Prior Authorization : Services Requiring Prior Authorization

Hemgenix

Hemgenix requires clinical PA.

Hemgenix is covered and reimbursed under the pharmacy benefit. Providers should submit claims for Hemgenix to ForwardHealth using a noncompound drug claim. For specific questions about the billing or coverage of high cost, orphan, and accelerated approval drugs, providers may contact Provider Services or email DHSOrphanDrugs@dhs.wisconsin.gov.

Additional Requirements for Hemgenix

Physician-administered Hemgenix is reimbursed separately from physician and clinical services associated with the administration of Hemgenix. The pharmacy provider is required to establish a delivery process with the prescriber to ensure that physician-administered Hemgenix is delivered directly to the prescriber or an agent of the prescriber. Pharmacy providers may only submit a claim to ForwardHealth for Hemgenix that has been administered to a member. If Hemgenix has been dispensed for a member but the dose is not administered to the member, the prescriber is responsible for notifying the dispensing pharmacy. If ForwardHealth has paid the dispensing pharmacy for any portion of the dispensing of Hemgenix that is not administered to the member, the dispensing pharmacy is responsible for reversing any claims submitted to ForwardHealth.

Clinical Criteria for Hemgenix

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

• Hemgenix must be prescribed by a hematologist at a dose of 2 x 10¹³ genome copies (gc) per kilogram of body weight.
• The member has been diagnosed with Hemophilia B (congenital Factor IX deficiency).
• The member is 18 years of age or older.
• The member must currently be treated with Factor IX prophylaxis therapy.
• The member must have a current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
• The prescriber must include documentation of Factor IX inhibitor titer testing. In case of a positive test result for human Factor IX inhibitors, perform a re-test within approximately 2 weeks. If both the initial test and re-test results are positive, PA for Hemgenix will not be approved.
• The prescriber must include documentation of liver health assessments including, ALT, AST, ALP, total bilirubin, hepatic ultrasound, and hepatic elastography. If the member has radiological liver abnormalities and/or sustained liver enzyme elevations, documentation of a consultation with a hepatologist to assess eligibility for Hemgenix will be required.

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

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

Submitting PA Requests for Hemgenix

PA requests for Hemgenix must be completed, signed, and dated by the prescriber. PA requests for Hemgenix 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 Hemgenix 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 Hemgenix may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).