Blue Cross Blue Shield - Iowa Leqvio Prior Auth

Initial therapy — Clinical ASCVD

Covered when ALL of the following are met

Clinical ASCVD initial therapy: 1. Member is 18 years of age or older; 2. Member has a history of clinical ASCVD (Appendix A); 3. Member is engaging in healthy lifestyle changes; 4. Member has been unable to achieve an LDL-C < 70 mg/dL (or < 55 mg/dL with history of multiple ASCVD events or one major ASCVD event and multiple high-risk conditions [See Appendix D]) despite adherence to lifestyle changes and at least three months of specified lipid-lowering therapy (either both high-intensity statins at maximum tolerated dose with ezetimibe, or two moderate-intensity statins with ezetimibe if high-intensity trials cannot be completed); 5. Leqvio will not be combined with other PCSK9-targeted therapy (e.g., Repatha, Praluent); 6. Dose does not exceed 284 mg initially and at 3 months, then every 6 months thereafterage >=18; LDL-C thresholds as stated

Specified statin trial options described separately; prescriber requirements apply

Initial therapy — Clinical ASCVD with contraindication

Covered when ALL of the following are met

Clinical ASCVD with statin contraindication: 1. Member is 18 years of age or older; 2. Member has a history of clinical ASCVD (Appendix A); 3. Member is engaging in healthy lifestyle changes; 4. Leqvio will not be combined with other PCSK9-targeted therapy (e.g., Repatha, Praluent); 5. Member has a current LDL-C ≥ 70 mg/dL (or ≥ 55 mg/dL with history of multiple ASCVD events or one major ASCVD event and multiple high-risk conditions [See Appendix D]); 6. Member has a documented contraindication or medically justifiable reason that precludes statin use (e.g., active liver disease, pregnancy, breastfeeding, rhabdomyolysis, CK ≥ 10x ULN, or statin intolerance per National Lipid Association [Appendix E]); 7. Dose does not exceed 284 mg initially and at 3 months, then every 6 months thereafterage >=18; LDL-C thresholds as stated

Allows use when statins contraindicated or not tolerated

Initial therapy — Heterozygous familial hypercholesterolemia (HeFH)

Covered when ALL of the following are met

HeFH pathway A - documented genetic/diagnostic criteria: 1. Patient is 18 years of age or older; 2. Patient has diagnosis of HeFH documented by ONE of: LDL-receptor mutation, familial defective apo B-100, or a PCSK9 gain-of-function mutation; definite FH per Simon-Broome criteria; OR Dutch Lipid Network Criteria score >8; 3. Patient is engaging in healthy lifestyle changes; 4. Patient has been unable to achieve LDL-C <70 mg/dL (or <55 mg/dL with multiple ASCVD events or one major ASCVD event plus multiple high-risk conditions) despite adherence to lifestyle changes and at least three months of specified lipid-lowering therapy (either both high-intensity statins at maximum tolerated dose with ezetimibe, OR two moderate-intensity statins with ezetimibe if high-intensity trials cannot be completed); 5. Leqvio will not be combined with other PCSK9-targeted therapy (e.g., Repatha, Praluent); 6. Dose does not exceed 284 mg initially and at 3 months, then every 6 months thereafterage >=18; diagnostic confirmation of HeFH required

Diagnostic options include genetic testing or established criteria

Initial therapy — HeFH (statin contraindication)

Covered when ALL of the following are met

HeFH with statin contraindication: 1. Patient is 18 years of age or older; 2. Diagnosis of HeFH documented by one of specified methods (LDL-R mutation, familial defective apoB-100, Simon-Broome definite FH, or DLCN score >8); 3. Patient is engaging in healthy lifestyle changes; 4. Patient has a current LDL-C ≥ 70 mg/dL (or ≥ 55 mg/dL with multiple ASCVD events or one major ASCVD event plus multiple high-risk conditions [See Appendix D]); 5. Documented contraindication to statin or medically justifiable reason that precludes statin use (e.g., active liver disease, pregnancy, breastfeeding, rhabdomyolysis, CK ≥ 10x ULN, or statin intolerance per Appendix E); 6. Leqvio will not be combined with other PCSK9-targeted therapy (e.g., Repatha, Praluent); 7. Dose does not exceed 284 mg initially and at 3 months, then every 6 months thereafterage >=18; LDL-C thresholds as stated

Allows HeFH patients with statin intolerance/contraindication to qualify

Initial therapy — Primary hyperlipidemia

Covered when ALL of the following are met

Primary hyperlipidemia: 1. Member is 18 years of age or older; 2. Member has a diagnosis of primary hyperlipidemia with untreated LDL-C ≥ 190 mg/dL and no secondary cause of hyperlipidemia; 3. Member is engaging in healthy lifestyle changes; 4. Member has been unable to achieve LDL-C < 70 mg/dL despite adherence to lifestyle changes and at least three months of specified lipid-lowering therapy (either both high-intensity statins at maximum tolerated dose with ezetimibe, OR two moderate-intensity statins with ezetimibe if high-intensity trials cannot be completed); 5. Leqvio will not be combined with other PCSK9-targeted therapy (e.g., Repatha, Praluent); 6. Dose does not exceed 284 mg initially and at 3 months, then every 6 months thereafteruntreated LDL-C >=190 mg/dL; age >=18

Alternate pathway exists for statin contraindication with current LDL-C >=70 mg/dL

Continuation of therapy

Covered for continuation when ALL of the following are met

Continuation criteria: 1. Documented positive clinical response defined by achieving or maintaining an LDL-C reduction (LDL-C now at goal or ≥50% reduction from baseline); 2. Member continues to engage in healthy lifestyle changes; 3. Leqvio is not combined with other PCSK9-targeted therapy (e.g., Repatha, Praluent); 4. Dose does not exceed 284 mg every 6 monthsobjective LDL-C response (goal or >=50% reduction)

Documentation of LDL-C levels required (untreated baseline and current within 90 days of prior authorization request)

Coverage criteria for inclisiran (Leqvio)

Covered when documentation demonstrates ONE of the following diagnostic or risk conditions and supporting therapy/trial documentation

FH Diagnosis

Definite FH: Total cholesterol >290 mg/dL or LDL-C >190 mg/dL if >16 yrs OR total cholesterol >260 mg/dL or LDL-C >155 mg/dL if <16 yrsage-specific
Defining physical/genetic finding: Presence of tendon xanthomas in patient or first/second degree relative OR presence of LDL-receptor mutation, familial defective apo B-100, or PCSK9 mutationbinary

Possible FH: Same biochemical thresholds PLUS family history of premature MI in first-degree relative (men <55, women <60) or in second-degree at earlier age, OR family history of elevated total cholesterol (>290 mg/dL adult, >260 mg/dL child/sibling <16).

Leqvio (inclisiran) must not be used concurrently with other PCSK9-targeted therapies. The policy explicitly states that Leqvio will not be combined with other PCSK9-targeted therapy (e.g., Repatha, Praluent) for initial approvals, alternative pathways, primary hyperlipidemia approvals, and continuation of therapy.

This exclusion applies across initial approval pathways (clinical ASCVD, HeFH, and primary hyperlipidemia) and the continuation criteria; requests combining inclisiran with another PCSK9 agent should be denied as not meeting the stated coverage conditions.

Within the sections of the policy addressing exclusions, no other explicit absolute exclusions are listed beyond the prohibition on combining Leqvio with other PCSK9-targeted therapies. The procedures and billing section lists the HCPCS code for inclisiran (J1306) but does not add additional exclusionary language in this segment.

Leqvio is considered not medically necessary for members who do not meet the coverage criteria specified in this policy. Requests that lack documentation meeting the stated diagnostic, therapy-trial, LDL-C threshold, age, prescriber, or dosing requirements should be denied on the basis that the member does not satisfy the policy criteria.

Although the policy does not list additional named exclusions in the main exclusion field, several limits and inferred exclusions are embedded in appendices and definitions. Appendix D defines Very High Risk ASCVD criteria (including major ASCVD events and multiple high-risk conditions) and requires documentation of persistently elevated LDL-C (e.g., LDL‑C ≥100 mg/dL despite maximally tolerated statin plus ezetimibe) as a high-risk condition. Appendix E and the definitions require demonstration of statin intolerance consistent with the NLA definition (inability to tolerate at least two statins with appropriate trials and re-challenges).

Consequently, patients who do not meet the age, LDL-C thresholds, FH diagnostic criteria, required statin/ezetimibe trial documentation, or who lack evidence supporting statin intolerance per the NLA definition would be effectively excluded from coverage under the policy's stated requirements.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Leqvio (inclisiran) and supporting documentation must be submitted to initiate review. Ensure documentation includes baseline and on-treatment lipid values, prescriber specialty and chart notes demonstrating lifestyle modification efforts and prior therapy trials. Leqvio will not be combined with other PCSK9-targeted therapy (e.g., Repatha, Praluent).

Affected HCPCS: J1306 (Injection, inclisiran, 1 mg)
Initial approval duration: 9 months; Renewals approved for 12 months
Dose limit: 284 mg initially and at 3 months, then every 6 months

Prior Authorization

Prior Authorization for inclisiran (J1306)

Prior authorization is likely required for inclisiran billed as J1306. Include documentation of prior statin therapy trials or documentation of statin intolerance/contraindication when applicable.

Submit chart notes showing prior statin ± ezetimibe trials (see step therapy expectations and statin intensity requirements)
If statin intolerance is claimed, provide documentation per National Lipid Association definition (Appendix E)

Denial Risk

Risk of Denial for Insufficient ASCVD Risk Documentation

Members who do not have documentation of clinical ASCVD, major ASCVD events, or qualifying 'Very High Risk' conditions (see Appendix D) may be at risk for denial. Lack of adequate LDL-C values (untreated baseline, LDL while on statin prior to Leqvio, and current LDL) or absent evidence of prior therapy trials increases the likelihood of denial.

Ensure documentation of major ASCVD events (e.g., acute coronary syndrome within 12 months, history of MI, ischemic stroke, symptomatic PAD) or high-risk conditions per Appendix D
Provide clear timelines and supporting chart notes for ASCVD events and high-risk conditions

Documentation Required

Required Documentation for Prior Authorization and Renewals

Required documentation for initial prior authorization and renewals includes untreated baseline LDL-C, LDL-C while receiving statin therapy (prior to starting Leqvio), and current LDL-C (within 90 days of the request). Chart notes must show engagement in healthy lifestyle changes and any statin intolerance or contraindication claims. For HeFH, provide genetic testing or documentation confirming the diagnosis; for ASCVD, provide chart notes confirming clinical ASCVD.

Untreated baseline LDL level
LDL levels while receiving statin therapy (prior to starting Leqvio)
Current LDL level (within 90 days of prior authorization request)
Chart notes demonstrating lifestyle changes (diet, exercise)
Chart notes demonstrating statin intolerance or contraindication, if applicable (see Appendix E)
Genetic testing or medical records for HeFH (Appendix C) when applicable
Chart notes confirming clinical ASCVD (Appendix A) when applicable

Documentation Required

Required Clinical Documentation to Support Medical Necessity

Clinical documentation must support medical necessity based on LDL-C thresholds, family history, and clinical features. For HeFH, include diagnostic criteria (genetic mutation, Simon-Broome, or Dutch Lipid Network score). For ASCVD, document major events and high-risk conditions per Appendix D. Continuation requires documented positive clinical response: LDL-C at goal or ≥50% reduction from baseline.

For HeFH: confirm diagnosis with LDL-receptor mutation, familial defective apo B-100, PCSK9 mutation, Simon-Broome criteria, or Dutch Lipid Network score >8 (Appendix C)
Provide total cholesterol and LDL-C values with patient age to apply FH thresholds
For ASCVD: document major ASCVD events or high-risk conditions (Appendix D)
Continuation of therapy: documentation of LDL-C reduction to goal or ≥50% from baseline

Step Therapy

Required Trials of Statin ± Ezetimibe

Prior to initiating Leqvio, members must have attempted and adhered to at least three months of specified lipid-lowering therapy as outlined below. Document the specific agents, doses, durations, and any tolerability issues.

Either: Trial of BOTH high-intensity statins (atorvastatin 40–80 mg and rosuvastatin 20–40 mg) at a maximum tolerated dose in combination with ezetimibe, OR
Trial of TWO moderate-intensity statins in combination with ezetimibe when unable to complete high-intensity statin trials (e.g., pravastatin, lovastatin, fluvastatin, pitavastatin, simvastatin dosed per guidance)
Each statin trial and re-challenge when relevant should meet duration expectations (see statin intolerance definition in Appendix E)

Step Therapy

Step Therapy Expectations

Step therapy expectations require escalation through maximally tolerated statin therapy plus ezetimibe before approval of Leqvio, unless there is a documented contraindication or statin intolerance per the National Lipid Association definition. Statin intolerance requires inability to tolerate at least two statins (one at any dose and one at the lowest daily dose) with symptoms or biomarkers temporally related to use and reproducible on re-challenge.

Stepwise escalation: maximally tolerated high-intensity statin ± ezetimibe, or documented contraindication/intolerance permitting alternative pathway
Statin intolerance definition and recommended trial list per Appendix E (e.g., rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, etc.)
Each statin trial, including re-challenges, should be at least two weeks in duration unless clinically justified otherwise

Clinical Definitions and Thresholds

Clinical ASCVD — definition

Included conditionsAcute coronary syndromes; myocardial infarction; stable or unstable angina; coronary or other arterial revascularization (e.g., PCI, CABG)

Other cerebrovascular and vascular diseaseStroke of presumed atherosclerotic origin; transient ischemic attack (TIA); non-cardiac PAD of atherosclerotic origin

Anatomic and imaging criteriaObstructive coronary artery disease (≥50% stenosis) and Coronary Artery Calcium (CAC) score ≥ 300

Definite familial hypercholesterolemia — diagnostic thresholds

Definite FH — adults (>16 years)Total cholesterol > 290 mg/dL or LDL‑C > 190 mg/dL

Definite FH — children (<16 years)Total cholesterol > 260 mg/dL or LDL‑C > 155 mg/dL

Required additional finding for 'definite' FHTendon xanthomas in patient or first/second‑degree relative OR presence of LDL‑receptor mutation, familial defective apoB‑100, or PCSK9 mutation

Definite familial hypercholesterolemia — biochemical thresholds (alternate)

Biochemical thresholds repeatedTotal cholesterol > 290 mg/dL or LDL‑C > 190 mg/dL (>16 years) or total cholesterol > 260 mg/dL or LDL‑C > 155 mg/dL (<16 years)

Genetic/physical criteriaPresence of tendon xanthomas or confirmed pathogenic mutation (LDLR, apoB, PCSK9)

Use in coverage pathwaysThese biochemical thresholds plus genetic/clinical findings satisfy criteria for documented HeFH

Possible familial hypercholesterolemia — thresholds and family history

Biochemical thresholds for possible FHTotal cholesterol > 290 mg/dL or LDL‑C > 190 mg/dL (>16 years) or total cholesterol > 260 mg/dL or LDL‑C > 155 mg/dL (<16 years)

Family history criteriaFamily history of premature MI (first‑degree: men <55, women <60) or elevated total cholesterol (>290 mg/dL adult or >260 mg/dL child) in first‑ or second‑degree relative

Role in diagnosisBiochemical thresholds plus specified family history support designation of 'possible' FH

DLCN score categories (Dutch Lipid Clinic Network)

DLCN category — Certain> 8 points

DLCN category — Probable6–8 points

DLCN category — Possible3–5 points

DLCN category — Unlikely< 3 points

Statin intolerance — National Lipid Association definition

Minimum statin trial requirement for intolerance definitionInability to tolerate at least two statins (one at any dose, one at the lowest daily dose)

Temporal and reproducibility requirementsAdverse symptoms/biomarkers must be temporally related to statin use, reversible on discontinuation, and reproducible on re‑challenge

Exclusion of other determinantsOther causes (e.g., hypothyroidism, severe renal/hepatic dysfunction, recent trauma, etc.) should be excluded

Minimum trial durationEach statin trial, including re‑challenge, should be at least two weeks

OpenPayer

Leqvio (inclisiran) prior authorization and coverage criteria

Coverage and Medical Necessity Criteria

Billing and Coding

Prior Authorization and Documentation Requirements

Product and Indication Background

Clinical Definitions and Thresholds