ph-9991072
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Statin Step Therapy Program Summary

Policy Number: PH-9991072

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

Statin Step Therapy

TARGET AGENTS (brands only)

Altoprev® (lovastatin extended release)

Crestor® (rosuvastatin)a

Ezallor™ Sprinkle (rosuvastatin)

Flolipid™ (simvastatin oral suspension)

Lescol® (fluvastatin)a

Lescol XL® (fluvastatin extended release)a

Lipitor® (atorvastatin)a

Livalo® (pitavastatin)

Mevacor® (lovastatin)a

Pravachol® (pravastatin)a

Roszet™ (ezetimibe/rosuvastatin)

Simvastatin oral suspension 20 mg/5ml

Vytorin® (ezetimibe/simvastatin)a

Zocor® (simvastatin)a

Zypitamag (pitavastatin)

a - currently available as a generic; included as a prerequisite in step therapy program

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL

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

  1. Information has been provided that indicates the patient is currently being treated with the requested agent within the past 90 days

OR

  1. The prescriber states the patient is currently being treated with the requested agent within the past 90 days AND is at risk if therapy is changed

OR

  1. The patient’s medication history included use of a generic statin or statin combination within the past 90 days 

OR

  1. The patient has an intolerance or hypersensitivity to an available generic statin or statin combination product

OR

  1. The patient has an FDA labeled contraindication to ALL available generic statins and statin combination products

Length of approval:  12 months

 

FDA APPROVED INDICATIONS AND DOSAGE1-9,11-13,14

Single Ingredient Products

Drug

Indication

                                                   

Dosage

Altoprev®

(lovastatin extended release)

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.

20-60 mg once daily

Mevacor®*

(lovastatin)

tablet

Adjunctive therapy to diet for:

  • Primary prevention of coronary heart disease
  • 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.
  • Reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb2)
  • To reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with Heterozygous Familial Hyperlipidemia

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).

10 mg to 80 mg daily in single or two divided doses

Crestor®*

(rosuvastatin)

tablet

  • Adult patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C
  • Pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy
  • Pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, nonHDL-C and ApoB as an adjunct to diet, either alone or with other lipid-lowering treatments
  • Adult patients with hypertriglyceridemia as an adjunct to diet
  • Adult patients with primary dysbeta-lipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet
  • Adults patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB
  • Slowing the progression of atherosclerosis as part of a treatment strategy to lower total-C and LDL-C as an adjunct to diet
  • Risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors

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

5-40 mg once daily.  Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg.

Adult HoFH: starting dose 20 mg/day

Pediatric patients with HeFH: 5 to 10 mg/day for patients 8 to less than 10 years of age, and 5 to 20 mg/day for patients 10 to 17 years of age.

Pediatric patients with HoFH: 20 mg/day for patients 7 to 17 years of age.

Ezallor™ Sprinkle

(rosuvastatin)

capsule

  • Adult patients with hypertriglyceridemia as an adjunct to diet
  • Adult patients with primary dysbetalipoproteinemia (Type III hypercholesterolemia) as an adjunct to diet
  • Adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB

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

5-40 mg once daily.  Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg.

Adult HoFH: Starting dose 20 mg once daily.

Flolipid™*

(simvastatin)

oral suspension
(20 mg/mL available generically)

  • Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, 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 post-menarchal 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.

Usual starting dose is 10 or 20 mg once a day in the evening on an empty stomach.  Recommended starting dose for patients at high risk of CHD is 40 mg/day.  Due to the increased risk of myopathy, use of the 80 mg dose of Flolipid should be restricted to patients who have been taking simvastatin 80 mg chronically

Lescol®*

(fluvastatin)

capsule

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 post-menarchal 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 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)

Recommended starting dose is 40 to 80 mg (as 40 mg twice daily)

Children with HeFH, ages 10 to 16 recommended starting dose is 20 mg once daily

Lescol XL®*

(fluvastatin)

ER tablet

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.

The recommended starting dosage is 2 mg once daily, the maximum is 4 mg once daily.  Individualize the dose according to patient characteristics, goal of therapy, and response.

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 dysbeta-lipoproteinemia
  • 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.

10-80 mg once daily, recommended start dose: 10 or 20 mg once daily.  Patients requiring large LDL-C reduction (<45%) may start at 40 mg once daily.  Pediatric patients with HeFH: starting dose: 10 mg once daily; range 10 to 20 mg/day

Pravachol®*

(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 dysbeta-lipoproteinemia 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.

10 mg to 80 mg once daily.  Adults: the recommended starting dose is 40 mg once daily.  Use 80 mg dose only for patients not reaching LDL-C goal with 40 mg.  Children (ages 8 to 13): recommended starting dose is 20 mg once daily

Adolescents (ages 14 to 18 years): the recommended starting dose is 40 mg once daily.

Zocor®*

(simvastatin)

tablet

Adjunctive therapy to diet to:

  • Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, 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 dysbeta-lipoproteinemia.
  • 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.

5 mg to 80 mg once daily.  Recommended usually starting dose is 10 or 20 mg once a day in the evening.  Due to the increased risk of myopathy, use of the 80 mg dose should be restricted to patients who have been taking simvastatin 80 mg chronically.

Adolescents (10-17 years of age) with HeFH: starting dose 10 mg/day, maximum recommended dose is 40 mg/day.

Zypitamag™
(pitavastatin)

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:  Has not been studied in Fredrickson Type I, III, and V dyslipidemias

1-4 mg once daily

Starting dose 2 mg.  When lowering of LDL-C is insufficient, the dosage may be increased to a maximum of 4 mg per day.

* - Generic available

Combination Products

Drug

Indication

Dosage

Roszet™

(ezetimibe/rosuvastatin)

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

Dosage range is 5 mg/10 mg to 40 mg/10 mg once daily

Vytorin®*

(ezetimibe/ simvastatin)

tablet

Adjunctive therapy to diet to:

  • Reduce elevated total-C, 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

10 mg/10 mg to 10 mg/80 mg once daily.  Recommended usual starting dose is 10/10 or 10/20 mg/day.  Due to the increased risk of myopathy, use of the 10/80 mg dose of Vytorin should be restricted to patients who have been taken Vytorin 10/80 mg chronically without evidence of muscle toxicity.

* - Generic available

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.10   

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

  1. Lipitor Prescribing Information. Pfizer. November 2019.
  2. Lescol XL Prescribing Information. Novartis. August 2017.
  3. Pravachol Prescribing Information. BMS. July 2016.
  4. Zocor Prescribing Information. Merck & Co. October 2019.
  5. Crestor Prescribing Information. AstraZeneca. November 2018.
  6. Lovastatin Prescribing Information. Actavis Pharma, Inc.  March 2017.
  7. Altoprev prescribing information. Andrx Labs, Inc. February 2018.
  8. Vytorin prescribing information. Merck & Co, Inc.. October 2019.
  9. Livalo prescribing information. Kowa Pharmaceuticals America, Inc./Lilly USA LLC. May 2019.
  10. 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.  Accessed April 9, 2020. https://www.ahajournals.org/doi/full/10.1161/01.cir.0000437738.63853.7a, 2019
  11. Flolipid prescribing information. Rosemont Pharmaceuticals. October 2017.
  12. Zypitamag Prescribing Information.  Zydus.  August 2018.
  13. Ezallor Sprinkle Prescribing Information.  Sun Pharmaceutical Industries, Inc.  April 2019.
  14. Roszet Prescribing Information. Alethera Pharmaceuticals LLC. March 2021

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 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.

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