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Table 18: Cardiovascular Agents


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Drug Category: Cardiovascular Agents

Medication Class/Individual Agents: Cardiovascular Agents

I. Prior-Authorization Requirements

 Cardiovascular Agents – Aldosterone Receptor Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

eplerenone Inspra test   BP

Carospir

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the use of a suspension formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube, J tube); or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • member is < 13 years of age.

Kerendia

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • documentation of concurrent therapy with an ACE-I or ARB; and
    • inadequate response or adverse reaction to one or contraindication to all of the following: Farxiga, Invokana, Jardiance, Steglatro; and
    • requested quantity ≤ one unit/day.
 
finerenone Kerendia PA  
spironolactone suspension Carospir PA  
spironolactone tablet Aldactone test   #

 Cardiovascular Agents – Alpha Agonists / Centrally Acting Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

clonidine patch Catapres-TTS PA   BP

clonidine patch

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • medical records documenting an inadequate response or adverse reaction to oral clonidine; or
      • member has a swallowing disorder or condition affecting ability to swallow; and
    • inadequate response or adverse reaction to two other antihypertensive agents.

 

clonidine powder

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale why other commercially available alternatives cannot be used.

In addition to individual drug PA criteria where applicable, some behavioral health medications are subject to additional polypharmacy and age limit restrictions (see below).

 
clonidine powder PA  
clonidine tablet PA   - < 3 years
guanfacine PA   - < 3 years
methyldopa test  

 Cardiovascular Agents – Alpha Blocking Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

doxazosin immediate-release Cardura test   #

phenoxybenzamine

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years old; and
    • appropriate dosing; and
    • one of the following:
      • inadequate response or adverse reaction to one selective α-1 blocker (prazosin, terazosin or doxazosin); or
      • contraindication to all selective α-1 blockers (prazosin, terazosin and doxazosin).
 
phenoxybenzamine PA  
prazosin Minipress test   #
terazosin test  

 Cardiovascular Agents – Anti-Anginal Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

isosorbide dinitrate 40 mg tablet Isordil PA   BP

Gonitro, nitroglycerin lingual spray, Nitromist

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to nitroglycerin sublingual tablets.

isosorbide dinitrate 40mg

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • requested dose is > 40 mg per dose; and
    • medical records documenting an inadequate response (defined as at least four weeks of therapy) or adverse reaction to two units of isosorbide dinitrate 20 mg tablet.
 
isosorbide dinitrate 5 mg, 10 mg, 20 mg, 30 mg tablet Isordil test   #
isosorbide dinitrate extended-release capsule Dilatrate-SR test  
isosorbide dinitrate extended-release tablet test  
isosorbide mononitrate test  
nitroglycerin 2% ointment Nitro-Bid test   #
nitroglycerin lingual aerosol Nitromist PA  
nitroglycerin lingual spray Nitrolingual PA   BP
nitroglycerin patch Nitro-Dur test   #
nitroglycerin sublingual powder Gonitro PA  
nitroglycerin sublingual tablet Nitrostat test   #
ranolazine Ranexa test   #

 Cardiovascular Agents – Antiarrhythmics

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

amiodarone test  

quinidine gluconate extended-release

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to quinidine sulfate.

SmartPA: Claims for quinidine gluconate extended-release will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for quinidine sulfate.†

 
disopyramide controlled-release Norpace CR test  
disopyramide immediate-release Norpace test   #
dofetilide Tikosyn test   #
dronedarone Multaq test  
flecainide test  
mexiletine test  
propafenone extended-release Rythmol SR test   #
propafenone immediate-release test  
quinidine gluconate extended-release PA  
quinidine sulfate test  

 Cardiovascular Agents – Beta-Adrenergic Blocking Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

acebutolol test  

carvedilol extended-release

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction or contraindication to immediate release carvedilol.

 

Hemangeol

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the use of a solution formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube, J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • member is < 13 years of age.

 

Inderal XL, Innopran XL

  • Documentation of all of the following is required for a diagnosis of hypertension:
    • diagnosis of hypertension; and
    • adverse reaction or inadequate response to all of the following: a long-acting formulation of propranolol that does not require a prior authorization, a beta-blocker, and one other antihypertensive agent. 
  • Documentation of all of the following is required for a diagnosis of migraine, angina, pulmonary hypertension, Raynaud’s syndrome:
    • diagnosis of migraine, angina, pulmonary hypertension, Raynaud’s syndrome; and
    • adverse reaction (not class specific) or inadequate response to a long-acting formulation of propranolol.

 

Kapspargo

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the use of a capsule formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube, J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • member is < 13 years of age.

 

Sotylize

  • Documentation of all of the following is required:
    • diagnosis of life-threatening ventricular arrhythmias or highly symptomatic atrial fibrillation or atrial flutter; and
    • medical necessity for the use of a solution formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube, J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • member is < 13 years of age.
 
atenolol Tenormin test   #
betaxolol tablet test  
bisoprolol test  
carvedilol Coreg test   #
carvedilol extended-release Coreg CR PA   BP
esmolol Brevibloc test   #
labetalol test  
metoprolol Lopressor test   #
metoprolol extended-release capsule Kapspargo PA  
metoprolol extended-release tablet Toprol XL test   #
nadolol Corgard test   BP
nebivolol Bystolic test   BP
pindolol test  
propranolol extended-release Inderal LA test   #
propranolol immediate-release test  
propranolol long-acting capsule Inderal XL PA  
propranolol long-acting capsule Innopran XL PA  
propranolol solution Hemangeol PA  
sotalol solution Sotylize PA  
sotalol tablet Betapace test   #
timolol tablet test  

 Cardiovascular Agents – Calcium Channel Blocking Agents - Dihydropyridine

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

amlodipine Norvasc test   #

Katerzia

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the use of a suspension formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube, J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • member is < 13 years of age.

 

nimodipine capsule and Nymalize > 21 days treatment/365 days

  • Documentation of all of the following is required:
    • appropriate diagnosis (subsequent episode of subarachnoid hemorrhage); and
    • appropriate dosing; and
    • if the request is for solution, medical necessity for the use of a solution formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube, J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow

 

isradipine, nicardipine capsules, nisoldipine

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two calcium channel blockers available without PA or contraindication to all calcium channel blockers available without PA

SmartPA: Claims for isradipine, nicardipine capsules, and nisoldipine will usually process at the pharmacy without a PA request if the member has MassHealth medical claims for an appropriate clinical indication (for example: hypertension, migraine, angina, pulmonary hypertension, or Raynaud’s phenomenon), and a history of paid MassHealth pharmacy claims for two calcium channel blockers that do not require PA.†

 
amlodipine suspension Katerzia PA  
felodipine extended-release test  
isradipine immediate-release PA  
nicardipine capsule PA  
nicardipine injection test  
nifedipine capsule test  
nifedipine extended-release Procardia XL test   #
nifedipine tablet Adalat test   #
nimodipine capsule PA   - > 21 days treatment/365 days
nimodipine oral solution Nymalize PA   - > 21 days treatment/365 days
nisoldipine Sular PA  

 Cardiovascular Agents – Calcium Channel Blocking Agents - Non-Dihydropyridine

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

diltiazem 120 mg, 180 mg, 240 mg, 300 mg-Cardizem CD Cardizem CD test   #

Cardizem CD (diltiazem) 360 mg

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • clinical rationale for the use of the 360 mg strength.
 
diltiazem 360 mg-Cardizem CD Cardizem CD PA  
diltiazem extended-release tablet Cardizem LA test   #
diltiazem-Cardizem Cardizem test   #
diltiazem-Tiazac ER Tiazac ER test   #
verapamil capsule Verelan test   #
verapamil extended-release Verelan PM test   #
verapamil sustained-release Calan SR test   #
verapamil tablet test  

 Cardiovascular Agents – Cardiac glycosides

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

digoxin Lanoxin test   #

 Cardiovascular Agents – Combination Antihypertensives

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

aliskiren / hydrochlorothiazide Tekturna HCT test  

amlodipine/atorvastatin

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
      • one of the following:
        • inadequate response to ≥ 40 mg/day rosuvastatin for at least three months, adverse reaction or contraindication to rosuvastatin; or
        • clinical rationale for not using rosuvastatin; and
      • one of the following:
        • request is within quantity limits; or
        • medical necessity for the requested agent above quantity limits. 

SmartPA: Claims for amlodipine/atorvastatin at a quantity of ≤ one unit/day will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 days out of the last 120 days of the requested agent, or has a history of paid MassHealth pharmacy claims for rosuvastatin at a dose of at least 40 mg for at least three months in all claims history.

 

amlodipine/olmesartan/hydrochlorothiazide, amlodipine/telmisartan, candesartan/hydrochlorothiazide, captopril/hydrochlorothiazide, trandolapril/verapamil

  • Documentation of one of the following is required:
    • stable dosing of each separate agent for at least three months; or
    • stability on the combination agent for at least three months; or
    • medical necessity for one agent in patients with complex, multiple, comorbid conditions.

SmartPA: Claims will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 days (on separate agents or combination agents) in the past 120 days.†

    

Concurrent therapy – ACE inhibitor, ARB, and/or direct renin inhibitor

  • Requests for concurrent therapy with two or more renin angiotensin system agents are evaluated on a case-by-case basis.
 
amiloride / hydrochlorothiazide test  
amlodipine / atorvastatin Caduet PA  
amlodipine / benazepril Lotrel test   #
amlodipine / olmesartan Azor test   #
amlodipine / olmesartan / hydrochlorothiazide Tribenzor PA  
amlodipine / telmisartan Twynsta PA  
amlodipine / valsartan Exforge test   #
amlodipine / valsartan / hydrochlorothiazide Exforge HCT test   #
atenolol / chlorthalidone Tenoretic test   #
azilsartan / chlorthalidone Edarbyclor test  
benazepril / hydrochlorothiazide Lotensin HCT test   #
bisoprolol / hydrochlorothiazide Ziac test   #
candesartan / hydrochlorothiazide Atacand HCT PA  
captopril / hydrochlorothiazide PA  
enalapril / hydrochlorothiazide Vaseretic test   #
fosinopril / hydrochlorothiazide test  
hydrochlorothiazide / triamterene Maxzide test   #
hydrochlorothiazide / triamterene test  
irbesartan / hydrochlorothiazide Avalide test   #
isosorbide dinitrate / hydralazine Bidil test  
lisinopril / hydrochlorothiazide Zestoretic test   #
losartan / hydrochlorothiazide Hyzaar test   #
methyldopa / hydrochlorothiazide test  
metoprolol / hydrochlorothiazide test  
olmesartan / hydrochlorothiazide Benicar HCT test   #
propranolol / hydrochlorothiazide test  
quinapril / hydrochlorothiazide Accuretic test   #
spironolactone / hydrochlorothiazide Aldactazide test   #
telmisartan / hydrochlorothiazide Micardis HCT test   #
trandolapril / verapamil PA  
valsartan / hydrochlorothiazide Diovan HCT test   #

 Cardiovascular Agents – Direct Vasodilators

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

hydralazine test  

    

 
minoxidil test  

 Cardiovascular Agents – Diuretics

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

amiloride test  

ethacrynic acid tablet

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response or adverse reaction to furosemide, bumetanide or torsemide; or
      • contraindication to furosemide, bumetanide and torsemide.

SmartPA: Claims for ethacrynic acid tablet will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for furosemide, bumetanide or torsemide.†

triamterene

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response or adverse reaction to spironolactone or amiloride; or
      • contraindication to spironolactone and amiloride.

SmartPA: Claims for triamterene will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for amiloride or spironolactone.†

 
bumetanide test  
chlorothiazide Diuril test   #
chlorthalidone Thalitone test  
chlorthalidone test  
ethacrynic acid tablet Edecrin PA  
furosemide Lasix test   #
hydrochlorothiazide test  
indapamide test  
metolazone test  
torsemide test  
triamterene PA  

 Cardiovascular Agents – Ganglionic Blocking Agent

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

mecamylamine Vecamyl PA  

Vecamyl

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • prescriber is a cardiologist or nephrologist, or consultation notes from a cardiologist or nephrologist are provided; and
    • causes of secondary hypertension have been ruled out or addressed; and
    • adverse reaction, inadequate response or contraindication to one agent from all of the following classes:
      • aldosterone antagonists; and
      • alpha agonists; and
      • angiotensin converting enzyme (ACE) inhibitors; and
      • angiotensin II receptor blockers (ARB); and
      • beta blockers; and
      • calcium channel blockers; and
      • diuretics (thiazide or loop).
 

 Cardiovascular Agents – HCN Channel Inhibitor

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

ivabradine Corlanor PA  

Corlanor

  • Documentation of all of the following is required for a diagnosis of chronic heart failure with LVEF ≤ 35%:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • prescriber is a cardiologist or consultation notes from a cardiologist are provided; and
    • member has a resting heart rate of ≥ 70 beats per minute (bpm); and
    • one of the following:
      • member is currently receiving a beta-blocker (carvedilol, metoprolol succinate or bisoprolol) at maximally tolerated doses; or
      • adverse reaction to one beta-blocker or contraindication to all beta-blockers;  and
    • one of the following:
      • member is currently receiving standard of care therapy with an ACE inhibitor, ARB, or angiotensin-receptor neprilysin inhibitor (ARNI); or
      • contraindication to all ACE inhibitors, ARBs and ARNIs; and
    • if the request is for tablets, request does not exceed two tablets/day; and
    • if the request is for solution formulation, medical necessity for the use of the solution formulation as noted by one of the following:
      • requested dose is < 2.5 mg; or
      • member utilizes tube feeding (G-tube, J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow.

 

  • Documentation of all of the following is required for a diagnosis of heart failure due to dilated cardiomyopathy:
    • appropriate diagnosis; and
    • member is ≥ six months of age and < 18 years of age; and
    • member has normal sinus rhythm with an elevated heart rate; and
    • prescriber is a cardiologist or consultation notes from a cardiologist are provided; and
    • one of the following:
      • member is currently receiving a beta-blocker (carvedilol, metoprolol succinate or bisoprolol) at maximally tolerated doses; or
      • adverse reaction to one beta-blocker or contraindication to all beta-blockers;  and
    • one of the following:
      • member is currently receiving standard of care therapy with an ACE inhibitor, ARB, or angiotensin-receptor neprilysin inhibitor (ARNI); or
      • adverse reaction to one or contraindication to all ACE inhibitors, ARBs and ARNIs; and
    • if the request is for tablet formulation, request does not exceed two tablets/day; and
    • if the request is for solution, medical necessity for use of the solution formulation as noted by one of the following:
      • member is < 13 years of age; or
      • requested dose is < 2.5 mg; or
      • member utilizes tube feeing (G-tube, J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow.
 

 Cardiovascular Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

droxidopa Northera PA  

droxidopa

  • Documentation of all of the following is required:
    • diagnosis of symptomatic neurogenic orthostatic hypotension (NOH) caused by one of the following:
      • primary autonomic failure; or
      • dopamine beta-hydroxylase deficiency; or
      • non-diabetic autonomic neuropathy (NDAN); and
    • inadequate response, adverse reaction, or contraindication to midodrine; and
    • inadequate response, adverse reaction, or contraindication to fludrocortisone.
  • For recertification, medical records documenting positive response to therapy (e.g., increased standing blood pressure following treatment with droxidopa without increasing supine blood pressure, improvement on the Orthostatic Hypotension Questionnaire or Orthostatic Hypotension Symptom Assessment score for dizziness/lightheadedness, decreased symptoms of dizziness, lightheadedness, fainting episodes) is required.
 
metyrosine Demser test   BP

 Cardiovascular Agents – Renin Angiotensin System Antagonists - Angiotensin II Receptor Antagonists (ARBS)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

azilsartan Edarbi test  

candesartan, eprosartan

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to both of the following: losartan, irbesartan or valsartan.

SmartPA: Claims will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 days in the past 120 days of the requested agent, or if the member has a history of paid MassHealth pharmacy claims for losartan and irbesartan or valsartan.†

 

Concurrent therapy – ACE inhibitor, ARB, and/or direct renin inhibitor

Requests for concurrent therapy with two or more renin angiotensin system agents are evaluated on a case-by-case basis.

 
candesartan Atacand PA  
eprosartan PA  
irbesartan Avapro test   #
losartan Cozaar test   #
olmesartan Benicar test   #
telmisartan Micardis test   #
valsartan Diovan test   #

 Cardiovascular Agents – Renin Angiotensin System Antagonists - Angiotensin-Converting Enzyme (ACE) Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

benazepril Lotensin test   #

captopril

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to two ACE inhibitors available without PA.

SmartPA: Claims for captopril will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for 90 days in the past 120 days of the requested agent, or if the member has MassHealth medical claims for hypertension, heart failure, left ventricular dysfunction, myocardial infarction, or diabetic nephropathy and a history of paid MassHealth pharmacy claims for two ACE inhibitors that are available without PA.†

 

Epaned and Qbrelis

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the use of a solution formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube/J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow; or
      • member is < 13 years of age

 

Concurrent therapy – ACE inhibitor, ARB, and/or direct renin inhibitor

Requests for concurrent therapy with two or more renin angiotensin system agents are evaluated on a case-by-case basis.

 
captopril PA  
enalapril Vasotec test   #
enalapril solution Epaned PA  
fosinopril test  
lisinopril Zestril test   #
lisinopril test  
lisinopril solution Qbrelis PA  
moexipril test  
perindopril test  
quinapril Accupril test   #
ramipril Altace test   #
trandolapril test  

 Cardiovascular Agents – Renin Angiotensin System Antagonists - Direct Renin Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

aliskiren Tekturna PA   BP

aliskiren

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to both of the following: ARB and ACE inhibitor.

 

Concurrent therapy – ACE inhibitor, ARB, and/or direct renin inhibitor

Requests for concurrent therapy with two or more renin angiotensin system agents are evaluated on a case-by-case basis.

 

 Cardiovascular Agents – Renin Angiotensin System Antagonists – Angiotensin Receptor Neprilysin Inhibitor (ARNI)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

sacubitril / valsartan Entresto PA  

Entresto

  • Documentation of all the following is required:
    • diagnosis of chronic heart failure; and
    • member is ≥ one year old.

SmartPA: Claims will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for at least 90 out of the last 120 days of the requested agent or if the member is ≥ one year of age and has a history of MassHealth medical claims for a diagnosis of chronic heart failure.†

 

 Cardiovascular Agents – Soluble Guanylate Cyclase (sGC) Stimulator

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

vericiguat Verquvo PA  

Verquvo

  • Documentation of all of the following is required:
    • diagnosis of chronic heart failure NYHA Class II to IV; and
    • left ventricular ejection fraction (LVEF) < 45%; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • member has had a hospitalization related to heart failure within the last six months; or
      • member has received outpatient IV diuretic therapy for heart failure within the last three months; and
    • prescriber is a cardiologist or consultation notes from a cardiologist are provided; and
    • one of the following:
      • member has remained symptomatic despite receiving standard of care therapy with an ACEI/ARB/ARNI in combination with a β-blocker (carvedilol, metoprolol succinate or bisoprolol); or
      • adverse reaction to one ACE inhibitor, ARB, ARNI and/or beta blocker, or contraindication to all ACE inhibitors, ARBs, ARNIs and beta blockers; and
    • request does not exceed one unit/day.

 

 

 Cardiovascular Agents – Vasopressin Antagonist

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

tolvaptan-Samsca Samsca PA   BP

tolvaptan (generic Samsca)

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years old; and
    • member is currently stabilized on the requested agent; and
    • one of the following:
      • request is within quantity limits of one unit/day for 15 mg tablets or two units/day for 30 mg tablets; or
      • clinical rationale for high dose.
 
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Angina pectoris
  • Arrhythmias, paroxysmal supraventricular tachycardia
  • Cardiac arrhythmias
  • Cardiovascular events risk reduction
  • Chronic kidney disease associated with type 2 diabetes (Kerendia)
  • Congestive heart failure
  • Congestive heart failure post MI
  • Coronary artery disease (stable or variant angina)
  • Diabetic nephropathy
  • Euvolemic hyponatremia (SIADH)
  • Heart failure
  • Hypertension
  • Hypertrophic subaortic stenosis
  • Hypervolemic hyponatremia (CHF)
  • Left ventricular dysfunction
  • Left ventricular dysfunction following MI
  • Migraine prophylaxis
  • Myocardial infarction
  • Pheochromocytoma
  • Post-myocardial infarction
  • Proliferating infantile hemangioma
  • Raynaud phenomenon
  • Reduction of stroke risk with left ventricular hypertrophy
  • Subarachnoid hemorrhage (nimodipine)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon requested medication (see below)

Please see clinical criteria for agents requiring PA in the table above under the Clinical Notes section.


In addition to individual drug PA criteria where applicable, some behavioral health medications are subject to additional polypharmacy and age limit restrictions.

  

Behavioral Health Medication Polypharmacy (pharmacy claims for any combination of four or more behavioral health medications [i.e., alpha2 agonists, antidepressants, antipsychotics, armodafinil, atomoxetine, benzodiazepines, buspirone, cerebral stimulants, donepezil, hypnotic agents, memantine, modafinil, mood stabilizers (agents considered to be used only for seizure diagnoses are not included), naltrexone, and viloxazine] within a 45-day period) for members < 18 years old

  • For all requests, individual drug PA criteria must be met first where applicable.
  • For regimens including ≤ two mood stabilizers (also includes regimens that do not include a mood stabilizer), documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided.

 

  • For regimens including ≥ three mood stabilizers, documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
    • all of the following:
      • appropriate diagnoses; and
      • treatment plan including names of current behavioral health medications and corresponding diagnoses; and
      • prescriber is a specialist (e.g., psychiatrist, neurologist) or consult is provided; and
      • one of the following:
        • member has a seizure diagnosis only; or
        • member has an appropriate psychiatric diagnosis, with or without seizure diagnosis, and one of the following:
          • cross-titration/taper of mood stabilizer therapy; or
          • inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate; or
        • member has a diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis, and that other clinically appropriate therapies have been tried and failed; therefore, multiple mood stabilizers are needed; or
        • member has psychiatric and comorbid diagnosis in which mood stabilizers may be clinically appropriate (e.g., migraine, neuropathic pain), with or without seizure diagnosis and that other clinically relevant therapies have been tried and failed; therefore, multiple mood stabilizers are needed, and one of the following:
          • cross-titration/taper of mood stabilizer therapy; or
          • inadequate response or adverse reaction to two monotherapy trials and/or multiple combination therapy trials as clinically appropriate.

 

Alpha Agonist for members < three years old

  • For all requests, individual drug PA criteria must be met first where applicable.  
  • Documentation of the following is required:
    • one of the following:
      • member had a recent psychiatric hospitalization (within the last three months); or
      • member has a history of severe risk of harm to self or others; or
      • member has a cardiovascular diagnosis only; or
    • all of the following:
      • appropriate diagnosis; and
      • treatment plan including names of current alpha agonist(s) and corresponding diagnoses; and
      • clinical rationale for use of alpha agonist in member < three years old.

 

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 04/2003

Last Revised Date: 02/2022


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Last updated 06/21/22

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