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New Notification/Prior Authorization Required for Exondys-51, Xolair, and Inflectra
March 2, 2017
UnitedHealthcare commercial plans are implementing new notification/Prior Authorization requirements for administration of the following new specialty medications:
Exondys-51™ Notification/Prior Authorization
Effective Feb. 1
Exondys-51 is used to treat Duchenne muscular dystrophy (DMD) in patients who carry a specific gene mutation. Approximately 13 percent of the DMD population may be eligible for treatment with this medication. Upon receipt of notification for Exondys-51, UnitedHealthcare will determine if the member’s benefit plan requires services to be medically necessary for coverage. If so, a clinical review will be conducted. Members on a Medical Necessity-based benefit will also have site of service redirection requirements applied during the review process, if services are requested in an outpatient facility. If coverage is approved, providers may purchase and directly bill UnitedHealthcare for this medication.
Xolair® Notification/Prior Authorization
Effective April 1
Xolair (J2357 omalizumab) is a monoclonal anti-IgE antibody used in moderate to severe persistent asthma. Previously, this drug required specialty pharmacy distribution protocol as part of UnitedHealthcare’s Physician, Health Care Professional, Facility and Ancillary Provider Administrative Guide. Upon receipt of notification for Xolair, UnitedHealthcare will determine if the member’s benefit plan requires services to be considered medically necessary for coverage. If so, a clinical review will be conducted as part of the Prior Authorization process. If the coverage is approved, providers may purchase and directly bill UnitedHealthcare for this medication.
Inflectra® Notification/Prior Authorization
Effective April 1
Inflectra (infliximab biosimilar) is used to treat inflammatory conditions such as: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and ulcerative colitis. A clinical review will be conducted as part of the Prior Authorization process, as well as reviewed for use of our preferred infliximab product, Remicade®. We will also review for Site of Service, if requested in an outpatient hospital setting.
Spinraza™ Notification/Prior Authorization
Effective April 1
Spinraza (nusinersen) is a newly approved specialty injectable medication used to treat spinal muscular atrophy, a rare genetic disease which impacts muscle strength and movement. This medication requires physician administration into the fluid surrounding the spinal cord and will be covered on the medical benefit starting April 1. The Prior Authorization requirement applies to members who are new to therapy and members currently on Spinraza. A clinical review will be conducted as part of the Prior Authorization process to evaluate whether this drug is appropriate for the individual member, taking the following into account:
- Our drug coverage policy
- Confirmation of the gene mutation resulting in a condition amenable to treatment
- The member’s respiratory status
- Dosage recommendation from the U.S. Food and Drug Administration-approved labeling
These notification/Prior Authorization requirements are part of our ongoing efforts to give members access to services that are medically appropriate while working toward delivering better care, better outcomes and lower costs of care.
The provider and member will be notified of the coverage determination within 15 calendar days of receiving all required information, although review times may vary based on applicable state regulation. If a provider does not complete the notification/Prior Authorization process before administering these drugs, claims may be denied and the member cannot be billed for the service.
For more information, visit UnitedHealthcare’s Specialty Pharmacy Information Center or contact your UnitedHealthcare representative with any questions.
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