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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® Tablet |
Adjunctive therapy to diet to:
Limitations of use: has not been studied in Fredrickson Types I, III, and V dyslipidemias. |
Single Ingredient Products |
1 |
Atorvaliq® |
|
Single Ingredient Products |
16 |
Crestor®ª (rosuvastatin) Tablet |
Adjunctive therapy to diet for:
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
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:
Limitations of use:
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:
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:
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:
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:
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:
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:
Limitations of use:
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:
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 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
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 |
|
|
ALTOPREV*lovastatin tab er ; LOVASTATIN*lovastatin tab |
10 MG ; 20 MG ; 40 MG ; 60 MG |
M ; N ; O ; Y |
N ; O ; Y |
|
|
ATORVALIQ*atorvastatin calcium susp ; ATORVASTATIN*atorvastatin calcium tab ; LIPITOR*atorvastatin calcium tab |
10 MG ; 20 MG ; 20 MG/5ML ; 40 ; 40 MG ; 80 MG |
M ; N ; O |
N ; O ; Y |
|
|
CRESTOR*rosuvastatin calcium tab ; EZALLOR*rosuvastatin calcium sprinkle cap ; ROSUVASTATIN*rosuvastatin calcium tab |
10 MG ; 20 MG ; 40 MG ; 5 ; 5 MG |
M ; N ; O ; Y |
N ; O ; Y |
|
|
FLOLIPID*simvastatin susp ; SIMVASTATIN*simvastatin 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 |
|
|
FLUVASTATIN*fluvastatin sodium cap ; FLUVASTATIN*fluvastatin sodium tab er ; LESCOL*fluvastatin sodium tab er |
20 MG ; 40 MG ; 80 MG |
M ; N ; O ; Y |
O ; Y |
|
|
LIVALO*pitavastatin calcium tab ; ZYPITAMAG*pitavastatin magnesium tab |
1 MG ; 2 MG ; 4 MG |
M ; N ; O ; Y |
N |
|
|
EZETIMIBE/ROSUVASTATIN*ezetimibe-rosuvastatin calcium tab ; ROSZET*ezetimibe-rosuvastatin calcium tab |
10-10 MG ; 10-20 MG ; 10-40 MG ; 10-5 MG |
M ; N ; O |
M |
|
|
EZETIMIBE/ATORVASTATIN*ezetimibe-atorvastatin tab ; EZETIMIBE/ROSUVASTATIN*ezetimibe-rosuvastatin calcium tab ; EZETIMIBE/SIMVASTATIN*ezetimibe-simvastatin tab ; ROSZET*ezetimibe-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/SIMVASTATIN*ezetimibe-simvastatin tab ; VYTORIN*ezetimibe-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 |
||||
|
Target Agent(s) will be approved when ANY ONE of the following is met:
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