Prior Authorization : Services Requiring Prior Authorization

Roctavian

Roctavian requires clinical PA and is covered under the pharmacy benefit. Pharmacy providers should submit a pharmacy noncompound drug claim for Roctavian.

For 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.

Claim Requirements for Roctavian

Physician-administered Roctavian will be reimbursed separately from physician and clinical services associated with the administration of Roctavian.

The pharmacy provider is required to establish a delivery process with the prescriber to ensure that physician-administered Roctavian is delivered directly to the prescriber or an agent of the prescriber. Pharmacy providers may only submit a claim to ForwardHealth for Roctavian that has been administered to a member. If Roctavian 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 Roctavian that is not administered to the member, the dispensing pharmacy is responsible for reversing any claims submitted to ForwardHealth.

Clinical Criteria for Roctavian

The following clinical criteria that must be documented for approval of a PA request for Roctavian are all of the following:

• Roctavian must be prescribed by a hematologist at a dose of 6 x 1013 vector genomes per kilogram of body weight.
• The member is 18 years of age or older.
• The member has been diagnosed with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL) without pre-existing antibodies to AAV5.
• The prescriber must include documentation of testing for pre-existing antibodies to AAV5 using the FDA-approved companion diagnostic. If the companion diagnostic test is positive for antibodies to AAV5, PA for Roctavian will not be approved.
• The prescriber must include documentation of liver health assessments including ALT, AST, GGT, ALP, total bilirubin, INR, hepatic ultrasound and elastography, or laboratory assessments for liver fibrosis. If the member has radiological liver abnormalities and/or sustained liver enzyme elevations, documentation of a consultation with a hepatologist to assess eligibility for Roctavian will be required.

Supporting clinical information and a copy of the member's current medical records must be included in all PA requests for Roctavian. 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 Roctavian

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