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Table 13: Lipid-Lowering Agents


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Drug Category: Cardiovascular

Medication Class/Individual Agents: Lipid-Lowering Agent

I. Prior-Authorization Requirements

 Lipid-Lowering Agents – Bile Acid Sequestrants

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

cholestyramine / aspartame test   M90
cholestyramine / sucrose test   M90
colesevelam Welchol test   BP, M90
colestipol Colestid test   # , M90

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.

 

Available treatment guidelines for the management of hyperlipidemia include:

  • The National Cholesterol Education Program (NCEP) Adult Treatment Program (ATP) III guideline (2004)1
  • The American College of Cardiology and American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults (2013)2
  • The American College of Cardiology and American Heart Association Guideline on the Management of Blood Cholesterol Adults (2019)3


 

 

 

1. Grundy SM, Cleeman JI, Merz NB, Brewer Jr B, Clark LT, Hunninghake DB, et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004;110:227-39.

2.Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PWF. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;00:000–000. DOI: 10.1161/01.cir.0000437738.63853.7a

3. Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS et al.  AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary. Circulation. 2018 Nov 10:CIR0000000000000624.

 

 Lipid-Lowering Agents – Cholesterol Absorption Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

ezetimibe Zetia test   # , M90
ezetimibe / simvastatin Vytorin PA   - > 1 unit/day # , M90

 Lipid-Lowering Agents – Fibric Acids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

fenofibrate 30 mg, 90 mg capsule test   M90
fenofibrate 40 mg, 120 mg tablet Fenoglide PA   M90
fenofibrate 43 mg, 67 mg, 130 mg, 134 mg, 200 mg capsule test   M90
fenofibrate 48 mg, 145 mg tablet Tricor test   # , M90
fenofibrate 50 mg, 150 mg capsule Lipofen test   M90
fenofibrate 54 mg, 160 mg tablet test   M90
fenofibric acid Trilipix test   # , M90
fenofibric acid tablet test   M90
gemfibrozil Lopid test   # , M90

 Lipid-Lowering Agents – Nicotinic Acids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

niacin vitamin B-3 test   *, M90
niacin extended-release tablet test   M90
niacinamide test   *, M90

 Lipid-Lowering Agents – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

bempedoic acid Nexletol PA  
bempedoic acid / ezetimibe Nexlizet PA  
evinacumab-dgnb Evkeeza PA   MB
icosapent ethyl Vascepa PA   BP, M90
inclisiran Leqvio PA  
lomitapide Juxtapid PA  
omega-3 acid ethyl esters Lovaza test   # , M90

 Lipid-Lowering Agents – PCSK9 Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

alirocumab Praluent PA  
evolocumab Repatha PA  

 Lipid-Lowering Agents – Statins

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

amlodipine / atorvastatin Caduet PA   M90
atorvastatin 10 mg, 20 mg, 40 mg tablet Lipitor PA   - > 1.5 units/day # , M90
atorvastatin 80 mg tablet Lipitor PA   - > 1 unit/day # , M90
atorvastatin suspension Atorvaliq PA  
fluvastatin PA   M90
fluvastatin extended-release Lescol XL PA   M90
lovastatin 10 mg, 20 mg PA   - > 1.5 units/day M90
lovastatin 40 mg PA   - > 2 units/day M90
lovastatin extended-release Altoprev PA  
pitavastatin calcium Livalo PA   M90
pitavastatin magnesium Zypitamag PA  
pravastatin 10 mg, 20 mg, 40 mg PA   - > 1.5 units/day M90
pravastatin 80 mg PA   - > 1 unit/day M90
rosuvastatin 40 mg Crestor PA   - > 1 unit/day # , M90
rosuvastatin 5 mg, 10 mg, 20 mg Crestor PA   - > 1.5 units/day # , M90
rosuvastatin sprinkle capsule Ezallor PA  
simvastatin 5 mg, 10 mg, 20 mg, 40 mg Zocor PA   - > 1.5 units/day # , M90
simvastatin 80 mg Zocor PA   - > 1 unit/day # , M90
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. PA 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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without PA.
 
MB This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the hospital outpatient and inpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable.
 
M90 Mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply.
 

II. Therapeutic Uses

Evkeeza

FDA-approved, for example:

  • homozygous familial hypercholesterolemia (HoFH)

Fenoglide

FDA-approved, for example:

  • hypercholesterolemia
  • hypertriglyceridemia
  • mixed dyslipidemias

icosapent ethyl

FDA-approved, for example:

  • cardiovascular risk reduction (with established cardiovascular disease or diabetes mellitus and risk factors for cardiovascular disease)
  • hypertriglyceridemia (not inclusive of those with established cardiovascular disease or diabetes mellitus and cardiovascular risk factors)

Juxtapid

FDA-approved, for example:

  • HoFH

Leqvio

FDA-approved, for example:

  • hypercholesterolemia in a member with clinical atherosclerotic cardiovascular disease in combination with a statin
  • HeFH in combination with a statin

Nexletol, Nexlizet

FDA-approved, for example:

  • atherosclerotic cardiovascular disease
  • heterozygous familial hypercholesterolemia (HeFH)

Praluent, Repatha

FDA-approved, for example:

  • HeFH in combination with a statin
  • HoFH in combination with a statin
  • hypercholesterolemia in a member with clinical atherosclerotic cardiovascular disease in combination with a statin
  • primary hyperlipidemia

Statins

FDA-approved, for example:

  • hypercholesterolemia

 

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.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
  • 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
 

Table 1. Statin Quantity Limits

 

1 unit/day

1.5 units/day

2 units/day

 Altoprev 60 mg

 Altoprev 20 mg, 40 mg

 fluvastatin 40 mg

 amlodipine/atorvastatin

 atorvastatin 10 mg, 20 mg, 40 mg

 lovastatin 40 mg

 atorvastatin 80 mg

 fluvastatin 20 mg

 

 Ezallor

 pitavastatin calcium 1 mg, 2 mg

 

 ezetimibe/simvastatin

 lovastatin 10 mg, 20 mg

 

 fluvastatin extended-release 80 mg

 pravastatin 10 mg, 20 mg, 40 mg

 

 pitavastatin calcium 4 mg

 rosuvastatin 5 mg, 10 mg, 20 mg

 

 pravastatin 80 mg

 simvastatin 5 mg, 10 mg, 20 mg, 40 mg

 

 rosuvastatin 40 mg

 Zypitamag 1 mg, 2 mg

 

 simvastatin 80 mg

 

 

 Zypitamag 4 mg

 

 

 
 

amlodipine/atorvastatin

  • Documentation of the following is required: 
    • diagnosis of one of the following: 
      • heterozygous familial hypercholesterolemia; or 
      • homozygous familial hypercholesterolemia; or 
      • hypercholesterolemia in a member with a previous history of any cardiovascular event; or 
      • hypertriglyceridemia; or 
      • primary dysbetaliproteinemia; or 
      • primary hyperlipidemia; or
      • primary prevention of cardiovascular events; 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 tablet/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 80 mg 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 of the requested agent for 90 days out of the last 120 days 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.
    

Altoprev, fluvastatin, fluvastatin extended-release, pitavastatin calcium, and Zypitamag

  • Documentation of the following is required: 
    • diagnosis of one of the following: 
      • heterozygous familial hypercholesterolemia; or 
      • homozygous familial hypercholesterolemia; or 
      • hypercholesterolemia in a member with a previous history of any cardiovascular event; or 
      • hypertriglyceridemia; or 
      • primary dysbetaliproteinemia; or 
      • primary hyperlipidemia; or
      • primary prevention of cardiovascular events; and
    • one of the following:
      • inadequate response (defined as ≥ the last 3 months) or adverse reaction to one or contraindication to all high-intensity statins; or
      • clinical rationale for not using a high-intensity statin; and
    • one of the following:
      • request is within quantity limits; 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 80 mg daily.
SmartPA: Claims for Altoprev (60 mg), fluvastatin extended-release (80 mg), pitavastatin calcium (4 mg), or Zypitamag (4 mg) at a quantity of ≤ one unit/day, Altoprev (20 mg, 40 mg), fluvastatin (20 mg), pitavastatin calcium (1 mg, 2 mg), or Zypitamag (1 mg, 2 mg) at a quantity of ≤ 1.5 units/day, and fluvastatin (40 mg) at a quantity of ≤ 2 units/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 90 days out of the last 120 days 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.

  

Atorvaliq

  • Documentation of the following is required:  
    •   diagnosis of one of the following: 
      • heterozygous familial hypercholesterolemia; or 
      • homozygous familial hypercholesterolemia; or 
      • hypercholesterolemia in a member with a previous history of any cardiovascular event; or 
      • hypertriglyceridemia; or 
      • primary dysbetaliproteinemia; or 
      • primary hyperlipidemia; or
      • primary prevention of cardiovascular events; and
    • medical necessity for the requested formulation as noted by one of the following:
      • member is < 13 years of age; or 
      • member utilizes tube feeding (G-tube/J-tube); or 
      • member has severe dysphagia and is currently utilizing only formulations that can easily be swallowed (e.g., solutions,suspensions, films, or dispersible tablets); and
    • appropriate dosing; and
    • clinical rationale for the use of the requested agent instead of Ezallor.

*Recertification of the requested agent will be contingent upon continued medical necessity for the requested formulation instead of tablets.

   

atorvastatin, ezetimibe/simvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin over quantity limits

  • Documentation of the following is required: 
    • diagnosis of one of the following: 
      • heterozygous familial hypercholesterolemia; or 
      • homozygous familial hypercholesterolemia; or 
      • hypercholesterolemia in a member with a previous history of any cardiovascular event; or 
      • hypertriglyceridemia; or 
      • primary dysbetaliproteinemia; or 
      • primary hyperlipidemia; or
      • primary prevention of cardiovascular events; and
    • medical necessity for exceeding the quantity limits.
   

Evkeeza

  • Documentation of the following is required: 
    • diagnosis of homozygous familial hypercholesterolemia confirmed by one of the following:
      • both of the following:
        • baseline LDL-C ≥ 400 mg/dL; and
        • current LDL-C ≥ 100 mg/dL; or
      • one of the following:
        • member had evidence of xanthoma before 10 years of age; or
        • evidence of HeFH in both parents; or 
      • laboratory test confirming genetic mutation associated with HoFH including low density lipoprotein receptor (LDLR) mutations, PCSK9 mutations and familial defective apoB mutations; and
    • member is ≥ five years of age; and
    • prescriber is a specialist (e.g. cardiologist, vascular neurologist, lipid-lowering specialist, endocrinologist) or consultation notes from a specialist regarding the use of the agent are provided; and
    • one of the following:
      • agent to be used as add-on therapy with a high-intensity statin, ezetimibe, and PCSK9 inhibitor; or
      • contraindication or other compelling clinical rationale for omitting one or more of the following standard lipid-lowering therapies: statin, ezetimibe, PCSK9 inhibitor; and
    • member's current weight; and
    • appropriate dosing.

*Recertification of the requested agent will be contingent upon MassHealth pharmacy claims history or additional documentation addressing adherence to the entire lipid-lowering regimen, as well as updated information regarding the member's current weight, and positive response to therapy, including decrease in LDL-C laboratory values from baseline.

 

Ezallor

  • Documentation of the following is required:
    • diagnosis of one of the following: 
      • heterozygous familial hypercholesterolemia; or 
      • homozygous familial hypercholesterolemia; or 
      • hypercholesterolemia in a member with a previous history of any cardiovascular event; or 
      • hypertriglyceridemia; or 
      • primary dysbetaliproteinemia; or 
      • primary hyperlipidemia; or
      • primary prevention of cardiovascular events; and
    • medical necessity for the requested formulation as noted by one of the following:
      • member is < 13 years of age; or 
      • member utilizes tube feeding (G-tube/J-tube); or 
      • member has severe dysphagia and is currently utilizing only formulations that can easily be swallowed (e.g., solutions,suspensions, films, or dispersible tablets); and
    • appropriate dosing; and
    • requested quantity is ≤ one sprinkle capsule/day.

*Recertification of the requested agent will be contingent upon continued medical necessity for the requested formulation instead of tablets.

     

fenofibrate 40 mg, 120 mg tablet

  • Documentation of the following is required:  
    • diagnosis of one of the following: 
      • hypertriglyceridemia; or 
      • hypercholesterolemia; or 
      • mixed dyslipidemia; and
    • medical records documenting an inadequate response or adverse reaction to a therapeutically equivalent fenofibrate formulation available without PA; and
    • one of the following:
      • requested quantity is ≤ one unit/day; or
      • medical necessity for exceeding the quantity limits.

   

icosapent ethyl for cardiovascular risk reduction (with established cardiovascular disease or diabetes mellitus and risk factors for cardiovascular disease)

  • Documentation of the following is required:   
    • diagnosis of cardiovascular risk reduction with one of the following;
      • member has established cardiovascular disease (e.g., prior MI, hospitalization for high-risk NSTE-ACS cerebrovascular or carotid disease: prior ischemic stroke, carotid artery disease, PAD); or
      • member has diabetes mellitus with at least one risk factor for CVD (e.g., age [women ≥ 65 years, men ≥ 55 years], smoker, HTN, low HDL-C [≤ 40 mg/dL for men and ≤ 50 mg/dL for women], renal dysfunction [CrCl >30 and < 60 mL/min], retinopathy, micro- or macroalbuminuria), high-sensitivity C-reactive protein (hs-CRP) > 3.0 mg/dL, or ankle-brachial index < 0.9 without symptoms of intermittent claudication; and
    • triglyceride level ≥ 135 mg/dL; and
    • one of the following:
      • agent to be used in combination with a statin; or
      • clinical rationale why member cannot take a statin; and
    • one of the following:
      • for icosapent ethyl one gram capsule, requested quantity is ≤ four capsules/day; or
      • for icosapent ethyl 0.5 gram capsule, requested quantity is ≤ eight capsules/day; or
      • medical necessity for exceeding the quantity limits.

SmartPA: Claims for icosapent ethyl one gram capsule at a quantity of ≤ four units/day will usually process at the pharmacy without a PA request if the member has history of paid MassHealth pharmacy claims of the requested agent for at least 90 days out of the last 120 days.

SmartPA: Claims for icosapent ethyl 0.5 gram capsule at a quantity of ≤ eight units/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 for at least 90 days out of the last 120 days.

 

icosapent ethyl for hypertriglyceridemia (not inclusive of those with established cardiovascular disease or diabetes mellitus and cardiovascular risk factors)

  • Documentation of the following is required:   
    • diagnosis of hypertriglyceridemia (not inclusive of those with established cardiovascular disease or diabetes mellitus and cardiovascular risk factors); and
    • triglyceride level ≥ 500 mg/dL; and
    • inadequate response, adverse reaction, or contraindication to omega-3 acid ethyl esters; and
    • inadequate response, adverse reaction, or contraindication to a fibric acid derivative (i.e., fenofibrate or gemfibrozil); and
    • one of the following:
      • for icosapent ethyl one gram capsule, requested quantity is ≤ four capsules/day; or
      • for icosapent ethyl 0.5 gram capsule, requested quantity is ≤ eight capsules/day; or
      • medical necessity for exceeding the quantity limits.

SmartPA: Claims for icosapent ethyl one gram capsule at a quantity of ≤ four units/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.

SmartPA: Claims for icosapent ethyl 0.5 gram capsule at a quantity of ≤ eight units/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.

  

Juxtapid

  • Documentation of the following is required: 
    • diagnosis of homozygous familial hypercholesterolemia confirmed by one of the following:
      • both of the following:
        • baseline LDL-C ≥ 400 mg/dL; and
        • current LDL-C ≥ 100 mg/dL; or
      • one of the following:
        • member had evidence of xanthoma before 10 years of age; or
        • evidence of HeFH in both parents; or 
      • laboratory test confirming genetic mutation associated with HoFH including low density lipoprotein receptor (LDLR) mutations, PCSK9 mutations and familial defective apoB mutations; and
    • member is ≥ 18 years of age; and
    • prescriber is a specialist (e.g. cardiologist, vascular neurologist, lipid-lowering specialist, endocrinologist) or consultation notes from a specialist regarding the use of the agent are provided; and
    • one of the following: 
      • inadequate response (defined as ≥ the last 3 months) or adverse reaction to one or contraindication to all high intensity statins; or
      • clinical rationale for not using a high intensity statin; and
    • one of the following:
      • agent to be used as add-on therapy with a high intensity statin; or
      • contraindication to statin therapy; and
    • inadequate response or adverse reaction to one additional non-statin lipid-lowering agent or contraindication to all other non-statin lipid-lowering agents.

       

Leqvio

  • Documentation of the following is required*:
    • diagnosis of hypercholesterolemia with one of the following:
      • for members with a diagnosis of heterozygous familial hypercholesterolemia, current LDL-C is ≥ 70 mg/dL; or
      • for members with a previous history of a cardiovascular event, current LDL-C is ≥ 55 mg/dL; and
    • member is ≥ 18 years of age; and
    • appropriate dosing; and
    • prescriber is a specialist (e.g., cardiologist, endocrinologist, lipid-lowering specialist, vascular neurologist) or consultation notes from a specialist regarding the use of the agent are provided; and
    • inadequate response (defined as ≥ the last 3 months)** or adverse reaction to one or contraindication to both of the following: Praluent, Repatha; and
    • one of the following:
      • inadequate response (defined as ≥ the last 3 months) to a high intensity statin in combination with ezetimibe; or 
      • adverse reaction or contraindication to ezetimibe and inadequate response (defined as ≥ the last 3 months) to high intensity statin monotherapy; or
      • adverse reaction to one high intensity statin or contraindication to all high intensity statins.

*Recertification of the requested agent will be contingent upon MassHealth pharmacy claims history or additional documentation addressing adherence to the entire lipid-lowering regimen, as well as positive response to therapy, including decrease in LDL-C laboratory values from baseline.


**Requests will be evaluated taking into account MassHealth pharmacy claims history or additional documentation addressing adherence to these agents.

 

Nexletol and Nexlizet

  • Documentation of the following is required:
    • diagnosis of hypercholesterolemia with one of the following:
      • for members with a diagnosis of heterozygous familial hypercholesterolemia, current LDL-C is ≥ 70 mg/dL; or
      • for members with a previous history of a cardiovascular event, current LDL-C is ≥ 55 mg/dL; and
    • member is ≥ 18 years of age; and
    • prescriber is a specialist (e.g., cardiologist, endocrinologist, lipid-lowering specialist, vascular neurologist) or consultation notes from a specialist regarding the use of the requested agent are provided; and
    • one of the following:
      • inadequate response (defined as ≥ the last 3 months) to a high intensity statin in combination with ezetimibe; or 
      • adverse reaction or contraindication to ezetimibe and inadequate response (defined as ≥ the last 3 months) to high intensity statin monotherapy; or
      • adverse reaction to one high intensity statin or contraindication to all high intensity statins; and
    • requested quantity is ≤ one tablet/day.

     

Praluent 

  • Documentation of the following is required:
    • diagnosis of hypercholesterolemia with one of the following:
      • for members with a diagnosis of heterozygous familial hypercholesterolemia or homozygous familial hypercholesterolemia, current LDL-C is ≥ 70 mg/dL; or
      • for members with a previous history of a cardiovascular event, current LDL-C is ≥ 55 mg/dL; or
      • for members with primary hyperlipidemia without a history of a cardiovascular event and/or heterozygous familial hypercholesterolemia or homozygous familial hypercholesterolemia, baseline LDL-C is ≥ 190 mg/dL, and current LDL-C is ≥ 70 mg/dL; and
    • member is ≥ 18 years of age; and
    • appropriate dosing; and
    • requested quantity is two pens or syringes/28 days; and
    • one of the following:
      • inadequate response (defined as ≥ the last 3 months) to a high intensity statin in combination with ezetimibe; or 
      • adverse reaction or contraindication to ezetimibe and inadequate response (defined as ≥ the last 3 months) to high intensity statin monotherapy; or
      • adverse reaction to one high intensity statin or contraindication to all high intensity statins.

 

Repatha 

  • Documentation of the following is required:
    • one of the following:
      • diagnosis of heterozygous familial hypercholesterolemia or homozygous familial hypercholesterolemia and member is ≥ 10 years of age; or
      • member is ≥ 18 years of age; and
    • diagnosis of hypercholesterolemia with one of the following:
      • for members with a diagnosis of heterozygous or homozygous familial hypercholesterolemia, current LDL-C is ≥ 70 mg/dL; or
      • for members with a previous history of a cardiovascular event, current LDL-C is ≥ 55 mg/dL; or
      • for members with primary hyperlipidemia without a history of a cardiovascular event and/or heterozygous familial hypercholesterolemia or homozygous familial hypercholesterolemia, baseline LDL-C is ≥ 190 mg/dL, and current LDL-C is ≥ 70 mg/dL; and
    • one of the following:
      • inadequate response (defined as ≥ the last 3 months) to a high intensity statin in combination with ezetimibe; or 
      • adverse reaction or contraindication to ezetimibe and inadequate response (defined as ≥ the last 3 months) to high intensity statin monotherapy; or
      • adverse reaction to one high intensity statin or contraindication to all high intensity statins; and
    • appropriate dosing; and
    • requested quantity is two autoinjectors or syringes/28 days or one to two on-body infusor systems/28 days.

  

  
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: 10/2002

Last Revised Date: 03/2024


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Last updated 03/04/24

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