Tobramycin Inhaled Products (BETHKIS, TOBI)

Tobramycin Inhaled Products (BETHKIS, TOBI)

Self-Administration – inhaled solutions

Diagnosis considered for coverage:

TOBI: 
Cystic fibrosis Indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older 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 >75% predicted, or patients colonized with Burkholderia cepacia.

BETHKIS:
Cystic Fibrosis Indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of six years, patients with FEV 1 less than 40% or greater than 80% predicted, or patients colonized with Burkholderia cepacia.

Coverage Criteria:

For diagnosis of cystic fibrosis:

• Diagnosis of cystic fibrosis; AND
• Patient has evidence of Pseudomonas aeruginosa in the lungs; AND
• Patient is six years of age or older; AND
• Trial and failure of a minimum 30 day supply, or intolerance to both of the following: 
  • generic tobramycin 300 mg/4 ml nebulized solution 
  • generic tobramycin 300 mg/5 ml nebulized solution 

Reauthorization Criteria:

For diagnosis of cystic fibrosis:

• Diagnosis of cystic fibrosis; AND
• Patient has evidence of Pseudomonas aeruginosa in the lungs; AND
• Patient is benefiting from treatment (i.e., improvement in lung function [forced expiratory volume in one second {FEV1}], decreased number of pulmonary exacerbations)

Dosing:

For CF (age 6 years and older):

• One single-dose ampule (300 mg) administered twice daily for a 28-day course (followed by 28 days off therapy).
• Doses should be taken as close to 12 hours apart as possible and not less than 6 hours apart

Coverage Duration: 

• Initial:1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Each medication is to be used with its own specific compatible nebulizer.
• According to guidelines from the Cystic Fibrosis Foundation for the eradication of initial P. aeruginosa infections, inhaled antibiotic therapy (tobramycin 300 mg twice a day for 28 days) is recommended for the treatment of initial or new growth of P. aeruginosa.

Policy Updates:

• 09/01/2023 – New program for Tobramycin Inhaled Products approved by P&T (P&T meeting date).

References:

1.    TOBI Prescribing Information. Novartis Pharmaceuticals. East Hanover, NJ. February 2023. 
2.    Bethkis Prescribing Information. Chiesi USA, Inc. Woodstock, IL. February 2023.