Prior Authorization : Services Requiring Prior Authorization

Luxturna

Luxturna requires clinical PA.

Note: The Select High Cost, Orphan, and Accelerated Approval Drugs data table identifies select high cost, orphan, and accelerated approval drugs and interim billing and coverage information for these drugs. The table also identifies which drugs have specific PA or policy requirements. For specific questions about the billing or coverage of high cost, orphan, and accelerated approval drugs listed in the Select High Cost, Orphan, and Accelerated Approval Drugs data table, providers may contact Provider Services or email DHSOrphanDrugs@dhs.wisconsin.gov.

Clinical Criteria for Luxturna

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

• The member has a confirmed diagnosis of an inherited retinal dystrophy due to biallelic RPE65 mutations.
• The member has sufficient viable retinal cells (defined as an area of retinal thickness greater than 100 microns within the posterior pole) as measured by OCT.
• The member has remaining light perception in the eye(s) that will receive treatment.
• Luxturna is prescribed and administered by an ophthalmologist or retinal surgeon with experience providing subretinal injections.

If clinical criteria for Luxturna are met, PA requests may be approved on a unilateral basis for up to four weeks (one lifetime dose per eye). For consideration of continued therapy on the second eye, all of the following must apply:

• All clinical criteria for initial PA request approval must be met.
• Administration is planned within a close interval to the treatment of the first eye, but at least six days apart.
• The PA request is not for a repeat treatment of a previously treated eye.

Submitting PA Requests for Luxturna

For PA requests for Luxturna, the prescriber is required to complete, sign, and date the PA/DGA form, using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the form. The prescriber is required to send the completed PA/DGA form to the pharmacy where the prescription will be filled. The pharmacy provider is required to complete a PA/RF and submit it, along with the PA/DGA form received from the prescriber, to ForwardHealth using the PA submission option most appropriate for the drug.

PA requests for Luxturna may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).