Prior Auth Protocol

FDA Approved Indications:

Tobi, Tobi Podhaler: Management of cystic fibrosis patients with Pseudomonas aeruginosa
Kitabis Pak: Management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa

Health Net Approved Indications and Usage Guidelines:

Documented diagnosis of cystic fibrosis in patients with Pseudomonas aeruginosa

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Safety and efficacy of Tobi, Tobi Podhaler, and Kitabis Pak have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volumne in 1 second (FEV1) <25% or >75% predicted (Tobi, Kitabis Pak) or >80% (Podhaler) predicted, or patients colonized with Burkholderia cepacia.
Tobi, Tobi Podhaler, and Kitabis Pak should be taken in repeated cycles of 28 days on drug followed by 28 days off drug.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Tobi	The recommended dosage for both adults and pediatric patients > 6 years of age is 1 single-use ampule (300 mg) administered via nebulizer twice daily for 28 days. Dosage is not adjusted by weight. All patients should be administered 300 mg twice daily. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart. 28 day on/off cycle.	Length of benefit AHCS: One year
Tobi Podhaler	Four 28 mg capsules inhaled twice daily (28 day on/off cycle)	Length of benefit AHCS: One year
Kitabis Pak	One single-use ampule (300 mg) administered via nebulizer twice daily (28 day on/off cycle)	Length of benefit AHCS: One year

Product Availability:

References:

Micromedex^R Healthcare Series, [Internet database]. Greenwood Village, Colorado: Thomson Healthcare. Updated periodically. Accessed May 29, 2015.
Tobi [prescribing information] East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2014.
Tobi Podhaler [prescribing information] East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2014.
Kitabis Pak [prescribing information] Woodstock, IL: Catalent Pharma Solutions; November 2014.