CurrentCentenePolicy CP.PHAR.2H

Tobramycin inhalation (Bethkis, Kitabis Pak, TOBI, TOBI Podhaler)

Defines medical necessity criteria, dosing, approval durations, formulary routing, and coding implications for inhaled tobramycin products for treatment of cystic fibrosis with Pseudomonas aeruginosa across Commercial, HIM (Health Insurance Marketplace), and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyTobramycin inhalation (Bethkis, Kitabis Pak, TOBI, TOBI Podhaler)

Policy CodePolicy CP.PHAR.2H

Change TypeRedirects, duration revisions, formulary updates

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Re-directed requests for Bethkis, Kitabis Pak, and TOBI to generic nebulized tobramycin solution unless contraindicated.

Commercial approval duration revised to '12 months or duration of request, whichever is less'.

Multiple annual reviews with no significant clinical changes; updated references and FEV1 limitations to reflect current prescribing information.

Removed brand Kitabis Pak and brand TOBI from HIM duration and HIM disclaimer statements in 3Q 2023 and 3Q 2025 updates.

1Covered Indications (CF with Pseudomonas aeruginosa)

>=6Minimum age (years)

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Max inhalation solution dose

224 mg/dayMax inhalation powder dose

Coverage Summary

Policy stance: covered_with_criteria. This policy defines medical necessity for inhaled tobramycin (Bethkis, Kitabis Pak, TOBI, TOBI Podhaler) for treatment of cystic fibrosis patients with Pseudomonas aeruginosa. Coverage requires a diagnosis of CF, prescription by or in consultation with a pulmonologist/infectious disease specialist/CF expert, and presence of Pseudomonas aeruginosa in at least one airway culture. The policy applies to patients aged >= 6 years (Kitabis Pak and TOBI explicitly indicated ≥6 years) and includes both inhalation solution products (Bethkis, Kitabis Pak, TOBI) and inhalation powder (TOBI Podhaler) with specified dosing limits.

Thresholds

Age>= 6 years

Inhalation solution max600 mg/day

Inhalation powder max224 mg/day

Dosing cycle28 days on / 28 days off

Policy statusCURRENT

Last review2025-08-25

Initial Therapy Criteria

Initial Approval Criteria

Tobramycin (Bethkis, Kitabis Pak, TOBI, TOBI Podhaler) is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of cystic fibrosis (CF).
Prescribed by or in consultation with a pulmonologist, an infectious disease specialist, or an expert in treatment of cystic fibrosis.
Age ≥ 6 years.
Pseudomonas aeruginosa is present in at least one airway culture.
Product-specific drug preference

Continuation Therapy Criteria

Continued Therapy (Renewal) Criteria

Continuation is authorized when ONE of the following is met and other relevant conditions are satisfied:

ALL of the following

ANY of the following
- Member is currently receiving the medication via Centene benefit.
- Member has previously met initial approval criteria.
- Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums).
Member is responding positively to therapy as evidenced by reduction in respiratory symptoms (e.g., cough, wheezing, sputum production) or reduction in pulmonary exacerbations due to Pseudomonas aeruginosa.

Unproven / Exclusions

Diagnoses/Indications Not Authorized

Non-FDA approved indications which are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per applicable off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Applicable Codes

Drug HCPCS codes (informational)HCPCS

J7682	Tobramycin, inhalation solution, FDA-approved final product, non-compounded, unit dose form, administered through DME, per 300 mg
J7685	Tobramycin, inhalation solution, compounded product, administered through DME, unit dose form, per 300 mg

Provider Actions & Billing Guidance

Documentation Required

Provide supporting documentation

Submit office chart notes, laboratory results, or other clinical information that demonstrate the patient meets all approval criteria (diagnosis, specialty prescriber, age, presence of Pseudomonas aeruginosa, dosing, product preference, and concurrent-therapy rationale).

Documentation Required

Concurrent therapy justification

If tobramycin is prescribed concurrently with or alternated with Cayston (aztreonam), provide documentation showing inadequate response to either agent alone (for example, deteriorating pulmonary status or recurrent pulmonary exacerbations) to justify combined or alternating use.

Prior Authorization

Product substitution preference

Requests for Bethkis, Kitabis Pak, or TOBI should be redirected to generic nebulized tobramycin solution and approval requires use of the generic nebulized solution unless the brand is contraindicated or the member has had a clinically significant adverse effect to the generic.

Clinical Evidence & Guidelines

Evidence: The 2013 American Thoracic Society cystic fibrosis guidelines recommend tobramycin for chronic use in both mild and moderate-to-severe disease. A randomized double-blind phase 3 trial evaluated continuous alternating inhaled antibiotics (tobramycin alternating with aztreonam vs tobramycin/placebo); although it showed reduced exacerbation and hospitalization rates, the study was underpowered and results were not statistically significant. Safety/label limitations note that safety and efficacy have not been demonstrated in patients <6 years, and some products include FEV1-based limitations in their prescribing information.

Background & Definitions

Background: Tobramycin inhalation products (Bethkis, Kitabis Pak, TOBI, TOBI Podhaler) are aminoglycoside antibacterials indicated for management of cystic fibrosis patients with Pseudomonas aeruginosa. Kitabis Pak and TOBI are specifically indicated for patients 6 years of age and older. Dosing: inhalation solution (Bethkis, Kitabis Pak, TOBI) is 300 mg inhaled twice daily (maximum 600 mg/day) on a 28 days on / 28 days off cycle; inhalation powder (TOBI Podhaler) is 112 mg capsules inhaled twice daily (maximum 224 mg/day) on the same cycle. Safety and efficacy have not been demonstrated in patients <6 years, and product labeling contains FEV1-based limitations for use.

Definitions

FEV1Forced expiratory volume in one second; used to define severity of lung disease in CF.

HIMHealth Insurance Marketplace

Revision History

10.22.21revised

Commercial approval duration revised from 'length of benefit' to '12 months or duration of request, whichever is less'.

10.03.22clarified

Added redirection: requests for Bethkis, Kitabis Pak, and TOBI are re-directed to generic nebulized tobramycin solution unless contraindicated; template changes applied to other sections.

02.23administrative

1Q 2023 annual review: no significant clinical changes; updated FEV1 limitations per current prescribing information and consolidated Legacy Wellcare initial approval duration to align with Medicaid initial approval duration.

Policy Summary

PayerCentene

PolicyTobramycin inhalation (Bethkis, Kitabis Pak, TOBI, TOBI Podhaler)

Policy CodePolicy CP.PHAR.2H

Change TypeRedirects, duration revisions, formulary updates

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

If request is for Bethkis, Kitabis Pak, or TOBI, member must use generic tobramycin nebulized solution unless contraindicated or clinically significant adverse effects are experienced.

For HIM (Health Insurance Marketplace), Bethkis and TOBI Podhaler are non-formulary and should not be approved using these criteria; refer to HIM.PA.103 (formulary exception).

If tobramycin is prescribed concurrently or for alternating use with Cayston (aztreonam), documentation must support inadequate response to either agent alone (e.g., deteriorating pulmonary status, recurrent pulmonary exacerbations).

Dosing restraint (choose appropriate product dosing)

Inhalation solution (Bethkis, Kitabis Pak, TOBI): 300 mg inhaled twice daily (600 mg/day) on a 28 days on / 28 days off cycle; does not exceed 600 mg/day.
Inhalation powder (TOBI Podhaler): 112 mg capsules inhaled twice daily (224 mg/day) on a 28 days on / 28 days off cycle; does not exceed 224 mg/day.

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If request is for Bethkis, Kitabis Pak, or TOBI, member must use generic tobramycin nebulized solution unless contraindicated or clinically significant adverse effects are experienced.

Dose increase limit (continued therapy)

Inhalation solution (Bethkis, Kitabis Pak, TOBI): maximum 600 mg/day administered on a 28 days on / 28 days off cycle.
Inhalation powder (TOBI Podhaler): maximum 224 mg/day administered on a 28 days on / 28 days off cycle.

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Prior Authorization

Formulary routing and HIM exceptions

For Health Insurance Marketplace (HIM) members, Bethkis and TOBI Podhaler are non-formulary and should not be approved under these criteria; route HIM requests per the HIM formulary exception policy HIM.PA.103.

Billing Rule

Code usage guidance

HCPCS codes for inhaled tobramycin (informational):

J7682 — Tobramycin, inhalation solution, FDA-approved unit dose product, per 300 mg
J7685 — Tobramycin, inhalation solution, compounded product, per 300 mg
Inclusion of these codes is informational and does not guarantee coverage.

Note

Approval duration by line of business

Commercial: approval up to 12 months or the duration of the request, whichever is less. HIM: 6 months for nebulized solution (refer to HIM.PA.103 for Bethkis and TOBI Podhaler) with continued-therapy durations noted in the policy. Medicaid: initial 6 months with continued therapy reviews at 12 months as specified in the policy.

05.08.23revised

3Q 2023 annual review: removed brand Kitabis Pak and brand TOBI from the HIM disclaimer/statement per HIM formulary status; references reviewed and updated.

05.09.24administrative

3Q 2024 annual review: no significant changes; references reviewed and updated.

04.14.25revisedLatest

3Q 2025 annual review: removed brand Kitabis Pak and brand TOBI from HIM duration statements and updated references; Commercial approval duration retained as '12 months or duration of request, whichever is less'.