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Clinical Prior Authorization Updates for Cystic Fibrosis Agents

Last updated on 2/12/2021

On March 1, 2021, the Texas Health and Human Services Commission (HHSC) will update the prior authorization criteria for Cystic Fibrosis Agents. All agents will be optional, with Orkambi no longer required.

On April 6, 2021, HHSC will update the cystic fibrosis (CF) agents prior authorization criteria to reflect recent FDA-approved indication expansions:

  • Kalydeco
    • Question 9 updated.
    • Removed specific mutations and modified question to ask if the client has a diagnosis of CF with one mutation in the CFTR gene responsive to Kalydeco based on clinical or in vitro assay data.
    • Added statement noting if the genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation.
  • Orkambi
    • Question 9 updated.
    • Modified question to ask if the genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation of both alleles of the CFTR gene.
  • Symdeko
    • Question 5 updated.
    • Removed specific mutations and modified question to ask if the client has a diagnosis of CF with one mutation in the CFTR gene responsive to Symdeko based on clinical and/or in vitro assay data.
    • Added a statement noting that if the genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation.
  • Trikafta
    • Question 2 updated.
    • Modified question to ask if client has at least one F508del mutation OR a mutation in the CFTR gene responsive to Trikafta based on in vitro data.
    • Added a statement noting that if the genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation.

The Cystic Fibrosis Agents prior authorization is optional, as of March 1, 2021. The Pharmacy Clinical Prior Authorization Assistance Chart (PDF) shows the prior authorization each managed care organization (MCO) uses and how those authorizations relate to the authorizations used for processing fee-for-service Medicaid claims. This chart is updated quarterly. Providers can also refer to the MCO Resources for links to each MCO's list of clinical prior authorizations.