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)    Leqvio (inclisiran) requires prior authorization.

2)    Leqvio is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

Initial Approval Criteria A. Heterozygous Familial Hypercholesterolemia and Atherosclerotic Cardiovascular Disease (must meet all):

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

a. 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. HeFH, and member meets both of the following (i and ii):

i. Baseline LDL-C (prior to any lipid-lowering pharmacologic therapy) was ≥ 190 mg/dL;

ii. HeFH diagnosis is confirmed by one of the following (a or b):

c.    World Health Organization (WHO)/Dutch Lipid Network familial hypercholesterolemia diagnostic criteria score of > 8 as determined by requesting provider;

d.    Definite diagnosis per Simon Broome criteria

2. Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist;

a.    3. Age ≥ 18 years;

b.    4. For members on statin therapy, both of the following (a and b):

a.    Leqvio is prescribed in conjunction with a statin at the maximally tolerated dose;

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

i. A high intensity statin;

ii.             A moderate intensity statin, and member has one of the following (i or ii):

a) Intolerance to two high intensity statins;

b) A statin risk factor;

iii.           . A low intensity statin and member has one of the following (i or ii):

a) Intolerance to one high and one moderate intensity statins;

b) A statin risk factor and history of intolerance to two moderate intensity statins;

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

a. Statin therapy is contraindicated;

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

i. Member has documented statin risk factors;

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

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

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

4. Member has been adherent to ezetimibe therapy used concomitantly with a statin at the maximally tolerated dose for at least the last 4 months, unless contraindicated or member has a history of ezetimibe intolerance (e.g., associated diarrhea or upper respiratory tract infection);

5. Documentation of recent (within the last 60 days) LDL-C of one of the following (a or b):

a. ≥ 70 mg/dL for ASCVD;

b. ≥ 100 mg/dL for HeFH;

6. Failure of a preferred PCSK9 inhibitor, if applicable, at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;

*Prior authorization may be required for PCSK9 inhibitors

7. Treatment plan does not include coadministration with Juxtapid®, Repatha®, or Praluent®;

8. Dose does not exceed 284 mg initially and at 3 months, then every 6 months thereafter.

Approval duration: 9 months

Continued Therapy

A. Heterozygous Familial Hypercholesterolemia and Atherosclerotic Cardiovascular Disease (must meet all):

1. Currently receiving medication via QualChoice benefit or member has previously met all initial approval criteria;

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

3. Member is responding positively to therapy as evidenced by lab results within the last 3 months showing an LDL-C reduction since initiation of Leqvio therapy;

4. If request is for a dose increase, new dose does not exceed 284 mg every 6 months.

Approval duration: 12 months

Codes Used In This BI: