Cardiovascular

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
• A patient-specific, clinically significant reason why the member cannot use Eliquis^® (apixaban), Pradaxa^® (dabigatran), and Xarelto^® (rivaroxaban) must be provided; 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.

Prior Authorization form

Evkeeza^® (Evinacumab-dgnb) Approval Criteria:

• An FDA approved diagnosis of homozygous familial hypercholesterolemia (HoFH) defined by the presence of at least 1 of the following:
  • Documented functional mutation(s) in both low-density lipoprotein (LDL) receptor alleles or alleles known to affect LDL receptor functionality via genetic testing (results of genetic testing must be submitted); or
  • An untreated LDL-cholesterol (LDL-C) >500mg/dL and at least 1 of the following:
    • Documented evidence of definite heterozygous familial hypercholesterolemia (HeFH) in both parents; or
    • Presence of tendinous/cutaneous xanthoma prior to 10 years of age; or
• Member must be 5 years of age or older; and
• Documented trial of high dose statin therapy (LDL reduction capability equivalent to rosuvastatin 40mg) or maximally tolerated statin therapy at least 12 weeks in duration; and
• Members with statin intolerance must meet 1 of the following:
  • Creatine kinase (CK) labs verifying rhabdomyolysis; or
  • An FDA labeled contraindication to all statins; or
  • Documented intolerance to at least 2 different statins at lower doses (dosing, dates, duration of treatment, and reason for discontinuation must be provided); or
  • Documented intolerance to at least 2 different statins at intermittent dosing (dosing, dates, duration of treatment, and reason for discontinuation must be provided); and
• Documented trial of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (e.g., Praluent^®, Repatha^®) 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
• Female members must not be pregnant and must have a negative pregnancy test prior to therapy initiation. Female members of reproductive potential must be willing to use effective contraception while on therapy and for 5 months after discontinuation of therapy; and
• Initial approvals will be for the duration of 6 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 6 months thereafter for continued approval.

Leqvio^® (Inclisiran) Approval Criteria:

• An FDA approved indication as an adjunct to diet and statin therapy for the treatment of 1 of the following:
  • Heterozygous familial hypercholesterolemia (HeFH) as confirmed by 1 of the following:
    • Documented functional mutation(s) in low-density lipoprotein (LDL) receptor alleles or alleles known to affect LDL receptor functionality via genetic testing (results of genetic testing must be submitted); or
    • Both of the following:
      • Pre-treatment total cholesterol >290mg/dL or LDL-C >190mg/dL; and
      • History of tendon xanthomas in either the member, first degree relative, or second degree relative; or
    • Dutch Lipid Clinic Network Criteria score of >8; or
  • Established atherosclerotic cardiovascular disease (ASCVD); and
    • Supporting diagnoses/conditions and dates of occurrence signifying established ASCVD; and
  • Primary hyperlipidemia; and
    • Member’s untreated LDL-C level must be ≥190mg/dL; and
    • Current LDL-C level is ≥100mg/dL; and
• Member must be 18 years of age or older; and
• Documented trial of all of the following for at least 12 weeks in duration each:
  • High dose statin therapy (LDL reduction capability equivalent to rosuvastatin 40mg) or maximally tolerated statin therapy; and
  • Ezetimibe; and
  • Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (e.g., Praluent^®, Repatha^®); and
• Members with statin intolerance must meet 1 of the following:
  • Creatine kinase (CK) labs verifying rhabdomyolysis; or
  • An FDA labeled contraindication to all statins; or
  • Documented intolerance to at least 2 different statins at lower doses (dosing, dates, duration of treatment, and reason for discontinuation must be provided); or
  • Documented intolerance to at least 2 different statins at intermittent dosing (dosing, dates, duration of treatment, and reason for discontinuation must be provided); and
• Member requires additional lowering of LDL-C (baseline, current, and goal LDL-C levels must be provided); and
• Leqvio^® must be administered by a health care professional. Approvals will not be granted for self-administration; and
  • Prior authorization requests must indicate how Leqvio^® will be administered (e.g., prescriber, pharmacist, home health care provider); and
    • Leqvio^® must be shipped to the facility where the member is scheduled to receive treatment; or
    • Prescriber must verify the member has been counseled on the proper storage of Leqvio^®; and
• Initial approvals will be for the duration of 6 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 6 months thereafter for continued approval.

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

• An FDA approved indication of 1 of the following:
  • Severe hypertriglyceridemia; and
    • Laboratory documentation of severe hypertriglyceridemia (fasting triglycerides ≥500mg/dL) and controlled diabetes mellitus [fasting glucose <150mg/dL at the time of triglycerides measurement and hemoglobin A1c (HgA1c) <7.5%]; and
    • Previous failure with fibric acid medications; and
    • Use of Vascepa^® or Omtryg^™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 prior authorization; or
  • For the use of Vascepa^® as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels; and
    • Member must be on a stable dose of maximally tolerated statin therapy for at least 4 weeks (dosing, dates, duration of treatment, and reason for discontinuation must be provided); and
    • Laboratory documentation of fasting triglycerides ≥150mg/dL; and
    • Member must have 1 of the following:
      • Established cardiovascular disease (CVD); or
      • Diabetes mellitus and ≥2 additional risk factors for CVD; and
• Use of Vascepa^® 0.5 gram requires a patient-specific, clinically significant reason why the member cannot use Vascepa^® 1 gram.

• An FDA approved indication as an adjunct to diet and statin therapy for the treatment of 1 of the following:
  • Heterozygous familial hypercholesterolemia (HeFH) as confirmed by 1 of the following:
    • Documented functional mutation(s) in low-density lipoprotein (LDL) receptor alleles or alleles known to affect LDL receptor functionality via genetic testing (results of genetic testing must be submitted); or
    • Both of the following:
      • Pre-treatment total cholesterol >290mg/dL or LDL-cholesterol (LDL-C) >190mg/dL; and
      • History of tendon xanthomas in either the member, first degree relative, or second degree relative; or
    • Dutch Lipid Clinic Network Criteria score of >8; or 
  • Established atherosclerotic cardiovascular disease (ASCVD); and
    • Supporting diagnoses/conditions and dates of occurrence signifying established ASCVD; or
  • Primary hyperlipidemia; and
    • Member’s untreated LDL-C level must be ≥190mg/dL; and
    • Current LDL-C level is ≥100mg/dL; and 
• Member must be 18 years of age or older; and
• Member must be on a stable dose of maximally tolerated statin therapy for at least 4 weeks (dosing, dates, duration of treatment, and reason for discontinuation must be provided); and
  • LDL-cholesterol (LDL-C) levels should be included following at least 4 weeks of treatment; and
  • Member must not be taking simvastatin at doses >20mg or pravastatin at doses >40mg due to drug interactions with Nexletol^® and Nexlizet™; and
• Members with statin intolerance must meet 1 of the following:
  • Creatine kinase (CK) labs verifying rhabdomyolysis; or
  • An FDA labeled contraindication to all statins; or
  • Documented intolerance to at least 2 different statins at lower doses (dosing, dates, duration of treatment, and reason for discontinuation must be provided); or
  • Documented intolerance to at least 2 different statins at intermittent dosing (dosing, dates, duration of treatment, and reason for discontinuation must be provided); and
• Member requires additional lowering of LDL-cholesterol (LDL-C) (baseline, current, and goal LDL-C levels must be provided); and
• A quantity limit of 30 tablets per 30 days will apply; and
• Initial approvals will be for the duration of 3 months, after which time compliance and recent LDL-C levels to demonstrate the effectiveness of this medication will be required for continued approval. Subsequent approvals will be for the duration of 1 year.
  
  

Welchol^® (Colesevelam) Packets for Oral Suspension Approval Criteria:

• An FDA approved diagnosis; AND
• A patient-specific, clinically significant reason (beyond convenience) why the member cannot use the oral tablet other formulations of colesevelam, which is available without prior authorization, must be provided; AND
• The following quantity limits will apply:
  • 30 packets for oral suspension per 30 days.

Leqvio® (Inclisiran) PA Form

Nexletol® (Bempedoic Acid) and Nexlizet™ (Bempedoic Acid/Ezetimibe) Prior Authorization Form

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.

amlodipine oral suspension (Katerzia™) and Norliqva^® (Amlodipine Oral Solution) Approval Criteria:  

• An FDA approved diagnosis of 1 of the following :
  • Hypertension in adults and pediatric members 6 years of age and older; OR  
  • Coronary artery disease; OR
  • Chronic stable angina; OR
  • Vasospastic angina; AND 
• A patient-specific, clinically significant reason why the member cannot use amlodipine oral tablets even when crushed must be provided; AND
• A quantity limit of 300mL per 30 days will apply.

levamlodipine tablet (Conjupri®) Approval Criteria:

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

lisinopril oral solution (Qbrelis™) Approval Criteria:  

• An age restriction of 7 years or older will apply with the following 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.

propranolol hydrochloride oral solution (Hemangeol™) Approval Criteria:

• An FDA approved diagnosis of treatment of proliferating infantile hemangioma requiring systemic therapy.

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 4mg/mL Oral Solution Approval Criteria:

• An FDA approved diagnosis of 1 of the following:
  • Hypertension in adults and pediatric members 6 years of age and older; or
  • Heart failure; or
  • Post-myocardial infarction; and
• A patient specific, clinically significant, reason why the member cannot use valsartan tablets must be provided; and
• A quantity limit of 360mL per 36 days will apply. 

**no products available for coverage by SoonerCare currently

*All strengths other than 32mg.
+Unique criteria applies

HCTZ = hydrochlorothiazide

**no products available for coverage by SoonerCare currently 

aspirin/dipyridamole ER (Aggrenox®)

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.

Pradaxa^® (Dabigatran) Approval Criteria:

• Pradaxa (dabigatran) capsules require the following:
  • An FDA approved indication of 1 of the following:
    • Non-valvular atrial fibrillation; or
    • Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) after treatment with a parenteral anticoagulant for 5 to 10 days; or
    • To reduce the risk of recurrent DVT or PE in members who have been previously treated; or
    • For the prophylaxis of DVT and PE in members who have undergone hip replacement surgery; or
    • Treatment of venous thromboembolic events (VTE) in pediatric members 8 to 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days; or
    • To reduce the risk of recurrent VTE in pediatric members 8 to 18 years of age who have been previously treated; and
  • A patient-specific, clinically significant reason why the member cannot use Eliquis^® (apixaban) and Xarelto^® (rivaroxaban) must be provided.
• Pradaxa (dabigatran) oral pellets require the following:
  • An FDA approved indication of 1 of the following:
    • Treatment of VTE in members who have been treated with a parenteral anticoagulant for at least 5 days; or
    • To reduce the risk of recurrent VTE in members who have been previously treated; and
  • Member must be 3 months of age or older; and
  • Members older than 7 years of age require a patient-specific, clinically significant reason why the oral capsule formulation cannot be used; and
  • A patient-specific, clinically significant reason why the member cannot use Xarelto^® (rivaroxaban) oral suspension must be provided.

Prior Authorization form

Camzyos™ (Mavacamten) Approval Criteria:

• An FDA approved diagnosis of obstructive hypertrophic cardiomyopathy (HCM); AND
• Member must be 18 years of age or older; AND
• Member must have New York Heart Association (NYHA) class II to III heart failure; AND
• Camzyos™ must be prescribed by, or in consultation with, a cardiologist (or an advanced care practitioner with a supervising physician who is a cardiologist); AND
• Member must have left ventricular ejection fraction (LVEF) ≥55%; AND
• Member must be on current treatment with or have a documented failure, contraindication, or intolerance to beta blockers or nondihydropyridine calcium channel blockers; AND
• Member must not be taking concurrent moderate to strong CYP2C19 inhibitors (e.g., proton pump inhibitors, clopidogrel, voriconazole, fluvoxamine), strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir), moderate to strong CYP2C19 inducers (e.g., rifampicin, carbamazepine), or moderate to strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin); AND
• Member must not be taking or planning to take disopyramide, ranolazine, or a combination of a beta blocker and a calcium channel blocker concomitantly with Camzyos™; AND
• Female members of reproductive potential must have a negative pregnancy test prior to initiation of therapy and must agree to use effective contraception during treatment and for 4 months after the final dose of Camzyos™; AND
• Prescriber, pharmacy, and member must be enrolled in the Camzyos™ Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; AND
• Initial approvals will be for the duration of 6 months. Further approval may be granted if the prescriber documents that the member is responding well to treatment; AND
• Subsequent approvals will be for the duration of 1 year. 

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   

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  

**no products available for coverage by SoonerCare currently

Verquvo™ (Vericiguat) Approval Criteria:

• An FDA approved indication to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with all of the following:
  • Chronic symptomatic HF [New York Heart Association (NYHA) Class II, III, or IV]; and
  • Reduced left ventricular ejection fraction (LVEF) <45%; and
  • Already receiving guideline-directed medical therapy for HF, as documented in member’s pharmacy claims history; and
• Member has evidence of worsening HF (decompensation) demonstrated by at least 1 of the following:
  • Hospitalization for HF within the past 6 months; or
  • Received outpatient intravenous (IV) diuretics within the past 3 months; and
• Member must be 18 years of age or older; and
• Member must not be taking concomitant soluble guanylate cyclase (sGC) stimulators (e.g., riociguat); and
• Female members of reproductive potential must not be breastfeeding, must have a negative pregnancy test prior to initiation of therapy, and must agree to use effective contraception during treatment and for 1 month after the final dose of Verquvo™; and
• Prescriber must agree to titrate to the target maintenance dose according to package labeling, as tolerated by the member; and
• Initial approvals will be for the duration of 6 months. Compliance will be checked for continued approval every 6 months; and
• A quantity limit of 30 tablets per 30 days will apply.

Prior Authorization Form

Cinryze^® (C1 Esterase Inhibitor), Haegarda^® (C1 Esterase Inhibitor), Orladeyo™ (Berotralstat), and Takhzyro^® (Lanadelumab-flyo) Approval Criteria:

• An FDA approved diagnosis of hereditary angioedema (HAE); and
• Must be used for prophylaxis of HAE; and
• Not currently taking an angiotensin converting enzyme (ACE) inhibitor or estrogen replacement therapy; and
• Based on HAE attack frequency, attack severity, comorbid conditions, and member’s access to emergent treatment, the prescriber has determined long-term prophylaxis is appropriate for the member; or
• Approval consideration will be given if the member has a recent hospitalization for a severe episode of angioedema; and
• Authorization of Cinryze^® or Haegarda^® will also require a patient-specific, clinically significant reason why the member cannot use Orladeyo™; and
• Authorization of Takhzyro^® (lanadelumab-flyo) will also require a patient-specific, clinically significant reason why the member cannot use Cinryze^®, Haegarda^®, or Orladeyo™; and
• Cinryze^® Dosing:
  • The recommended dose of Cinryze^® is 1,000 units intravenously (IV) every 3 to 4 days, approximately 2 times per week, to be infused at a rate of 1mL/min; and
  • Initial doses should be administered in an outpatient setting by a health care provider; members can be taught by their health care provider to self-administer Cinryze^® IV; and
  • A quantity limit of 8,000 units per month will apply (i.e., 2 treatments per week or 8 treatments per 28 days); or
• Haegarda^® Dosing:
  • The recommended dose of Haegarda^® is 60 IU/kg subcutaneously (sub-Q) twice weekly; 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
  • A quantity limit of 2 treatments per week or 8 treatments per 28 days will apply; or
• Orladeyo™ Dosing:
  • The recommended dose of Orladeyo™ is 150mg by mouth once daily; and
  • A quantity limit of 28 capsules per 28 days will apply; or
• Takhzyro^® Dosing:
  • For members 12 years of age and older: The recommended dose of Takhzyro^® is 300mg sub-Q every 2 weeks (dosing every 4 weeks may be considered in some members); and
  • For members 6 to 11 years of age: The recommended dose of Takhzyro^® is 150mg sub-Q every 2 weeks (every 4 weeks may be considered in some members); and
  • For members 2 to 5 years of age: The recommended dose of Takhzyro^® is 150mg sub-Q every 4 weeks; and
  • Prescriber must verify member or caregiver has been trained by a health care professional on proper storage and sub-Q administration of Takhzyro^®; and
  • A quantity limit of (2) vials per 28 days will apply.

• An FDA approved diagnosis of hereditary angioedema (HAE); and
• Must be used for the treatment of acute attacks of HAE; and
• For authorization consideration of Firazyr^® (icatibant) or Kalbitor^® (ecallantide), a patient-specific, clinically significant reason why the member cannot use Berinert^® (C1 esterase inhibitor) must be provided; or
• For authorization consideration of Ruconest^® (C1 esterase inhibitor), a patient-specific, clinically significant reason why the member cannot use Berinert^® (C1 esterase inhibitor), Firazyr^® (icatibant), or Kalbitor^® (ecallantide) must be provided.

PA Forms  

• Prior Authorization form
• Physician/Outpatient Administered

Tier 1 products available with no authorization necessary

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 Atorvaliq^® (atorvastatin oral suspension) will require:
  • An FDA approved indication; and
  • Member must be 10 years of age or older; and
  • A patient specific, clinically significant reason why the member cannot use atorvastatin oral tablets, even when the tablets are crushed; 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; and
• Use of Ezallor Sprinkle™ (rosuvastatin capsule) will require a patient-specific, clinically significant reason why the member cannot use rosuvastatin oral tablets, even when the tablets are crushed.

Prior Authorization form

Juxtapid^® (Lomitapide) Approval 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 (results of genetic testing must be submitted); OR
  • An untreated LDL cholesterol (LDL-C) >500 mg/dL and triglycerides <300 mg/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; 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
• Members with statin intolerance must meet 1 of the following:
  • Creatine kinase (CK) labs verifying rhabdomyolysis; or
  • An FDA labeled contraindication to all statins; or
  • Documented intolerance to at least 2 different statins at lower doses (dosing, dates, duration of treatment, and reason for discontinuation must be provided); or
  • Documented intolerance to at least 2 different statins at intermittent dosing (dosing, dates, duration of treatment, and reason for discontinuation must be provided); and
• Documented trial of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor (e.g., Praluent^®, Repatha^®) 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™ REMS program.

Prior Authorization form

Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitors [Praluent^® (Alirocumab) and Repatha^® (Evolocumab)] Approval Criteria:

• An FDA approved indication of 1 of the following:
  • Heterozygous familial hypercholesterolemia (HeFH) as confirmed by 1 of the following:
    • Documented functional mutation(s) in low-density lipoprotein (LDL) receptor alleles or alleles known to affect LDL receptor functionality via genetic testing (results of genetic testing must be submitted); or
    •  Both of the following:
  • Pre-treatment total cholesterol >290mg/dL or LDL-cholesterol (LDL-C) >190mg/dL; and
  • History of tendon xanthomas in either the member, first degree relative, or second degree relative; or
    • Dutch Lipid Clinic Network Criteria score of >8; or
  • Homozygous familial hypercholesterolemia (HoFH) defined by the presence of at least 1 of the following:
    • Documented functional mutation(s) in both LDL receptor alleles or alleles known to affect LDL receptor functionality via genetic testing (results of genetic testing must be submitted); or
    • An untreated LDL-C >500mg/dL and at least 1 of the following:
      • Documented evidence of definite HeFH in both parents; or
      • Presence of tendinous/cutaneous xanthoma prior to 10 years of age; or
  • As an adjunct to maximally tolerated statin therapy 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; or
  • Primary hyperlipidemia; and
    • Member’s untreated LDL-C level must be ≥190mg/dL; and
    • Current LDL-C level is ≥100mg/dL; and
• For the use of Repatha^® in members with HeFH or HoFH, member must be 10 years of age or older; AND
• For the use of Repatha^® for FDA approved indications other than HeFH or HoFH or for the use of Praluent^® for all FDA approved indications, the member must be 18 years of age or older; 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; AND
• Members with statin intolerance must meet 1 of the following:
  • Creatine kinase (CK) labs verifying rhabdomyolysis; or
  • An FDA labeled contraindication to all statins; or
  • Documented intolerance to at least 2 different statins at lower doses (dosing, dates, duration of treatment, and reason for discontinuation must be provided); or
  • Documented intolerance to at least 2 different statins at intermittent dosing (dosing, dates, duration of treatment, and reason for discontinuation must be provided); and
• Member must have a recent trial of a statin with ezetimibe, or a recent trial of ezetimibe without a statin for members with documented statin intolerance, or a patient-specific, clinically significant reason why ezetimibe is not appropriate must be provided; 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. 

(PCSK9) Inhibitors Prior Authorization Form

Adcirca^® (Tadalafil) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• A patient-specific, clinically significant reason why the member cannot use generic sildenafil oral tablets must be provided; or
• A clinical exception for use as initial combination therapy with Letairis^® (ambrisentan) applies; and
• Members who are stabilized inpatient and who have a PAH diagnosis will be approved for continuation of therapy; and
• A quantity limit of 60 tablets per 30 days will apply.

Adempas^® (Riociguat) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH); and
  • Members with a diagnosis of PAH must have previous failed trials of at least 1 medication in each of the following categories or have a contraindication to use of all alternatives:
    • Adcirca^® (tadalafil) or Revatio^® (sildenafil); and
    • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
  • Members with a diagnosis of CTEPH must currently be on anticoagulation therapy; and
• Medical supervision by a pulmonary specialist or cardiologist; and
• Member must not be on any concurrent phosphodiesterase (PDE) inhibitor therapy; and
• Member must not have a diagnosis of pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP); and
• Female members and all health care professionals (prescribers and dispensing pharmacies) must be enrolled in the Adempas^® Risk Evaluation and Mitigation Strategy (REMS) program; and
• Members who are stabilized inpatient and who have a PAH or CTEPH diagnosis will be approved for continuation of therapy; and
• A quantity limit of 90 tablets per 30 days will apply.

Liqrev^® (Sildenafil Suspension) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Member must be 18 years of age or older; and
• Medical supervision by a pulmonary specialist or cardiologist; and
• A patient-specific, clinically significant reason why the member cannot use generic sildenafil 20mg oral tablets, even when tablets are crushed, must be provided; and
• A patient-specific, clinically significant reason why the member cannot use generic sildenafil oral suspension (generic Revatio^®) must be provided. 

Opsumit^® (Macitentan) and Opsynvi^® (Macitentan/Tadalafil) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Member must have previous failed trials of at least 1 medication in each of the following categories or have a contraindication to use of all alternatives:
  • Adcirca^® (tadalafil) or Revatio^® (sildenafil); and
  • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• Requests for Opsynvi^® will also require a patient-specific, clinically significant reason why the member cannot use Opsumit^® in combination with generic sildenafil or tadalafil; and 
• Female members and all health care professionals (prescribers and dispensing pharmacies) must be enrolled in the Opsumit^® Risk Evaluation and Mitigation Strategy (REMS) program or the Macitentan-Containing Products REMS program; and
• A quantity limit of 30 tablets per 30 days will apply.

Orenitram^® (Treprostinil) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Member must have previous failed trials of at least 1 medication in each of the following categories or have a contraindication to use of all alternatives:
  • Adcirca^® (tadalafil) or Revatio^® (sildenafil); and
  • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• Members who are stabilized inpatient and who have a PAH diagnosis will be approved for continuation of therapy; and
• A quantity limit of 180 tablets per 30 days will apply.

Revatio^® (Sildenafil Tablets) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• A quantity limit of 90 tablets per 30 days will apply.

Revatio^® (Sildenafil Suspension) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• An age restriction will apply. The oral suspension formulation may be approvable for members 6 years of age and younger. Members 7 years of age and older must have a patient-specific, clinically significant reason why the member is not able to use the oral tablet formulation; and
• A quantity limit of 224mL (2 bottles) per 30 days will apply.

Tadliq^® (Tadalafil Oral Suspension) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• A patient-specific, clinically significant reason why the member cannot use generic sildenafil oral suspension must be provided; and
• An age restriction will apply. The oral suspension formulation may be approvable for members 6 years of age and younger. Members 7 years of age and older must have a patient-specific, clinically significant reason why the member cannot use generic tadalafil 20mg oral tablets, even when the tablets are crushed; and
• Members who are stabilized inpatient and who have a PAH diagnosis will be approved for continuation of therapy; and
• A quantity limit of 300mL per 30 days (2 bottles) will apply. 

Tyvaso DPI^® (Treprostinil Powder for Inhalation) Approval Criteria:

• An FDA approved diagnosis of 1 of the following:
  • Pulmonary arterial hypertension (PAH); or
  • Pulmonary hypertension associated with interstitial lung disease (PH-ILD); and
    • Diagnosis of PH-ILD must be confirmed by right-sided heart catheterization; and
• Medical supervision by a pulmonary specialist or cardiologist; and
• For a diagnosis of PAH:
  • Member must have previous failed trials of at least 1 of each of the following categories or have a contraindication to use of all alternatives:
    • Revatio^® (sildenafil) or Adcirca^® (tadalafil); and
    • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
  • A patient-specific, clinically significant reason why Tyvaso^® (treprostinil inhalation solution) and Remodulin^® (treprostinil injection), which are available without a prior authorization, are not appropriate for the member must be provided; and
• For a diagnosis of PH-ILD, a patient-specific, clinically significant reason why Tyvaso^® (treprostinil inhalation solution), which is available without a prior authorization, is not appropriate for the member must be provided.

Uptravi^® (Selexipag) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Member must be 18 years of age or older; and
• Member must have previous failed trials of at least 1 medication in each of the following categories (alone or in combination) or have a contraindication to use of all alternatives:
  • Adcirca^® (tadalafil), Adempas^® (riociguat), or Revatio^® (sildenafil); and
  • Letairis^® (ambrisentan) or Tracleer^® (bosentan); and
• Medical supervision by a pulmonary specialist or cardiologist; and
• Members who are stabilized inpatient and who have a PAH diagnosis will be approved for continuation of therapy; and
• A quantity limit of 2 tablets daily will apply for all strengths with an upper dose limit of 1,600mcg twice daily.

Winrevair™ (Sotatercept-csrk) Approval Criteria:

• An FDA approved diagnosis of pulmonary arterial hypertension (PAH); and
• Member must be 18 years of age or older; and
• Member is currently taking PAH medications from at least 2 of the following categories for ≥90 days or has a contraindication to use of all alternatives:
  • Phosphodiesterase-5 (PDE-5) inhibitor (e.g., sildenafil, tadalafil) or soluble guanylate cyclase stimulator (e.g., riociguat); or
  • Endothelin-receptor antagonist (e.g., ambrisentan, bosentan); or
  • Prostacyclin analogue or receptor agonist (e.g., epoprostenol, treprostinil); and
• Prescriber must verify that Winrevair™ will be used concurrently with member’s current PAH therapies; and
• Medical supervision by a pulmonary specialist and/or cardiologist; and
• Prescriber must confirm the member or caregiver has been trained by a health care professional on the preparation, subcutaneous (sub-Q) administration, and proper storage of Winrevair™; and
• Prescriber must agree to monitor hemoglobin and platelet counts prior to each dose for the first 5 doses and periodically thereafter; and
• Female members of reproductive potential must not be pregnant, must have a negative pregnancy test prior to initiation of therapy, and must agree to use effective contraception during therapy and for at least 4 months after the last dose; 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
• A quantity limit of 1 kit every 3 weeks will apply.
  • Members requiring (2) 45mg or (2) 60mg vials based on their body weight will not be approved for multiple 1-vial kits but should use the 2-vial kits to achieve the dose required. 

Prior Authorization form

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: 
  • Coronary insufficiency
  • Recent myocardial infarction
  • Rising or elevated BUN, or known renal insufficiency
  • Uremia
  • Glaucoma
  • Organic pyloric stenosis
  • Currently receiving sulfonamides or antibiotics
  • Known sensitivity to mecamylamine (Vecamyl™)  

• 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