TOBI Podhaler

Drug - TOBI Podhaler [Novartis]

October 2013

Therapeutic area - Cystic Fibrosis

Approval criteria

• Patient is 6 years of age or older AND
• Patient has a diagnosis of cystic fibrosis AND
• The prescriber has submitted detailed clinical justification for prescribing TOBI™ Podhaler™ instead of TOBI™ inhalation solution, including clinical information why the member cannot use TOBI™ inhalation solution and why it is medically necessary for the member to receive TOBI™ Podhaler™ instead of TOBI™ inhalation solution.

Quantity limit

224 capsules per a 28-day supply

Background information

TOBI™ Podhaler™ is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >80% predicted, or patients colonized with Burkholderia cepacia.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411