CurrentBlue Cross Blue Shield - TennesseePolicy N/A

Inclisiran (Leqvio®)

Customize your policy alerts

Sign up for all blue cross blue shield - tennessee policy alerts

Know when blue cross blue shield - tennessee releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

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.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyInclisiran (Leqvio®) - coverage criteria for LDL-C lowering therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2026

Last ReviewSep 1, 2026

Next Review DateSep 1, 2026

Key ActionSubmit prior authorization with current LDL-C within 6 months, documentation of statin trial or intolerance, and evidence of diagnosis (including genetic or clinical criteria for HoFH) to request up to 12 months of coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

≥12min age (HoFH)

≥55 mg/dLLDL-C threshold (high risk)

≥70 mg/dLLDL-C threshold (ASCVD)

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentBlue Cross Blue Shield - TennesseePolicy N/A

Inclisiran (Leqvio®)

Customize your policy alerts

Sign up for all blue cross blue shield - tennessee policy alerts

Know when blue cross blue shield - tennessee releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyInclisiran (Leqvio®) - coverage criteria for LDL-C lowering therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2026

Last ReviewSep 1, 2026

Next Review DateSep 1, 2026

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

≥12min age (HoFH)

≥55 mg/dLLDL-C threshold (high risk)

≥70 mg/dLLDL-C threshold (ASCVD)

≥190 mg/dLuntreated LDL-C (severe)

>400 mg/dLuntreated LDL-C (HoFH)

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)

Primary severe hypercholesterolemia: Untreated (before any lipid-lowering therapy) LDL-C ≥190 mg/dL in the absence of a secondary cause AND current LDL-C ≥100 mg/dL AND (statin contraindication/intolerance OR ≥3 months high-intensity statin (or moderate-intensity if high-intensity not tolerated))

inv-02: Primary severe hypercholesterolemia

Covered when ALL of the following are met:

Severe hypercholesterolemia: Untreated (before any lipid-lowering therapy) LDL-C ≥190 mg/dL in the absence of a secondary cause AND current LDL-C ≥100 mg/dL AND statin contraindication/intolerance OR ≥3 months high-intensity statin (or moderate if not tolerated)

inv-03: COVERAGE CRITERIA

Authorization of 12 months may be granted when either of the following is met:

Adult HeFH with ASCVD: Member is ≥18 years AND has history of clinical ASCVD (see Appendix A) AND (current LDL-C ≥55 mg/dL with multiple ASCVD events/high-risk conditions OR current LDL-C ≥70 mg/dL) AND (statin contraindication/intolerance OR ≥3 months high-intensity statin (or moderate-intensity if high-intensity not tolerated))

HeFH without ASCVD (age-specific untreated LDL-C): Either: member age 12 to <18 with untreated LDL-C ≥160 mg/dL OR member ≥18 with untreated LDL-C ≥190 mg/dL, AND current LDL-C ≥100 mg/dL, AND (statin contraindication/intolerance OR ≥3 months high-intensity statin (or moderate-intensity if not tolerated))

inv-04: COVERAGE CRITERIA

Authorization of 12 months may be granted for members ≥12 years when ALL of the following are met:

HoFH diagnostic criteria: Member has a documented diagnosis of homozygous familial hypercholesterolemia confirmed by genetic criteria or clinical criteria (see HoFH diagnostic details)

Current LDL-C requirement: Current LDL-C ≥70 mg/dL OR (current LDL-C ≥55 mg/dL AND major ASCVD risk factors OR history of clinical ASCVD event)

Therapy requirement: ≥3 months high-intensity statin in combination with ezetimibe OR statin contraindication/intolerance

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.

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).

Indication-specific: See coverage criteria sets for hypercholesterolemia, HeFH, and HoFH which specify age, LDL-C thresholds, and statin trial or intolerance requirements

inv-25: Initial Therapy (HoFH)

Initial authorization may be granted when diagnostic, LDL-C, and prior therapy/intolerance criteria are met.

Initial inclisiran for HoFH: See Coverage.criteria_sets Initial Therapy (HoFH) entry for full logic.

Continuation Criteria

inv-26: Continuation Requirements

Continuation requests

Continuation documentation: Current LDL-C level must be dated within six months preceding the authorization request

inv-27: Continuation

Continuation authorization criteria

Continued use: Member has achieved or maintained LDL-C reduction (e.g., LDL-C at goal or robust lowering) to justify continued authorization for up to 12 months.

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

inv-10: Current LDL-C — Must be dated within 6 months prior to authorization request.

Current LDL-C requirementCurrent LDL-C must be dated within 6 months preceding the authorization request (applies to initial and continuation requests)

Initial request documentationFor initial requests, submit current LDL-C within 6 months along with other required documentation (e.g., untreated LDL-C if no ASCVD, genetic testing for HoFH)

Continuation requestsContinuation requests require a current LDL-C level dated within six months preceding the authorization request

inv-11: LDL-C thresholds — 55 mg/dL, 70 mg/dL, 100 mg/dL, 190 mg/dL, >400 mg/dL as specified per indication.

LDL-C thresholds (clinical ASCVD high-risk)Current LDL-C ≥ 55 mg/dL when multiple ASCVD events or high-risk conditions are present

LDL-C threshold (clinical ASCVD)

Provider Actions & Documentation

Prior Authorization

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.

Prior Authorization

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.

Site of Care & Prescribing

Note

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

inv-22: HoFH diagnosis confirmation — Homozygous familial hypercholesterolemia may be confirmed by variants in two LDLR alleles, homozygous/compound heterozygous APOB or PCSK9...

Genetic confirmation optionsVariant in two LDLR alleles

Alternate genetic findingsHomozygous or compound heterozygous variants in APOB or PCSK9

Other genetic/clinical confirmationsCompound homozygosity or homozygosity for variants in LDLRAP1

Clinical criteriaUntreated LDL-C > 400 mg/dL plus either untreated LDL-C ≥ 190 mg/dL in both parents OR cutaneous/tendinous xanthomas before age 10

inv-23: Clinical ASCVD — Conditions listed as clinical ASCVD include myocardial infarction, acute coronary syndromes, angina, stroke of presumed atherosclerotic o...

Myocardial infarction

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.

Policy Summary

PayerBlue Cross Blue Shield - Tennessee

PolicyInclisiran (Leqvio®) - coverage criteria for LDL-C lowering therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2026

Last ReviewSep 1, 2026

Next Review DateSep 1, 2026

SourceLink

On This Page

title": "inv-05: Initial Therapy (HoFH)"

Current LDL-C ≥ 70 mg/dL

Severe hypercholesterolemia (current)Current LDL-C ≥ 100 mg/dL for individuals with untreated LDL-C ≥ 190 mg/dL

Untreated LDL-C diagnostic thresholdsUntreated (pre-therapy) LDL-C ≥ 190 mg/dL (primary severe hypercholesterolemia)

HoFH diagnostic untreated LDL-CUntreated LDL-C > 400 mg/dL (used as a HoFH clinical diagnostic criterion)

inv-12: LDL-C and CAC thresholds — Untreated LDL-C > 400 mg/dL; current LDL-C ≥70 mg/dL or ≥55 mg/dL (with risk factors); Coronary artery calcium score ≥300.

HoFH clinical untreated LDL-CUntreated LDL-C > 400 mg/dL (with additional parental LDL-C ≥190 mg/dL or early xanthomas as clinical confirmation)

Current LDL-C treatment thresholds for HoFHCurrent LDL-C ≥ 70 mg/dL OR current LDL-C ≥ 55 mg/dL when major ASCVD risk factors or history of clinical ASCVD are present

Coronary artery calcium (CAC) scoreCAC score ≥ 300 meets criterion for clinical ASCVD (Appendix A)

Step Therapy

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

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.

Documentation Required

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.

Documentation Required

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.

Denial Risk

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.

Denial Risk

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.

Included as clinical ASCVD (Appendix A)

Acute coronary syndromes and anginaIncluded as clinical ASCVD (Appendix A)

Stroke and TIAStroke of presumed atherosclerotic origin and transient ischemic attack (TIA) are clinical ASCVD events

Revascularization and obstructive CADCoronary or other arterial revascularization procedures and obstructive coronary artery disease (≥50% stenosis) are clinical ASCVD

Peripheral arterial disease and CACNon-cardiac peripheral arterial disease of presumed atherosclerotic origin and coronary artery calcium (CAC) score ≥300 are clinical ASCVD