ModifiedColorado Rocky Mountain Health PlansPolicy 2026D0101L

Leqvio (inclisiran)

Medical benefit drug policy defining coverage criteria, required documentation, prescriber specialties, and authorization limits for inclisiran (Leqvio) for primary hyperlipidemia, HeFH, HoFH, and ASCVD populations, including initial and continuation criteria and applicable codes.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLeqvio (inclisiran)

Policy CodePolicy 2026D0101L

Change TypeAdded HoFH coverage criteria; updated supporting info

Effective DateJun 1, 2026

Next Review Date

Key ActionProviders must submit medical records (chart notes, laboratory values) confirming diagnosis, prior therapies, LDL-C values, and HoFH genetic or clinical confirmation as applicable to support authorization.

POLICY UPDATE CHANGES

Coverage Rationale updated to indicate Leqvio is proven and medically necessary for treatment of homozygous familial hypercholesterolemia (HoFH) with specific diagnostic, therapy, and prescriber criteria.

Supporting information sections (Clinical Evidence, FDA, CMS, References) updated to reflect current information.

3Covered Indications (HeFH, HoFH, ASCVD/primary hyperlipidemia)

55 mg/dLLDL-C threshold for coverage

12 moAuthorization duration (initial & reauth)

J1306Single HCPCS code used

Coverage Summary & Scope

Leqvio (inclisiran) is covered with specific criteria for primary hyperlipidemia, heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), and clinical ASCVD when all requirements are met. Coverage requires submission of medical records documenting diagnosis and prior therapies (history of PCSK9 inhibitor use or ≥12 consecutive weeks of high‑intensity statin therapy or documented statin intolerance/contraindication), an LDL‑C ≥ 55 mg/dL for HeFH/ASCVD/primary hyperlipidemia, prescriber specialty limited to Cardiologist, Endocrinologist, or Lipid specialist, prohibition of concurrent PCSK9 inhibitor therapy (and for HoFH also no lomitapide), and adherence to the U.S. FDA‑approved dosing. Initial and reauthorization approvals are limited to no more than 12 months. Effective date: June 1, 2026; Last review: June 1, 2026.

Key thresholds & quick facts

LDL-C threshold for coverage>= 55 mg/dL

Untreated LDL-C for HoFH clinical confirmation> 400 mg/dL

Statin trial duration>= 12 consecutive weeks

Authorization duration12 months (initial and reauthorization limit)

HCPCS codeJ1306

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Leqvio coverage for primary hyperlipidemia / HeFH / ASCVD - Continuation of Therapy

Covered when ALL of the following are met:

ALL of the following

Positive clinical response: Documentation of a positive clinical response to Leqvio therapy
Prescriber specialty: Prescribed by one of: Cardiologist, Endocrinologist, or Lipid specialist
Combination exclusion: Leqvio will NOT be used in combination with PCSK9 inhibitor therapy
Dosing:

Provider Actions & Authorization Requirements

Prior Authorization

Submission of medical records required

Providers must submit medical records (chart notes, laboratory values) confirming diagnosis, prior therapies (including history of PCSK9 therapy or documentation of statin trials/intolerance), LDL-C values, and genetic or clinical confirmation for HoFH as applicable to support authorization.

Affected code: J1306

Prior Authorization

Prescriber specialty restriction

Leqvio must be prescribed by a Cardiologist, Endocrinologist, or Lipid specialist for both initial and continuation authorizations.

Applicable Codes

J-code for LeqvioHCPCSCovered

J1306

Injection, inclisiran, 1 mg

Diagnosis codes referencedICD-10

E75.5	Other lipid storage disorders
E78.00	Pure hypercholesterolemia, unspecified
E78.010	Homozygous familial hypercholesterolemia [HoFH]
E78.011	Heterozygous familial hypercholesterolemia [HeFH]
E78.019	Familial hypercholesterolemia, unspecified
E78.2	Mixed hyperlipidemia
E78.49	Other hyperlipidemia
E78.5	Hyperlipidemia, unspecified
E78.9	Disorder of lipoprotein metabolism, unspecified

Clinical Evidence Summary

-39.7%ORION-9 inclisiran percent change in LDL-C at day 510

+8.2%ORION-9 placebo percent change in LDL-C at day 510

-47.9 ppORION-9 between-group difference (percentage points) at day 510

-52.3% / -49.9%ORION-10 / ORION-11 LDL-C % change at day 510 (inclisiran)

Inclisiran (Leqvio) is a GalNAc‑conjugated double‑stranded small interfering RNA (siRNA) that reduces hepatic PCSK9 production by directing catalytic degradation of PCSK9 mRNA, thereby increasing LDL receptor recycling and lowering LDL‑C. In the ORION phase 3 program, inclisiran administered on a schedule consistent with every‑6‑month dosing produced LDL‑C reductions versus placebo of approximately 40–53% across trials (e.g., ORION‑9 ~39.7% at day 510; ORION‑10/11 ~49.9–52.3% at day 510).

Background & Definitions

Inclisiran (Leqvio) is an siRNA, GalNAc‑conjugated for hepatocyte uptake, that leverages RNA interference to degrade PCSK9 mRNA in hepatocytes, increasing LDL receptor expression and lowering circulating LDL‑C. Phase 3 trials dosed inclisiran on Day 1, Day 90, and thereafter every 6 months (e.g., dosing on days 1, 90, 270, 450 in ORION‑10/11), which aligns with the U.S. FDA‑approved labeling for Leqvio as an adjunct to diet and exercise to reduce LDL‑C in approved populations.

Term	Definition / Example
High-intensity statin therapy	atorvastatin 40-80 mg, rosuvastatin 20-40 mg
Low/moderate-intensity statin examples	atorvastatin 10-20 mg; rosuvastatin 5-10 mg; simvastatin ≥10 mg; pravastatin ≥10 mg; lovastatin 20-40 mg; fluvastatin XL 80 mg or 20-40 mg (up to 40 mg twice daily); pitavastatin ≥1 mg
Myositis	Muscle symptoms with creatine kinase (CK) elevations < 10 times upper limit of normal (ULN)

Revision History

2026-06-01material_changeLatest

Added coverage for homozygous familial hypercholesterolemia (HoFH) with initial and continuation criteria: genetic confirmation (biallelic pathogenic/likely pathogenic variants at LDLR, APOB, PCSK9, or LDLRAP1 or ≥2 variants at different loci) OR clinical criteria (untreated LDL-C > 400 mg/dL plus xanthoma before age 10 or FH in a parent); requirement for other lipid-lowering therapy (e.g., statin, ezetimibe, LDL apheresis); requirement to document failure/contraindication/intolerance to PCSK9 therapy; prescriber restricted to Cardiologist, Endocrinologist, or Lipid specialist; exclusion of concomitant use with PCSK9 inhibitors and Juxtapid (lomitapide); Leqvio dosing per FDA labeling; and initial and reauthorization limits of no more than 12 months.

2026-06-01non_material_update

Updated Supporting Information sections (Clinical Evidence, FDA, CMS, References) and archived prior policy version 2025D0101K; see Policy History/Revision Information for details.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLeqvio (inclisiran)

Policy CodePolicy 2026D0101L

Change TypeAdded HoFH coverage criteria; updated supporting info

Effective DateJun 1, 2026

Next Review Date

On This Page

Leqvio dosing is in accordance with the US FDA approved labeling

Includes FDA label dosing schedule

Reauthorization duration: no more than 12 months<= 12 months

Leqvio coverage for homozygous familial hypercholesterolemia (HoFH) - Continuation of Therapy

Covered when ALL of the following are met:

ALL of the following

Positive clinical response: Documentation of a positive clinical response to Leqvio therapy
Prescriber specialty: Prescribed by one of: Cardiologist, Endocrinologist, or Lipid specialist
Combination exclusions: Leqvio will NOT be used in combination with PCSK9 inhibitor therapy or Juxtapid (lomitapide)
Dosing: Leqvio dosing is in accordance with the US FDA approved labeling
Includes FDA label dosing schedule
Reauthorization duration: no more than 12 months<= 12 months

Documentation Required

Statin therapy documentation

Document at least 12 consecutive weeks of high-intensity statin therapy at maximally tolerated dose, or document statin intolerance/contraindication including symptom type and creatine kinase (CK) values. Intolerance requires persistent/intolerable symptoms lasting more than 2 weeks. CK thresholds: myositis defined as CK elevations < 10 × ULN; rhabdomyolysis noted with CK elevations > 10 × ULN.

Billing Rule

Combination therapy restriction

Leqvio must not be used in combination with PCSK9 inhibitor therapy. For patients with HoFH, Leqvio must also not be used in combination with lomitapide (Juxtapid).

Affected code: J1306

Prior Authorization

Authorization duration limits

Initial and reauthorization approvals are limited to no more than 12 months.

Denial Risk

Denial if insufficient evidence

Claims or prior authorizations may be denied if required medical records are not provided to confirm prior therapy failure or intolerance (including PCSK9 history or statin trial documentation), required LDL-C thresholds, or genetic/clinical confirmation for HoFH.