Inclisiran (Leqvio®)
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Covers medical necessity and prior-authorization criteria for inclisiran (Leqvio®) as adjunct to diet and exercise to reduce LDL-C for specified FDA‑approved indications; applies to Blue Cross Blue Shield - Tennessee members and prescribing providers.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: COVERAGE CRITERIA
Covered when ALL of the following are met for adult members (authorization up to 12 months).
General hypercholesterolemia
- LDL and risk: (current LDL-C ≥55 mg/dL AND multiple ASCVD events or high-risk conditions) OR (current LDL-C ≥70 mg/dL)
- Statin requirement: statin contraindication/intolerance OR ≥3 months high-intensity statin (or moderate if high-intensity not tolerated)
inv-02: Primary severe hypercholesterolemia
Covered when ALL of the following are met:
inv-03: COVERAGE CRITERIA
Authorization of 12 months may be granted when either of the following is met:
inv-04: COVERAGE CRITERIA
Authorization of 12 months may be granted for members ≥12 years when ALL of the following are met:
inv-06: Continuation of Therapy
Authorization of 12 months may be granted when ALL of the following are met:
HoFH authorization criteria
- Diagnostic confirmation: One of: variant in two LDLR alleles; homozygous or compound heterozygous variants in APOB or PCSK9; compound homozygosity in LDLRAP1; untreated LDL-C > 400 mg/dL and either untreated LDL-C >=190 mg/dL in both parents OR cutaneous/tendinous xanthomas before age 10.clinical/genetic
- LDL-C treatment thresholds: Either current LDL-C >=70 mg/dL OR current LDL-C >=55 mg/dL plus either major ASCVD risk factors or history of clinical ASCVD (see Appendix A).LDL-C mg/dL
- Prior lipid-lowering therapy: At least 3 months of high-intensity statin plus ezetimibe (or moderate-intensity statin if unable to tolerate high-intensity), OR contraindication/intolerance to statin per Appendix B.3 months
All indications for inclisiran (Leqvio®) that are not among the FDA‑approved uses listed in the policy are considered experimental/investigational and not medically necessary. The FDA‑approved indications include use as an adjunct to diet and exercise to reduce LDL‑C in: adults with hypercholesterolemia; adult and pediatric patients ≥12 years with heterozygous familial hypercholesterolemia (HeFH); and pediatric patients ≥12 years with homozygous familial hypercholesterolemia (HoFH).
Pregnancy, planned pregnancy, and breastfeeding are listed contraindications in the policy context of statin intolerance/contraindication pathways and should be treated as exclusionary for pathways that rely on a documented statin contraindication or intolerance. Specifically, the policy identifies pregnancy, planned pregnancy, and breastfeeding among conditions that constitute statin contraindications/intolerance.
Use of inclisiran for indications that are not FDA‑approved is stated as not medically necessary. Providers should seek prior authorization only for the covered FDA‑labeled indications (adults with hypercholesterolemia; HeFH in patients ≥12 years; HoFH in patients ≥12 years); all other uses will be considered experimental/investigational and denied as not medically necessary.
Initial Therapy Criteria
inv-24: Initial Therapy Criteria
Initial authorization criteria (12 months).
inv-25: Initial Therapy (HoFH)
Initial authorization may be granted when diagnostic, LDL-C, and prior therapy/intolerance criteria are met.
Continuation Criteria
inv-26: Continuation Requirements
Continuation requests
inv-27: Continuation
Continuation authorization criteria
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | |
| Trial of at least three months of high-intensity statin therapy (or moderate-intensity if high-intensity not tolerated) unless the member has a documented contraindication or intolerance to statin therapy. |
| Step | Requirement |
|---|---|
| 1 | |
| Trial of at least 3 months of high-intensity statin in combination with ezetimibe prior to authorization for HoFH (if unable to tolerate high-intensity statin, a moderate-intensity statin dose may be used), unless the member has a documented contraindication or intolerance to statin therapy. |
Laboratory & Coding Requirements
Provider Actions & Documentation
Prior authorization may be granted for 12 months
Prior authorization may be granted for up to 12 months when the coverage criteria for hypercholesterolemia, heterozygous familial hypercholesterolemia (HeFH), or homozygous familial hypercholesterolemia (HoFH) are met. Submit a prior authorization request to initiate review when the member satisfies the applicable age, LDL-C thresholds, and prior-therapy or intolerance criteria described in the coverage criteria sections.
HoFH prior authorization requires documented diagnosis and thresholds
For HoFH, prior authorization of up to 12 months may be granted for members aged 12 years or older only when all HoFH-specific diagnostic, LDL-C, and prior‑therapy/intolerance criteria are documented. The request must demonstrate a documented HoFH diagnosis (genetic or clinical criteria), meet current LDL‑C thresholds, and meet the required prior lipid‑lowering therapy or statin intolerance criteria.
Statin contraindication/intolerance or ≥3 months trial required
Members must have either a documented contraindication or intolerance to statins OR a trial of at least three months of high‑intensity statin therapy; if high‑intensity is not tolerated, a moderate‑intensity statin may be used. For HoFH, the required trial is at least three months of high‑intensity statin in combination with ezetimibe unless statin intolerance/contraindication is documented.
Step therapy: high‑intensity statin + ezetimibe for 3 months
Prior to approval, the member should have received at least 3 months of high‑intensity statin plus ezetimibe; if the member is unable to tolerate high‑intensity statin, a moderate‑intensity statin dose may be used. A documented contraindication or intolerance to statin therapy is an acceptable alternative pathway.
Initial requests: required clinical and lab documentation
Initial prior authorization requests must include chart notes confirming clinical ASCVD when applicable, genetic testing or medical record documentation confirming HoFH (if applicable), the untreated (pre‑therapy) LDL‑C when requested by the criteria, and a current LDL‑C value dated within six months preceding the authorization request.
HoFH documentation: genetic/clinical confirmation, LDL‑C, prior therapy
For HoFH requests specifically, documentation must include evidence of HoFH diagnosis (one of the genetic criteria or the clinical criteria such as untreated LDL‑C >400 mg/dL with parental LDL‑C ≥190 mg/dL or early xanthomas), a current LDL‑C value (within 6 months), and prior lipid‑lowering therapy history including ≥3 months of high‑intensity statin plus ezetimibe or documentation of statin contraindication/intolerance.
Non‑approved indications are not medically necessary
Use of inclisiran for indications other than the FDA‑approved indications and compendial uses listed in the policy is considered experimental/investigational and will be considered not medically necessary; such requests are subject to denial.
Failure to document HoFH criteria may lead to denial
Authorization for HoFH requires documentation that the member meets the diagnostic confirmation, current LDL‑C threshold (≥70 mg/dL or ≥55 mg/dL with additional risk factors/history), and prior‑therapy or documented statin intolerance criteria; failure to provide this documentation may result in denial of the request.
Site of Care & Prescribing
Prescriber specialty requirement
This medication must be prescribed by or in consultation with a cardiologist, endocrinologist, lipid specialist, or a prescriber specialized in the treatment of hypercholesterolemia.
Definitions
Background
Inclisiran (Leqvio®) is indicated as an adjunct to diet and exercise to reduce LDL‑C in adults with hypercholesterolemia, in adult and pediatric patients aged ≥12 years with heterozygous familial hypercholesterolemia (HeFH), and in pediatric patients aged ≥12 years with homozygous familial hypercholesterolemia (HoFH). The policy bases coverage criteria and prior authorization requirements on these FDA‑approved indications; uses outside these indications are considered experimental/investigational and not medically necessary.
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