CurrentCentenePolicy CP.PHAR.209

Aztreonam (Cayston) (PDF)

Defines medical necessity criteria, prior authorization and approval durations for inhaled aztreonam (Cayston) for cystic fibrosis patients with Pseudomonas aeruginosa, continued therapy criteria, contraindications and dosing limits for Centene-affiliated health plans (HIM, Medicaid).

Policy Summary

PayerCentene

PolicyAztreonam (Cayston) (PDF)

Policy CodePolicy CP.PHAR.209

Change TypeStep therapy bypass added; prescriber and preferred product clarifications

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Updated prescriber restriction to include 'expert in treatment of cystic fibrosis' to align with other inhaled antibiotic policies.

Added Kitabis Pak to list of preferred tobramycin inhalation agents in initial criteria.

Added step therapy bypass for IL HIM per IL HB 5395.

Consolidated legacy Wellcare initial approval duration to 6 months consistent with standard Medicaid initial approval duration.

1FDA-approved indication (CF with P. aeruginosa)

6Minimum age (years)

225 mg/dayMaximum daily dose

28/28

Coverage Summary

Inhaled aztreonam (Cayston) is covered with criteria for patients with cystic fibrosis known to have Pseudomonas aeruginosa; it is intended for use in CF patients meeting the policy’s clinical criteria (including diagnosis of CF, Pseudomonas aeruginosa in airway culture, prescribed by or in consultation with a pulmonologist/infectious disease specialist/CF expert, and age ≥ 6 years). Prior authorization may be required. Initial approvals are for 6 months; continued therapy approvals are for 12 months when continued therapy criteria are met.

Initial Therapy - Cystic Fibrosis (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of cystic fibrosis
Prescribed by or in consultation with a pulmonologist, infectious disease specialist, or an expert in treatment of cystic fibrosis
Age ≥ 6 years>= 6 years
Pseudomonas aeruginosa is present in at least one airway culture
Member meets one of the following (a or b)
- Failure of inhaled tobramycin (Kitabis Pak, TOBI, TOBI Podhaler are preferred) unless contraindicated or clinically significant adverse effects are experienced
- Antibiotic susceptibility testing indicates that aztreonam would be more effective than tobramycin
If prescribed concurrently (or for alternating use) with inhaled tobramycin (Bethkis, Kitabis Pak, TOBI, TOBI Podhaler), documentation supports inadequate response to either agent alone (e.g., deteriorating pulmonary status, recurrent pulmonary exacerbations)
Requirement applies to concurrent or alternating use
Dose does not exceed 225 mg per day administered on a 28 days on / 28 days off cycle<= 225 mg/day

Initial Therapy - Other Diagnoses/Indications

Initial Therapy - Other diagnoses/indications

If not covered by CF criteria:

ANY of the following

If drug has recently (within last 6 months) undergone a label change not reflected in this policy, refer to applicable formulary/no coverage or non-formulary policies
Refer to HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable
If requested use is not specifically listed under 'Diagnoses/Indications for which coverage is NOT authorized' and above does not apply, refer to off-label use policy
Refer to HIM.PA.154 or CP.PMN.53

Continued Therapy - Cystic Fibrosis (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Member meets one of the following (a or b)
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
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)

Continued Therapy - Other Diagnoses/Indications

Continued Therapy - Other diagnoses/indications

If not covered by CF continued therapy criteria:

ANY of the following

If drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to applicable formulary/no coverage or non-formulary policies
Refer to HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable
If the requested use is NOT specifically listed under 'Diagnoses/Indications for which coverage is NOT authorized' AND criterion 1 above does not apply, refer to off-label use policy
Refer to HIM.PA.154 or CP.PMN.53

Diagnoses/Indications NOT Authorized

Diagnoses/Indications NOT authorized

Coverage is not authorized for:

Non-FDA approved indications that are not addressed in this policy unless sufficient documentation of efficacy and safety per off-label use policy

Refer to HIM.PA.154 or CP.PMN.53

Provider Actions

Documentation Required

Submit supporting documentation

Provider must submit supporting documentation such as office chart notes, laboratory results, or other clinical information to demonstrate the member meets all approval criteria.

Prior Authorization

Prior authorization required

Prior authorization may be required for Cayston and for inhaled tobramycin per policy. Approval durations: initial authorization 6 months; continued therapy authorization 12 months.

Applicable Codes

Informational HCPCS/J-code for inhalation solution administered through DMEHCPCS

J7699

NOC drugs, inhalation solution administered through DME

Background & Clinical Evidence

Aztreonam (Cayston) is an inhaled monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below 7 years, in patients with FEV1 < 25% or > 75% predicted, or in patients colonized with Burkholderia cepacia. The policy notes that the practice of continuous alternating inhaled antibiotic therapy lacks sufficient evidence; a randomized phase 3 trial of alternating tobramycin and aztreonam was underpowered and did not show statistically significant results.

Evidence includes: Cayston Prescribing Information (Gilead Sciences, November 2019; referenced 2025); the American Thoracic Society 2013 CF guidelines recommending aztreonam for chronic use in mild and moderate-to-severe disease; and data from a randomized phase 3 trial of alternating inhaled antibiotics which was underpowered and did not demonstrate statistically significant benefit for alternating tobramycin/aztreonam versus tobramycin/placebo.

Definitions

Definitions: CF = cystic fibrosis; FEV1 = forced expiratory volume in one second.

Key Thresholds

Key thresholds for Aztreonam (Cayston)

Minimum age>= 6 years

Maximum daily dose<= 225 mg/day

Dosing cycle28 days on / 28 days off

Revision History

04.09.25material_changeLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 (logged 1Q2025 / 3Q2025; P&T approval 08.25).

08.25.25material_changeLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 (logged 1Q2025 / 3Q2025; effective 04.09.25).

05.09.24policy_update