Prior Authorization : Preferred Drug List

Lipotropics, Apo-B Inhibitors

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

PA is required for all lipotropics, apo-B inhibitor drugs.

PA requests for lipotropics, apo-B inhibitor drugs must be completed, signed, and dated by the prescriber. PA requests for lipotropics, apo-B inhibitor drugs must 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, apo-B 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. Prescribers 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, apo-B inhibitor drugs may be submitted 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.

Clinical Criteria for Lipotropics, Apolipoprotein B Inhibitor Drugs

Clinical criteria that must be documented for approval of a PA request for lipotropics, apo-B inhibitor drugs are all of the following:

• The member has HoFH, as evidenced by one of the following:
  • The member has genetic confirmation of two of the following mutant alleles at the LDL receptor:
    • Apo-B
    • PCSK9
    • ARH adaptor protein gene locus
  • The member has an untreated LDL-C greater than 500 mg/dL or a total treated LDL-C greater than or equal to 300 mg/dL and one of the following:
    • Cutaneous tendinous xanthoma(s) before 10 years of age
    • Untreated LDL-C levels of greater than or equal to 190 mg/dL in both parents
• The member must have attempted to maximize treatment with LDL-lowering therapies prior to requesting a lipotropics, apo-B inhibitor drug. The member must have taken a PCSK9 inhibitor combined with a statin for at least three continuous months with failure to reach an LDL level of 130 mg/dL or less, or the member has had a clinically significant adverse drug reaction, clinically significant drug interaction, or medical condition preventing the member from using these drugs. Members also must continue to take the maximized LDL-lowering treatment regimen during treatment with the lipotropics, apo-B inhibitor drug.

Note: The member's inability to use one or more of the previously described drug therapies does not preclude the requirement for the member to use all of the above drug therapies for which the member does not have a clinically significant adverse drug reaction, clinically significant drug interaction, or medical condition preventing the member from using a specific drug.

Supporting clinical information and a copy of the member's current medical records must be submitted with all PA requests for lipotropics, apo-B inhibitor drugs. The supporting clinical information and medical records must document the following:

• Evidence that the member has HoFH
• 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 lipotropics, apo-B inhibitor drugs are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for lipotropics, apo-B inhibitor drugs may be approved for up to 365 days. Renewal PA requests for members who have HoFH 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 160 mg/dL or less. Members also must continue to take the maximized LDL-lowering treatment regimen during treatment with the lipotropics, apo-B 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.