Pharmacy Prior Authorization Criteria

Statins

Indications for Prior Authorization

Altoprev (lovastatin extended-release)

• For diagnosis of Prevention of coronary heart disease
  A) Indicated in patients without symptomatic coronary heart disease (CHD), but at high risk, to reduce the risk of myocardial infarction, unstable angina, and coronary revascularization procedures. B) Indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower Total-C and LDL-C to target levels. Limitations of use: Altoprev has not been studied in Fredrickson Types I, III, and V.

• For diagnosis of Hyperlipidemia
  Indicated as an adjunct to diet for the reduction of elevated Total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson types IIa and IIb). Limitations of use: Altoprev has not been studied in Fredrickson Types I, III, and V.

Lipitor (atorvastatin)

• For diagnosis of Prevention of cardiovascular disease
  A) Indicated in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, to reduce the risk of myocardial infarction, risk of stroke, and risk for revascularization procedures and angina.

  B) Indicated in adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, to reduce the risk of myocardial infarction and stroke.

  C) Indicated in adult patients with clinically evident coronary heart disease to reduce the risk of non-fatal myocardial infarction, fatal and non-fatal stroke, revascularization procedures, hospitalization for chronic heart failure (CHF), and angina.

• For diagnosis of Hyperlipidemia
  Indicated as 1) An adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: a) Adults with primary hyperlipidemia and b) Adult and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). 2) 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 homozygous familial hypercholesterolemia (HoFH). 3) As an adjunct to diet for the treatment of adults with: a) primary dysbetalipoproteinemia and b) hypertriglyceridemia.

Zypitamag (pitavastatin magnesium)

• For diagnosis of Primary hyperlipidemia and mixed dyslipidemia
  Indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia. Limitations of use: The effect of Zypitamag on cardiovascular morbidity and mortality has not been determined.

Livalo (pitavastatin calcium)

• For diagnosis of Primary hyperlipidemia and mixed dyslipidemia
  Indicated as an adjunctive therapy to diet in: A) Adults with primary hyperlipidemia and B) Adults and pediatric patients aged 18 years and older with heteroygous familial hypercholesterolemia (HeFH).

Flolipid (simvastatin)

• For diagnosis of Reductions in risk of CHD mortality and cardiovascular events
  Indicated in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease to reduce the risk of total mortality by reducing CHD deaths, non-fatal myocardial infarction and stroke, and reduce the need for coronary and non-coronary revascularization procedures. Limitations of use: Flolipid has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

• For diagnosis of Hyperlipidemia
  Indicated to reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb); to reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia); to reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia); and to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Limitations of use: Flolipid has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

• For diagnosis of Adolescent patients with heterozygous familial hypercholesterolemia (HeFH)
  Indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present: (1) LDL cholesterol remains greater than or equal to 190 mg/dL; or (2) LDL cholesterol remains greater than or equal to 160 mg/dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors are present in the adolescent patient. The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C less than 130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined. Limitations of use: Flolipid has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

Ezallor (rosuvastatin)

• For diagnosis of Homozygous familial hypercholesterolemia (HoFH)
  Indicated 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 homozygous familial hypercholesterolemia (HoFH).

• For diagnosis of Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia)
  Indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia) or Hypertriglyceridemia.

• For diagnosis of Heterozygous Familial Hypercholesterolemia
  Indicated as an adjunct to diet to: A) reduce LDL-C in adults with primary hyperlipidemia, B) Reduce low-density lipoprotein (LDL-C) and slow the progression of atherosclerosis in adults, or C) Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

• For diagnosis of Prevention of Cardiovascular disease
  Indicated to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor.

Lescol XL (fluvastatin sodium) extended-release

• For diagnosis of Hypercholesterolemia
  Indicated as an adjunct to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily.

• For diagnosis of Primary hyperlipidemia
  Indicated as an adjunct to diet to reduce LDL-C in adults with primary hyperlidpidemia.

• For diagnosis of Secondary Prevention of Cardiovascular Disease
  Indicated in patients with clinically evident Coronary Heart Disease (CHD) to reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis.

Zocor (simvastatin) film coated

• For diagnosis of Diagnosis
  A) Indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and noncoronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. B) As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia, In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). C) Indicated as an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). D) Indicated as an adjunct to diet for the treatment of adults with Primary dysbetalipoproteinemia, Hypertriglyceridemia.

Criteria

Altoprev*, Ezallor*, Flolipid*, Brand Lescol XL*, Livalo*, Brand Lipitor*, Brand Zocor*

*Step Therapy may not apply depending on the plan.

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to one of the following generics:
• atorvastatin
• fluvastatin
• fluvastatin ER
• lovastatin
• pravastatin
• rosuvastatin
• simvastatin

Zypitamag*

*Step Therapy may not apply depending on the plan.

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply) or intolerance to one of the following generics:
• atorvastatin
• fluvastatin
• fluvastatin ER
• lovastatin
• pravastatin
• rosuvastatin
• simvastatin
AND
• Trial and failure (of a minimum 30-day supply), or intolerance to Livalo

P & T Revisions

2024-02-14, 2023-02-07, 2022-06-02, 2021-06-07, 2020-05-26, 2020-04-30, 2020-02-27, 2019-10-29, 2019-07-31

References

1. Altoprev Prescribing Information. Covis Pharma. Zug, Switzerland. September 2020.
2. Lipitor Prescribing Information. Pfizer Inc. New York, NY. December 2022.
3. Livalo Prescribing Information. Kowa Pharmaceuticals America, Inc. Montgomery, AL. November 2022.
4. Zypitamag Prescribing Information. Zydus Pharmaceuticals, Inc. Pennington, NJ. September 2020.
5. Flolipid Prescribing Information. Salerno Pharmaceuticals LP. Brooksville, FL. September 2020.
6. Ezallor Prescribing Information. Sun Pharmaceutical Industries, Ltd. August 2023.
7. Lescol XL Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. November 2023.

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Revision History

• 2024-02-14: Removed obsolete drugs, Brand Pravachol and Brand ezetimibe/atorvastatin as targets
• 2023-02-07: Addition of brand ezetimibe-atorvastatin
• 2022-06-02: Annual Review - dx verification added to ST criteria and background updates.
• 2021-06-07: Annual Review
• 2020-05-26: 2020 Annual Review, no changes to criteria.
• 2020-04-30: gpi replication update
• 2020-02-27: Added brand simvastatin suspension as target
• 2019-10-29: Updated to add brand targets
• 2019-07-31: ezallor added as target to guideline

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