Inclisiran (Leqvio) — Coverage Criteria for Hypercholesterolemia
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This policy governs prior authorization, coverage criteria, and documentation requirements for inclisiran (Leqvio) to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, for Blue Cross Blue Shield of Tennessee members.
Coverage Criteria for Inclisiran (Leqvio)
Continuation Therapy
Covered when ALL of the following are met for continuation:
Authorization may be granted for up to 12 months; current LDL-C should be documented within 6 months of the request
All indications for inclisiran (Leqvio) other than the FDA‑approved indication to reduce LDL‑C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH), are considered experimental/investigational and not medically necessary.
Use of Leqvio for indications that are not FDA‑approved or supported by accepted compendia is considered not medically necessary and will not be approved.
Clinical Thresholds and Lab Requirements
Prior Authorization and Documentation Requirements
Prior Authorization Required
Prior authorization is required for Leqvio (inclisiran). Authorization may be granted for up to 12 months when the member meets the coverage criteria for hypercholesterolemia or HeFH. Requests that do not meet labeled or compendial indications or the coverage criteria are considered experimental / not covered.
- Authorization duration: up to 12 months when criteria met
- Non‑covered when not meeting labeled/compendial indications
Statin Therapy Requirement
For initial approval, members must have trialed at least 3 months of high‑intensity statin therapy (or a tolerated moderate‑intensity statin if high intensity not tolerated). Documentation of statin contraindication or intolerance (see Appendix B) is acceptable in lieu of statin therapy.
- At least 3 months high‑intensity statin prior to approval, or documented intolerance/contraindication
- If unable to tolerate high intensity, moderate intensity acceptable with documentation
Required Documentation
Submit the following with the initial prior authorization request: untreated (pre‑treatment) LDL‑C when applicable, current LDL‑C dated within 6 months, chart notes confirming clinical ASCVD when relevant, and documentation of statin therapy or statin intolerance/contraindication (see Appendices A and B). For continuation requests, provide a current LDL‑C dated within 6 months and evidence of achieved or maintained LDL‑C reduction.
- Initial: untreated LDL‑C (when applicable), current LDL‑C within 6 months, ASCVD chart notes (if applicable), statin therapy details or intolerance documentation
- Continuation: current LDL‑C within 6 months and evidence of LDL‑C reduction/maintenance
Prescriber Specialty Requirement
Medication must be prescribed by or in consultation with a cardiologist, endocrinologist, lipid specialist, or a prescriber specialized in treatment of hypercholesterolemia.
- Prescriber specialties: cardiology, endocrinology, lipid specialist, or similar
Denial Risk: Insufficient Criteria or Documentation
Requests that do not meet the coverage criteria (including FDA‑approved indications and the policy's LDL‑C thresholds, ASCVD history, and statin requirements) are considered experimental and not covered. Failure to provide required documentation (e.g., current LDL‑C, ASCVD confirmation, statin therapy or intolerance documentation) may result in denial.
- Non‑covered = requests failing labeled/compendial indications or policy criteria
- Insufficient documentation (missing LDL‑C, ASCVD proof, or statin info) may lead to denial
Background on Inclisiran (Leqvio)
Inclisiran (Leqvio) is indicated as an adjunct to diet and exercise to reduce low‑density lipoprotein cholesterol (LDL‑C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Clinical Definitions Used in This Policy
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