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New Notification/Prior Authorization Required for Specialty Medications Renflexis and Brineura

August 1, 2017

Renflexis™, Effective Aug. 1
Renflexis (infliximab-abda), a biosimilar to Remicade®, is covered under the medical benefit and has been added to the notification/Prior Authorization program for dates of service on or after Aug.1. The notification/Prior Authorization includes:

  • Indication
  • Preferred product
  • Site of service (if requested in an outpatient hospital setting)

Renflexis has similar indications to Remicade including ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, ulcerative colitis and rheumatoid arthritis.

If coverage is not approved, the prescribing physician and patient may decide to switch to Remicade, UnitedHealthcare’s preferred infliximab product, and/or transition services to an alternate site of service for the patient to continue benefit coverage. Note Inflectra® was the first infliximab biosimilar product approved by the U.S. Food and Drug Administration (FDA), which also requires Prior Authorization.

Brineura™, Effective Oct. 1
Effective April 27, the FDA approved BioMarin Pharmaceutical’s Brineura (cerliponase alfa), a specialty injectable medication used to treat a form of Batten1 disease. Brineura will be covered on the UnitedHealthcare medical benefit with Prior Authorization review required, effective Oct. 1.

The notification/Prior Authorization requirement for Renflexis and Brineura applies to all UnitedHealthcare commercial plans including:

  • UnitedHealthcare of the Mid-Atlantic
  • UnitedHealthcare Oxford
  • Neighborhood Health Partnership (NHP)
  • UnitedHealthcare of the River Valley

Failure to complete the Prior Authorization process prior to the administration could result in claim denial. Health care providers cannot bill members for services that are denied for failure to complete the Prior Authorization process.

For more information, visit UnitedHealthcare’s Specialty Pharmacy Information Center or contact your UnitedHealthcare representative.

1 Batten disease is a fatal, inherited disorder of the nervous system that typically begins in childhood.