Prior Authorization : Services Requiring Prior Authorization

Vyjuvek

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

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 Vyjuvek

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

The pharmacy provider is required to establish a delivery process with the prescriber to ensure that physician-administered Vyjuvek is delivered directly to the prescriber, an agent of the prescriber, or a health care provider designated to administer Vyjuvek to the member. Pharmacy providers may only submit a claim to ForwardHealth for the Vyjuvek that has been administered to a member. If Vyjuvek has been dispensed for a member but the dose is not administered to the member, the prescriber or health care provider designated to administer Vyjuvek to the member is responsible for notifying the dispensing pharmacy. If ForwardHealth has paid the dispensing pharmacy for any portion of the dispensing of Vyjuvek that is not administered to the member, the dispensing pharmacy is responsible for reversing any claims submitted to ForwardHealth.

Clinical Criteria for Vyjuvek

The following clinical criteria must be met and documented for approval of a PA request for Vyjuvek:

• Vyjuvek must be prescribed by a dermatologist or wound care specialist.
• The member is 6 months of age or older.
• The member has been diagnosed with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain gene.
• The prescriber must include documentation of at least one cutaneous wound that is appropriate to be treated with Vyjuvek and confirm that the wound does not appear to be infected.
• The prescriber must include documentation of the size of the wound area(s) to be treated and confirm the calculated dose of Vyjuvek will not exceed the recommended maximum weekly dose.
• The prescriber must include documentation that the member's treatment plan includes the appropriate administration of Vyjuvek by a health care provider and the wound dressing care required for treatment with Vyjuvek.
• The prescriber must include documentation that the member's treatment plan addresses the requirement for Vyjuvek to be properly prepared at a pharmacy for administration to the member's wound(s) within eight hours of mixing of the Vyjuvek gel with the Vyjuvek biological suspension.

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

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