Cystic Fibrosis Treatment Agents

Traditional Medicaid

HHSC requires prior authorization for claims for Kalydeco, Orkami, Symdeko, and Trikafta. Prescribing providers complete and submit the Cystic Fibrosis Treatment Agents Prior Authorization Request (Medicaid) (HHS Form 1338).

CSHCN Services Program

HHSC requires prior authorization for the following specific cystic fibrosis treatment agents:

  • HHSC covers Kalydeco and Pulmozyme for treating cystic fibrosis as prescribed by a program-approved pulmonologist and may approve treatment for six months with subsequent approval for one year.  Pharmacy providers can only dispense one month’s supply at a time.
  • HHSC covers Cayston and inhaled Tobramycin for treating cystic fibrosis as prescribed by a program-approved pulmonologist and limits an administration cycle of 28 days of treatment followed by 28 days with no agent treatment.
    • Pharmacy providers can submit an eligibility verification transaction to find a client's most current period of approval for Tobramycin. Refer to the Eligibility Verification (E1) Transaction for specific transaction, segment, field requirements, and response messages.

Prescribing providers complete and submit the Cystic Fibrosis Treatment Products Authorization Request (HHS Form 1143). The provider must submit the form annually, certifying the client requires these medications. Providers must supply medical necessity documentation for clients with a diagnosis other than cystic fibrosis.