CurrentUnitedHealthcarePolicy 2025 P 1109-14

Pa Notification Bethkis Kitabis Tobi Tobramycin

Defines UnitedHealthcare prior authorization/notification coverage criteria, authorization length, reauthorization requirement, exclusions, and additional clinical/billing rules for inhaled tobramycin products (Bethkis, Kitabis Pak, TOBI solutions and Podhaler). Applies to members subject to plan benefits and state/federal mandates.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Bethkis Kitabis Tobi Tobramycin

Policy CodePolicy 2025 P 1109-14

Change TypeClarified / Revised / Annual review

Effective DateNov 16, 2025

Next Review Date

Key ActionPrior authorization/notification required; initial approval requires diagnosis criteria and positive Pseudomonas aeruginosa culture.

SourceLink

POLICY UPDATE CHANGES

9/2023 added coverage criteria for noncystic fibrosis bronchiectasis with recurrent exacerbations.

2/2021 notation of exclusion for Kitabis Pak from the majority of benefits.

9/2025 annual review with no changes to coverage criteria; updated references.

12 monthsAuthorization Duration

CF; non-CF bronchiectasisCovered Indications

Kitabis PakExcluded Product

Positive P. aeruginosa

Microbiology Requirement

Coverage Summary

This UnitedHealthcare prior authorization/notification policy applies to inhaled tobramycin products including Bethkis, TOBI Nebulizer Solution, TOBI Podhaler, and tobramycin solution for inhalation. The policy defines coverage criteria, authorization length, reauthorization requirements, and utilization rules for members subject to plan benefits and applicable mandates. Kitabis Pak is noted as excluded from coverage for the majority of benefits and may be denied based on the member's benefit plan. Overall coverage stance: covered_with_criteria.

Key policy thresholds and requirements

Authorization duration12 months

Covered indicationsCystic fibrosis and noncystic fibrosis bronchiectasis

Excluded productKitabis Pak excluded from coverage for majority of benefits

Microbiology requirementPositive P. aeruginosa culture required

Medical Necessity and Authorization Criteria

Initial Authorization

Approved when ALL of the following are met:

ALL of the following

Diagnosis
- Diagnosis of cystic fibrosis (CF)
- Noncystic fibrosis bronchiectasis alternative
  - Exacerbation criteria (one of)
    Three or more exacerbations per year
    Two or more exacerbations requiring hospitalization per year

Product Codes and References

Product list referencedmixed

Bethkis	tobramycin inhalation solution (product name)
Kitabis Pak	co-packaged tobramycin inhalation solution and PARI LC Plus Reusable Nebulizer (excluded for majority of benefits)
TOBI Nebulizer Solution	tobramycin inhalation solution formulated for DeVilbiss Pulmo-Aide and PARI LC Plus
TOBI Podhaler	tobramycin inhalation powder for Podhaler device
tobramycin solution for inhalation	generic/formulation reference

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization/notification required for Bethkis, Kitabis Pak, TOBI Nebulizer Solution, TOBI Podhaler, or tobramycin solution for inhalation; initial approval requires diagnosis criteria and positive Pseudomonas aeruginosa culture.

Bethkis
Kitabis Pak
TOBI Nebulizer Solution
TOBI Podhaler
tobramycin solution for inhalation

Documentation Required

Documentation of positive culture

Provider must document lung infection with positive culture demonstrating Pseudomonas aeruginosa for initial approval. Note: a positive P. aeruginosa culture is required for initial approval.

Background and Definitions

Inhaled tobramycin products are aminoglycoside antibacterials indicated for management of cystic fibrosis patients with Pseudomonas aeruginosa. Product-specific labeling states safety and efficacy have not been established in young children (under age 6 years) or in patients with certain lung function ranges (Bethkis: FEV1 <40% or >80% predicted; TOBI/TOBI Podhaler/Kitabis Pak: FEV1 <25% or >75–80% predicted) or in patients colonized with Burkholderia cepacia. Per product labeling, dosing is given as repeated cycles of 28 days on therapy followed by 28 days off.

P&T approval history: the program was initially approved May 2013 with subsequent P&T approvals and annual reviews in 2/2014, 2/2015, 2/2016, 2/2017, 2/2018, 2/2019, 2/2020, 2/2021, 2/2022, 2/2023, and reviews on 9/2023, 9/2024, and 9/2025. The policy cites multiple package inserts and clinical guideline references (see product package inserts and bronchiectasis guidelines/systematic reviews).

Definitions — Exacerbation

Definition: Exacerbation: Clinical worsening episode of bronchiectasis requiring medical intervention; policy uses number of exacerbations per year as coverage criterion (three or more) or hospitalizations (two or more).

Revision History

2/2021exclusion_added

Annual review updated references and added notation that Kitabis Pak is excluded from coverage for the majority of benefits (explicit exclusion noted).

9/2023criteria_added

Added coverage criteria allowing use for noncystic fibrosis bronchiectasis when diagnostic and exacerbation/hospitalization frequency criteria are met (alternative diagnosis path added for non-CF bronchiectasis with recurrent exacerbations plus positive P. aeruginosa culture).

9/2025annual_reviewLatest

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Bethkis Kitabis Tobi Tobramycin

Policy CodePolicy 2025 P 1109-14

Change TypeClarified / Revised / Annual review

Effective DateNov 16, 2025

Next Review Date

Key ActionPrior authorization/notification required; initial approval requires diagnosis criteria and positive Pseudomonas aeruginosa culture.

SourceLink

On This Page

Lung infection with positive culture demonstrating Pseudomonas aeruginosa infection

ref specifies that this block corresponds to the initial authorization criteria exactly. Please keep the JSON-encoded criteria nodes intact. (Ref: b1_0)

title": "Initial Authorization"}

Authorization Duration and Reauthorization

ALL of the following

ALL of the following
- Reauthorization
  - Authorization for 12 months on reauthorization
  - Documentation of positive clinical response to therapy (Bethkis, Kitabis Pak, TOBI Nebulizer Solution, TOBI Podhaler, or tobramycin solution for inhalation)

Documentation Required

Reauthorization documentation

For reauthorization, provider must document positive clinical response to the inhaled tobramycin therapy (Bethkis, Kitabis Pak, TOBI Nebulizer Solution, TOBI Podhaler, or tobramycin solution for inhalation).

Billing Rule

Authorization length

Authorization (initial and reauthorization) will be issued for 12 months.

Denial Risk

Excluded product

Kitabis Pak is excluded from coverage for the majority of our benefits and may be denied based on the member's benefit plan.

Documentation Required

Automated approvals

UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated approval and re-approval processes varies by program.

Annual review with no changes to clinical coverage criteria; references updated.