Cardiovascular

Brilinta^® (Ticagrelor) Approval Criteria:

• The first 365 days of therapy with generic Brilinta^® 90mg twice daily does not require prior authorization; and
• After the first 365 days, a patient-specific, clinically significant reason for continuing the 90mg twice daily dosage will need to be provided or the member should be switched to the 60mg twice daily dosage; and
• Brilinta® 60mg tablet is brand preferred. Requests for generic ticagrelor 60mg tablets will require a patient-specific, clinically significant reason why the member cannot use the brand formulation; and
• Approvals will be for the duration of 1 year. 

Eliquis^® (Apixaban) Tablet for Oral Suspension and Eliquis^® Sprinkle (Apixaban) Capsule for Oral Suspension Approval Criteria:

• Eliquis^® tablet for oral suspension and Eliquis^® Sprinkle capsule for oral suspension will not require prior authorization for members 10 years of age or younger. For members 11 years of age or older, a patient-specific, clinically significant reason why the member cannot use Eliquis^® tablets must be provided; and
• Clinical exceptions for the age restriction may be considered for approval (e.g., documented dysphagia, weight-based dose cannot be achieved with the tablet formulation). 

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.

Rivaroxaban 10mg, 15mg and 20mg Tablet (generic Xarelto) Approval Criteria:

• Authorization of generic rivaroxaban 10mg, 15mg and 20mg tablets (in place of brand Xarelto) will require a patient-specific, clinically significant reason why the member cannot use the brand formulation (brand formulation is preferred).

Savaysa® (edoxaban)  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.

Xarelto^® (Rivaroxaban) Oral Suspension Approval Criteria:

• Xarelto^® oral suspension will not require prior authorization for members 10 years of age or younger. For members 11 years of age or older, a patient-specific, clinically significant reason why the member cannot use rivaroxaban tablets must be provided; and
• Clinical exceptions for the age restriction may be considered for members with documented dysphagia.

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 >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; and
• Member must be 1 year 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-cholesterol (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 (subsequent approvals for 1 year). Continued authorization will require the prescriber to provide recent LDL-C levels to demonstrate the effectiveness of this medication. Additionally, compliance will be checked for continued approval.

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

cap = capsule; DR = delayed release; tab = tablet

Fibric Acid Derivative Medications Tier-2 Approval Criteria:

• Laboratory documented failure with a Tier-1 medication after a 6-month trial; or
• Documented adverse drug effect, drug interaction, or contraindication to all Tier-1 medication(s); or
• Prior stabilization on the Tier-2 medication documented within the last 100 days.

Juxtapid^® (Lomitapide) Approval Criteria:

• An FDA approved diagnosis of homozygous familial hypercholesterolemia (HoFH) defined by the presence of at least 1 of the following criteria:
  • A 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 >500mg/dL and triglycerides <300mg/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; 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-cholesterol (LDL-C) (baseline, current, and goal LDL-C levels must be provided); and
• Prescriber must be certified with Juxtapid^® Risk Evaluation and Mitigation Strategy (REMS) program.

Leqvio^® (Inclisiran) Approval Criteria:

• An FDA approved indication as an adjunct to diet and exercise 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
• 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 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 (subsequent approvals for 1 year). Continued authorization will require the prescriber to provide recent LDL-C levels to demonstrate the effectiveness of this medication. Additionally, compliance will be checked for continued approval.

Leqvio® PA Form

Nexletol^® (Bempedoic Acid) and Nexlizet^® (Bempedoic Acid/Ezetimibe) Approval Criteria:

• An FDA approved of 1 of the following:
  • As an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies or alone when concomitant LDL-C lowering therapies are not possible to reduce LDL-C in those with heterozygous familial hypercholesterolemia (HeFH). HeFH must be 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
  • As an adjunct to diet and in combination with other LDL-C lowering therapies or alone when concomitant LDL-C lowering therapies are not possible to reduce LDL-C in those with primary hyperlipidemia; and
    • Member’s untreated LDL-C level must be ≥190mg/dL; and
    • Current LDL-C level is ≥100mg/dL; and
  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, and coronary revascularization in adults at increased risk for these events who are unable to take recommended statin therapy; and
    • Supporting diagnoses/conditions/risk factors signifying increased risk of major adverse CV events must be submitted; 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-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 lower dose statins (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
• A quantity limit of 30 tablets per 30 days will apply; and
• Initial approvals will be for the duration of 6 months (subsequent approvals for 1 year). Continued authorization will require the prescriber to provide recent LDL-C levels to demonstrate the effectiveness of the medication. Additionally, compliance will be checked for continued approval.

Nexletol® (Bempedoic Acid) and Nexlizet® PA Form

Praluent^® (Alirocumab) 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 know 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 >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
  • To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, and unstable angina requiring hospitalization) in adults at increased risk for these events; and
    • Supporting diagnoses/conditions/risk factors signifying increased risk of major adverse CV events must be submitted; or
  • Primary hyperlipidemia; and
    • Member’s untreated LDL-C level must be ≥190mg/dL; and
    • Current LDL-C level is ≥100mg/dL; and
• For HeFH, member must be 8 years of age or older; and
• For FDA approved indications other than HeFH, 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-C levels should be included following at least 12 weeks of treatment; and
• Members with statin intolerance must meet 1 of the following:
  • Creatinine kinase (CK) labs verifying rhabdomyolysis; or
  • An FDA labeled contraindication to all statins; or
  • Documented intolerance to at least 2 different lower dose statins (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 with a statin with ezetimibe, or a recent trial of ezetimibe without a statin for members with a 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 will be counseled on appropriate use, storage of the medication, and administration technique; and
• A quantity limit of 2 syringes or pens per 28 days will apply; and
• Initial approvals will be for the duration of 6 months (subsequent approvals for 1 year). Continued authorization will require the prescriber to provide recent LDL-C levels to demonstrate the effectiveness of the medication. Additionally, compliance will be checked for continued approval.

Praluent® PA Form

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 know 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 >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
  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events; and
    • Supporting diagnoses/conditions/risk factors signifying increased risk of major adverse CV events must be submitted; or
  • Primary hyperlipidemia; and
    • Member’s untreated LDL-C level must be ≥190mg/dL; and
    • Current LDL-C level is ≥100mg/dL; and
• For HeFH or HoFH, member must be 10 years of age or older; and
• For FDA approved indications other than HeFH or HoFH, 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-C levels should be included following at least 12 weeks of treatment; and
• Members with statin intolerance must meet 1 of the following:
  • Creatinine kinase (CK) labs verifying rhabdomyolysis; or
  • An FDA labeled contraindication to all statins; or
  • Documented intolerance to at least 2 different lower dose statins (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 with a statin with ezetimibe, or a recent trial of ezetimibe without a statin for members with a 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 will be counseled on appropriate use, storage of the medication, and administration technique; and
• A quantity limit of 2 syringes or auto-injectors per 28 days will apply; and
• Initial approvals will be for the duration of 6 months (subsequent approvals for 1 year). Continued authorization will require the prescriber to provide recent LDL-C levels to demonstrate the effectiveness of the medication. Additionally, compliance will be checked for continued approval.

Repatha® PA Form

Vascepa^® (Icosapent Ethyl) Approval Criteria:

• An FDA approved indication of 1 of the following:
  • Severe hypertriglyceridemia; and
    • 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
    • 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
  • 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 members 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; or
      • Diabetes mellitus and ≥2 additional risk factors for cardiovascular disease; and
• Use of Vascepa^® 0.5 gram requires a patient-specific, clinically significant reason why the member cannot use Vascepa^® 1 gram.

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

ER = extended-release; PA = prior authorization

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 low-density lipoprotein-cholesterol (LDL-C) 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.

• Tryngolza™ (Olezarsen) Approval Criteria:
  
  An FDA approved indication to reduce triglyceride levels in adults with familial chylomicronemia syndrome (FCS); and
  Diagnosis of FCS must be confirmed by the following:
  • Fasting triglyceride levels ≥880mg/dL; and
  • One of the following:
    • Genetic testing identifying biallelic pathogenic variants in the LPL, GPIHBP1, APOA5, APOC2, or LMF1 genes (results of genetic testing must be submitted); or
    • Familial chylomicronemia score ≥10; or
    • North American familial chylomicronemia syndrome score ≥45; or
    • History of clinical signs and symptoms associated with FCS (i.e., pancreatitis and/or abdominal pain, eruptive xanthomas, lipemia retinalis, lipemic plasma) and a diagnosis of multifactorial chylomicronemia syndrome (MCS) has been ruled out; and
• Member must be 18 years of age or older; and
• Must be prescribed by, or in consultation with, a cardiologist, an endocrinologist, or a specialist with expertise in the treatment of disorders related to severe hypertriglyceridemia; and
• Prescriber must verify the member is on a low-fat diet of ≤20g of fat per day and will continue the low-fat diet while on treatment with Tryngolza™; and
• Member or caregiver will be trained by a health care professional on the subcutaneous (sub-Q) administration and proper storage of Tryngolza™; and
• A patient specific, clinically significant reason why the member cannot use Redemplo^® (plozasiran) must be provided; and 
• Initial approvals will be for 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment, as indicated by a reduction in fasting triglyceride levels, decreased episodes of acute pancreatitis, and/or other documentation of a positive clinical response to therapy. 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 formulation 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

CD = controlled-delivery; ER, XR, XL = extended-release; LA = long-acting; SR = sustained-release

Antihypertensive Medications Tier-2 Approval Criteria:

• A documented inadequate response to 2 Tier-1 medications (trials must include medication(s) from all available classes where applicable); or
• An adverse drug reaction to all Tier-1 classes of medications; or
• Previous stabilization on the Tier-2 medication; or
• A unique indication for which the Tier-1 antihypertensive medications lack.

Antihypertensive Medications Special Prior Authorization (PA) Approval Criteria:

• Angiotensin I Converting Enzyme Inhibitors (ACEIs):
  • Epaned® (Enalapril Solution) and Qbrelis^® (Lisinopril Oral Solution) Approval Criteria:
    • A patient-specific, clinically significant reason why the member cannot use the oral tablets in place of the oral solution formulation, even when the tablets are crushed, must be provided (e.g., dose was stabilized inpatient, clinically indicated dose cannot be achieved by splitting available tablet formulations); and
    • For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request; and
    • A quantity limit of 300mL per 60days will apply. For members who require doses exceeding this quantity limit, a quantity limit override may be approved with the submission of supporting clinical documentation.
• Angiotensin II Receptor Blockers (ARBs) and ARB Combination Products:
  • Arbli™ (Losartan Oral Suspension) Approval Criteria:
    • A patient-specific, clinically significant reason (beyond convenience) why the member cannot use the oral tablet formulation in place of the oral suspension, even when the tablets are split or crushed, must be provided (e.g., dose stabilized inpatient, clinically indicated dose cannot be achieved with available tablet formulations); and
    • For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request.
    • A quantity limit of 330mL per 33 days will apply.
  • Valsartan Oral Solution Approval Criteria:
    • A patient-specific, clinically significant, reason why the member cannot use the oral tablets or the oral suspension prepared from the tablets must be provided (i.e., dose was stabilized inpatient); and
    • For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request; and
    • A quantity limit of 360mL per 36 days will apply.
• Calcium Channel Blockers (CCBs):
  • Conjupri^® (Levamlodipine Tablets) 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.
  • Katerzia^® (Amlodipine Oral Suspension) and Norliqva^® (Amlodipine Oral Solution) Approval Criteria:
    • A patient specific, clinically significant reason why the member cannot use amlodipine oral tablets, even when the tablets are split or crushed, must be provided (i.e., dose was stabilized inpatient or dose cannot be achieved with available tablet formulations); and
    • For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request; and
    • A quantity limit of 300mL per 30 days will apply.
• Bisoprolol Fumarate 2.5mg Tablet Approval Criteria:
  • A patient-specific, clinically specific reason (beyond convenience) why the member cannot split the 5mg tablet, which is available without prior authorization, to achieve the 2.5mg dose must be provided; and
  • A quantity limit of 30 tablets per 30 days will apply. 
• CaroSpir^® (Spironolactone Oral Suspension) Approval Criteria:
  • An FDA approved indication; and
  • A patient-specific, clinically significant reason why the member cannot use spironolactone oral tablets must be provided, including, but not limited to the following:
    • Member is unable to swallow the oral tablet (i.e., has diagnosis characterized by difficulty or inability to swallow); or
    • Clinically indicated dose cannot be achieved with available tablet formulations; or
    • Dose was stabilized inpatient; and
  • For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request.
• Hemangeol^® (Propranolol Hydrochloride Oral Solution) Approval Criteria:
  • An FDA approved indication for the treatment of proliferating infantile hemangioma requiring systemic therapy; and
  • For the 50mL bottle of Hemangeol^®, a patient-specific, clinically significant reason why the member cannot use the 120mL bottle, which is the preferred package size, must be provided.
• Hemiclor™ (Chlorthalidone 12.5mg Tablet) Approval Criteria:
  • A patient-specific, clinically specific reason (beyond convenience) why the member cannot split a generic chlorthalidone 25mg tablet, which is available without prior authorization, to achieve a 12.5mg dose must be provided; and
  • A quantity limit of 240 tablets per 30 days will apply. 
• Inzirqo™ (Hydrochlorothiazide Oral Suspension) Approval Criteria:
  • A patient-specific, clinically significant reason (beyond convenience) why the member cannot use the oral tablet formulation available without prior authorization, even when the tablets are crushed or split, must be provided (e.g., dose was stabilized inpatient, clinically indicated dose cannot be achieved with available tablet formulations); and
  • For members who require weight-based dosing, the member’s recent weight must be provided on the prior authorization request; and
  • A quantity limit of 240mL per 30 days will apply. For members who require doses that exceed this quantity limit, a quantity limit override may be approved with the submission of supporting clinical documentation. 

• Kapspargo™ Sprinkle [Metoprolol Succinate Extended-Release (ER) Capsules] 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.
• Labetalol Hydrochloride 400mg Tablet Approval Criteria:
  • An FDA-approved indication of the management of hypertension; and
  • A patient-specific, clinically significant reason (beyond convenience) why the member cannot use labetalol hydrochloride 200mg tablets, which are available without prior authorization, to achieve a 400mg dose must be provided.
• Lopressor^® (Metoprolol Tartrate Oral Solution) Approval Criteria:
  • A patient-specific, clinically specific reason (beyond convenience) why the member cannot use oral tablet formulation available without prior authorization, even when the tablets are crushed or split, must be provided (e.g., dose was stabilized inpatient, clinically indicated dose cannot be achieved with available tablet formulations); and
  • A quantity limit of 1,200mL per 30 days will apply. For members who require doses that exceed this quantity limit, a quantity limit override may be approved with the submission of supporting clinical documentation. 
• Nexiclon® XR [Clonidine Extended-Release (ER) Tablet] and Javadin™ (Clonidine Oral Solution) Criteria:
  • An FDA approved diagnosis of hypertension; and
  • A patient-specific, clinically significant reason why the member cannot utilize clonidine immediate-release tablet and clonidine transdermal patch, which are available without a prior authorization, must be provided; and
  • For Nexiclon™ XR, the request must be for an FDA-approved once-daily dosing regimen, according to package labeling; and
  • For Javadin™, the following will apply:
    • Member must be 18 years of age or older; and
    • A quantity limit of 1,000mL per 30 days will apply. For members who require doses greater than this quantity limit, a quantity limit override may be approved with the submission of supporting clinical documentation. 
• Nymalize^® (Nimodipine Oral Solution) Approval Criteria:
  • A patient-specific, clinically significant reason why the member cannot use nimodipine liquid-filled capsules, which are available without prior authorization and can be opened for administration of the liquid contents via oral syringe for members unable to swallow the capsules whole, must be provided.
• Sotylize^® (Sotalol Oral Solution) Approval Criteria:
  • An FDA approved diagnosis of life-threatening ventricular arrhythmias or for the maintenance of normal sinus rhythm in members 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 must be provided (e.g., dose was stabilized inpatient, clinically indicated dose cannot be achieved by splitting available tablet formulations); and
  • For pediatric members, a recent weight or body surface area (BSA) must be provided on the prior authorization request; and
  • A quantity limit of 64mL per day or 1,920mL per 30 days will apply.
• Tekturna^® (Aliskiren Oral Pellets and Tablets) and Tekturna HCT^® (Aliskiren/Hydrochlorothiazide) Approval Criteria:
  • An FDA approved diagnosis; and
  • Member must be 6 years of age or older; and
  • A recent trial, within the previous 6 months and at least 4 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
  • May be used in either monotherapy or combination therapy; and
  • For Tekturna^® oral pellets, a patient-specific, clinically significant reason why the member cannot use Tekturna^® oral tablets must be provided.
• Tryvio™ (Aprocitentan) Approval Criteria:
  • An FDA approved diagnosis of hypertension; and
  • Member has a reported systolic blood pressure of ≥140mmHg confirmed on at least 2 separate blood pressure readings on 2 separate occasions within the last month (documentation of blood pressure readings with dates must be submitted); and
  • Prescriber must rule out other causes of elevated blood pressure including:
    • Inaccurate readings due to faulty or inappropriate equipment (i.e., cuff size) or improper technique; and
    • White coat hypertension; and
    • Prescription non-adherence. Compliance with antihypertensive medications will be evaluated prior to initiation of Tryvio™; and
  • Member must be currently on at least 3 antihypertensive medications at optimal (or maximally tolerated) doses for at least 4 weeks prior to systolic blood pressure reading of ≥140mmHg; and
  • Member must have tried at least 6 different classes of medications, including a diuretic, in the past 12 months that did not yield adequate blood pressure control. Medications can include, but are not limited to, angiotensin I converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), calcium channel blockers (CCBs), direct renin inhibitors (DRIs), beta blockers, alpha blockers, alpha agonists, or diuretics; and
  • Female members of reproductive potential must not be pregnant or breastfeeding during treatment with aprocitentan and must be willing to use an effective method of contraception during treatment and for 1 month after discontinuing Tryvio™; and
  • Female members of reproductive potential must have a negative pregnancy test prior to initiation of Tryvio™ and if pregnancy occurs during therapy, Tryvio™ must be discontinued immediately; and
  • Member must not have elevated aminotransferases >3 times the upper limit of normal (ULN) or moderate to severe hepatic impairment (Child Pugh class B or C); and
  • Prescriber must attest that they will monitor liver transaminase levels during treatment and discontinue Tryvio™ if a sustained, unexplained, clinically relevant elevation occurs or if elevations occur with an increase in bilirubin that is >2 times the ULN; and
  • Member must not have severe anemia prior to initiation of aprocitentan; and
  • A quantity limit of 30 tablets per 30 days will apply; and
  • Initial approvals will be for the duration of 3 months. After 3 months, compliance with all antihypertensive medications, including aprocitentan, will be evaluated and the provider must provide documentation that the member has had a positive response to treatment, including a decrease in blood pressure. Inadequate compliance or a lack of positive response will result in denial of continuation. Subsequent approvals will be for 1 year.
• Vecamyl^® (Mecamylamine) Approval 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 4-drug regimen. Medications can be from, but not limited to, the following classes: angiotensin I converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), calcium channel blockers (CCBs), direct renin inhibitors (DRIs), beta blockers, alpha blockers, alpha agonists, or diuretics; and
  • Prescriber must verify member does not have any of the following contraindications:
    • Coronary insufficiency; or
    • Recent myocardial infarction; or
    • Rising or elevated blood urea nitrogen (BUN), or known renal insufficiency; or
    • Uremia; or
    • Glaucoma; or
    • Organic pyloric stenosis; or
    • Currently receiving sulfonamides or antibiotics; or
    • Known sensitivity to Vecamyl^® (mecamylamine).

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 strong CYP2C19 inhibitors (e.g., fluvoxamine, fluconazole), moderate to strong CYP2C19 inducers (e.g., rifampin), or moderate to strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin); and
• If the member is taking moderate to strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) or weak to moderate CYP2C19 inhibitors (e.g., proton pump inhibitors, clopidogrel, voriconazole), the prescriber must verify that the Camzyos® dose will be adjusted according to the package labelling; 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. 

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); and
    • For requests exceeding the quantity limit, clinical documentation supporting the need for the dose increase (i.e., up to a maximum of 16,000 units per month) must be provided for a quantity limit override; 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) or Sajazir™ (icatibant), 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
• Hereditary Angioedema (HAE) Medications PA

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