Inhalation Products for the Management of Cystic Fibrosis

Section: Injections
Effective Date: June 01, 2020
Revised Date: May 19, 2020
Last Reviewed: May 19, 2020

Description

Tobramycin (Tobi®, Bethkis®, Kitabis™ Pak), an inhaled aminoglycoside antibacterial, is indicated for the management of Cystic Fibrosis (CF) in individuals with Pseudomonas aeruginosa.

Dornase alfa (Pulmozyme®) is a recombinant DNase enzyme indicated in individuals in conjunction with standard therapies for the management of CF to improve pulmonary function.

Aztreonam (Cayston®), an inhaled monobactam antibacterial, is indicated to improve respiratory symptoms in CF in individuals with Pseudomonas aeruginosa.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

The use of Tobramycin, inhaled product, may be considered medically necessary for the management of CF when ALL of the following criteria are met:

  • The individual is six years of age or older; and
  • The individual tests positive for Pseudomonas aeruginosaand
  • The individual is not colonized with Burkholderia cepacia.

The use of Tobramycin, inhaled product, for any other indication is considered experimental/investigational and therefore, non-covered. There is a lack of clinical data to support its effectiveness and safety in other conditions.

Procedure Codes

J7682

J7685

The use of dornase alfa (Pulmozyme), inhaled product, may be considered medically necessary for the management of CF when used in conjunction with standard therapies to improve pulmonary function (i.e. chest physiotherapy, bronchodilators, antibiotics, anti-inflammatory therapy).

The use of dornase alfa (Pulmozyme), inhaled product, for any other indication is considered experimental/investigational and therefore, non-covered. There is a lack of clinical data to support its effectiveness and safety in other conditions.

Procedure Codes

J7639

The use of aztreonam (Cayston), inhaled product, may be considered medically necessary to improve respiratory symptoms in individuals with CF when ALL of the following criteria are met:

  • The individual is seven (7) years of age or older; and
  • The individual tests positive for Psuedomonas aeruginosaand
  • The individual is not colonized with Burkholderia cepacia.

The use of aztreonam (Cayston), inhaled product, for any other indication is considered experimental/investigational and therefore, non-covered. There is a lack of clinical data to support its effectiveness and safety in other conditions.

Procedure Codes

J3490

NOTE: Product specific dosage and/or frequency limits may apply in accordance with the U.S.Food and Drug Administration (FDA)-approved product prescribing information,national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis Codes for J7682, J7685, and J7639

E84.0

E84.11

E84.19

E84.8

E84.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-19-2020 Adopt policy

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.