Prior Authorization : Services Requiring Prior Authorization

Cystic Fibrosis Drugs Containing Ivacaftor

Clinical PA is required for all cystic fibrosis drugs containing ivacaftor.

PA requests for cystic fibrosis drugs containing ivacaftor will only be approved for one cystic fibrosis drug containing ivacaftor per member. ForwardHealth does not cover treatment with more than one cystic fibrosis drug containing ivacaftor.

PA requests for cystic fibrosis drugs containing ivacaftor should be submitted using Section VI (Clinical Information for Drugs With Specific Criteria Addressed in the ForwardHealth Online Handbook) of the PA/DGA form.

PA requests for cystic fibrosis drugs containing ivacaftor may be submitted on the Portal, by fax, or by mail (but not using the STAT-PA system).

Clinical criteria that must be documented for approval of a PA request for cystic fibrosis drugs containing ivacaftor are all of the following:

• The member has cystic fibrosis.
• The member's age is consistent with the FDA-approved indication for the use of the specific cystic fibrosis drug containing ivacaftor.
• The member has a gene mutation consistent with the FDA-approved indication for the use of the specific cystic fibrosis drug containing ivacaftor. (Note: A copy of the gene mutation test results must be included with an initial PA request.)

A copy of the member's medical records must be submitted with all PA requests for cystic fibrosis drugs containing ivacaftor. Medical records should document the following:

• Current progress notes related to the member's cystic fibrosis treatment plan
• A copy of the member's current pulmonary function test results

Initial PA requests for cystic fibrosis drugs containing ivacaftor may be approved for up to 183 days.

Renewal PA requests require that the member has been adherent with their entire cystic fibrosis medication regimen and that there is documentation demonstrating the member has experienced clinical improvement with the prescribed cystic fibrosis drug containing ivacaftor. Renewal PA requests may be approved for up to a maximum of 365 days.