BlueCross BlueShield of Tennessee Medical Policy Manual

Inclisiran (Leqvio®)

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

1. INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications

Leqvio is indicated as an adjunct to diet and statin therapy for the treatment of adults with primary

hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density

lipoprotein cholesterol (LDL-C).

All other indications are considered experimental/investigational and not medically necessary.

2. DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:

1. Initial requests:
   1. With clinical atherosclerotic cardiovascular disease (ASCVD): Chart notes confirming clinical ASCVD (see appendix A).
   2. Without ASCVD: Untreated (before any lipid lowering therapy) LDL-C level.
2. Both initial and continuation requests:
   1. LDL-C level must be dated within six months preceding the authorization request.
   2. If member has contraindication or intolerance to statins, chart notes or medical record documentation confirming the contraindication or intolerance (See Appendix B).

3. CRITERIA FOR INITIAL APPROVAL

Primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH)

Authorization of 12 months may be granted for treatment of primary hyperlipidemia when either of the following criteria is met:

1. Member meets all of the following criteria:
   1. Member has a history of clinical atherosclerotic cardiovascular disease (ASCVD) (See Appendix A).

2. Member meets either of the following criteria:
   1. 1. 1. 1. 1. Current LDL-C level ≥ 70 mg/dL after at least three months of treatment with a high-intensity statin. If the member is unable to tolerate a high-intensity statin dose, a moderate-intensity statin dose may be used.
               2. Current LDL-C level ≥ 70 mg/dL with a contraindication or intolerance to statins (see Appendix B).
3. Member will continue to receive concomitant statin therapy if no contraindication or intolerance (see Appendix B).

2. Member meets all of the following criteria:
   1. Member had an untreated (before any lipid-lowering therapy) LDL-C level ≥ 190 mg/dL in the absence of a secondary cause.
   2. Member meets one of the following:
      1. 1. 1. Current LDL-C level ≥ 100 mg/dL after at least three months of treatment with a high-intensity statin. If the member is unable to tolerate a high-intensity statin dose, a moderate-intensity statin dose may be used.
            2. Current LDL-C level ≥ 100 mg/dL with a contraindication or intolerance to statins (see Appendix B).

1. 3. Member will continue to receive concomitant statin therapy if no contraindication or intolerance (see Appendix B).

4. CONTINUATION OF THERAPY  

Authorization of 12 months may be granted for continued treatment in members (including new members) who meet both of the following criteria:

1. Member has achieved or maintained an LDL-C reduction (e.g., LDL-C is now at goal, robust lowering of LDL-C).
2. Member will continue to receive concomitant statin therapy if no contraindication or intolerance

(See Appendix B).

5. APPENDICES

APPENDIX A. Clinical ASCVD

• Acute coronary syndromes
• Myocardial infarction
• Stable or unstable angina
• Coronary or other arterial revascularization procedure (e.g., percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG] surgery)
• Stroke of presumed atherosclerotic origin
• Transient ischemic attack (TIA)
• Non-cardiac peripheral arterial disease (PAD) of presumed atherosclerotic origin (e.g., carotid artery stenosis, lower extremity PAD)
• Obstructive coronary artery disease (defined as fifty percent or greater stenosis on cardiac computed tomography angiogram or catheterization)
• Coronary Artery Calcium (CAC) Score ≥  300

APPENDIX B.  Contraindications to statin therapy

• Score of 7 or higher on the Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) and failed statin rechallenge
• Presence of statin-associated muscle symptoms with elevation in creatine kinase (CK) level ≥ 3 times upper limit of normal (ULN)

• Statin-associated elevation of creatine kinase (Ck)level  ≥ 10 times ULN

• Active liver disease, including unexplained persistent elevations in hepatic transaminase levels (e.g., alanine transaminase [ALT] level ≥ 3 times ULN)

• Pregnancy or planned pregnancy
• Breastfeeding    

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION  

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1. Leqvio [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2023.
2. Ray KK, Wright RS, Kallend D, et al. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020;382(16):1507-1519.
3. Raal FJ, Kallend D, Ray KK, et al. Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020;382(16):1520-1530.
4. McGowan MP, Hosseini Dehkordi SH, Moriarty PM, et al. Diagnosis and treatment of heterozygous familial hypercholesterolemia. J Am Heart Assoc. 2019; 8(24):e013225.
5. Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 1 - full report. J Clin Lipidol. 2015;9(2):129–169. doi:10.1016/j.jacl.2015.02.003
6. 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/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139 (25):e1082-e1143.
7. Min JK, Labounty TM, Gomez MJ, et al. Incremental prognostic value of coronary computed tomographic angiography over coronary artery calcium score for risk prediction of major adverse cardiac events in asymptomatic diabetic individuals. Atherosclerosis. 2014;232(2):298-304.
8. Rosenson, RS. Miller, K, Bayliss M, et al. The statin-associated muscle symptom clinical index (SAMS-CI): revision for clinical use, content validation and inter-rater reliability. Cardiovasc Drugs Ther. 2017;31(2):179-186.
9. Warden BA, Guyton JR, Kovacs AC, et al.  Assessment and management of statin-associated muscle symptoms (SAMS): A clinical perspective from the National Lipid Association. J Clin Lipidol. 2023;17(1):19-39.

10. Lloyd-Jones DM, Morris PB, Ballantyne CM. et al. 2022 ACC Expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: A report of the American college of cardiologic solution set oversight committee. J Am Coll Cardiol. 2022, 80(14):1366–1418.
11. Budoff MJ, Kinninger A, Gransar H, et al. When does a calcium score equate to secondary prevention?: Insights from the multinational CONFIRM registry. JACC Cardiovasc Imaging. 2023;16(9):1181-1189.

ORIGINAL EFFECTIVE DATE: 4/2/2022

MOST RECENT REVIEW DATE: 10/31/2024

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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