On Sept. 25, 2020, the FDA approved Kalydeco (ivacaftor) to treat children four months through six months of age with cystic fibrosis who have at least one cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation. Previously, Kalydeco was approved only for children six months and older. On Dec. 28, 2020, VDP will update the Kalydeco clinical prior authorization criteria to reflect the newly FDA-approved indication for use in children age four months to less than six months with at least one CFTR gene mutation responsive to Kalydeco.
This prior authorization is optional for use in Medicaid managed care. The Pharmacy Clinical Prior Authorization Assistance Chart (PDF) shows the prior authorization each health plans uses and how those authorizations relate to the authorizations used for traditional Medicaid claim processing. This chart is updated quarterly. Providers can also refer to the MCO Resources for links to each MCO's clinical prior authorizations.