CurrentCignaPolicy N/A

Antibiotics (Inhaled) - Tobramycin Products Preferred Specialty Management Policy

Defines Cigna's preferred product management and prior authorization exception criteria for inhaled tobramycin products (solutions and Podhaler) used primarily for cystic fibrosis and non-CF bronchiectasis; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAntibiotics (Inhaled) - Tobramycin Products Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypePreferred list expandedcontinuation approval clarified

Effective DateN/A

Next Review DateMar 27, 2024

Key ActionDocument that the patient meets the Tobramycin Inhalation Solution prior authorization criteria and has tried a preferred tobramycin product before requesting a non-preferred product.

SourceLink

POLICY UPDATE CHANGES

Generic to Bethkis was added to the policy and included among preferred tobramycin inhalation solution products.

Kitabis Pak (brand) is not targeted in the PSM program; tobramycin inhalation solution includes generics for Bethkis, Kitabis Pak, and TOBI.

Continuation of therapy condition was added allowing 1-month approvals when criteria met and preferred product trial completed.

1 yrstandard approval duration for new approvals

1 mocontinuation approval duration

No PAPreferred product prior auth status

NCgoverned state

Coverage Criteria for Inhaled Tobramycin Products

Non-Preferred Product Exception Criteria

Non-Preferred products (Bethkis, TOBI inhalation solution) are covered as medically necessary only when the following exception criteria are met:

Bethkis - Cystic Fibrosis (Approve 1 year): Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution Prior Authorization (PA) criteria; AND patient has tried tobramycin inhalation solution (generic) or TOBI Podhaler.both conditions required

If PA criteria met but preferred product trial not met, Bethkis is not approved; approve tobramycin inhalation solution (generic) or TOBI Podhaler instead.

Bethkis - Bronchiectasis, Non-CF (Approve 1 year): Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution PA criteria; AND patient has tried tobramycin inhalation solution (generic).both conditions required

If PA criteria met but preferred product trial not met, Bethkis is not approved; approve tobramycin inhalation solution (generic) instead.

Policy Summary

PayerCigna

PolicyAntibiotics (Inhaled) - Tobramycin Products Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypePreferred list expandedcontinuation approval clarified

Effective DateN/A

Next Review DateMar 27, 2024

Key ActionDocument that the patient meets the Tobramycin Inhalation Solution prior authorization criteria and has tried a preferred tobramycin product before requesting a non-preferred product.

SourceLink

On This Page

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Bethkis - Continuation of Therapy (Approve 1 month): Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution PA criteria; AND patient has tried tobramycin inhalation solution (generic).both conditions required

If preferred product trial not met, Bethkis is not approved; approve tobramycin inhalation solution (generic) instead.

TOBI solution - Cystic Fibrosis (Approve 1 year): Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution Prior Authorization (PA) criteria; AND patient has tried tobramycin inhalation solution (generic) or TOBI Podhaler.both conditions required

If PA criteria met but preferred product trial not met, TOBI inhalation solution is not approved; approve tobramycin inhalation solution (generic) or TOBI Podhaler instead.

TOBI solution - Bronchiectasis, Non-CF (Approve 1 year): Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution PA criteria; AND patient has tried tobramycin inhalation solution (generic).both conditions required

If preferred product trial not met, TOBI inhalation solution is not approved; approve tobramycin inhalation solution (generic) instead.

TOBI solution - Continuation of Therapy (Approve 1 month): Patient meets the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution PA criteria; AND patient has tried tobramycin inhalation solution (generic).both conditions required

If preferred product trial not met, TOBI inhalation solution is not approved; approve tobramycin inhalation solution (generic) instead.

Any request for a Non-Preferred tobramycin product (e.g., Bethkis or TOBI inhalation solution) that does not meet the Non-Preferred Product Exception Criteria is considered not medically necessary. The policy requires that patients meet the standard Antibiotics (Inhaled) - Tobramycin Inhalation Solution Prior Authorization (PA) criteria and the applicable exception criteria (including documented trial of a Preferred Product) before a Non-Preferred product will be approved.

If the patient satisfies the standard Tobramycin Inhalation Solution PA criteria but has not documented a trial of an appropriate Preferred Product (generic tobramycin inhalation solution or TOBI Podhaler where allowed), requests for Bethkis or TOBI inhalation solution will be denied. In those cases the policy directs approval of the Preferred Product (generic tobramycin inhalation solution or TOBI Podhaler) instead.

Products and Codes Referenced

Tobramycin products referencedmixed

Bethkis	tobramycin inhalation solution (Chiesi, generic)
TOBI (solution)	tobramycin inhalation solution (Mylan, generic)
TOBI Podhaler	tobramycin inhalation powder (Novartis)
Kitabis Pak	tobramycin inhalation solution (authorized generic) - brand not included in this policy

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Non-Preferred Tobramycin products. Preferred Products (tobramycin inhalation solution generics and TOBI Podhaler) do not require prior authorization. All approvals (Preferred and Non-Preferred when authorized) are provided for 1 year unless otherwise noted; when months are specified, 1 month = 30 days.

Preferred: Tobramycin inhalation solution (generics for Bethkis, TOBI, and Kitabis Pak), TOBI Podhaler
Non-Preferred: Brand Bethkis and TOBI inhalation solution (subject to exception criteria)

Step Therapy

Preferred Product Trial Required

A trial of at least one Preferred Product is required before a Non-Preferred Tobramycin product will be approved, except when the Non-Preferred product meets specified exception criteria. Providers should document prior use of a Preferred Product (generic tobramycin inhalation solution or TOBI Podhaler) in the PA request.

Acceptable trials: tobramycin inhalation solution (generic) or TOBI Podhaler
If trial not completed, request may be denied unless exception criteria are met

Denial Risk

Denial Risk — Lack of Preferred Product Trial

Requests for Non-Preferred Tobramycin products will be denied if the patient has not tried a Preferred Product (as described above) unless the request meets the Non-Preferred Product Exception Criteria (e.g., documented clinical justification per the Antibiotics (Inhaled) - Tobramycin Inhalation Solution PA criteria and the specific exception pathways). When the exception criteria are met, approvals are granted per the criteria (typically 1 year; continuation approvals may be for 1 month when specified).

Denial risk if preferred product trial not completed and no exception criteria met
Exception pathways include Cystic Fibrosis and Bronchiectasis (non-CF) with documented meeting of standard PA criteria plus prior trial as required (see exception criteria)
Continuation of therapy: typically approve for 1 month when criteria and prior trial met; otherwise not approved

Background

Inhaled tobramycin products are indicated primarily for management of Pseudomonas aeruginosa infection in cystic fibrosis and related bronchiectasis contexts. Formulations referenced in this policy include nebulized tobramycin inhalation solution (available as generics to Bethkis, Kitabis Pak, and TOBI, administered via approved nebulizer systems) and the dry powder TOBI Podhaler for oral inhalation with the Podhaler device. The policy designates the generics and TOBI Podhaler as Preferred Products and manages coverage of branded Bethkis and TOBI solution as Non-Preferred, subject to exception criteria and prior authorization requirements.

Definitions

TOBI Podhaler — dry powder formulation definition

DefinitionDry powder formulation of tobramycin for oral inhalation administered only with the Podhaler device (TOBI Podhaler).

Indication contextUsed as an inhaled tobramycin product for management of Pseudomonas aeruginosa in cystic fibrosis patients.

Device specificityIntended for use only with the Podhaler device (not for nebulization).

Tobramycin inhalation solution (nebulized) — administered by PARI LC PLUS nebulizer details

Administration methodTobramycin inhalation solution administered by nebulization using the PARI LC PLUS jet nebulizer.

Compressor optionsGeneric TOBI/Kitabis Pak: PARI LC PLUS nebulizer with DeVilbiss Pulmo-Aide compressor; Bethkis: PARI LC PLUS nebulizer with PARI Vios Air compressor.

DurationAdministered over a period of approximately 15 minutes per treatment session.