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Prior Review Now Required for Ivacaftor (Kalydeco)

A new drug for cystic fibrosis, Kalydeco, was recently approved by the FDA and is about to be released to the market.  Effective February 7, 2012, Blue Cross and Blue Shield of North Carolina (BCBSNC) will require prior review of Kalydeco with the following criteria: 

Ivacaftor (Kalydeco) will be covered for an eligible BCBSNC member with the following conditions:

  1. Patient is age 6 years and older.
  2. Patient has a G551D mutation as detected by an FDA- cleared CF mutation test.

Ivacaftor (Kalydeco) will NOT be covered for the following conditions:

  1. Patient does not have the presence of the G551D mutation.
  2. Patients with CF who are homozygous for the F508del mutation in the CFTR gene.

This prior review requirement applies to all BCBSNC commercial lines of business, except for any ASO group accounts that carve out their pharmacy benefits. This requirement does not apply to the State Health Plan, the Federal Employee Program, Blue MedicareSM, or our Medicare Supplement products.