Table 13: Lipid-Lowering Agents
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Cardiovascular
Medication Class/Individual Agents: Lipid-Lowering Agent
I. Prior-Authorization Requirements
Lipid-Lowering Agents – Bile Acid Sequestrants |
Clinical Notes |
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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:
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. |
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Lipid-Lowering Agents – Cholesterol Absorption Inhibitors |
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Lipid-Lowering Agents – Fibric Acids |
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Lipid-Lowering Agents – Nicotinic Acids |
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Lipid-Lowering Agents – Not Otherwise Classified |
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Lipid-Lowering Agents – PCSK9 Inhibitors |
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Lipid-Lowering Agents – Statins |
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| # | 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.
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
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1 unit/day |
1.5 units/day |
2 units/day |
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Altoprev 60 mg |
Altoprev 20 mg, 40 mg |
fluvastatin 40 mg |
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amlodipine/atorvastatin |
atorvastatin 10 mg, 20 mg, 40 mg |
lovastatin 40 mg |
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atorvastatin 80 mg |
fluvastatin 20 mg |
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Ezallor |
pitavastatin calcium 1 mg, 2 mg |
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ezetimibe/simvastatin |
lovastatin 10 mg, 20 mg |
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fluvastatin extended-release 80 mg |
pravastatin 10 mg, 20 mg, 40 mg |
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pitavastatin calcium 4 mg |
rosuvastatin 5 mg, 10 mg, 20 mg |
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pravastatin 80 mg |
simvastatin 5 mg, 10 mg, 20 mg, 40 mg |
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rosuvastatin 40 mg |
Zypitamag 1 mg, 2 mg |
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simvastatin 80 mg |
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Zypitamag 4 mg |
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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.
- diagnosis of one of the following:
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.
- diagnosis of one of the following:
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.
- diagnosis of one of the following:
*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.
- diagnosis of one of the following:
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
- both of the following:
- 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.
- diagnosis of homozygous familial hypercholesterolemia confirmed by one of the following:
*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.
- diagnosis of one of the following:
*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.
- diagnosis of one of the following:
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.
- diagnosis of cardiovascular risk reduction with one of the following;
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.†
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.†
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
- both of the following:
- 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.
- diagnosis of homozygous familial hypercholesterolemia confirmed by one of the following:
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.
- diagnosis of hypercholesterolemia with one of the following:
*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.
- diagnosis of hypercholesterolemia with one of the following:
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.
- diagnosis of hypercholesterolemia with one of the following:
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.
- one of the following:
Original Effective Date: 10/2002
Last Revised Date: 03/2024
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Last updated 04/01/24