BLUE CROSS OF NORTHEASTERN PENNSYLVANIA
UTILIZATION MANAGEMENT CRITERIA
MANUAL: PHARMACY UTILIZATION
MANAGEMENT CRITERIA
REFERENCE NO.:
UMC-530-0229
[ ] PROPOSED [ X ] FINAL
Original Development Date
Revision Date
Original Effective Date
Review Date
SECTION:
PHARMACY MANAGEMENT DEPARTMENT
SUBJECT: CYSTIC FIBROSIS (CF) INHALED
ANTIBIOTICS PRIOR AUTHORIZATION
CRITERIA
June 3, 2015
June 2, 2016
September 29, 2015
June 3, 2015, June 1, 2016
CYSTIC FIBROSIS (CF) INHALED ANTIBIOTICS
PRIOR AUTHORIZATION CRITERIA
Drugs Addressed in this Policy

Bethkis (tobramycin inhalation solution)

Cayston (aztreonam inhalation solution)

Pulmozyme (dornase alfa)

Tobi (tobramycin inhalation solution, USP)

Tobi Podhaler (tobramycin inhalation powder)

Tobramycin inhalation solution
FDA-Approved Indications

Bethkis is indicated for the management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa.
Safety and efficacy have not been demonstrated in patients under the age of six years, patients
colonized with Burkholderia cepacia, or patients with an FEV1 <40% or >80% predicted. Note that
FEV1 is the volume of air that can be forced out in one second after taking a deep breath.

Cayston is indicated to improve respiratory symptoms in CF patients with Pseudomonas aeruginosa.
Safety and effectiveness have not been established in pediatric patients below the age of 7 years,
patients with an FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

Pulmozyme is indicated for daily administration in conjunction with standard therapies for the
management of CF patients to improve pulmonary function.

Tobi is indicated for the management of CF patients with P. aeruginosa. Safety and efficacy have not
been demonstrated in patients under the age of 6 years, patients with an FEV1 <25% or >75%
predicted, or patients colonized with Burkholderia cepacia.

Tobi Podhaler is indicated for the management of CF patients with Pseudomonas aeruginosa. Safety
and efficacy have not been demonstrated in patients under the age of 6 years, patients with an FEV1
<25% or >80%, or patients colonized with Burkholderia cepacia.

Tobramycin inhalation solution is indicated for the management of CF patients with Pseudomonas
aeruginosa. Safety and efficacy have not been demonstrated in patients under the age of 6 years,
patients with an FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
Background

Bethkis, Tobi, Tobi Podhaler, Tobramycin inhalation solution: Tobramycin, an aminoglycoside
antimicrobial, acts primarily by disrupting protein synthesis in the bacterial cell which eventually leads to
death of the cell. Tobramycin has activity against a wide range of gram-negative bacteria including P.
aeruginosa.

Cayston: Aztreonam binds to penicillin-binding proteins of susceptible bacteria, which leads to inhibition
of bacterial cell wall synthesis and death of the cell. Aztreonam exhibits activity in vitro against gramnegative aerobic pathogens including P. aeruginosa. Aztreonam activity is not decreased in the
presence of CF lung secretions.

Pulmozyme: Dornase alfa, a recombinant human deoxyribonuclease I (rhDNase), is an enzyme which
selectively cleaves DNA. In CF patients, retention of viscous purulent secretions in the airways
contributes both to reduced pulmonary function and to exacerbations of infection. Purulent pulmonary
secretions contain very high concentrations of extracellular DNA released by degenerating leukocytes
that accumulate in response to infection.
Approval Criteria
Initial:
When a benefit, inhaled antibiotics for cystic fibrosis may be approved when all of the following criteria are met:
Bethkis
1.
2.
3.
4.
Member is 6 years of age or older AND
Diagnosis of cystic fibrosis with Pseudomonas aeruginosa AND
Documentation confirming member is not colonized with Burkholderia cepacia AND
Generic tobramycin inhalation solution was ineffective, not tolerated, or is contraindicated
Cayston
1. Member is 7 years of age or older AND
2. Diagnosis of cystic fibrosis with Pseudomonas aeruginosa AND
3. Documentation confirming member is not colonized with Burkholderia cepacia
Pulmozyme
1. Documentation of Pulmozyme being used in conjunction with standard therapies (e.g., bronchodilators,
antibiotics, anti-inflammatory therapy) for the management of cystic fibrosis patients to improve
pulmonary function
Tobi
1.
2.
3.
4.
Member is 6 years of age or older AND
Diagnosis of cystic fibrosis with Pseudomonas aeruginosa AND
Documentation confirming member is not colonized with Burkholderia cepacia AND
Generic tobramycin inhalation solution was ineffective, not tolerated, or is contraindicated
Tobi Podhaler
1. Member is 6 years of age or older AND
2. Diagnosis of cystic fibrosis with Pseudomonas aeruginosa AND
3. Documentation confirming member is not colonized with Burkholderia cepacia AND
4. Generic tobramycin inhalation solution was ineffective, not tolerated, or is contraindicated.
Tobramycin Inhalation Solution
1. Member is 6 years of age or older AND
2. Diagnosis of cystic fibrosis with Pseudomonas aeruginosa AND
3. Documentation confirming member is not colonized with Burkholderia cepacia
Use of inhaled antibiotics for cystic fibrosis for disease states outside of their FDA-approved indications will be
denied based on the lack of clinical data to support its effectiveness and safety in other conditions.
Reauthorization:
For reauthorization, documentation of clinical improvement must be provided by the following information:

Decreased sputum density of Pseudomonas aeruginosa OR

Disease response as indicated by absence or decreased number of respiratory tract infections
Duration of authorization:
If approved, up to a 12 month authorization may be granted.
The following quantity limits will also be in place:
Brand Name
Generic Name
Bethkis
Tobramycin
inhalation
solution
Aztreonam
Cayston
Pulmozyme ampules
Tobi
Tobi Podhaler
Tobramycin inhalation solution
Dornase alfa
Retail
Mail order
56 doses (224 ml) per 56 56 doses (224 ml) per 56
rolling days
rolling days
84 doses(28 days supply) 84 doses(28 days supply)
per 56 rolling days
per 56 rolling days
150 mL
450 mL
Tobramycin
inhalation 56 ampules per 56 rolling 56 ampules per 56 rolling
solution
days
days
Tobramycin
inhalation
powder
224 capsules per 56
rolling days
224 capsules per 56
rolling days
Tobramycin
inhalation 56 ampules per 56 rolling 56 ampules per 56 rolling
days
days
solution
References
1.
2.
3.
4.
5.
6.
Bethkis [Prescribing information]. Cornerstone Therapeutics Inc., Woodstock, IL. October 2013.
Cayston [Prescribing Information]. Gilead Sciences, Inc. Foster City, CA. May 2014.
Kitabis Pak [Prescribing information]. Catalent Pharma Solutions, Woodstock, IL. November 2014.
Pulmozyme [Prescribing information]. Genentech, Inc., South San Francisco, CA. December 2014.
Tobi [Prescribing information]. Novartis Pharmaceuticals Corporation, East Hanover, NJ. March 2015.
Tobi Podhaler [Prescribing information]. Novartis Pharmaceuticals Corporation, East Hanover, NJ.
March 2015.
7. Tobramycin Inhalation Solution [Prescribing information]. Akorn, Inc., Lake Forest, IL. June 2014.
8. DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; 2016.
Accessed April 20, 2016.
HIGHMARK PHARMACY POLICY BULLETIN J-430