Leqvio (inclisiran) — Coverage Criteria for Primary Hyperlipidemia, HeFH, and ASCVD
Defines UnitedHealthcare coverage criteria for Leqvio (inclisiran) as an adjunct to diet and statin therapy for adults with primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), or clinical ASCVD; specifies initial and continuation authorization requirements and prescribing conditions.
No material clinical or coverage changes in this revision.
Coverage Criteria for Leqvio (inclisiran)
Initial Therapy Criteria
Covered when ALL of the following are met for initial therapy:
Initial therapy criteria
Diagnosis (one of)
- Heterozygous familial hypercholesterolemia (HeFH).
- Atherosclerotic cardiovascular disease (ASCVD) (e.g., acute coronary syndromes, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease presumed to be of atherosclerotic origin).
- Primary hyperlipidemia.
- Prescribed by a lipid specialist (e.g., cardiologist, endocrinologist, lipid specialist/lipidologist).
Prior PCSK9 therapy or intolerance
Prior PCSK9 therapy with inadequate response
- Patient has received PCSK9 therapy for at least 12 consecutive weeks; AND patient has clinical ASCVD; AND despite adherence to PCSK9 therapy the patient failed to achieve LDL-C goal (see LDL‑C thresholds).
- Intolerance/contraindication: Patient has a documented history of intolerance or contraindication to PCSK9 therapy.
- Patient will continue other traditional LDL‑C lowering therapies (e.g., maximally tolerated statins, ezetimibe) in combination with Leqvio.
- Leqvio will not be used in combination with PCSK9 inhibitor therapy.
- Leqvio dosing is in accordance with the United States Food and Drug Administration approved labeling.
- Initial authorization will be for no more than 12 months.
LDL-C thresholds (referenced)
ANY of the following
- Patient failed to achieve LDL‑C goal of < 55 mg/dL.
Primary hyperlipidemia exception
- Pre‑treatment LDL‑C ≥ 190 mg/dL; AND patient failed to achieve LDL‑C goal of < 100 mg/dL.
Continuation Therapy Criteria
Covered when ALL of the following are met for continuation of therapy:
Continuation therapy criteria
- Documentation of a positive clinical response to Leqvio therapy as documented by the provider.
- Leqvio will not be used in combination with PCSK9 inhibitor therapy.
- Leqvio dosing is in accordance with the United States Food and Drug Administration approved labeling.
- Reauthorization will be for no more than 12 months.
Use of Leqvio (inclisiran) in combination with a PCSK9 inhibitor is not permitted.
Leqvio is considered not appropriate when requested for use together with a PCSK9 inhibitor or when dosing is not in accordance with the FDA-approved labeling. Requests that lack documentation of the required prescriber specialty or fail to demonstrate required prior therapy, intolerance to PCSK9 therapy, or adherence to concomitant LDL‑C lowering therapies may be denied or deemed not medically necessary.
Coding
| J1306 | Injection, inclisiran, 1 mg. |
| E75.5 | Other lipid storage disorders |
| E78.00 | Pure hypercholesterolemia, unspecified. |
| E78.01 | Familial hypercholesterolemia. |
| E78.2 | Mixed hyperlipidemia. |
| E78.49 | Other hyperlipidemia. |
| E78.5 | Hyperlipidemia, unspecified. |
| E78.9 | Disorder of lipoprotein metabolism, unspecified |
Provider Actions and Authorization Requirements
Prior Authorization Required
Prior Authorization Required. Prior authorization is required before initiation of Leqvio (inclisiran). Initial authorization will be for no more than 12 months; reauthorization (continuation) approvals are also limited to ≤ 12 months and must document ongoing clinical benefit.
- Initial and reauthorization requests must include clinical documentation that meets diagnostic and treatment criteria in the Coverage Rationale.
- Initial authorization duration: ≤ 12 months. Reauthorization duration: ≤ 12 months.
Step Therapy / Prior Therapy Requirements
Step therapy / prior therapy requirements must be documented prior to approval. The prescriber must demonstrate that the member has been treated with and is adherent to appropriate prior lipid‑lowering therapies.
- Documentation of maximally tolerated statin therapy is required (dose and reason for intolerance if applicable).
- Ezetimibe use: when clinically appropriate, trials of ezetimibe in combination with statin therapy should be documented prior to Leqvio approval.
- PCSK9 inhibitor use: if the request is based on inadequate response to a PCSK9 inhibitor, document at least 12 consecutive weeks of prior PCSK9 therapy and persistent LDL‑C above goal per criteria in the Coverage Rationale.
Required Documentation
Required documentation must be submitted with the prior authorization request to allow timely review.
- Diagnosis supporting use (e.g., HeFH, ASCVD, or primary hyperlipidemia) with relevant ICD‑10 code(s).
- Prescriber specialty: indication that a lipid specialist (e.g., cardiologist, endocrinologist, lipidologist) prescribed the therapy.
- Evidence of prior therapies: records showing maximally tolerated statin therapy, use of ezetimibe when applicable, and duration/details of prior PCSK9 inhibitor therapy if applicable.
- Baseline and follow‑up LDL‑C values and other relevant laboratory results demonstrating need and response.
- For continuation/reauthorization: documentation of a positive clinical response to Leqvio (e.g., LDL‑C reduction or other clinical benefit).
- Medication regimen: confirmation that Leqvio will be used in combination with other LDL‑C lowering therapies and not in combination with a PCSK9 inhibitor.
- Dosing: documentation that requested dosing is consistent with FDA‑approved labeling.
Denial Risk Conditions
Denial risk conditions — common reasons for denial or incomplete review.
- Concurrent use with a PCSK9 inhibitor is not permitted and may result in denial.
- Requested dosing not consistent with FDA‑approved labeling may be denied.
- Insufficient documentation of prior therapies (including lack of evidence of maximally tolerated statin or missing duration details for prior PCSK9 therapy).
- Missing prescriber specialty information or absence of required baseline/follow‑up LDL‑C lab values.
- Failure to document clinical response for reauthorization requests.
Background
Atherosclerosis results from accumulation of lipids—primarily low-density lipoprotein cholesterol (LDL‑C)—in the arterial intima and is a major driver of events such as myocardial infarction and ischemic stroke. Therapeutic lowering of LDL‑C reduces atherosclerotic risk. PCSK9 protein decreases hepatic LDL receptor availability, raising circulating LDL‑C, whereas inclisiran is a GalNAc-conjugated small interfering RNA that degrades PCSK9 mRNA in hepatocytes, increasing LDL receptor expression and thereby lowering LDL‑C. Inclisiran is indicated as an adjunct to diet and statin therapy for adults with primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), or clinical ASCVD when the stated coverage criteria are met.
Definitions
Revision History
Corrected formatting issue in References section.
Policy became effective July 1, 2025 (template update and removal of Mississippi-specific language; previous version archived).
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