Does J1306 require prior authorization?

Yes, J1306 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J1306?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J1306`, Injection, inclisiran, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Submission of medical records (e.g., chart notes, laboratory values) confirming prior PCSK9 therapy or prior/concurrent statin therapy as specified in the policy.
For patients previously treated with PCSK9 therapy: documentation of prior PCSK9 use and reason for discontinuation if applicable (failure, contraindication, or intolerance).
For patients on statin therapy: documentation of at least 12 consecutive weeks of high-intensity statin therapy (atorvastatin 40-80 mg, rosuvastatin 20-40 mg) and plan to continue at maximally tolerated dose; OR documentation of at least 12 consecutive weeks of low- or moderate-intensity statin therapy if unable to tolerate high-intensity statins and plan to continue at maximally tolerated dose.
If statin intolerance claimed, documentation of intolerable and persistent symptoms (>2 weeks) such as: myalgia (muscle symptoms without CK elevations); myositis (muscle symptoms with CK elevations < 10x ULN); or rhabdomyolysis/muscle symptoms with CK elevations > 10x ULN; or documented contraindication to statins.
Laboratory documentation of LDL-C value(s) showing LDL-C ≥ 55 mg/dL.
For reauthorization: documentation of a positive clinical response to Leqvio therapy (clinical notes/lab values demonstrating treatment benefit).

Key Coverage Criteria

Treatment of primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), or clinical atherosclerotic cardiovascular disease (ASCVD) in patients who meet all of the following criteria (initial therapy):
Diagnosis of one of the following: Heterozygous familial hypercholesterolemia (HeFH); or 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); or Primary hyperlipidemia.
For Medicare reviews and determinations, follow the CMS section of the policy (Medicare has no NCD or LCD for Leqvio; MAOs may create their own coverage determinations).
FDA indication (informational): Leqvio is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Continuation of therapy: Leqvio is covered for patients with documentation of a positive clinical response to Leqvio therapy who continue to meet prescribing and other policy requirements.
Approved Off-Label Compendial Use: "Established cardiovascular disease"

20 Active Policies

ARKBLUE-INCLISIRAN-E-G-LEQVIO-B28A852633, Inclisiran (e.g., Leqvio)

FLORIDA_BLUE-FLBLUE-INCLISIRAN-LEQVIO-4E7BFE4578, Inclisiran (Leqvio)

BCIDAHO-05-01-663-7710D6A0E8, Leqvio (inclisiran). Medical Policy MP 5.01.663 Leqvio (inclisiran) DISCLAIMER/INSTRUCTIONS FOR USE This medical policy provides general guidance for applying Blue Cross of Idaho benefit plans

BCIDAHO-05-01-663-F42C607AD8, Leqvio (inclisiran). Medical Policy MP 5.01.663 Leqvio (inclisiran) DISCLAIMER/INSTRUCTIONS FOR USE This medical policy provides general guidance for applying Blue Cross of Idaho benefit plans

BCBSLA-00786-5AFE2EB348, 00786 inclisiran (Leqvio)

BCBSMS-L-5-01-587-B322966D97, Leqvio (inclisiran)

BCBSMS-S-5-01-587-251191E7D1, State and School Employees' Health Insurance Plan - Leqvio (inclisiran)

HEALTHPARTNERS-CC-ENTRY-248558, Inclisiran (Leqvio)

MULTI

POINT32HEALTH-MDMNG-13151, Leqvio (inclisiran)

MULTI

POINT32HEALTH-MDMNG-13161, Leqvio (inclisiran)

MULTI

BCBSNE-X-189-91AF3AF97B, LEQVIO (PREAUTHORIZATION REQUIRED)

MODA-LEQVIO-A0E6DB9175, Leqvio (inclisiran)

HEALTHNET_OR-HNOR-INCLISIRAN-LEQVIO-CP-PHAR-568-C5DD36851B, Inclisiran (Leqvio); CP.PHAR.568

IBX-COMMERCIAL-08-01-91A-D80812CDC9, Inclisiran (Leqvio)

IBX-MEDICARE-ADVANTAGE-MA08-149A-B7CE3834B0, Inclisiran (Leqvio)

BCBSTN-16e935264b, Inclisiran (Leqvio)

EVICORE-MEDICAL_DRUG-8CD2FD92B9A2, Leqvio (inclisiran subcutaneous injection)Effective 10/01/2026

EVICORE-MEDICAL_DRUG-E814EEC48B04, Leqvio (inclisiran subcutaneous injection)

UHC-COMM-MD-LEQVIO-INCLISIRAN-COMMUNITY-PLAN-MEDICAL-42EC3497CF, Leqvio (Inclisiran) – Community Plan Medical Benefit Drug Policy

UHC-POL-leqvio, Leqvio (Inclisiran)

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J1306, Injection, inclisiran, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Submission of medical records (e.g., chart notes, laboratory values) confirming prior PCSK9 therapy or prior/concurrent statin therapy as specified in the policy.
For patients previously treated with PCSK9 therapy: documentation of prior PCSK9 use and reason for discontinuation if applicable (failure, contraindication, or intolerance).
For patients on statin therapy: documentation of at least 12 consecutive weeks of high-intensity statin therapy (atorvastatin 40-80 mg, rosuvastatin 20-40 mg) and plan to continue at maximally tolerated dose; OR documentation of at least 12 consecutive weeks of low- or moderate-intensity statin therapy if unable to tolerate high-intensity statins and plan to continue at maximally tolerated dose.
If statin intolerance claimed, documentation of intolerable and persistent symptoms (>2 weeks) such as: myalgia (muscle symptoms without CK elevations); myositis (muscle symptoms with CK elevations < 10x ULN); or rhabdomyolysis/muscle symptoms with CK elevations > 10x ULN; or documented contraindication to statins.
Laboratory documentation of LDL-C value(s) showing LDL-C ≥ 55 mg/dL.
For reauthorization: documentation of a positive clinical response to Leqvio therapy (clinical notes/lab values demonstrating treatment benefit).

Key Coverage Criteria

Treatment of primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), or clinical atherosclerotic cardiovascular disease (ASCVD) in patients who meet all of the following criteria (initial therapy):
Diagnosis of one of the following: Heterozygous familial hypercholesterolemia (HeFH); or 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); or Primary hyperlipidemia.
For Medicare reviews and determinations, follow the CMS section of the policy (Medicare has no NCD or LCD for Leqvio; MAOs may create their own coverage determinations).
FDA indication (informational): Leqvio is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Continuation of therapy: Leqvio is covered for patients with documentation of a positive clinical response to Leqvio therapy who continue to meet prescribing and other policy requirements.
Approved Off-Label Compendial Use: "Established cardiovascular disease"

20 Active Policies

ARKBLUE-INCLISIRAN-E-G-LEQVIO-B28A852633, Inclisiran (e.g., Leqvio)

FLORIDA_BLUE-FLBLUE-INCLISIRAN-LEQVIO-4E7BFE4578, Inclisiran (Leqvio)

BCBSLA-00786-5AFE2EB348, 00786 inclisiran (Leqvio)

BCBSMS-L-5-01-587-B322966D97, Leqvio (inclisiran)

BCBSMS-S-5-01-587-251191E7D1, State and School Employees' Health Insurance Plan - Leqvio (inclisiran)

HEALTHPARTNERS-CC-ENTRY-248558, Inclisiran (Leqvio)

MULTI

POINT32HEALTH-MDMNG-13151, Leqvio (inclisiran)

MULTI

POINT32HEALTH-MDMNG-13161, Leqvio (inclisiran)

MULTI

BCBSNE-X-189-91AF3AF97B, LEQVIO (PREAUTHORIZATION REQUIRED)

MODA-LEQVIO-A0E6DB9175, Leqvio (inclisiran)

HEALTHNET_OR-HNOR-INCLISIRAN-LEQVIO-CP-PHAR-568-C5DD36851B, Inclisiran (Leqvio); CP.PHAR.568

IBX-COMMERCIAL-08-01-91A-D80812CDC9, Inclisiran (Leqvio)

IBX-MEDICARE-ADVANTAGE-MA08-149A-B7CE3834B0, Inclisiran (Leqvio)

BCBSTN-16e935264b, Inclisiran (Leqvio)

EVICORE-MEDICAL_DRUG-8CD2FD92B9A2, Leqvio (inclisiran subcutaneous injection)Effective 10/01/2026

EVICORE-MEDICAL_DRUG-E814EEC48B04, Leqvio (inclisiran subcutaneous injection)

UHC-COMM-MD-LEQVIO-INCLISIRAN-COMMUNITY-PLAN-MEDICAL-42EC3497CF, Leqvio (Inclisiran) – Community Plan Medical Benefit Drug Policy

UHC-POL-leqvio, Leqvio (Inclisiran)

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Ask Backwork about documentation requirements, denial risks, or coverage in your state.

Ask Backwork about J1306 Sign up free

J1306, Injection, inclisiran, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Have a follow-up question?

J1306, Injection, inclisiran, 1 mg

Prior Authorization

Medicare Pricing

Documentation Required

Key Coverage Criteria

20 Active Policies

Have a follow-up question?

`J1306`, Injection, inclisiran, 1 mg

`J1306`, Injection, inclisiran, 1 mg