Effective Date

Date of Origin 

10-01-2024            

Altoprev®

(lovastatin ER)

Tablet

Adjunctive therapy to diet to:

• Reduce the risk of Myocardial infarction (MI), revascularization procedures, and angina in patients without coronary heart disease (CHD), but with multiple risk factors.
• Slow the progression of coronary atherosclerosis in patients with CHD as part of a treatment strategy to lower Total-C and low-density lipoprotein cholesterol (LDL-C).
• Reduce elevated Total-C, LDL-C, Apo B, and triglyceride (TG) levels and increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

Limitations of use: has not been studied in Fredrickson Types I, III, and V dyslipidemias.

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

To reduce the risk of stroke, MI, and arterial revascularization procedures in adults without established CHD who are at increased risk of cardiovascular (CV) disease based on age, 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

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, or alone if such treatments are unavailable, 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

Pravachol®

(pravastatin)*

Tablet

To reduce the risk of MI, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated LDL-C without clinically evident CHD.

To reduce the risk of coronary death, MI, myocardial revascularization procedures, stroke or transient ischemic attack (TIA), and slow the progression of coronary atherosclerosis in adults with clinically evident CHD.

As an adjunct to diet:

• To reduce LDL-C in adults with primary hyperlipidemia.
• To reduce LDL-C in pediatric patients ages 8 years and older with HeFH.
• For the treatment of adults with:
  • Primary dysbetalipoproteinemia.
  • Hypertriglyceridemia.

*generic available

8

Roszet®

(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:

• 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 elevated LDL-C in adults with HoFH.

*generic available

10

Zocor®

(simvastatin)*

Tablet

To 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
• Concomitant administration of erythromycin
• Active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels
• Pregnancy
• Lactation

Atorvaliq, Crestor, Ezallor Sprinkle, Lescol XL, Lipitor, Pravachol, Roszet, are contraindicated in patients with:(2,3,5,6,8,12,16)​​​​​​

• 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. September 2020.

2

Crestor prescribing information. AstraZeneca. July 2023.

3

Ezallor Sprinkle prescribing information. Sun Pharmaceutical Industries, Inc. August 2023.

4

Flolipid prescribing information. Salerno Pharmaceuticals LP. September 2020.   

5

Lescol XL prescribing information. Sandoz Inc. November 2023.

6

Lipitor prescribing information. Pfizer Inc. December 2022.

7

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

8

Pravachol prescribing information. Bristol-Myers Squibb Company. May 2022.

9

Zocor prescribing information. Organon LLC. August 2023. 

10

Vytorin prescribing information. Organon LLC. February 2024.

11

Zypitamag prescribing information. Medicure. January 2024.

12

Roszet prescribing information. Althera Pharmaceuticals LLC. March 2021.

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. February 2023.

Altoprev

lovastatin tab  ; lovastatin tab er

10 MG ; 20 MG ; 40 MG ; 60 MG

M ; N ; O

N ; Y

Atorvaliq ; Lipitor

atorvastatin calcium susp  ; atorvastatin calcium tab

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

M ; N ; O

N ; O ; Y

Crestor ; Ezallor sprinkle

rosuvastatin calcium sprinkle cap  ; rosuvastatin calcium tab

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

M ; N ; O

N ; O ; Y

Flolipid ; Zocor

simvastatin susp  ; simvastatin tab

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

M ; N ; O

N ; O ; Y

Lescol xl

fluvastatin sodium cap  ; fluvastatin sodium tab er

20 MG ; 40 MG ; 80 MG

M ; N ; O

O ; Y

Livalo ; Zypitamag

pitavastatin calcium tab  ; pitavastatin magnesium tab

1 MG ; 2 MG ; 4 MG

M ; N ; O

N ; O ; Y

Roszet

ezetimibe-rosuvastatin calcium tab

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

M ; N ; O

M ; N

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

ezetimibe-simvastatin tab

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

M ; N ; O

O ; Y

Altoprev

lovastatin tab  ; lovastatin tab er

10 MG ; 20 MG ; 40 MG ; 60 MG

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

Atorvaliq ; Lipitor

atorvastatin calcium susp  ; atorvastatin calcium tab

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

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

Crestor ; Ezallor sprinkle

rosuvastatin calcium sprinkle cap  ; rosuvastatin calcium tab

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

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

Flolipid ; Zocor

simvastatin susp  ; simvastatin tab

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

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

Lescol xl

fluvastatin sodium cap  ; fluvastatin sodium tab er

20 MG ; 40 MG ; 80 MG

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

Livalo ; Zypitamag

pitavastatin calcium tab  ; pitavastatin magnesium tab

1 MG ; 2 MG ; 4 MG

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

Roszet

ezetimibe-rosuvastatin calcium tab

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

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

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

Vytorin

ezetimibe-simvastatin tab

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

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

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. 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
3. ONE of the following:
   1. The patient has a medication history of use in the past 90 days, intolerance or hypersensitivity to ONE prerequisite agent OR
   2. The patient has an FDA labeled contraindication to ALL prerequisite agents

Length of approval:  12 months