Clinical Prior Authorization Updates for Cystic Fibrosis Agents

Published on
January 29, 2021

HHSC currently requires all MCOs to implement the Orkambi criteria of the current cystic fibrosis agents clinical prior authorization (PDF). On March 1, 2021, HHSC will update the clinical prior authorization, and all agents will be optional, with Orkambi no longer required.

The Food and Drug Administration recently expanded the indications for Kalydeco, Orkambi, Symdeko, and Trikafta. On April 6, 2021, HHSC will update the cystic fibrosis 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 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 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 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