J1306 — Injection, inclisiran, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without 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.
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.
- Authorization of hospital outpatient facility infusion services (place of service codes 19 and 22) for specialty medications and IVIG/SCIG when outpatient hospital facility-based administration is medically necessary and the member meets at least one of the criteria below.
14 Active Policies
UHC-POL-leqvio — Leqvio (Inclisiran)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-leqvio — Leqvio (Inclisiran)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-leqvio — Leqvio (Inclisiran)
Related Codes
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