

macitentan (Opsumit®)  

• FDA approved diagnosis of pulmonary arterial hypertension; AND
• Previous failed trials of at least one of each of the following categories:
• Revatio® (sildenafil) or Adcirca® (tadalafil); AND
• Letairis® (ambrisentan), or Tracleer® (bosentan); AND 
• Medical supervision by a pulmonary specialist and/or cardiologist; AND
• Female members and all healthcare professionals (prescribers and dispensing pharmacies) must be enrolled in the Opsumit® REMS program. 
• A quantity limit of 30 tablets per 30 days will apply. 

riociguat (Adempas®)

• FDA approved diagnosis of pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension 
• Members with a diagnosis of pulmonary arterial hypertension must have previous failed trials of at least one of each of the following categories:
• Revatio® (sildenafil) or Adcirca® (tadalafil); AND
• Letairis® (ambrisentan), or Tracleer® (bosentan); AND
• Members with a diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) must currently be on anticoagulation therapy; AND
• Medical supervision by a pulmonary specialist and/or cardiologist; AND
• Member must not be on concurrent PDE-5 inhibitor therapy; AND
• Member must not have a diagnosis of pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP); AND
• Female members and all healthcare professionals (prescribers and dispensing pharmacies) must be enrolled in the Adempas® REMS program.
• A quantity limit of 90 tablets per 30 days will apply. 

selexipag (Uptravi®) Tablets  

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); AND
• Member must be 18 years of age or older; AND
• Previous failed trials of at least one of each of the following categories (alone or in combination):
• Revatio® (sildenafil) Adcirca® (tadalafil) of Adempas® (riociguat); AND
• Letairis® (ambrisentan) or Tracleer® (bosentan); AND
• Orenitram™ (treprostinil); AND 
• Medical supervision by a pulmonary specialist and/or cardiologist; AND
• A quantity limit of two tablets daily will apply for all strengths with an upper dose limit of 1,600mcg twice daily.

sildenafil (Revatio®)

• FDA approved diagnosis of pulmonary arterial hypertension.
• Medical supervision by a pulmonary specialist and/or cardiologist.
• Quantity limits:
• sildenafil (Revatio®) 20mg tabs:#90 tablets per 30 days.

sildenafil Suspension (Revatio®)  

• An FDA approved diagnosis of pulmonary arterial hypertension; AND
• Medical supervision by a pulmonary specialist and/or cardiologist; AND
• An age restriction will apply. The oral suspension formulation may be approvable for ages six years and younger.  Members seven years and older must have a patient-specific, clinically significant reason why the member is not able to use the oral tablet formulation.
• A quantity limit of 224mL per 30 days (two bottles) will apply.

tadalafil (Adcirca®)

• An FDA approved diagnosis of pulmonary arterial hypertension; AND
• Medical supervision by a pulmonary specialist and/or cardiologist; AND
• A patient-specific, clinically significant reason why the member cannot use generic sildenafil oral tablets; OR
• A clinical exception for use as initial combination therapy with Letairis® (ambrisentan); AND
• A quantity limit of 60 tablets per 30 days will apply.

treprostinil (Orenitram™)  

• An FDA approved diagnosis of pulmonary arterial hypertension; AND
• Previous failed trials of at least one of each of the following categories:
• Revatio® (sildenafil) or Adcirca® (tadalafil); AND
• Letairis® (ambrisentan) or Tracleer® (bosentan); AND
• Medical supervision by a pulmonary specialist and/or cardiologist; AND  
• A quantity limit of 90 tablets per 30 days will apply. 

Prior Authorization form  

apixiban (Eliquis®) Approval Criteria:

An FDA approved diagnosis of one of the following:

• Non-valvular atrial fibrillation; OR
• Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for the reduction in the risk of recurrent DVT and PE following initial therapy; OR
• PE or DVT prophylaxis in patients who have had hip or knee replacement surgery. 

dabigatran etexilate mesylate (Pradaxa®) Approval Criteria:

An FDA approved diagnosis of one of the following:  

• Non-valvular atrial fibrillation; OR
• Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) after treatment with parenteral anticoagulant for 5 to 10 days; OR
• To reduce the risk of recurrent DVT or PE in patients who have been previously treated.
• Prophylaxis of DVT and PE in patients who have undergone hip replacement surgery 

edoxaban (Savaysa®) Approval Criteria:  

An FDA approved diagnosis of one of the following: 

• To reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation; OR
• For the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant; AND
• Requests for therapy for the treatment of DVT and PE must verify that the member has undergone 5 to 10 days of initial therapy with a parenteral anticoagulant; AND
• Members with NVAF must not have a creatinine clearance (CrCl) greater than 95mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60mg); AND
• A quantity limit of 30 tablets per 30 days will apply.

rivaroxaban (Xarelto®) Approval Criteria:

• An FDA approved diagnosis of one of the following:
  • Non-valvular atrial fibrillation; OR
  • Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), to reduce the risk of recurrent DVT and PE; OR
  • Prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery; OR
  • In combination with aspirin, to reduce the risk of major cardiovascular events [cardiovascular (CV) death, myocardial infarction (MI) and stroke] in members with chronic coronary artery disease (CAD) or peripheral artery disease (PAD); AND
   
• Xarelto® (rivaroxaban) 15mg and 20mg:  
• A diagnosis of non-valvular atrial fibrillation, DVT, PE, or prophylaxis of recurrent DVT or PE will be required; OR
• Xarelto® (rivaroxaban) 10mg:
• One prescription for up to 39 days of therapy is allowed without prior authorization every 6 months to allow for DVT prophylaxis use in patients following hip or knee replacement surgery or hospitalized acutely ill medical patients at risk for thromboembolic complications but not at high risk of bleeding; OR 
• Xarelto® (rivaroxaban) 2.5mg :
• Must be used combination with aspirin 75-100mg to reduce the risk of major CV events in members with chronic CAD or PAD. 

Prior Authorization form  

• Documented diagnosis of HAE
• Only for acute attacks of HAE

PA Forms  

• Prior Authorization form
• Physician/Outpatient Administered

C1 esterase inhibitor (Berinert®, Cinryze®)

Corlanor® (Ivabradine Tablet and Oral Solution) Approval Criteria:

• An FDA approved indication of 1 of the following:
• To reduce the risk of hospitalization for worsening heart failure (HF) in adult patients with stable, symptomatic chronic HF with reduced left ventricular ejection fraction; OR
• For the treatment of stable, symptomatic HF due to dilated cardiomyopathy (DCM) in patients 6 months of age and older; AND 
• For a diagnosis of worsening HF in adults:
• The prescriber must verify that the member has left ventricular ejection fraction ≤35%; AND  
• The prescriber must verify that the member is in sinus rhythm with a resting heart rate ≥70 beats per minute; AND
• The member must be on maximal/maximally tolerated doses of beta-blockers or have a contraindication to beta-blockers; AND 
• For a diagnosis of DCM in patients 6 months of age or older:
• The prescriber must verify that the member has left ventricular ejection fraction ≤45%; AND
• The prescriber must verify that the member is in sinus rhythm with a resting heart rate (HR) as follows:
• Age 6 to 12 months, HR ≥105 beats per minute (bpm); OR
• Age 1 to 3 years, HR ≥95 bpm; OR
• Age 3 to 5 years, HR ≥75 bpm; OR
• Age 5 to 18 years, HR ≥70 bpm; AND 
• The prescriber must verify that dose titration will be followed according to package labeling; AND
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; AND 
• Authorization of Corlanor® solution for members >40kg requires a patient-specific, clinically significant reason why Corlanor® tablets cannot be used; AND
• For Corlanor® tablets, a quantity limit of 60 tablets per 30 days will apply; AND  
• For Corlanor® solution, a quantity limit of 56 ampules (2 boxes) per 28 days will apply.  

Prior Authorization form

Repatha® (evolocumab) Approval Criteria:

• An FDA approved diagnosis of homozygous familial hypercholesterolemia (HoFH) defined by the presence of at least one of the following:
• Documented functional mutation(s) in both LDL receptor alleles or alleles known to affect LDL receptor functionality via genetic testing; OR
• An untreated total cholesterol >500mg/dL and at least one of the following:
• Documented evidence of definite heterozygous familial hypercholesterolemia (HeFH) in both parents; OR
• Presence of tendinous/cutaneous xanthoma prior to age 10 years; OR  
• An FDA approved diagnosis of primary hyperlipidemia; OR
• An FDA approved indication to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease (CVD); AND
• Documentation of established CVD; AND
• Supporting diagnoses/conditions and dates of occurrence signifying established CVD. 

Praluent® (alirocumab) Approval Criteria:

• An FDA approved diagnosis of primary hyperlipidemia; OR  
• An FDA approved indication to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established CVD; and
  
  • Documentation of established CVD; AND
    
    • Supporting diagnoses/conditions and dates of occurrence signifying established CVD; OR  
     
   
• Member must be 13 years of age or older for the diagnosis of HoFH or must be 18 years of age or older for all other FDA-approved diagnoses or indications; AND
• Member must be on high dose statin therapy (LDL reduction capability equivalent to rosuvastatin 40mg) or on maximally tolerated statin therapy; AND
• Statin trials must be at least 12 weeks in duration (dosing, dates, duration of treatment, and reason for discontinuation must be provided); AND
• LDL-cholesterol (LDL-C) levels should be included following at least 12 weeks of treatment with each statin medication; AND
• For statin intolerance due to myalgia, creatine kinase (CK) labs verifying rhabdomyolysis must be provided; AND
• Tier structure rules still apply; AND  
• Member requires additional lowering of LDL-C (baseline, current, and goal LDL-C levels must be provided); AND
• Prescriber must verify that member has been counseled on appropriate use, storage of the medication, and administration technique; AND
• A quantity limit of two syringes or pens per 28 days will apply for Praluent®.  A quantity limit of two syringes or autoinjectors per 28 days will apply for Repatha® 140mg and a quantity limit of one autoinjector per 28 days for Repatha® 420mg.  Patients requesting Repatha® 420mg strength will not be approved for multiple 140mg syringes or autoinjectors but instead should use one 420mg autoinjector.
• Initial approvals will be for the duration of three months.  Continued authorization at that time will require the prescriber to provide recent LDL-C levels to demonstrate the effectiveness of this medication, and compliance will be checked at that time and every six months thereafter for continued approval. 

Prior Authorization Form