Kerendia

• Documentation of all of the following is required: 
  • appropriate diagnosis; and
  • concurrent therapy with an ACE-I or ARB; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: Farxiga, Inpefa, Invokana, Jardiance, Steglatro; and
  • requested quantity ≤ one unit/day.

spironolactone suspension

• 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.

Lodoco

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a cardiologist or consult notes from a cardiologist are provided; and
  • clinical rationale for use of the requested agent instead of colchicine 0.6 mg tablet; and
  • requested quantity is ≤ one tablet/day.

clonidine extended-release 0.17 mg tablet

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to clonidine immediate-release tablets; and
  • inadequate response or adverse reaction to two or contraindication to all other antihypertensive agents; and
  • appropriate dosing.

clonidine patch

• Documentation of all of the following is required for a diagnosis of hypertension:
  • 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 or contraindication to all other antihypertensive agents.
• Documentation of all of the following is required for a diagnosis of ADHD:
  • appropriate diagnosis; and
  • one of the following:
    • medical records documenting an inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to oral clonidine; or
    • medical necessity for the transdermal formulation; and
  • inadequate response (defined as ≥ seven days of therapy) or adverse reaction to one or contraindication both of the following: an amphetamine product, a methylphenidate product.
• Documentation of all of the following is required for a diagnosis of ASD:
  • appropriate diagnosis; and
  • one of the following:
    • medical records documenting an inadequate response (defined as ≥ 30 days of therapy) or adverse reaction to oral clonidine; or
    • medical necessity for the transdermal formulation.

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

phenoxybenzamine

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

Aspruzyo

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: beta-blockers, calcium channel blockers, nitrates, ranolazine tablets; and
  • one of the following:
    • member has severe dysphagia and is currently utilizing only formulations that can easily be swallowed (e.g., solutions, suspensions, films, or dispersible tablets); or
    • member utilizes tube feeding; or
    • medical necessity for the requested formulation instead of ranolazine tablets; and
  • appropriate dosing; and
  • requested quantity is ≤ two packets/day.

Gonitro, nitroglycerin lingual spray

• 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/dose; and
  • medical records documenting an inadequate response (defined as ≥ four weeks of therapy) or adverse reaction to two units of isosorbide dinitrate 20 mg tablet.

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.†

carvedilol extended-release

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

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
  • inadequate response or adverse reaction to all of the following: a long-acting formulation of propranolol that is available without PA, 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
  • inadequate response or adverse reaction to a long-acting formulation of propranolol that is available without PA.

Kapspargo

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical necessity for the use of the requested 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.

Katerzia and Norliqva

• 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.

levamlodipine

• Documentation of all the following is required:
  • appropriate diagnosis; and
  • inadequate response, adverse drug reaction or contraindication to amlodipine; and
  • inadequate response or adverse drug reaction to one or contraindication to all other calcium channel blockers available without PA.

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
  •  for solution formulation, 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 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 available without PA.†

digoxin 62.5 mcg tablet

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical necessity for use of the requested agent instead of digoxin formulations available without PA; and
  • requested quantity is one tablet/day.

digoxin oral solution

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

amlodipine/atorvastatin

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical necessity for use of the combination product instead of the commercially available separate agents; and
  • one of the following:
    • requested quantity is ≤ one unit/day; or
    • medical necessity for exceeding the quantity limits; or
    • for requests above the maximum FDA-approved dose, inadequate response (defined as ≥ the last 3 months) to atorvastatin 80mg daily.

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 20 mg or atorvastatin at a dose of at least 40 mg for at least 90 days in all claims history.^†

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

• Documentation of one of the following is required:
  • medical necessity for use of the combination product instead of the commercially available separate agents.

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.

ethacrynic acid tablet

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

Furoscix

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a specialist (e.g., cardiologist, heart failure specialist) or consultation notes from a specialist are provided; and
  • member continues to have fluid overload despite loop diuretic therapy with 40 to 160 mg of oral furosemide equivalents; and
  • treatment with oral diuretics will be discontinued until transitioned back to oral diuretic maintenance therapy; and
  • requested quantity is ≤ eight kits.

furosemide solution

• Documentation of all of the following is required:
  • appropriate diagnosis; and 
  • medical necessity for the requested 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.

triamterene

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

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.^†

Tryvio

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • inadequate response (defined as ≥ four weeks of therapy), adverse reaction, or contraindication to all of the following: RAAS inhibitor, calcium channel blocker, thiazide-type diuretic, mineralcorticoid receptor antagonist, one other antihypertensive agent; and
  • member will continue background therapy with three or more antihypertensive agents; and
  • requested quantity is ≤ one unit/day.

ivabradine

• 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 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
  • for tablet formulation, requested quantity is ≤ two tablets/day; and
  • for solution formulation, medical necessity for the use of the 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.

• 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 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
  • for tablet formulation, requested quantity is ≤ two tablets/day; and
  • for solution formulation, 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.

• Documentation of all of the following is required for a diagnosis of postural tachycardia syndrome (POTS):
  • appropriate diagnosis; and
  • inadequate response or adverse reaction to two or contraindication to all of the following: a beta blocker, droxidopa, fludrocortisone, midodrine, pyridostigmine; and
  • for tablet formulation, requested quantity is ≤ two tablets/day; and
  • for solution formulation, medical necessity for use of the solution formulation as noted by one of the following:
    • member is < 13 years of age; or
    • member utilizes tube feeing (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 inappropriate sinus tachycardia:
  • appropriate diagnosis; and
  • for tablet formulation, requested quantity is ≤ two tablets/day; and
  • for solution formulation, medical necessity for use of the solution formulation as noted by one of the following:
    • member is < 13 years of age; or
    • member utilizes tube feeing (G-tube/J-tube); or
    • member has a swallowing disorder or condition affecting ability to swallow.

Camzyos

• Documentation of all of the following is required:
  • diagnosis of NYHA class II-III obstructive hypertrophic cardiomyopathy; and
  • prescriber is a cardiologist or consultation notes from a cardiologist are provided; and
  • inadequate response or adverse reaction to one or contraindication to all beta blockers; and
  • inadequate response or adverse reaction to one or contraindication to both of the following: diltiazem, verapamil; and
  • inadequate response, adverse reaction, or contraindication to disopyramide; and
  • appropriate dosing; and
  • requested quantity is ≤ one tablet/day
• For recertification, documentation of positive response to therapy is required.

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 or adverse reaction to one or contraindication to both of the following: atomoxetine, 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.

candesartan

• Documentation of all of the following is required for the diagnosis of hypertension or heart failure:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to both of the following: losartan, irbesartan or valsartan.
• Documentation of all of the following is required for the diagnosis of migraine prevention:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • appropriate dosing; and
  • requested quantity is ≤ one unit/day.

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

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 for eprosartan will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 days out of the last 120 days, or if the member has a history of paid MassHealth pharmacy claims for losartan and irbesartan or valsartan.^†

valsartan solution

Documentation of all of the following is required:

• appropriate diagnosis; and
• medical necessity for the use of the 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

• 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 of the requested agent for at least 90 days out of the last 120 days, 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

quinapril

• 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 quinapril will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims of the requested agent for at least 90 days out of the last 120 days, or if the member has MassHealth medical claims for hypertension or heart failure and a history of paid MassHealth pharmacy claims for two ACE inhibitors that are available without PA.^†

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.

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.

Entresto tablet

• Documentation of all the following is required:
  • appropriate diagnosis; and
  • member is ≥ one year of age; and
  • requested quantity is ≤ two tablets/day.

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

Entresto pellet

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member's weight is ≥ 13 kg and < 50 kg; and
  • appropriate dosing; and
  • one of the following:
    • inadequate response, adverse reaction, or contraindication to Entresto tablets; or
    • medical necessity for the requested formulation instead of the tablet formulation as noted by one of the following:
      • member has swallowing disorder or condition affecting ability to swallow; or
      • member is unable to swallow tablets.

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
  • requested quantity is ≤ one unit/day.

tolvaptan (generic Samsca)

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • member is currently taking and stabilized on the requested agent; and
  • one of the following:
    • for 15 mg tablet, requested quantity is ≤ one unit/day; or
    • for 30 mg tablet, requested quantity is ≤ two units/day; or
    • clinical rationale for high dose.

Filspari

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • prescriber is a nephrologist or consult notes from a nephrologist are provided; and
  • medical records documenting one of the following despite treatment with a maximally tolerated dose of an ACE inhibitor or ARB for ≥ 90 days:
    • urine protein-to-creatinine ratio (UPCR) ≥0.5 g/g; or
    • proteinuria >0.5 g/day; and
  • both of the following:
    • requested initial dose of 200 mg daily for two weeks followed by 400 mg daily for maintenance treatment; and 
    • requested quantity is ≤ one tablet/day; and
  • one of the following:
  • inadequate response (defined as ≥ 90 days of therapy) to the maximum FDA-approved dose of an ACE inhibitor or ARB; or
  • both of the following:
    • inadequate response (defined as ≥ 90 days of therapy) to the maximally tolerated dose of an ACE inhibitor or ARB; and
    • medical records documenting intolerance to an ACE inhibitor or ARB at a dose above the maximally tolerated dose.