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ph-1072

Statin Step Therapy Program Summary

Policy Number: PH-1072

This program applies to Blue Partner, Commercial, GenPlus, SourceRx and Health Insurance Marketplace formularies.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
7/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

Agent(s)	FDA Indication(s)	Notes	Ref#
Altoprev^® (lovastatin ER) Tablet	Adjunctive therapy to diet to: Reduce the risk of MI, revascularization procedures, and angina in patients without 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 LDL-C. Reduce elevated Total-C, LDL-C, Apo B, and TG levels and increase 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.	Single Ingredient Products	1
Atorvaliq® (atorvastatin) Suspension	To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (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 low-density lipoprotein (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. As an adjunct to diet for the treatment of adults with: Primary dysbetaliproteinemia. Hypertriglyceridemia.	Single Ingredient Products	16
Crestor^®ª (rosuvastatin) Tablet	Adjunctive therapy to diet for: reduce elevated total-C , LDL-C, ApoB, non HDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or missed dyslipidemia reduce total-C, LDL-C and ApoB in children and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy, the following findings are present: LDL-C greater than 190 mg/dL, or greater than 160 mg/dL along with a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors reduce LDL-C, total-C, non HDL-C and ApoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis) adult patients with hypertriglyceridemia adult patients with primary dysbeta-lipoproteinemia (Type III hyperlipoproteinemia) slowing the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total-C and LDL-C to target levels Adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in patients without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age greater to or equal to 50 years old in men and greater than or equal to 60 years old in women, hsCRP greater or equal to 2 mg/L and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease Limitations of use: Has not been studied in Fredrickson Type I and V dyslipidemias.	Single Ingredient Products a - Generic equivalent available	2
Ezallor™ Sprinkle (rosuvastatin) Capsule	Adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia adult patients with primary dysbetalipoproteinemia (Type III hypercholesterolemia) Adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. Limitations of use: Not studied in Fredrickson Type I and V dyslipidemias	Single Ingredient Products	3
EZETIMIBE/ATORVASTATIN	Adjunctive therapy to diet to: Reduce elevated TC, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid lowering treatments Limitations of use: No incremental benefit of ezetimibe/atorvastatin on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established. Ezetimibe/atorvastatin has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias	Combination products	15
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 homozygous familial hypercholesterolemia. Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. Limitations of use: Simvastatin has not been studied in Fredrickson Types I and V dyslipidemias.	Single Ingredient Products	4
Lescol XL^®ª (fluvastatin) Extended release tablet	Adjunctive therapy to diet to: Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia Reduce elevated TC, LDL-C, and Apo B levels in boys and postmenarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD Slow the progression of atherosclerosis in patients with clinically evident CHD Limitations of use: Not studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V)	Single Ingredient Products a - Generic equivalent available	5
Lipitor^® (atorvastatin) Tablet	Adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors Reduce the risk of MI and stroke in patients with type 2 diabetes without CHD, but with multiple risk factors Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with CHD Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia Reduce elevated TG in patients with hypertriglyceridemia and primary dysbetalipoproteinemia Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) Reduce elevated total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy Limitations of use: has not been studied in Fredrickson Types I and V dyslipidemias.	Single Ingredient Products a – Generic equivalent available	6
Livalo^® (pitavastatin) Tablet	Adjunctive therapy to diet in: Adult patients with primary hyperlipidemia or mixed dyslipidemia 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) Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and ApoB. Limitations of use: The effect of Livalo on cardiovascular morbidity and mortality has not been determined.	Single Ingredient Products	7
Pravachol^®ª (pravastatin) Tablet	Adjunctive therapy to diet to: Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD. Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. Reduce elevated serum TG levels in patients with hypertriglyceridemia. Treat patients with primary dysbetalipoproteinemia who are not responding to diet. Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy Limitations of use: Has not been studied in Fredrickson Types I and V dyslipidemias.	Single Ingredient Products a – Generic equivalent available	8
Roszet™ (ezetimibe-rosuvastatin) Tablet	Adjunctive therapy to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C) Alone or as an adjunct to other LDL-C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C	Combination Products	12
Vytorin^®ª (ezetimibe-simvastatin) Tablet	Adjunctive therapy to diet to: Reduce elevated TC, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid lowering treatments Limitations of use: No incremental benefit of ezetimibe/simvastatin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. Ezetimibe/simvastatin has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias	Combination Products a – Generic equivalent available	10
Zocor^®ª (simvastatin) Tablet	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 homozygous familial hypercholesterolemia. Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. Limitations of use: Has not been studied in Fredrickson Types I and V dyslipidemias.	Single Ingredient Products a - Generic equivalent available	9
Zypitamag™ (pitavastatin magnesium) Tablet	Patients with primary hyperlipidemia or mixed dyslipidemia 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) Limitations of use: The effect of Zypitamag on cardiovascular morbidity and mortality has not been determined.	Single Ingredient Products a - Generic equivalent available	11

Agent(s)

FDA Indication(s)

Notes

Ref#

Altoprev^®
(lovastatin ER)

Tablet

Adjunctive therapy to diet to:

Reduce the risk of MI, revascularization procedures, and angina in patients without 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 LDL-C.
Reduce elevated Total-C, LDL-C, Apo B, and TG levels and increase 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.

Single Ingredient Products

Atorvaliq®
(atorvastatin)

Suspension

To reduce the risk of:
- Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (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 low-density lipoprotein (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.
As an adjunct to diet for the treatment of adults with:
- Primary dysbetaliproteinemia.
- Hypertriglyceridemia.

Single Ingredient Products

Crestor^®ª

(rosuvastatin)

Tablet

Adjunctive therapy to diet for:

reduce elevated total-C , LDL-C, ApoB, non HDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or missed dyslipidemia

reduce total-C, LDL-C and ApoB in children and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy, the following findings are present: LDL-C greater than 190 mg/dL, or greater than 160 mg/dL along with a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors
reduce LDL-C, total-C, non HDL-C and ApoB in children and adolescents 7 to 17 years of age with homozygous familial hypercholesterolemia, either alone or with other lipid-lowering treatments (e.g., LDL apheresis)
adult patients with hypertriglyceridemia
adult patients with primary dysbeta-lipoproteinemia (Type III hyperlipoproteinemia)
slowing the progression of atherosclerosis in adult patients as part of a treatment strategy to lower total-C and LDL-C to target levels

Adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia

To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in patients without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age greater to or equal to 50 years old in men and greater than or equal to 60 years old in women, hsCRP greater or equal to 2 mg/L and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease

Limitations of use: Has not been studied in Fredrickson Type I and V dyslipidemias.

Single Ingredient Products

a - Generic equivalent available

Ezallor™ Sprinkle

(rosuvastatin)

Capsule

Adjunctive therapy to diet for the treatment of

adult patients with hypertriglyceridemia
adult patients with primary dysbetalipoproteinemia (Type III hypercholesterolemia)

Adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

Limitations of use: Not studied in Fredrickson Type I and V dyslipidemias

Single Ingredient Products

EZETIMIBE/ATORVASTATIN

Adjunctive therapy to diet to:

Reduce elevated TC, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid lowering treatments

Limitations of use:

No incremental benefit of ezetimibe/atorvastatin on cardiovascular morbidity and mortality over and above that demonstrated for atorvastatin has been established.

Ezetimibe/atorvastatin has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias

Combination products

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 homozygous familial hypercholesterolemia.
Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

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

Single Ingredient Products

Lescol XL^®ª

(fluvastatin)

Extended release tablet

Adjunctive therapy to diet to:

Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia
Reduce elevated TC, LDL-C, and Apo B levels in boys and postmenarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy
Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD
Slow the progression of atherosclerosis in patients with clinically evident CHD

Limitations of use: Not studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V)

Single Ingredient Products

a - Generic equivalent available

Lipitor^®

(atorvastatin)

Tablet

Adjunct therapy to diet to:

Reduce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors
Reduce the risk of MI and stroke in patients with type 2 diabetes without CHD, but with multiple risk factors
Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with CHD
Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia
Reduce elevated TG in patients with hypertriglyceridemia and primary dysbetalipoproteinemia
Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH)
Reduce elevated total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy

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

Single Ingredient Products

a – Generic equivalent available

Livalo^®

(pitavastatin)

Tablet

Adjunctive therapy to diet in:

Adult patients with primary hyperlipidemia or mixed dyslipidemia 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)
Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and ApoB.

Limitations of use: The effect of Livalo on cardiovascular morbidity and mortality has not been determined.

Single Ingredient Products

Pravachol^®ª

(pravastatin)

Tablet

Adjunctive therapy to diet to:

Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD.
Reduce the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis in patients with clinically evident CHD.
Reduce elevated Total-C, LDL-C, ApoB, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia.
Reduce elevated serum TG levels in patients with hypertriglyceridemia.
Treat patients with primary dysbetalipoproteinemia who are not responding to diet.
Treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy

Limitations of use: Has not been studied in Fredrickson Types I and V dyslipidemias.

Single Ingredient Products

a – Generic equivalent available

Roszet™

(ezetimibe-rosuvastatin)

Tablet

Adjunctive therapy to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C)

Alone or as an adjunct to other LDL-C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C

Combination Products

Vytorin^®ª

(ezetimibe-simvastatin)

Tablet

Adjunctive therapy to diet to:

Reduce elevated TC, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.
Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid lowering treatments

Limitations of use:

No incremental benefit of ezetimibe/simvastatin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.

Ezetimibe/simvastatin has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias

Combination Products

a – Generic equivalent available

Zocor^®ª

(simvastatin)

Tablet

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 homozygous familial hypercholesterolemia.
Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

Limitations of use: Has not been studied in Fredrickson Types I and V dyslipidemias.

Single Ingredient Products

a - Generic equivalent available

Zypitamag™

(pitavastatin magnesium)

Tablet

Patients with primary hyperlipidemia or mixed dyslipidemia 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)

Limitations of use: The effect of Zypitamag on cardiovascular morbidity and mortality has not been determined.

Single Ingredient Products

a - Generic equivalent available

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Among lipid-lowering drugs, statins are the cornerstone of LDL-C lowering therapy, in addition to healthy lifestyle interventions. Statins are recommended as first-line treatment to prevent atherosclerotic cardiovascular disease events (ASCVD) [Clinical ASCVD is defined as acute coronary syndromes, or a history of myocardial infarction (MI), or stable or unstable angina, coronary or other arterial revascularization, stroke, TIA, or peripheral arterial disease presumed to be of atherosclerotic origin]. Both high intensity and medium intensity statin therapy reduce primary and secondary ASCVD events.(14)

Safety

All statin and statin combinations are contraindicated in active liver disease, pregnancy, and lactation. Livalo and Zypitamag are also contraindicated with the concomitant use of cyclosporine. Altoprev, Flolipid, Vytorin, and Zocor are contraindicated with concomitant administration of strong CTP3A4 inhibitors. Flolipid, Vytorin, and Zocor are also contraindicated with the concomitant use of gemfibrozil, cyclosporine, or danazol, while Altoprev is contraindicated with the concomitant use of erythromycin.(1-13)

For additional clinical information see Prime Therapeutics Formulary Chapters 5.9C: HMG-CoA Reductase Inhibitors and 5.9D HMG-CoA Reductase Inhibitor Combinations, and Prime Therapeutics Formulary Monograph: Livalo (pitavastatin).

REFERENCES

Number	Reference
1	Altoprev prescribing information. Covis Pharma. September 2020.
2	Crestor Prescribing Information. AstraZeneca. September 2020.
3	Ezallor Sprinkle Prescribing Information. Sun Pharmaceutical Industries, Inc. October 2020.
4	Flolipid prescribing information. Salerno Pharmaceuticals. June 2020.
5	Lescol XL Prescribing Information. Novartis. September 2020.
6	Lipitor Prescribing Information. Pfizer. November 2021.
7	Livalo prescribing information. Kowa Pharmaceuticals America, Inc./Lilly USA LLC. May 2019.
8	Pravastatin Prescribing Information. Accord Healthcare Inc. November 2020.
9	Zocor Prescribing Information. Merck & Co. March 2022.
10	Vytorin prescribing information. Merck & Co, Inc.. June 2021.
11	Zypitamag Prescribing Information. Medicure. September 2020.
12	Roszet Prescribing Information. Althera Pharmaceuticals LLC. March 2021.
13	Fluvastatin prescribing information. Teva Pharmaceuticals USA, Inc. August 2020.
14	ACC/AHA Task Force on Clinical Practice Guidelines. “2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/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:e1082-e1143. Available at: https://www.ahajournals.org/doi/epub/10.1161/CIR.0000000000000625
15	Ezetimbe and atorvastatin tablet Prescribing Information. Althera Pharmaceuticals, LLC. September 2022.
16	Atorvaliq prescribing information. CMP Pharma, Inc. February 2023

POLICY AGENT SUMMARY STEP THERAPY

Agent Names	Strength	Targeted MSC	Available MSC	Final Age Limit	Preferred Status

PRAVASTATIN*pravastatin sodium tab	10 ; 10 MG ; 20 ; 20 MG ; 40 MG ; 80 MG	M ; N ; O ; Y	O ; Y
ALTOPREVlovastatin tab er ; LOVASTATINlovastatin tab	10 MG ; 20 MG ; 40 MG ; 60 MG	M ; N ; O ; Y	N ; O ; Y
ATORVALIQatorvastatin calcium susp ; ATORVASTATINatorvastatin calcium tab ; LIPITOR*atorvastatin calcium tab	10 MG ; 20 MG ; 20 MG/5ML ; 40 ; 40 MG ; 80 MG	M ; N ; O	N ; O ; Y
CRESTORrosuvastatin calcium tab ; EZALLORrosuvastatin calcium sprinkle cap ; ROSUVASTATIN*rosuvastatin calcium tab	10 MG ; 20 MG ; 40 MG ; 5 ; 5 MG	M ; N ; O ; Y	N ; O ; Y
FLOLIPIDsimvastatin susp ; SIMVASTATINsimvastatin tab ; ZOCOR*simvastatin tab	10 ; 10 MG ; 20 ; 20 MG ; 20 MG/5ML ; 40 ; 40 MG ; 40 MG/5ML ; 5 MG ; 80 ; 80 MG	M ; N ; O ; Y	M ; N ; O ; Y
FLUVASTATINfluvastatin sodium cap ; FLUVASTATINfluvastatin sodium tab er ; LESCOL*fluvastatin sodium tab er	20 MG ; 40 MG ; 80 MG	M ; N ; O ; Y	O ; Y
LIVALOpitavastatin calcium tab ; ZYPITAMAGpitavastatin magnesium tab	1 MG ; 2 MG ; 4 MG	M ; N ; O ; Y	N
EZETIMIBE/ROSUVASTATINezetimibe-rosuvastatin calcium tab ; ROSZETezetimibe-rosuvastatin calcium tab	10-10 MG ; 10-20 MG ; 10-40 MG ; 10-5 MG	M ; N ; O	M
EZETIMIBE/ATORVASTATINezetimibe-atorvastatin tab ; EZETIMIBE/ROSUVASTATINezetimibe-rosuvastatin calcium tab ; EZETIMIBE/SIMVASTATINezetimibe-simvastatin tab ; ROSZETezetimibe-rosuvastatin calcium tab ; VYTORIN*ezetimibe-simvastatin tab	-40 MG ; -80 MG ; 10 MG ; 10-10 MG ; 10-20 MG ; 10-40 MG ; 10-5 MG ; 10-80 MG ; 20 MG	M ; N ; O ; Y	M ; N ; O ; Y
EZETIMIBE/SIMVASTATINezetimibe-simvastatin tab ; VYTORINezetimibe-simvastatin tab	10-10 MG ; 10-20 MG ; 10-40 MG ; 10-80 MG	M ; N ; O	N ; O ; Y

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
	pravastatin sodium tab	10 ; 10 MG ; 20 ; 20 MG ; 40 MG ; 80 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Altoprev	Lovastatin Tab ; 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 MG ; 20 MG ; 20 MG/5ML ; 40 ; 40 MG ; 80 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Crestor ; Ezallor sprinkle	rosuvastatin calcium sprinkle cap ; rosuvastatin calcium tab	10 MG ; 20 MG ; 40 MG ; 5 ; 5 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx
Flolipid ; Zocor	simvastatin susp ; simvastatin tab	10 ; 10 MG ; 20 ; 20 MG ; 20 MG/5ML ; 40 ; 40 MG ; 40 MG/5ML ; 5 MG ; 80 ; 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-atorvastatin tab ; ezetimibe-rosuvastatin calcium tab ; ezetimibe-simvastatin tab	-40 MG ; -80 MG ; 10 MG ; 10-10 MG ; 10-20 MG ; 10-40 MG ; 10-5 MG ; 10-80 MG ; 20 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 CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Prerequisite Agent(s)

Any generic statin or statin combination

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

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

Agents Eligible for Continuation of Therapy

All target agents are eligible for continuation of therapy

1. Information has been provided that indicates 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
The patient's medication history includes use of a prerequisite agent within the past 90 days OR
The patient has an intolerance or hypersensitivity to a prerequisite agent OR
The patient has an FDA labeled contraindication to ALL prerequisite agents

Length of Approval: 12 months

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

Commercial _ PS _ Statin Step Therapy _ProgSum_ 7/1/2023