CurrentCentenePolicy N/A

Amikacin (Arikayce) for MAC lung disease — Coverage Criteria

Medically necessary coverage criteria and utilization management for liposomal amikacin (Arikayce) used to treat refractory Mycobacterium avium complex (MAC) lung disease in adults within Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyAmikacin (Arikayce) for MAC lung disease — Coverage Criteria

Policy CodePolicy N/A

Change TypeRevised and Added criteria

Effective Date11.13.18

Next Review Date

Key ActionSubmit prior authorization documenting diagnosis, specialist involvement, prior multidrug regimen failure, and required sputum culture results.

SourceLink

POLICY UPDATE CHANGES

Extended initial authorization approval duration from 6 months to 12 months.

Revised continued therapy criteria language for negative monthly sputum cultures requirement and removed requirement that Provider must submit documentation.

Added requirement that member has not received more than 12 months of treatment following conversion to negative sputum status.

590 mg/8.4 mLvial strength

1 vial/daymax daily dose

Adults ≥18age requirement

Conversion by Month 6approval endpoint

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Coverage Criteria for Arikayce (amikacin liposomal)

Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval: 1) Diagnosis of Mycobacterium avium complex (MAC) lung disease; 2) Prescribed by or in consultation with an infectious disease specialist or pulmonologist; 3) Age ≥ 18 years; 4) Failure, evidenced by positive sputum culture, after at least a 6‑month trial of a multidrug background regimen at up to maximally indicated doses, unless contraindicated or not tolerated; 5) Dose does not exceed one vial per day.1 vial (590 mg/8.4 mL) per day

See Appendix B for examples of multidrug background regimens.

Continued Therapy Criteria

Continued coverage allowed when ONE of the following applies and specific conditions are met:

Continued Therapy

Continued Therapy Conditions: Confirmation of sputum culture conversion: at least 3 consecutive negative monthly sputum cultures in the first 6 months of therapy OR at least 2 consecutive negative monthly sputum cultures in the last 2 months of therapy; Member has not received more than 12 months of treatment following conversion to negative sputum status; If request is for a dose increase, new dose must not exceed one vial per day.Treatment duration cap: up to 12 months after conversion
Approval duration: up to a total of 12 months of treatment after converting to negative sputum status.

Requests for Arikayce for indications that are not FDA‑approved and are not specifically addressed by this policy are excluded from coverage unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09, HIM.PA.154, CP PMN.53) or other evidence of coverage.

Arikayce is indicated only for adults with refractory Mycobacterium avium complex (MAC) lung disease—patients who have failed to achieve negative sputum cultures after at least a 6‑month multidrug background regimen. Use of Arikayce for non‑refractory MAC disease or other non‑FDA approved indications is considered not medically necessary under this policy unless supporting evidence consistent with off‑label use requirements is provided.

Coding and Dosing Information

Not listed in policymixed

NDC or CPT not specified

No explicit billing/CPT/HCPCS/NDC codes provided in document

Maximum daily dose — Arikayce

Maximum daily dose1 vial (590 mg/8.4 mL) per day

Unit-dose strength590 mg / 8.4 mL per vial

Route of administrationOral inhalation of the vial contents

Dose limit statementDose must not exceed one vial per day

Provider Requirements, Prior Authorization, and Alternatives

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approvals are contingent on a confirmed diagnosis of Mycobacterium avium complex (MAC) lung disease, prescription by or in consultation with an infectious disease specialist or pulmonologist, documentation of prior failure of a ≥6‑month multidrug background regimen at adequate doses (unless contraindicated), patient age ≥18 years, and a dose that does not exceed one vial per day.

Applies to initial requests and continuing therapy requests that do not meet continuity-of-care exceptions.
Approval contingent on submission of supporting clinical documentation (see documentation callout in other sections).

Step Therapy

Step Therapy / Therapeutic Alternatives

Step therapy: consider and document trials of standard multidrug MAC regimens (e.g., macrolide-based combinations such as clarithromycin or azithromycin plus ethambutol with or without rifampin/rifabutin and, when indicated, an aminoglycoside) prior to approval of Arikayce. Prior authorization will generally be granted only after failure (persistent positive sputum culture) of at least a 6‑month trial of an appropriate multidrug background regimen at maximally indicated doses, unless alternatives are contraindicated or not tolerated.

Background on Arikayce and Indication

Arikayce is a liposomal inhaled formulation of amikacin approved under the FDA’s accelerated approval pathway for use in adults with refractory MAC lung disease who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen. The accelerated approval was granted based on the surrogate endpoint of sputum culture conversion—defined as 3 consecutive negative monthly sputum cultures by Month 6—while clinical benefit remains to be fully established.

Per the policy, Arikayce should be reserved for patients with limited or no alternative treatment options; prior authorization is required and initial approval is contingent upon meeting diagnosis, specialist involvement, adult age (≥18 years), prior multidrug regimen failure, and dosing limits (maximum 1 vial [590 mg/8.4 mL] per day). Continued therapy requires confirmation of sputum culture conversion and is limited so that treatment does not exceed 12 months after conversion.

Key Definitions

Sputum culture conversion (definition)

DefinitionSputum culture conversion = 3 consecutive negative monthly sputum cultures by Month 6

PurposeEndpoint supporting accelerated FDA approval for Arikayce

Timing requirementConversion must occur by the end of Month 6 of therapy

Clinical implicationUsed to determine continued treatment decisions under this policy

Refractory MAC disease (definition)

DefinitionRefractory MAC disease = failure to achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen

FDA indication context

Policy Revision History

2025-08-25annual_reviewLatest

3Q 2025 annual review: no significant change; references reviewed and updated.

2024-05-24policy_update

Per March SDC: extended initial authorization approval duration from 6 months to 12 months and revised continued therapy criteria language removing the provider documentation submission requirement and clarifying negative monthly sputum culture requirements.

2022-09-15