Pharmacy Prior Authorization Criteria

Tobramycin Inhaled Products - ST, NF

Indications for Prior Authorization

Bethkis (tobramycin) Inhalation Solution

• For diagnosis of 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.

Kitabis Pak (co-packaged tobramycin inhalation solution PARI LC PLUS reusable nebulizer)

• For diagnosis of Cystic fibrosis
  Indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with P. aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 less than 25% or greater than 75% predicted, or patients colonized with Burkholderia cepacia.

TOBI (tobramycin) Inhalation Solution

• For diagnosis of 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.

Criteria

Brand Bethkis Inhalation Solution, Kitabis Pak, Brand TOBI Inhalation Solution

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication.
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

Brand Bethkis Inhalation Solution, Kitabis Pak, Brand TOBI Inhalation Solution

Non Formulary

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication.
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming 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

P & T Revisions

2024-05-02, 2023-05-05, 2022-04-04, 2022-01-20, 2021-04-06, 2021-01-06, 2020-11-24, 2020-03-12

References

1. Kitabis Pak Prescribing Information. Catalent Pharma Solutions, LLC. Woodstock, IL. April 2023.
2. TOBI Prescribing Information. Novartis Pharmaceuticals. East Hanover, NJ. February 2023.
3. Bethkis Prescribing Information. Chiesi USA, Inc. Woodstock, IL. February 2023.

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Revision History

• 2024-05-02: Annual review: No criteria changes.
• 2023-05-05: Annual review: No criteria changes. Updated indications and references. Attached EHB formulary.
• 2022-04-04: Annual Review: No changes to clinical criteria. Updated references. Updated indications section to align with PI.
• 2022-01-20: updated criteria to create a separate NF section that asks for an FDA approved diagnosis and a trial/failure requirement. Update GL name to add "- ST, NF". Also, added a diagnosis requirement to current ST section.
• 2021-04-06: 2021 Annual Review. Added minimum days supply requirement, removed 'contraindication'.
• 2021-01-06: updated strategy to step through generics
• 2020-11-24: Added generic Bethkis as t/f alternative to existing step
• 2020-03-12: 2020 Annual Review, no changes to criteria.

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