Cardiovascular

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, ora 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
    

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.

propranolol hydrochloride oral solution (Hemangeol™) Approval Criteria:

• 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.

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.

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

• perindopril erbumine (Aceon®)

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

• fosinopril/HCTZ (Monopril-HCT®)

• amlodipine (Norvasc®)
• diltiazem (Cardizem®)
• diltiazem (Tiazac®, Taztia® XT)
• diltiazem CD (Cardizem® CD)
  • (All strengths except 360mg) 
    
• diltiazem ER (Cartia® XT, Diltia® XT)
• diltiazem SR (Cardizem® SR)
• 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®, Verelan®)
• verapamil SR (Calan® SR, Isoptin® SR)

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

• diltiazem CD (Cardizem® CD) 360mg

• Tier 1 ACE + Tier 1 CCB

• benazepril/amlodipine (Lotrel®)
• perindopril/amlodipine (Prestalia®)
• trandolapril/verapamil (Tarka®)

• benazepril (Lotensin®)
• captopril (Capoten®)
• enalapril (Vasotec®)
• enalaprilat (Vasotec® IV)
• fosinopril (Monopril®)
• lisinopril (Prinivil®, Zestril®)
• losartan (Cozaar®)
• losartan/HCTZ (Hyzaar®)
• moexipril (Univasc®)
  
• quinapril (Accupril®)
  
• ramipril (Altace®)
  
• trandolapril (Mavik®)
  
• irbesartan (Avapro®)
  
• irbesartan / HCTZ (Avalide®)
  
• valsartan / HCTZ (Diovan HCT®)

• amlodopine/valsartan (Exforge®)
• amlodopine/valsartan/HCTZ (Exforge® HCT)
• valsartan (Diovan®)

• amlodipine/olmesartan (Azor®)
• azilsartan/chlorthalidone (Edarbyclor®)
• azilsartan (Edarbi®)
• candesartan (Atacand®)
• candesartan/HCTZ (Atacand® HCT)
• eprosartan (Teveten®)
• eprosartan/HCTZ (Teveten® HCT)
• olmesartan (Benicar®)
• olmesartan/HCTZ (Benicar® HCT)
• olmesarten med/amlodipine/HCTZ (Tribenzor®)
• telmisartan (Micardis®)
• telmisartan/amlodipine (Twynsta®)
• telmisartan/HCTZ (Micardis® HCT)

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.
• Clinical exceptions will be granted for members already currently on aliskiren and valsartan at the available doses of Valturna.

• Tier 1 ACE Inhibitor + Diuretic

• ARB + Diuretic

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

Consideration will be based on ALL of the following 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:
  
  • Coronary insufficiency
  • Recent myocardial infarction
  • Rising or elevated BUN, or known renal insufficiency
  • d. Uremia
  • Glaucoma
  • Organic pyloric stenosis
  • Currently receiving sulfonamides or antibiotics
  • Known sensitivity to mecamylamine (Vecamyl™)  

Nexiclon® XR (clonidine extended release) and Catapres TTS Patch (clonidine transdermal patch) require 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.

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 both nicotinic acid and fibric acid medications; AND
• Use of Vascepa® or Epanova® requires a patient-specific, clinically significant reason why the member cannot use omega-3-acid ethyl esters (generic Lovaza®).

Consideration will be based on all of the following PA 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 failure of high dose statin therapy (LDL reduction capability equivalent to atorvastatin 80mg or higher); AND
• Prescriber must be certified with Juxtapid™ or Kynamro™ REMS program.

Tier 1 products available with no authorization necessary.

Tier 2 authorization requires:

• A trial with atorvastatin, consisting of at least 8 weeks of continuous therapy, titrated to 40mg, which did not yield adequate LDL reduction.  The minimum starting dose of the Tier 2 medication may only be at the moderate to high LDL lowering doses (20mg  rosuvastatin of higher), or
• Documented adverse effect or contraindication to all available lower tiered products, or
• Clinical exception for high risk members hospitalized for recent acute myocardial infarction or acute coronary syndrome for rosuvastatin 40mg.
  

To qualify for a Tier 3/Special PA medication, there must be:

• A clinically significant reason why lower tiered medications with similar or higher LDL reduction cannot be used.
  • simvastatin/niacin (Simcor®) and lovastatin/niacin (Advicor®) will also require a clinically significant reason why the member cannot use the individual products separately.
• Clinical exceptions for Ezetimibe: Documented active liver disease, or
• Documented unexplained, persistent elevations of serum transaminases, or
• Documented statin related myopathy.

• atorvastatin (Lipitor®)
• lovastatin (Mevacor®)
• pravastatin (Pravachol®)
• simvastatin (Zocor®)

• rosuvastatin (Crestor®)*

Crestor® 5mg and Crestor® 10 mg require special reason for use.

• lovastatin/niacin (Advicor®)
• lovastatin (Altoprev®)
• fluvastatin (Lescol® Lescol®  XL)
• ezetimibe/atorvastatin (Liptruzet®)
• pitavastatin (Livalo®)
• simvastatin/niacin (Simcor®)
• simvastatin/ezetimibe (Vytorin®)
• ezetimibe (Zetia®)

Tier 1 products are available with no authorization necessary.

Tier 2 prior 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 products.

• micronized fenofibrates (Lofibra®)
• gemfibrozil (Lopid®)
• micronized fenofibrates (Tricor®)
• fenofibrates (Trilipix®)

• micronized fenofibrates (Antara®)
• fenofibrate (Fenoglide®)
• micronized fenofibrates (Lipofen®)
• fenofibrates (Triglide®)

The first 90 days available with no authorization required for members new to therapy. After the first 90 days, the following criteria will apply.

• Therapy will be approved for members who are diagnosted with UA/NSTEMI and STEMI patients who are to be managed with percutaneous coronary intervention (PCI), primary or delayed.
• Length of approval will be for 1 year.
• Effient® will not be approved for members with the following situation:
  
  • CABG surgery
  • Members with a history of TIA or stroke.
• Members greater than 75 years of age will generally not be approved without supporting information.
  

• The first 90 days of therapy with the 90mg strength tablets does not require prior authorization; AND
• Approved diagnostic criteria:  acute coronary syndrome (ACS) (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction) with or without percutaneous coronary intervention (PCI); AND
• Approvals of the 90mg twice daily dosage will be for the duration of one year after which time the member should switch to the 60mg twice daily dosage or provide patient-specific, clinically significant reasoning for continuing the 90mg twice daily dosage; AND
• The 60mg twice daily dosage may be approved after one year of therapy with the 90mg twice daily dosage.

• Approved for diagnosis of non-ST-Segment elevated ACUTE coronary syndrome or ST-Segment elevated ACUTE myocardial infarction.
• Approval will be for only one dose of 300mg.

• 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
• 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.

• 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.

•  
• 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.

• 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.

• 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; and
• A quantity limit of 60 tablets per 30 days will apply.

• 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.

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.

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.

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
• Member 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.

• Xarelto® 10mg: One prescription for up to 35 days of therapy is allowed without prior authorization every 6 months.
• Xarelto® 15mg and 20mg: diagnosis of non valvular atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE), or to reduce the risk of recurrent DVT and PE will be required.

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

• An FDA approved diagnosis of symptomatic stable, chronic worsening heart failure; AND
• 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; AN
• The member must be on maximal/maximally tolerated doses of beta blockers or have a contraindication to beta blockers; AND
• A quantity limit of 60 tablets per 30 days will apply.

• An FDA approved diagnosis of heterozygous familial hypercholesterolemia (HeFH) defined by the presence of one of the following criteria:
  • A documented functional mutation(s) in the LDL receptor (LDLR) gene or other HeFH-related genes via genetic testing; OR
  • Definite HeFH using either the Simon Broome Register criteria or the Dutch Lipid Network criteria; OR
• An FDA approved diagnosis of homozygous familial hypercholesterolemia (HoFH) defined by the presence of at least one of the following OR
  • 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 greater than 500mg/dL and at least one of the following:
    • Documented evidence of definite HeFH in both parents; OR
    • Presence of tendinous/cutaneous xanthoma prior to age 10 years; OR
• An FDA approved diagnosis of clinical atherosclerotic cardiovascular disease defined by the presence of one of the following criteria:
  • High cardiovascular risk confirmed by Framingham risk score; AND
    • Supporting diagnoses/conditions signifying this risk level; OR
  • Documented history of Coronary Heart Disease (CHD); AND
    • Supporting diagnoses/conditions and dates of occurrence signifying history of CHD; AND
• Member must be 18 years of age or older for the diagnosis of HeFH or clinical atherosclerotic cardiovascular disease, or must be 13 years of age or older for the diagnosis of HoFH; 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
• Repatha™ requests for the dosing regimen of 420mg once monthly require a diagnosis of HoFH or require a patient-specific, clinically significant reason why the member cannot use Repatha™ at the dosing regimen of 140mg every 2 weeks; AND
• A quantity limit of 2 syringes or pens per 28 days will apply for Praluent® and a quantity limit of 2 syringes or autoinjectors per 28 days will apply for Repatha™. Patients with the diagnosis of HoFH needing 3 Repatha™ syringes or autoinjectors per 30 days (for the dosing regimen of 420mg once monthly) will be approved for a quantity limit override upon meeting PCSK9 inhibitors approval criteria.
• Initial approvals will be for the duration of 3 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.