CurrentCignaPolicy IP0499

Antibiotics (Inhaled) - TOBI Podhaler

Defines prior authorization and medical necessity criteria for coverage of TOBI Podhaler (tobramycin inhalation powder) under Cigna-administered health benefit plans, including FDA-approved indication (cystic fibrosis) and limited continuation/individual plan criteria. Also states non-covered uses and billing/code instructions requirement.

Policy Summary

PayerCigna

PolicyAntibiotics (Inhaled) - TOBI Podhaler

Policy CodePolicy IP0499

Change TypeName changeduration and criteria revisions

Effective DateJun 15, 2024

Next Review DateJun 15, 2025

Key ActionSubmit prior authorization requests and include required documentation (pulmonologist/CF specialist consult for CF indication, airway culture showing Pseudomonas, and preferred product criteria) with the requested approval duration noted.

SourceLink

POLICY UPDATE CHANGES

Policy name changed from 'Tobramycin Inhalation Powder' to 'Antibiotics (Inhaled) - TOBI Podhaler.'

Continuation of TOBI Podhaler approval duration changed from 12 months to 1 month.

Removed the requirement that the medication be prescribed by or in consultation with a pulmonologist.

1FDA-Approved Indications covered

1Continuation approval durations changed

1Individual/Family Plan criteria added

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Coverage Summary & Criteria Overview

Coverage: Covered with criteria for TOBI Podhaler (tobramycin inhalation powder) for the FDA‑approved indication of cystic fibrosis with Pseudomonas aeruginosa when prior authorization criteria are met. Effective date: 2024-06-15. Policy number: IP0499.

Surface thresholds and review dates

Age>= 6 years

FDA-approved indication approval duration1 year

Continuation approval duration1 month (30 days)

Last review date2024-06-15

Next review date2025-06-15

Initial Therapy Criteria (FDA‑Approved Indication — Cystic Fibrosis)

FDA-Approved Indication (Cystic Fibrosis)

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

Age: Patient is ≥ 6 years of age>= 6 years
Microbiology: Patient has Pseudomonas aeruginosa in culture of the airway (examples include sputum culture, oropharyngeal culture, bronchoalveolar lavage culture)
Prescriber specialty requirement: The medication is prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis
Preferred product criteria are met for the product(s) as listed in the below table

Continuation Therapy Criteria (Non‑CF / Other Uses with Supportive Evidence)

Other Uses with Supportive Evidence — Continuation (not Cystic Fibrosis)

Approve for 1 month if the patient meets BOTH of the following (A and B):

Other Uses - Continuation (not Cystic Fibrosis)

Continuation of therapy: Patient was started on TOBI Podhaler and is continuing a course of therapy1 month (30 days)
Preferred product criteria are met for the product(s) as listed in the below table

Individual & Family Plan Specific Criteria

Individual and Family Plans Specific Criteria

TOBI Podhaler (tobramycin inhalation powder), Criteria = ONE of the following:

Intolerance to ONE of the following: a) tobramycin 300 mg/5 mL inhalation solution (generic for TOBI) b) tobramycin pak 300mg/5ml inhalation solution
Current use: Currently taking TOBI Podhaler

Not Covered / Experimental Uses

Not Covered / Experimental

Any other use is considered experimental, investigational, or unproven (criteria will be updated as new published data are available).

Not Covered / Experimental: Any use not described in the covered criteria above

Background: Evidence for use of TOBI Podhaler in non‑cystic fibrosis bronchiectasis is lacking, and safety/efficacy have not been demonstrated in patients 6 years of age, patients with FEV1 <25% or >80% predicted, or patients colonized with Burkholderia cepacia — considerations that may exclude patients from coverage.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of TOBI Podhaler. Approvals are provided for specified durations: 1 year for the cystic fibrosis indication and 1 month (30 days) for continuation when not for CF.

Documentation Required

Prescriber specialty requirement

For the cystic fibrosis indication, TOBI Podhaler must be prescribed by or in consultation with a pulmonologist or a physician who specializes in the treatment of cystic fibrosis.

Documentation Required

Microbiologic evidence required

Documentation of Pseudomonas aeruginosa in a culture of the airway (examples include sputum culture, oropharyngeal culture, or bronchoalveolar lavage culture) is required for the CF indication.

Applicable Codes

No specific procedure or drug billing codes listed in policy bodymixed

No codes listed

Clinical Evidence & Guidance

Evidence summary: Prescribing information — TOBI Podhaler prescribing information (Novartis, February 2023) supports the product's indication and safety statements. Guideline support — Cystic Fibrosis Foundation recommendations (2013, 2014) support chronic inhaled tobramycin for patients with CF and Pseudomonas aeruginosa. There is no clinical trial evidence supporting TOBI Podhaler for non‑CF bronchiectasis.

Background & Definitions

TOBI Podhaler is an aminoglycoside antibiotic indicated for management of cystic fibrosis patients with Pseudomonas aeruginosa. Safety and efficacy have not been demonstrated in patients <6 years of age, patients with FEV1 <25% or >80% predicted, or patients colonized with Burkholderia cepacia. Cystic Fibrosis Foundation guidance supports chronic inhaled tobramycin in CF with P. aeruginosa; however, guideline reviews and society statements do not include TOBI Podhaler for treatment of non‑CF bronchiectasis and no clinical trials of TOBI Podhaler have been published for that indication.

Preferred product criteria — definition

Definition termPreferred product criteria

DefinitionCriteria referenced in policy that must be met for approval; specific table not included in document excerpt.

Where referencedRequired for FDA‑approved CF indication and for continuation/non‑CF and Individual and Family Plans approvals (see policy criteria).

NoteSpecific preferred product table is not included in the provided document excerpt.

Revision History

2024-06-15revisedLatest

Policy name changed from 'Tobramycin Inhalation Powder' to 'Antibiotics (Inhaled) - TOBI Podhaler.' (Revision noted 06/15/2024.)

2024-06-15revisedLatest

Added preferred product requirement criteria for Individual and Family Plans (material change).

2024-06-15