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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 05/01/2020 Title: Vascepa (icosapent ethyl)
Revision Date: 01/01/2021 Document: BI650:00
CPT Code(s):
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Vascepa (icosapent ethyl) requires prior authorization.

2)    Vascepa is used to treat severe hypertriglyceridemia and to reduce cardiovascular disease risk.


Medical Statement

Vascepa (icosapent ethyl) is considered medically necessary for members meeting the following criteria: (Initial authorization for 6 months)

Hypertriglyceridemia without ASCVD

1)    Diagnosis of severe hypertriglyceridemia;

2)    Age > 18 years;

3)    Fasting triglycerides >500 mg/dL (lab must be dated within past 90 days);

4)    Failure of a minimum 3 months trial of fibrate therapy in the last 6 months at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

5)    Failure of omega-3-acid ethyl esters (generic Lovaza) at up to maximally indicated doses.

6)    Dose does not exceed 4g (4 capsules) per day.

Approval Duration: 6 months

 

Reduction of Cardiovascular Disease Risk

1)    Diagnosis of one of the following (a or b):

a.    Atherosclerotic cardiovascular disease (ASCVD) as evidenced by a history of any one of the following conditions (i-vii);

                                          i.    Acute coronary syndromes;

                                        ii.    Clinically significant coronary heart disease (CHD) diagnosed by invasive or noninvasive testing (such as coronary angiography, stress test using treadmill, stress echocardiography, or nuclear imaging);

                                       iii.    Coronary or other arterial revascularization;

                                       iv.    Myocardial infarction;

                                        v.    Peripheral arterial disease presumed to be of atherosclerotic origin;

                                       vi.    Stable or unstable angina;

                                      vii.    Stroke or transient ischemic attack (TIA);

b.    Diabetes with >2 CVD risk factors;

2)    Age >45 years;

3)    Documentation (labs must be dated within 90 days) of fasting triglycerides between 150-499 mg/dL;

4)    Documentation of low-density lipoprotein cholesterol (LDL-C) (labs must be dated within 90 days) between 41-100mg/dL;

5)    For members on statin therapy, both of the following (a or b):

a.    Vascepa is prescribed in combination with a statin at the maximally tolerated dose;

b.    Member has been adherent for at least the last 4 months to maximally tolerated odses of the of the following statin regimens (I, ii, or iii):

                                          i.    A high intensity statin (atorvastatin 40-80mg; rosuvastatin 20-40mg);

                                        ii.    A moderate intensity statin (atorvastatin 10-20mg; fluvastatin XL 80mg; fluvastatin 40mg BID; lovastatin 40mg; pitavastatin 1-4mg; pravastatin 40-80mg; rosuvastatin 5-10mg; simvastatin 20-40mg) and one of the following (a or b):

1.    Intolerance to two high intensity statins;

2.    A statin risk factor (see table below)

                                       iii.    Alow intensity statin and member has one of the following (a or b):

1.    Intolerance to one high and one moderate intensity statin;

2.    A statin risk factor (see table below) and history of intolerance to two moderate intensity statins;

6)    For members not on statin therapy, member meets one of the following (a or b):

a.    Statin therapy is contraindicated (see table below);

b.    For members who are statin intolerant, member has tried at least two statins, 1 of which must be a hydrophilic statin (pravastatin, fluvastatin, or rosuvastatin), and members meets one of the following (i or ii):

                                          i.    Member has documented statin risk factors (see table below);

                                        ii.    Member is statin intolerant due to statin-associated muscle symptoms (SAMS) and meets both of the following (1 and 2):

1.    Documentation of intolerable SAMS persisting at least two weeks, which disappeared with discontinuing the statin therapy and recurred with a statin re-challenge;

2.    Documentation of re-challenge with titration from lowest possible dose and/or intermittent dosing frequency (e.g. 1 to 3 times weekly);

7)    Dose does not exceed 4g (4 capsules) per day.

Approval Duration: 6 months

 

Reauthorization Criteria

Hypertriglylceridemia without ASCVD:

1)    Member is responding positively to therapy as evidenced by one of the following:

a.    Initial reauthorization: 20% reduction in TG levels from baseline;

b.    Subsequent reauthorizations: continue reduction or maintenance in reduction of TG levels from baseline;

2)    If request of for a dose increase, new dose does not exceed 4g (4 capsules) per day.

Reauthorization Approval Duration: 12 months

 

Reduction of Cardiovascular Disease Risk (must meet all):

1.    Member is responding positively to therapy as evidenced by no increase in TG and LDL-C levels from baseline;

2.    If statin tolerant, documentation of adherence to a statin at the maximally tolerated dose;

3.    If request is for a dose increase, new dose does not exceed 4g (4 capsules) per day.

Reauthorization Approval Duration: 12 months

 

Statin Risk Factors:

1.    Multiple or serious comorbidities, including impaired renal or hepatic function

2.    Unexplained alanine transaminase (ALT) elevations > 3 times upper limit of normal, or active liver disease.

3.    Concomitant use of drugs adversely affecting statin metabolism

4.    Age > 75 years, or history of hemorrhagic stroke

5.    Asian ancestry

 

Statin Contraindications:

1.    Decompensated liver disease (development of jaundice, ascites, variceal bleeding, encephalopathy)

2.    Laboratory-confirmed acute liver injury or rhabdomyolysis resulting from statin treatment

3.    Pregnancy, actively trying to become pregnant, or nursing

4.    Immune-mediated hypersensitivity to the HMG-CoA reductase inhibitor drug class (statins) as evidenced by an allergic reaction occurring with at least TWO different statins


Reference

1.    Vascapa Prescribing Information. Bedminster, NJ: Amarin Pharma, Inc.; December 27, 2019.

2.    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 Foundation/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2018;Nov 10:[Epub ahead of print].

3.    Miller M, Stone NJ, Ballantyne C, et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011; 123: 2292-2333.

4.    Jellinger PS, Handelsman Y, Rosenblit PD, et al. American Association of Clinical Endocrinologists and American College of Endocrinology Guidelines for management of dyslipidemia and prevention of cardiovascular disease. Endocr Pract 2017;23(Suppl 2):1-87.

5.    Berglund L, Brunzell JD, Goldberg AC, et al. Evaluation and treatment of hypertriglyceridemia: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2012;97(9):2969-2989.

6.    Bhatt DL, Steg G, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019 Jan 1;380(1):11-22.

7.    Skulas-Ray AC, Wilson PWF, Harris WS, et al. Omega-3 fatty acids for the management of hypertriglyceridemia: a science advisory from the American Heart Association. Circulation. 2019 Sep 17;140(12):e673-e691.

8.    Manpuya WM, Cho L, Frid D, et al. Treatment strategies in patients with statin intolerance: the Cleveland Clinic experience. American Heart Journal 2013; 166(3):597-603.

9.    Zhang H, Plutzky J, Skentzos S, et al. Discontinuation of statins in routine care settings. Ann of Intern Med 2013; 158(7):526-534.

10. Backes JM, Ruisinger JF, Gibson CA, et al. Statin-associated muscle symptoms—managing the highly intolerant. J Clin Lipidol. 2017;11:24-33. Available at: https://www.acc.org/latest-in-cardiology/ten-points-to-remember/2017/05/03/10/43/statin-associated-muscle-symptoms. Accessed December 5, 2019.

11. Thompson PD, Panza G, Zaleski A, et al. Statin-associated side effects. JACC 2016;67(20):2395-2410.

12. American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S103-S123.

13. Goff DC Jr, Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S49-73.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.