Leqvio (inclisiran)
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Defines medical necessity criteria and coverage conditions for Leqvio (inclisiran) injections as an adjunct to diet and statin therapy for adults with primary hyperlipidemia or established ASCVD under Blue Cross of Idaho benefit plans.
Indications added for Homozygous Familial Hypercholesterolemia (HoFH) and hypercholesterolemia.
Updated criteria to align with recent guideline changes.
Coverage Criteria for Leqvio (inclisiran)
Initial Therapy
Covered when ALL of the following are met for initial treatment:
See subsequent nodes for detailed definitions of high ASCVD risk and LDL/genetic thresholds.
Any one of these pathways satisfies the high ASCVD risk requirement.
Specific LDL thresholds apply to different genetic or clinical contexts as listed in policy.
Continuation Therapy
Continuation of therapy is covered when ALL of the following are met:
Maximally tolerated statin therapy is defined in policy (e.g., high‑intensity statin such as atorvastatin ≥40 mg or rosuvastatin ≥20 mg, or the maximum tolerated dose).
Not Medically Necessary
Not covered when any of the following apply:
Requests meeting any of these conditions are considered NOT medically necessary per policy.
Indications (summary)
Covered when ALL of the following are met (policy-level summary):
Safety and effectiveness in pediatric patients have not been established; cardiovascular outcomes impact not determined.
This policy may not apply to all lines of business. Examples of plans and arrangements potentially excluded from this medical policy include the Federal Employee Program, Medicare Supplement, Medicare Advantage, Medicaid, and certain self‑insured groups. Verify member-specific benefit plan terms and any applicable program rules before assuming coverage.
The policy states that the safety and effectiveness of Leqvio in pediatric patients have not been established. Coverage is directed to adult patients only (those with primary hyperlipidemia or ASCVD who require additional LDL‑C lowering); pediatric use is excluded from the indicated population.
Requests for Leqvio are considered not medically necessary when any of the listed non‑covered situations apply, including use in combination with Lerochol, Praluent, or Repatha, when the policy’s coverage criteria are not met, or for indications beyond those specifically listed in the policy. Do not authorize combination therapy with the agents named above under this policy.
The codes listed in this policy are provided for reference and administrative convenience only. Inclusion of a code does not guarantee coverage or reimbursement; conversely, absence of a code does not imply non‑coverage. All coverage and payment decisions remain subject to the member’s specific benefit plan, the terms and conditions of that plan, and applicable medical policy requirements — including documentation sufficiency.
Initial Therapy Criteria
Initial Leqvio Therapy
Initial therapy is covered when the patient meets all of the following:
See policy for the detailed LDL and genetic thresholds that further define eligibility.
Initial therapy (summary)
Initial therapy (summary):
Policy updates added HoFH and aligned criteria with guidelines; pediatric use not established.
Continuation / Maintenance Criteria
Continuation of Leqvio
Continuation requests may be considered medically necessary if the following are met:
Documentation of ongoing statin therapy or a justified statin intolerance should be maintained as part of the prior authorization/reauthorization process.
Continuation therapy (summary)
Continuation therapy (summary):
Specific refill intervals and numeric response thresholds are addressed in the full policy and prior authorization process.
Provider Actions, Prior Authorization, and Documentation
Prior authorization: document prior PCSK9 inhibitor trial
Initial prior authorization requests must include documentation that the patient completed an adequate trial and titration of a preferred PCSK9 inhibitor (for example, Repatha) consistent with the patient’s pharmacy benefit and had a suboptimal lipid‑lowering response after at least 90 days of compliant therapy; medication samples/coupons/discount cards do not count as a trial.
- At least 90 days of compliant therapy with a preferred PCSK9 inhibitor required.
- Medication samples, coupons or discount cards are excluded from consideration as a trial.
Prior authorization required; indicate diagnosis and prior therapies
Prior authorization is required for Leqvio per this policy; Leqvio is indicated as an adjunct to diet and statin therapy for adults with primary hyperlipidemia, ASCVD, and Homozygous Familial Hypercholesterolemia (HoFH). Ensure documentation of diagnosis and prior therapies with the authorization request.
- Leqvio is indicated as adjunct to diet and statin therapy for adults who require additional LDL‑C lowering.
- HoFH and expanded hypercholesterolemia indications were added/updated in the policy.
Step requirement: trial of preferred PCSK9 inhibitor before Leqvio
Prior to initiating Leqvio, the policy requires a step trial: the member must have had trial and titration of a preferred PCSK9 inhibitor (e.g., Repatha) with documentation of suboptimal response before Leqvio is authorized.
- Failure or inadequate LDL‑C lowering after the PCSK9 inhibitor trial is the step/failure criterion.
- Samples/coupons/discount cards are excluded when counting prior trials.
Document statin use or documented statin intolerance
Authorization and continuation require documentation that the patient is using Leqvio in combination with maximally tolerated statin therapy unless there is a documented contraindication or statin intolerance per policy definitions.
- Maximally tolerated statin is defined in policy (e.g., atorvastatin ≥40 mg or rosuvastatin ≥20 mg) or statin at the maximum tolerated dose.
- If statins are contraindicated or the patient is statin intolerant, document the specific intolerance or contraindication as described in policy.
Required documentation for initial authorization
For initial authorization, provide documentation of the prior adequate trial and titration of a preferred PCSK9 inhibitor (including dates and duration of therapy), evidence of suboptimal lipid lowering after ≥90 days of compliant therapy, and documentation of high ASCVD risk and statin use or documented statin contraindication/intolerance as specified in the policy.
- Specify dates and duration (≥90 days) of the PCSK9 inhibitor trial; note that samples/coupons/discount cards are excluded.
- Include documentation of ASCVD risk classification (e.g., HoFH, HeFH, prior clinical ASCVD events, or qualifying LDL thresholds) and statin therapy status or intolerance.
Coding and documentation: J1306, CPT 96372, include ICD‑10‑CM codes
Use HCPCS code J1306 to report inclisiran (Leqvio) dosing and CPT code 96372 for the therapeutic/prophylactic subcutaneous injection administration; include applicable ICD‑10‑CM diagnosis codes such as E78.01 (familial hypercholesterolemia) and relevant I25.* codes when submitting claims and prior authorization documentation.
Not medically necessary triggers: prohibited combinations and unmet criteria
Requests will be considered NOT medically necessary if Leqvio is used in combination with Lerochol, Praluent, or Repatha, or when the policy’s coverage criteria are not met.
- Combination therapy with Lerochol, Praluent, or Repatha is an explicit non‑covered scenario.
- Any request that does not meet the policy’s stated initial or continuation criteria may be denied as not medically necessary.
Coverage conditional on member benefit plan and documentation
Coverage and reimbursement for Leqvio are subject to the member‑specific benefit plan, plan terms and conditions, and the presence of required documentation; inclusion of codes in the policy does not guarantee payment.
- All determinations are subject to the member’s benefit plan and additional terms/conditions.
- Presence of a code in the policy does not imply coverage or reimbursement; submit complete documentation with the authorization/claim.
Coding and Diagnosis Codes
| No codes listed |
| 96372 | Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular |
| J1306 | Injection, inclisiran, 1 mg |
| E78.01 | Familial hypercholesterolemia |
| I25.10 - I25.119 | Atherosclerotic heart disease of native coronary artery |
| I25.700 - | |
| I25.799 I25.810 - | Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris; Atherosclerosis of other coronary vessels without angina pectoris |
| I25.812 |
Step Therapy Requirements
| Step | Requirement | Notes |
|---|---|---|
| 1 | Prior trial and titration of a preferred PCSK9 inhibitor (e.g., Repatha) with at least 90 days of compliant therapy | Medication samples, coupons, or discount cards are excluded and do not count as a trial; required evidence of suboptimal lipid‑lowering response after the trial |
| Step | Requirement | Notes |
|---|---|---|
| 1 | Leqvio is indicated as an adjunct to diet and statin therapy — documentation of prior statin use or documentation of statin intolerance/contraindication is required | Provider must document maximally tolerated or high‑intensity statin therapy per policy definition, or a documented contraindication/intolerance to statins; prior authorization will verify statin status in addition to PCSK9 step |
Quantity Limits and Dosing
Site of Care and Administration
Office administration by healthcare professional
Leqvio (inclisiran) must be administered by a healthcare professional as a subcutaneous injection (284 mg per administration per dosing schedule) in the office or appropriate clinical setting.
- Administered as subcutaneous injection by a healthcare professional
- Dose: 284 mg initially, at 3 months, then every 6 months
Definitions
Background
Leqvio (inclisiran) is a double‑stranded small interfering RNA that uses RNA interference to direct catalytic degradation of PCSK9 mRNA, increasing LDL receptor recycling and reducing circulating LDL‑C. It is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with primary hyperlipidemia (including familial forms) or established atherosclerotic cardiovascular disease who require additional LDL‑C lowering. The recommended administered dose is 284 mg per administration, given subcutaneously initially, at 3 months, and then every 6 months, and should be administered by a healthcare professional.
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