Prior Authorization : Preferred Drug List

Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitors

Note: The Preferred Drug List Quick Reference provides the most current list of preferred and non-preferred drugs in this drug class.

All drugs in the lipotropics, ACL inhibitor drug class are non-preferred and require PA.

PA requests for lipotropics, ACL inhibitor drugs must be completed and signed by the prescriber. PA requests for lipotropics, ACL inhibitor drugs should be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form. Clinical documentation supporting the use of a lipotropics, ACL inhibitor drug also must be submitted with the PA request.

The PA form must be sent to the pharmacy where the prescription will be filled. The prescriber may send the PA form to the pharmacy, or the member may carry the PA form with the prescription to the pharmacy. The pharmacy provider will use the completed PA form to submit a PA request to ForwardHealth. The prescriber should not submit the PA form to ForwardHealth.

Pharmacy providers are required to submit the completed PA/DGA form and a completed PA/RF to ForwardHealth.

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

For information about general ForwardHealth PA policy for drugs that require PA approval, prescribers and pharmacy providers may refer to the Standard Pharmacy Policy for Covered and Noncovered Drugs topic. Providers may also refer to this topic for information about what may not be considered criteria to support the need for a drug.

Conditions for Which PA Requests for Use of Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs Will Be Considered for Review

ForwardHealth will only consider PA requests for lipotropics, ACL inhibitor drugs to treat the following identified clinical conditions:

• Clinical ASCVD
• HeFH

Clinical Criteria for Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs for Members With Clinical Atherosclerotic Cardiovascular Disease

Clinical criteria that must be documented for approval of a PA request for lipotropics, ACL inhibitor drugs 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 ankle-brachial index of less than 0.85
    • Peripheral arterial revascularization procedure or amputation due to atherosclerotic disease
• The member must have taken a 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 a statin during treatment with a lipotropics, ACL inhibitor drug.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for lipotropics, ACL inhibitor drugs. 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 ACL 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)

Initial and Renewal PA Requests for Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs for Members With Clinical Atherosclerotic Cardiovascular Disease

If the clinical criteria for lipotropics, ACL inhibitor drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for lipotropics, ACL inhibitor drugs may be approved for up to 365 days. 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 a statin during treatment with the lipotropics, ACL inhibitor drug.

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 Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs for Members With Heterozygous Familial Hypercholesterolemia

Clinical criteria that must be documented for approval of a PA request for lipotropics, ACL inhibitor drugs for members with HeFH are all of the following:

• 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 must have taken a 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 a statin during treatment with a lipotropics, ACL inhibitor drug.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for lipotropics, ACL inhibitor drugs. 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 ACL 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)

Initial and Renewal PA Requests for Lipotropics, Adenosine Triphosphate—Citrate Lyase Inhibitor Drugs for Members With Heterozygous Familial Hypercholesterolemia

If the clinical criteria for lipotropics, ACL inhibitor drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for lipotropics, ACL inhibitor drugs may be approved for up to 365 days. 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 the pre-treatment baseline or a decrease to 130 mg/dL or less. Members also must continue to take a statin during treatment with a lipotropics, ACL inhibitor drug.

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.