Description
Tobramycin (Tobi®, Bethkis®, Kitabis™ Pak), an inhaled aminoglycoside antibacterial, is indicated for the management of Cystic Fibrosis (CF) in individuals with
Pseudomonas aeruginosa
.
Dornase alfa (Pulmozyme®) is a recombinant DNase enzyme indicated in individuals in conjunction with standard therapies for the management of CF to improve pulmonary function.
Aztreonam (Cayston®), an inhaled monobactam antibacterial, is indicated to improve respiratory symptoms in CF in individuals with
Pseudomonas aeruginosa
.
Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
The use of Tobramycin, inhaled product, may be considered medically necessary for the management of CF when the following criteria is met:
-
The individual tests positive for
Pseudomonas aeruginosa,
either for acute eradication protocol or for chronic inhalation therapy for chronic pseudomonas colonization.
Tobramycin nebs are clinically used for symptomatic pseudomonas tracheitis in children who are tracheostomy dependent.
The use of Tobramycin, inhaled product, for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.