Prior Authorization : Preferred Drug List

Glucocorticoids, Oral

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

Agamree and Emflaza

Clinical PA is required for Agamree and Emflaza.

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

Clinical criteria that must be documented for approval of a PA request for Agamree or Emflaza are all of the following:

• The member has a diagnosis of DMD.
• The member's age must be consistent with FDA-approved product labeling for Agamree or Emflaza.
• The prescription is written by or through consultation with a neurologist.
• The member has experienced a clinically significant glucocorticoid adverse drug reaction with an adequate trial of prednisone that has required a dose reduction or discontinuation of prednisone.

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

• The member's medical condition being treated
• Details regarding previous medication use
• The member's current treatment plan

If clinical criteria for Agamree or Emflaza are met, initial PA requests may be approved for up to 183 days.

Renewal PA requests for Agamree or Emflaza may be approved for up to 365 days. Renewal PA requests for members who have DMD must include supporting clinical information and copies of the member's current medical records demonstrating that the member has experienced an improvement or resolution of the initial glucocorticoid adverse effects experienced with prednisone.

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