Prior Authorization : Services Requiring Prior Authorization

Leqvio

Leqvio is a physician-administered drug that requires clinical PA.

All PA requests for Leqvio must be submitted with a specific HCPCS "J" code, J1306 (Injection, inclisiran, 1 mg).

PA requests for Leqvio must be completed, signed, and dated by the prescriber. PA requests for Leqvio must be submitted using Section V (Clinical Information for Physician-Administered Drugs With Specific PA Criteria Addressed in the ForwardHealth Online Handbook) on the PA/PAD form. Clinical documentation supporting the use of Leqvio must be submitted with the PA request.

Prescribers are required to submit the completed PA/PAD form and a completed PA/RF to ForwardHealth.

PA requests for Leqvio may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Conditions for Which PA Requests for Use of Leqvio Will Be Considered for Review

ForwardHealth will only consider PA requests for Leqvio to treat the following identified clinical conditions:

• Clinical ASCVD
• HeFH

Clinical Criteria for Leqvio for Members With Clinical Atherosclerotic Cardiovascular Disease

Clinical criteria that must be documented for approval of a PA request for Leqvio for members with clinical ASCVD are all of the following:

• The member has clinical ASCVD, as evidenced by one of the following:
  • The member has CAD, which is supported by a history of one of the following:
    • Myocardial infarction (heart attack)
    • Coronary revascularization
    • Angina pectoris
  • The member has a history of non-hemorrhagic stroke.
  • The member has symptomatic peripheral arterial disease as evidenced by one of the following:
    • Intermittent claudication with an ABI of less than 0.85
    • Peripheral arterial revascularization procedure or amputation due to atherosclerotic disease
• The member has taken a PCSK9 inhibitor drug concurrently with a maximized statin regimen for at least three continuous months with failure to reach an LDL less than or equal to 70 mg/dL. The member must continue to take the maximally tolerated dose of a statin during treatment with Leqvio.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Leqvio. The supporting clinical information and medical records must document the following:

• Evidence that the member has clinical ASCVD
• A current lipid panel lab report
• Documentation of the member's current and previous PCSK9 inhibitor and statin drug therapies, including the following for each trial:
  • Drug name(s) and dosage
  • Dates taken
  • Lipid panel report prior to and during drug therapy (including dates taken)
  • Reasons for discontinuation if drug therapy was discontinued

If the clinical criteria for Leqvio are met, initial PA requests may be approved for the initial and three-month doses.

Renewal PA requests for Leqvio may be approved for up to two doses per year. Renewal PA requests for members who have clinical ASCVD must include supporting clinical information and copies of the member's current medical records demonstrating evidence of LDL reduction of at least 30 percent from pre-treatment baseline or a decrease to 100 mg/dL or less. Members also must continue to take the maximized statin treatment regimen during treatment with Leqvio.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen. A copy of the current lipid panel report (within the past 30 days) must be included with the PA request.

Clinical Criteria for Leqvio for Members With Heterozygous Familial Hypercholesterolemia

Clinical criteria that must be documented for approval of Leqvio for members with HeFH are all of the following:

• The member's age is consistent with the FDA-approved product labeling for Leqvio.
• The member has been diagnosed by a specialist in cardiology or lipid management.
• The member has HeFH, as evidenced by clinical documentation that supports a definitive diagnosis of HeFH using either WHO criteria (Dutch Lipid Clinic Network clinical criteria with a score greater than eight) or Simon Broome diagnostic criteria.
• The member has taken a PCSK9 inhibitor drug concurrently with a maximized statin regimen for at least three continuous months with failure to reach an LDL less than or equal to 100 mg/dL. The member must continue to take the maximally tolerated dose of a statin during treatment with Leqvio.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for Leqvio. The supporting clinical information and medical records must document the following:

• Evidence that the member has HeFH
• A current lipid panel lab report
• Documentation of the member's current and previous PCSK9 inhibitor and statin drug therapies, including the following for each trial:
  • Drug name(s) and dosage
  • Dates taken
  • Lipid panel report prior to and during drug therapy (including dates taken)
  • Reasons for discontinuation if drug therapy was discontinued

If the clinical criteria for Leqvio are met, initial PA requests may be approved for the initial and three-month doses.

Renewal PA requests for Leqvio may be approved for up to two doses per year. Renewal PA requests for members who have HeFH must include supporting clinical information and copies of the member's current medical records demonstrating evidence of LDL reduction of at least 30 percent from pre-treatment baseline or a decrease to 130 mg/dL or less. Members also must continue to take the maximized statin treatment regimen during treatment with Leqvio.