ModifiedmhnPolicy CP.PHAR.211

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

Defines medical necessity criteria, dosing limits, and approval durations for Bethkis, Kitabis Pak, TOBI, and TOBI Podhaler for treatment of cystic fibrosis with Pseudomonas aeruginosa; applies to commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

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

Policy CodePolicy CP.PHAR.211

Change TypeMaterial clarifications and administrative revisions

Effective DateMay 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation showing CF diagnosis, specialist involvement, age ≥ 6 years, and Pseudomonas aeruginosa airway culture; use generic nebulized tobramycin for Bethkis/Kitabis/TOBI requests unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Removed brand Kitabis Pak and brand TOBI from HIM duration.

Revised Commercial approval durations to '12 months or duration of request, whichever is shorter' (reference to 1Q 2022 review).

Updated limitations of use section to reflect FEV1 from most current prescribing information.

≥6 yrsminimum age for initial approval

600 mg/daymax dose (solution)

224 mg/daymax dose (powder)

28 on / 28 off

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Coverage Criteria for Tobramycin Inhalation Products

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Approval - Cystic Fibrosis: 1. Diagnosis of cystic fibrosis; 2. Prescribed by or in consultation with a pulmonologist, an infectious disease specialist, or an expert in treatment of cystic fibrosis; 3. Age ≥ 6 years; 4. Pseudomonas aeruginosa present in at least one airway culture; 5. 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; 6. If tobramycin is prescribed concurrently (or for alternating use) with Cayston, documentation supports inadequate response to either agent alone (e.g., deteriorating pulmonary status or recurrent pulmonary exacerbations); 7. Dose does not exceed either: (a) inhalation solution (Bethkis, Kitabis Pak, TOBI): 600 mg/day administered on a 28 days on/28 days off cycle, or (b) inhalation powder (TOBI Podhaler): 224 mg/day administered on a 28 days on/28 days off cycle.

inv-02: Continuation Therapy

Covered when ALL of the following are met

Continuation Therapy - Cystic Fibrosis: 1. Member is currently receiving medication via the Centene benefit, previously met initial approval criteria, or is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by reduction in respiratory symptoms (e.g., cough, wheezing, sputum production, or pulmonary exacerbations due to Pseudomonas aeruginosa); 3. 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; 4. If tobramycin is prescribed concurrently (or for alternating use) with Cayston, documentation supports inadequate response to either agent alone; 5. If request is for a dose increase, the new dose does not exceed either: (a) inhalation solution: 600 mg/day on a 28 days on/28 days off cycle, or (b) inhalation powder (TOBI Podhaler): 224 mg/day on a 28 days on/28 days off cycle.

inv-03: Other/Unlisted Uses

If requested use is not covered in this policy

Other diagnoses/indications: 1. If the drug has undergone a label change within the last 6 months not yet reflected in this policy, follow the applicable no-coverage or non-formulary policy for the relevant line of business (references provided in policy); 2. If the requested use (diagnosis, age, dosing regimen) is not specifically listed under the policy's 'Diagnoses/Indications for which coverage is NOT authorized' section and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.

inv-04: Coverage overview

Policy covers inhaled tobramycin formulations with prior authorization and subject to product-specific availability and plan-level duration limits.

Product and dosing: Covered products include Bethkis, Kitabis Pak, TOBI (inhalation solutions, 300 mg per single-dose ampule) and TOBI Podhaler (inhalation powder, 28 mg capsules).

Product availability listed in policy.

Coding options: HCPCS codes referenced for informational purposes: J7682 (tobramycin inhalation solution, FDA-approved final product, per 300 mg) and J7685 (compounded inhalation solution, per 300 mg). Inclusion or exclusion of codes does not guarantee coverage.

Providers should reference up-to-date coding guidance.

Approval duration: Commercial approval duration: '12 months or duration of request, whichever is shorter.' Medicaid and HIM approval durations are specified in the policy and may vary by product/line of business.

See prior authorization section for specific durations and HIM formulary details.

Non‑FDA approved indications that are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

When state Medicaid coverage provisions conflict with the coverage provisions of this clinical policy, state Medicaid coverage provisions take precedence. Providers should refer to the relevant state Medicaid manual for any applicable coverage rules.

This policy does not authorize use of tobramycin inhalation products for patients who do not meet FDA‑label limitations. Specifically, use is not supported for patients under age 6 years, for patients colonized with Burkholderia cepacia, or for patients whose FEV1 falls outside product‑specific ranges (Kitabis Pak and TOBI: <25% or >75% predicted; TOBI Podhaler: <25% or >80% predicted; Bethkis: <40% or >80% predicted).

Inclusion of procedure or HCPCS codes in this policy is for informational purposes only and does not guarantee payment or coverage. Claims may be denied if documentation does not support the prior authorization or if coding is inconsistent with the clinical record; providers should reference current professional coding guidance prior to claim submission.

Coding, Dosing Ranges, and Approval Durations

Referenced HCPCS CodesHCPCS

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.

FEV1 inclusion/exclusion ranges by product

Kitabis Pak / TOBI (solution)Exclude if FEV1 < 25% predicted or > 75% predicted (per FDA labeling).

TOBI Podhaler (powder)Exclude if FEV1 < 25% predicted or > 80% predicted (per FDA labeling).

Bethkis (solution)Exclude if FEV1 < 40% predicted or > 80% predicted (per FDA labeling).

Commercial approval duration

Commercial approval duration12 months or duration of request, whichever is shorter.

Medicaid approval duration (context)Medicaid approvals referenced elsewhere as 6–12 months depending on scenario; see policy for line-of-business specifics.

Prior Authorization, Documentation, and Step Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must meet the prior authorization criteria below and will be approved for the durations shown based on product and benefit type.

Approval durations: Medicaid — 6 months; HIM — 6 months for tobramycin nebulized solution (refer to HIM.PA.103 for Bethkis and TOBI Podhaler); Commercial — 12 months or duration of request, whichever is less.
Failure to provide required supporting documentation (office notes, lab results, airway culture demonstrating Pseudomonas aeruginosa, documentation of prescriber specialty, prior treatment response or intolerance) may result in denial.
Coding inclusion/exclusion here is informational only; inclusion of codes does not guarantee coverage. Providers must reference up-to-date professional coding guidance before claim submission. Mismatches between coding and submitted clinical documentation can trigger claim or prior authorization denial.
Step/therapeutic-swap requirement: For requests of Bethkis, Kitabis Pak, or TOBI, member must use generic tobramycin nebulized solution unless there is a documented contraindication or clinically significant adverse effect to the generic. The policy redirects branded requests to the generic nebulized solution when appropriate.

Background on Tobramycin Inhalation Products

Tobramycin inhalation products are aminoglycoside antibiotics formulated for inhalation and indicated for management of cystic fibrosis (CF) in patients with Pseudomonas aeruginosa. Formulations covered by this policy include inhalation solutions supplied as single‑dose ampules (Bethkis, Kitabis Pak, TOBI; 300 mg per ampule) and an inhalation powder formulation (TOBI Podhaler; 28 mg capsules). Labeling and product‑specific limitations (including age and FEV1 ranges) vary by formulation and should guide authorization decisions.

Definitions and Formulation Details

cystic fibrosis (CF)

DefinitionCystic fibrosis (CF).

Clinical contextInherited disorder causing chronic pulmonary infection and bronchiectasis; policy applies to CF patients with Pseudomonas aeruginosa infection.

Age considerationSafety and efficacy not demonstrated in patients under age 6 years for some products; policy minimum age for approval is ≥ 6 years.

forced expiratory volume in one second (FEV1)

DefinitionForced expiratory volume in one second (FEV1).

Use in policyFEV1 percentage predicted is used to define lung disease severity and product-specific inclusion/exclusion ranges for tobramycin formulations.