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Clinical Criteria Update for Orkambi Scheduled for November 9, 2022

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On November 9, 2022, the Texas Health and Human Services Commission (HHSC) will implement the clinical prior authorization criteria updates for Orkambi (lumacaftor/ivacaftor). The U.S. Food and Drug Administration (FDA) has approved Orkambi for children one year through two years of age with cystic fibrosis with two F508del mutations. This change follows the recent approval for age expansion.

The prior authorization criteria for Orkambi are part of the clinical prior authorization criteria guide for cystic fibrosis agents.

Clinical prior authorization for cystic fibrosis agents is optional for MCOs. The Pharmacy Clinical Prior Authorization Assistance Chart shows each MCO's prior authorizations and how those authorizations relate to those used for processing fee-for-service Medicaid claims. This chart is updated quarterly. Providers can also refer to MCO Resources for links to each MCO's list of clinical prior authorizations.

Email vdp-formulary@hhsc.state.tx.us with comments or any questions.