Prior Authorization : Preferred Drug List

Bile Salts Drugs

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

Bylvay, Cholbam, and Livmarli

PA requests for Bylvay, Cholbam, or Livmarli must be completed, signed, and dated by the prescriber. PA requests for Bylvay, Cholbam, or Livmarli must be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of PA/DGA form.

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 Bylvay, Cholbam, or Livmarli 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 Bylvay and Livmarli

The clinical criteria for approval of a PA request for Bylvay or Livmarli are all of the following:

• The member's age must be consistent with FDA-approved product labeling for the drug requested.
• One of the following is true:
  • The member has pruritus associated with PFIC.
  • The member has cholestatic pruritus associated with ALGS.

Supporting clinical information and a copy of the member's current medical records must be submitted with the PA request to support the member's condition and outline the member's current treatment plan.

If the clinical criteria for Bylvay or Livmarli are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Bylvay and Livmarli may be approved for up to 365 days. Renewal PA requests must include supporting clinical information and copies of the member's current medical records demonstrating that the member had a significant reduction in pruritus symptoms compared to the member's baseline prior to the initiation of the drug requested.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.

Clinical Criteria for Cholbam

The clinical criteria for approval of a PA request for Cholbam are all of the following:

• The member's age must be consistent with FDA-approved product labeling for Cholbam.
• One of the following is true:
  • The member has a bile acid synthesis disorder due to single enzyme defects.
  • The member has a peroxisomal disorder (including Zellweger spectrum disorders) and exhibits manifestations of liver disease, steatorrhea, or complications from decreased fat-soluble vitamin absorption.

Supporting clinical information and a copy of the member's current medical records must be submitted with the PA request to support the member's condition and outline the member's current treatment plan. The member's baseline AST, ALT, GGT, alkaline phosphatase, bilirubin, and INR, prior to starting Cholbam, must be submitted with the initial PA request.

If the clinical criteria for Cholbam are met, initial PA requests may be approved for up to 90 days.

Renewal PA requests for Cholbam may be approved for up to 365 days. Renewal PA requests for Cholbam must include supporting clinical information and copies of the member's current medical records and lab work, including updated AST, ALT, GGT, alkaline phosphatase, bilirubin, and INR values, which demonstrate that the member's liver function has improved, compared to the member's baseline prior to the initiation of Cholbam.

All renewal PA requests require the member to be adherent with the prescribed treatment regimen.