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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-Prevalite Prevalite test   #
cholestyramine / aspartame-Questran Light Questran Light test   #
cholestyramine / sucrose Questran test   #
cholestyramine resin powder PA  
colesevelam Welchol test   BP
colestipol Colestid test   #

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   #
ezetimibe / simvastatin Vytorin PA   - > 1 unit/day BP

 Lipid-Lowering Agents – Fibric Acids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

fenofibrate 160 mg tablet Triglide test  
fenofibrate 40 mg, 120 mg tablet Fenoglide PA  
fenofibrate 48 mg, 145 mg tablet Tricor test   #
fenofibrate capsule Antara test  
fenofibrate capsule Lipofen test  
fenofibrate capsule, 54 mg and 160 mg tablet test  
fenofibric acid Fibricor test   #
fenofibric acid Trilipix test   #
gemfibrozil Lopid test   #

 Lipid-Lowering Agents – Nicotinic Acids

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

niacin vitamin B-3 test   *
niacin extended-release tablet Niaspan test   #
niacinamide test   *

 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  
icosapent ethyl Vascepa PA  
lomitapide Juxtapid PA  
omega-3 acid ethyl esters Lovaza test   #

 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  
atorvastatin 10 mg, 20 mg, 40 mg Lipitor PA   - > 1.5 units/day #
atorvastatin 80 mg Lipitor PA   - > 1 unit/day #
fluvastatin Lescol PA  
fluvastatin extended-release Lescol XL PA  
lovastatin 10 mg, 20 mg PA   - > 1.5 units/day
lovastatin 40 mg PA   - > 2 units/day
lovastatin extended-release Altoprev PA  
pitavastatin calcium Livalo PA  
pitavastatin magnesium Zypitamag PA  
pravastatin 10 mg, 20 mg, 40 mg Pravachol PA   - > 1.5 units/day #
pravastatin 80 mg Pravachol PA   - > 1 unit/day #
rosuvastatin 40 mg Crestor PA   - > 1 unit/day #
rosuvastatin 5 mg, 10 mg, 20 mg Crestor PA   - > 1.5 units/day #
rosuvastatin sprinkle capsule Ezallor PA  
simvastatin 5 mg, 10 mg, 20 mg, 40 mg Zocor PA   - > 1.5 units/day #
simvastatin 80 mg Zocor PA   - > 1 unit/day #
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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 

II. Therapeutic Uses

Fenoglide

FDA-approved, for example:

  • hypercholesterolemia
  • hypertriglyceridemia
  • mixed dyslipidemias

Juxtapid

FDA-approved, for example:

  • homozygous familial hypercholesterolemia (HoFH)

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

Statins

FDA-approved, for example:

  • hypercholesterolemia

Vascepa

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)

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 the member's condition and requested medication (see below).
 

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

 Ezallor 5 mg, 10 mg, 20 mg

 

 Ezallor 40 mg

 fluvastatin 20 mg

 

 ezetimibe/simvastatin

 Livalo 1 mg, 2 mg

 

 fluvastatin extended-release 80 mg

 lovastatin 10 mg, 20 mg

 

 Livalo 4 mg

 pravastatin 10 mg, 20 mg, 40 mg

 

 pravastatin 80 mg

 rosuvastatin 5 mg, 10 mg, 20 mg

 

 rosuvastatin 40 mg

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

 

 simvastatin 80 mg

 Zypitamag 1 mg, 2 mg

 

 

 Zypitamag 4 mg

 

 

 
 
  

Altoprev, amlodipine/atorvastatin, fluvastatin, fluvastatin extended-release, Livalo, and Zypitamag

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response to ≥ 40 mg/day of 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 atorvastatin/amlodipine, Altoprev (60 mg), fluvastatin (40 mg), fluvastatin extended-release (80 mg), Livalo (4 mg), or Zypitamag (4 mg) at a quantity of ≤ one unit/day and Altoprev (20 mg, 40 mg), fluvastatin (20 mg), Livalo (1 mg, 2 mg), or Zypitamag (1 mg, 2 mg) at a quantity of ≤ 1.5 units/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.

  

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

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • medical necessity for the requested agent above quantity limits.
  

cholestyramine resin powder

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

 

Ezallor

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response or adverse reaction to rosuvastatin tablet; or
      • medical necessity for the use of a sprinkle capsule formulation; and
    • one of the following:
      • request is within quantity limits; or
      • medical necessity for the requested agent above quantity limits.

   

fenofibrate 40 mg, 120 mg tablet

  • Documentation of the following is required:  
    • appropriate diagnosis; and
    • medical records documenting an inadequate response or adverse reaction to a therapeutically equivalent fenofibrate formulation; and
    • one of the following:
      • requested quantity is ≤ one unit/day; or
      • medical necessity for the requested agent above quantity limits.

   

Juxtapid

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • laboratory test confirming genetic mutation associated with HoFH including low density lipoprotein receptor (LDLR) mutations, PCSK9 mutations and familial defective apoB mutations; and
    • age ≥ 18 years; and
    • one of the following:
      • inadequate response to ≥ 40 mg of rosuvastatin for at least three months, adverse reaction, or contraindication to rosuvastatin; or
      • clinical rationale for not using rosuvastatin; 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, adverse reaction, or contraindication to LDL-C apheresis; and
    • one of the following:
      • inadequate response or adverse reaction to one additional non-statin lipid-lowering agent (ezetimibe, niacin, fibric acid derivative or bile acid sequestrant); or
      • contraindication to all other available lipid-lowering agents.

    

Nexletol and Nexlizet

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • age ≥ 18 years; and
    • one of the following:
      • requested agent will be used in combination with a statin; or
      • clinical rationale why member cannot take a statin; and
    • requested quantity is ≤ one tablet/day; and
    • one of the following:
      • inadequate response to combination therapy with either atorvastatin at a dose of 80 mg daily or rosuvastatin at a dose of 40 mg daily and ezetimibe for at least three consecutive months;* or
      • inadequate response to combination therapy with either atorvastatin at a dose < 80 mg daily or rosuvastatin at a dose < 40 mg daily and ezetimibe for at least three consecutive months* and intolerance to higher doses of atorvastatin or rosuvastatin; or
      • for Nexletol, inadequate response to either atorvastatin at a dose of 80 mg daily or rosuvastatin at a dose of 40 mg daily for at least three consecutive months* and adverse reaction or contraindication to the use of ezetimibe; or
      • for Nexletol, all of the following:
        • inadequate response to either atorvastatin at a dose < 80 mg daily or rosuvastatin at a dose < 40 mg daily for at least three consecutive months;* and
        • intolerance to higher doses of atorvastatin or rosuvastatin; and
        • adverse reaction or contraindication to the use of ezetimibe.

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

  

Praluent

  • Documentation of the following is required:
    • age ≥ 18 years; and
    • diagnosis is hypercholesterolemia with one of the following:
      • for members with a diagnosis of heterozygous familial hypercholesterolemia, current LDL-C is ≥ 100 mg/dL; or
      • for members with a previous history of a cardiovascular event, current LDL-C is ≥ 70 mg/dL; and
    • requested agent will be used in combination with a statin;* and
    • requested quantity is two pens or syringes/28 days; and
    • one of the following:
      • prescriber is a specialist (e.g., cardiologist, vascular neurologist, lipid-lowering specialist); or
      • prescriber provides consultation notes from a cardiologist regarding the use of the agent (e.g., cardiologist, vascular neurologist, lipid-lowering specialist); and
    • one of the following:
      • inadequate response to combination therapy with rosuvastatin at a dose of 40 mg daily and ezetimibe for at least the past three months;** or
      • inadequate response to combination therapy with rosuvastatin at a dose < 40 mg daily and ezetimibe for at least the past three months** and intolerance to higher doses of rosuvastatin; or
      • inadequate response to rosuvastatin at a dose of 40 mg daily for at least the past three months** and adverse reaction or contraindication to the use of ezetimibe; or
      • all of the following:
        • inadequate response to rosuvastatin at a dose < 40 mg daily for at least the past three months;** and
        • intolerance to higher doses of rosuvastatin; and
        • adverse reaction or contraindication to the use of ezetimibe.

*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.

 

Repatha

  • Documentation of the following is required:
    • one of the following:
      • diagnosis is homozygous familial hypercholesterolemia and age ≥ 13 years; or
      • age ≥ 18 years; and
    • diagnosis is hypercholesterolemia with one of the following:
      • for members with a diagnosis of heterozygous or homozygous familial hypercholesterolemia, current LDL-C is ≥ 100 mg/dL; or
      • for members with a previous history of a cardiovascular event, current LDL-C is ≥ 70 mg/dL; and
    • requested agent will be used in combination with a statin;* and
    • one of the following:
      • prescriber is a specialist (e.g., cardiologist, vascular neurologist, lipid-lowering specialist); or
      • prescriber provides consultation notes from a cardiologist regarding the use of the agent (e.g., cardiologist, vascular neurologist, lipid-lowering specialist); and
    • one of the following:
      • inadequate response to combination therapy with rosuvastatin at a dose of 40 mg daily and ezetimibe for at least the past three months;** or
      • all of the following:
        • inadequate response to rosuvastatin at a dose < 40 mg daily for at least the past three months;** and
        • intolerance to higher doses of rosuvastatin; and
        • adverse reaction or contraindication to the use of ezetimibe; or
      • inadequate response to combination therapy with rosuvastatin at a dose < 40 mg daily and ezetimibe for at least the past three months** and intolerance to higher doses of rosuvastatin; or
      • inadequate response to rosuvastatin at a dose of 40 mg daily for at least the past three months** and adverse reaction or contraindication to the use of ezetimibe; and
    • one of the following:
      • requested quantity is two autoinjectors or syringes/28 days and one of the following: 
        • diagnosis is heterozygous familial hypercholesterolemia or hypercholesterolemia in a member with a previous history of any cardiovascular event; or
        • diagnosis is homozygous familial hypercholesterolemia and clinical rationale for every-two-week dosing is provided; or
      • requested quantity is three autoinjectors or syringes/28 days and all of the following: 
        • medical necessity for use of three injections given once monthly over the use of the once-monthly on-body infusor system; and
        • for members with heterozygous familial hypercholesterolemia or hypercholesterolemia in a member with a previous history of any cardiovascular event, medical necessity for once-monthly dosing is provided; or
      • requested quantity is 3.5 mL/28 days of on-body infusor system.

*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.

 

Vascepa 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 two risk factors 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); and
    • triglyceride level ≥ 150 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 Vascepa 1 gm capsule, requested quantity is ≤ four capsules/day; or
      • for Vascepa 0.5 gm capsule, requested quantity is ≤ eight capsules/day; or
      • medical necessity for the requested agent above quantity limits.

SmartPA: Claims for Vascepa 1 gm 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 for at least 90 days out of the last 120 days of the requested agent.

SmartPA: Claims for Vascepa 0.5 gm 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 for at least 90 days out of the last 120 days of the requested agent.

 

Vascepa 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 Vascepa 1 gm capsule, requested quantity is ≤ four capsules/day; or
      • for Vascepa 0.5 gm capsule, requested quantity is ≤ eight capsules/day; or
      • medical necessity for the requested agent above quantity limits.

SmartPA: Claims for Vascepa 1 gm 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 for at least 90 days out of the last 120 days of the requested agent.

SmartPA: Claims for Vascepa 0.5 gm 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 for at least 90 days out of the last 120 days of the requested agent.
  
  
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: 08/2020


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Last updated 08/13/20

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