Effective Date

Date of Origin 

10-01-2025            

Altoprev®

(lovastatin ER)

Tablet

Reduce the risk of myocardinal infarction (MI), unstable angina, and coronary revascularization procedures in adults at high risk for coronary heart disease (CHD).

Adjunct to diet to: 

• Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of coronary atherosclerosis in adults with CHD.
• Reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

1

Atorvaliq®

(atorvastatin)

Oral suspension

To reduce the risk of:

• MI, stroke, revascularization procedures, and angina in adults with multiple risk factors for CHD but without clinically evident CHD.
• MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
• Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.

As an adjunct to diet to reduce LDL-C in:

• Adults with primary hyperlipidemia.
• Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).

As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).

As an adjunct to diet for the treatment of adults with:

• Primary dysbetaliproteinemia.
• Hypertriglyceridemia.

16

Crestor®

(rosuvastatin)*

Tablet

Reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP)  greater than or equal to 2 mg/L, and at least one additional CV risk factor.

As an adjunct to diet to:

• Reduce LDL-C in adults with primary hyperlipidemia.
• Reduce LDL-C and slow the progression of atherosclerosis in adults.
• Reduce LDL-C in adults and pediatric patients aged 8 years and older with HeFH.

As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with HoFH.

As an adjunct to diet for the treatment of adults with: 

• Primary dysbetalipoproteinemia.
• Hypertriglyceridemia.

*generic available

2

Ezallor Sprinkle™

(rosuvastatin)

Capsule

Reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L, and at least one additional CV risk factor.

As an adjunct to diet to: 

• Reduce LDL-C in adults with primary hyperlipidemia.
• Reduce LDL-C and slow the progression of atherosclerosis in adults.
• Reduce LDL-C in adults and pediatric patients aged 8 years and older with HeFH.

As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with HoFH.

As an adjunct to diet for the treatment of adults with:

• Primary dysbetalipoproteinemia.
• Hypertriglyceridemia.

3

Flolipid™

(simvastatin)

Oral suspension

Adjunctive therapy to diet to:

• Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal MI, stroke, and the need for revascularization procedures in patients at high risk of coronary events.
• Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.
• Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia.
• Reduce total-C and LDL-C in adult patients with HoFH.
• Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with HeFH after failing an adequate trial of diet therapy.

Limitations of Use: simvastatin has not been studied in Fredrickson Types I and V dyslipidemias.

4

Lescol XL®

(fluvastatin ER)

Tablet*

To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.

As an adjunct to diet to:

• To reduce LDL-C in adults with primary hyperlipidemia.
• To reduce LDL-C in adults and pediatric patients 10 years of age and older with HeFH who require 80 mg of fluvastatin daily. 

*generic available

5

Lipitor®

(atorvastatin)

Tablet*

To reduce the risk of:

• MI, stroke, revascularization procedures, and angina in adults with multiple risk factors for CHD but without clinically evident CHD.
• MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
• Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure (CFH), and angina in adults with clinically evident CHD.

As an adjunct to diet to reduce LDL-C in:

• Adults with primary hyperlipidemia.
• Adults and pediatric patients aged 10 years and older with HeFH.

As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with HoFH.

As an adjunct to diet for the treatment of adults with:

• Primary dysbetalipoproteinemia.
• Hypertriglyceridemia.

*generic available

6

Livalo®

(pitavastatin)

Tablet*

As an adjunct to diet to reduce LDL-C in: 

• Adults with primary hyperlipidemia.
• Adults and pediatric patients aged 8 years and older with HeFH.

*generic available

7

Roszet®, Ezetimibe-rosuvastatin

(ezetimibe-rosuvastatin)

Tablet

As an adjunct to diet in adults with primary non-familial hyperlipidemia to reduce LDL-C.

Alone or as an adjunct to other LDL-C lowering therapies in adults with HoFH to reduce LDL-C.

12

Vytorin®

(ezetimibe-simvastatin)

Tablet*

As an adjunct to diet to reduce elevated LDL-C:

• Adults with primary hyperlipidemia.
• Adults and pediatric patients aged 10 years and older with HeFH.

As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with HoFH.

*generic available

10

Zocor®

(simvastatin)

Tablet*

Reduce the risk of total mortality by reducing risk of CHD death, non-fatal MI and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established CHD, CVD, peripheral vascular disease, and/or diabetes, who are at high risk of CHD events.

As an adjunct to diet to reduce LDL-C:

• In adults with primary hyperlipidemia.
• In adults and pediatric patients aged 10 years and older with HeFH.

As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with HoFH.

As an adjunct to diet for the treatment of adults with:

• Primary dysbetalipoproteinemia.
• Hypertriglyceridemia.

*generic available

9

Zypitamag®

(pitavastatin)

Tablet

As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia.

11

Statins

Among lipid-lowering drugs, statins are the cornerstone of low-density lipoprotein cholesterol (LDL-C) lowering therapy, in addition to healthy lifestyle interventions. Statins are recommended as first-line treatment to prevent atherosclerotic cardiovascular disease events (ASCVD). Both high intensity and medium intensity statin therapy reduce primary and secondary ASCVD events.(14)

The most recent 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the management of Blood Cholesterol states that clinical atherosclerotic cardiovascular disease (ASCVD) includes the following, all of atherosclerotic origin:(14) 

• Acute coronary syndrome (ACS)
• History of myocardial infarction (MI)
• Stable or unstable angina
• Coronary or other arterial revascularization
• Stroke
• Transient ischemic attack (TIA)
• Peripheral artery disease (PAD) including aortic aneurysm

Safety

Altoprev is contraindicated in the following conditions:(1)

• Concomitant administration of strong CYP3A inhibitors and erythromycin
• Acute liver failure or decompensated cirrhosis 
• Hypersensitivity to lovastatin or any excipients in Altoprev. Hypersensitivity reactions, including anaphylaxis, angioedema and Stevens-Johnson syndrome, have been reported

Atorvaliq, Crestor, Ezallor Sprinkle, Lescol XL, Lipitor, Roszet, are contraindicated in patients with:(2,3,5,6,12,16) 

• Acute liver failure or decompensated cirrhosis
• Hypersensitivity to any excipients in the product

Flolipid is contraindicated in the following conditions:(4)

• Concomitant administration of strong CYP3A4 inhibitors 
• Concomitant administration of gemfibrozil, cyclosporine, or danazol 
• Hypersensitivity to any component of this medication
• Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
• Women who are pregnant or may become pregnant
• Nursing mothers

Livalo and Zypitamag are contraindicated in the following conditions:(7,11)

• Concomitant use of cyclosporine
• Acute liver failure or decompensated cirrhosis
• Hypersensitivity to any excipients in the product

Vytorin and Zocor are contraindicated in the following conditions:(9,10) 

• Concomitant use of strong CYP3A4 inhibitors 
• Concomitant use of cyclosporine, danazol, or gemfibrozil
• Acute liver failure or decompensated cirrhosis
• Hypersensitivity to any excipients in the product

1

Altoprev prescribing information. Covis Pharma US, Inc. December 2024.

2

Crestor prescribing information. AstraZeneca Pharmaceuticals LP. July 2024.

3

Ezallor Sprinkle prescribing information. Sun Pharmaceutical Industries, Inc. February 2025.

4

Flolipid prescribing information. Salerno Pharmaceuticals LP. September 2020.   

5

Lescol XL prescribing information. Sandoz Inc. November 2023.

6

Lipitor prescribing information. Upjohn. April 2024.

7

Livalo prescribing information. Kowa Pharmaceuticals America, Inc. March 2024.

8

Reference no longer used.

9

Zocor prescribing information. Organon LLC. August 2023. 

10

Vytorin prescribing information. Organon LLC. March 2024.

11

Zypitamag prescribing information. Medicure International Inc. December 2024.

12

Roszet prescribing information. Althera Pharmaceuticals LLC. August 2024.

13

Reference no longer used. 

14

Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APHA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139(25). doi:10.1161/cir.0000000000000625

15

Reference no longer used. 

16

Atorvaliq prescribing information. CMP Pharma, Inc. April 2024.

Altoprev

10 MG ; 20 MG ; 40 MG ; 60 MG

M ; N ; O

N ; Y

Atorvaliq ; Lipitor

10 MG ; 20 MG ; 20 MG/5ML ; 40 MG ; 80 MG

M ; N ; O

N ; O ; Y

Crestor ; Ezallor sprinkle

10 MG ; 20 MG ; 40 MG ; 5 MG

M ; N ; O

N ; O ; Y

Flolipid ; Zocor

10 MG ; 20 MG ; 20 MG/5ML ; 40 MG ; 40 MG/5ML ; 5 MG ; 80 MG

M ; N ; O

N ; O ; Y

Lescol xl

20 MG ; 40 MG ; 80 MG

M ; N ; O

O ; Y

Livalo ; Zypitamag

1 MG ; 2 MG ; 4 MG

M ; N ; O

N ; O ; Y

Rosuvastatin/ezetimibe ; Roszet

10-10 MG ; 10-20 MG ; 10-40 MG ; 10-5 MG

M ; N ; O

M ; N

Rosuvastatin/ezetimibe ; Roszet ; Vytorin

ezetimibe-rosuvastatin calcium tab  ; ezetimibe-simvastatin tab

10-10 MG ; 10-20 MG ; 10-40 MG ; 10-5 MG ; 10-80 MG

M ; N ; O

M ; N ; O ; Y

Vytorin

10-10 MG ; 10-20 MG ; 10-40 MG ; 10-80 MG

M ; N ; O

O ; Y

Altoprev

10 MG ; 20 MG ; 40 MG ; 60 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx ; SourceRx-Performance

Atorvaliq ; Lipitor

10 MG ; 20 MG ; 20 MG/5ML ; 40 MG ; 80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx ; SourceRx-Performance

Crestor ; Ezallor sprinkle

10 MG ; 20 MG ; 40 MG ; 5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx ; SourceRx-Performance

Flolipid ; Zocor

10 MG ; 20 MG ; 20 MG/5ML ; 40 MG ; 40 MG/5ML ; 5 MG ; 80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx ; SourceRx-Performance

Lescol xl

20 MG ; 40 MG ; 80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx ; SourceRx-Performance

Livalo ; Zypitamag

1 MG ; 2 MG ; 4 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx ; SourceRx-Performance

Rosuvastatin/ezetimibe ; Roszet

10-10 MG ; 10-20 MG ; 10-40 MG ; 10-5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx ; SourceRx-Performance

Rosuvastatin/ezetimibe ; Roszet ; Vytorin

ezetimibe-rosuvastatin calcium tab  ; ezetimibe-simvastatin tab

10-10 MG ; 10-20 MG ; 10-40 MG ; 10-5 MG ; 10-80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx ; SourceRx-Performance

Vytorin

10-10 MG ; 10-20 MG ; 10-40 MG ; 10-80 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx ; SourceRx-Performance

Step Therapy

*generic available

Target Agent(s) will be approved when ONE of the following is met:

1. The requested agent is eligible for continuation of therapy AND ONE of the following:

1. 1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
   2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
2. The patient has ONE of the following:
   1. A medication history of use in the past 90 days to ONE prerequisite agent OR
   2. An intolerance or hypersensitivity to ONE prerequisite agent that is NOT expected to occur with the requested agent OR
   3. An FDA labeled contraindication to ALL prerequisite agents that is NOT expected to occur with the requested agent

Length of Approval: 12 months