CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tobramycin inhalation (solution & powder) — Coverage and Authorization Criteria

Coverage and authorization criteria for tobramycin inhalation formulations (solution and Podhaler/powder) for treatment of Pseudomonas aeruginosa respiratory infections in cystic fibrosis and select non-cystic fibrosis bronchiectasis patients.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTobramycin inhalation (solution & powder) — Coverage and Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization (up to 12 months) with documentation of Pseudomonas aeruginosa in airway cultures or history of infection/colonization and evidence of benefit for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moAuthorization period

2 yrsMin age (CF)

1FDA-covered indication

1Compendial use

Coverage and Authorization Criteria

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Initial Therapy — Cystic Fibrosis

Covered when ALL of the following are met:

CF initial authorization: Member is 2 years of age or older with a diagnosis of cystic fibrosis; Pseudomonas aeruginosa is present in airway cultures OR there is a documented history of Pseudomonas aeruginosa infection/colonization in the airways; member has no exclusions to the prescribed therapy.

Authorization up to 12 months may be granted.

Initial Therapy — Non-CF Bronchiectasis

Covered when ALL of the following are met:

Bronchiectasis initial authorization: Diagnosis of non-cystic fibrosis bronchiectasis; Pseudomonas aeruginosa is present in airway cultures OR there is a documented history of Pseudomonas aeruginosa infection/colonization in the airways; use corresponds to the compendial indication; member has no exclusions to the prescribed therapy.

Authorization up to 12 months may be granted.

Continuation of Therapy

Covered when ALL of the following are met:

Continuation authorization: Requesting reauthorization for an indication listed in Section II; member is experiencing benefit from therapy as evidenced by disease stability or disease improvement; member has no exclusions to the prescribed therapy.

Authorization up to 12 months may be granted.

Use of tobramycin inhalation formulations for indications not listed as FDA-approved or compendial in this policy is considered experimental/investigational and is not medically necessary.

Specifically, use of tobramycin inhalation for any indication other than the FDA‑approved management of cystic fibrosis with Pseudomonas aeruginosa or the listed compendial use for non‑cystic fibrosis bronchiectasis with Pseudomonas aeruginosa will be denied as not medically necessary.

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Prior authorization may be granted for up to 12 months when criteria are met.

Authorization duration: up to 12 months
Applies to: Cystic fibrosis (age ≥2) and non-cystic fibrosis bronchiectasis when criteria met

Note

Provider Action

Providers must submit documentation demonstrating membership of an FDA-approved or compendial indication and the specific provider action requested.

Provider action: Submit clinical documentation supporting the requested indication and prior authorization request

Documentation Required

Required Clinical Documentation

Documentation must demonstrate the presence or history of Pseudomonas aeruginosa infection or colonization in the airways for the covered indications.

Acceptable documentation: airway culture results showing Pseudomonas aeruginosa OR medical record evidence of prior Pseudomonas aeruginosa infection/colonization
Applicable indications: cystic fibrosis and non-cystic fibrosis bronchiectasis

Denial Risk

Experimental / Investigational Exclusions

Use of the therapy for indications outside the listed FDA-approved and compendial uses (including Pseudomonas aeruginosa lower respiratory tract infection only when not supported by compendia/FDA) is considered experimental/investigational and is not medically necessary.

Non-covered uses: any indication not listed in the policy's covered indications
Decision note: requests for unlisted uses will be denied as not medically necessary

Definitions and Compendial Use

Compendial use — non‑CF bronchiectasis (Pseudomonas aeruginosa)

DefinitionUse supported by compendia (non‑FDA) for treatment of Pseudomonas aeruginosa lower respiratory tract infection in patients with non‑cystic fibrosis bronchiectasis.

ScopeIncluded as a covered compendial indication alongside the FDA‑approved cystic fibrosis indication when criteria are met.

Documentation requirementRequest must document Pseudomonas aeruginosa present in airway cultures or a history of airway infection/colonization to meet compendial use criteria.

Authorization periodPrior authorization may be granted for up to 12 months when compendial use criteria are met.

ExclusionsAll other indications outside the FDA‑approved CF indication and this compendial use are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTobramycin inhalation (solution & powder) — Coverage and Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Tobramycin inhalation (solution & powder) — Coverage and Authorization Criteria

Coverage and Authorization Criteria

Drug / Product Coding

Provider Actions & Documentation Requirements

Definitions and Compendial Use

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