CurrentUnitedHealthcarePolicy 2025 P 2161-7

Arikayce (amikacin liposome inhalation suspension) prior authorization

Defines UnitedHealthcare prior authorization and medical necessity criteria for Arikayce (amikacin liposome inhalation suspension) for treatment of refractory Mycobacterium avium complex (MAC) lung disease in adults.

Policy Summary

PayerUnitedHealthcare

PolicyArikayce (amikacin liposome inhalation suspension) prior authorization

Policy CodePolicy 2025 P 2161-7

Change TypeNo material change

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit medical records documenting recent positive MAC respiratory cultures, prior ≥6 months multidrug background regimen, amikacin MIC < 64 mcg/mL, and specialist prescribing or consultation to request initial authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization duration

6 monthsreauthorization duration

<64amikacin MIC threshold

<=12max therapy w/ positive cultures

Coverage Criteria for Arikayce (amikacin liposome inhalation suspension)

Initial Therapy — Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: a) Diagnosis of refractory Mycobacterium avium complex (MAC) lung disease.

Initial Authorization: b) Submission of medical records (e.g., chart notes, laboratory values) documenting respiratory cultures positive for MAC within the previous 6 months.

Initial Authorization: c) Documentation that patient has been receiving a multidrug background regimen containing at least two of the following agents for a minimum of 6 consecutive months within the past 12 months: (1) macrolide antibiotic (e.g., azithromycin, clarithromycin); (2) ethambutol; (3) rifamycin antibiotic (e.g., rifampin, rifabutin).≥ 6 consecutive months

Prescription claims history may be used as supporting documentation of medication use, dose, and duration.

Initial Authorization: d) Patient will continue to receive a multidrug background regimen.

Initial Authorization: e) Documentation that the patient has not achieved negative sputum cultures after receipt of a multidrug background regimen for a minimum of 6 consecutive months.

Initial Authorization: f) In vitro susceptibility testing of recent (within 6 months) positive culture documents that the MAC isolate is susceptible to amikacin with a minimum inhibitory concentration (MIC) of < 64 mcg/mL.amikacin MIC < 64 mcg/mL

Testing should be from a recent positive culture within the prior 6 months.

Initial Authorization: g) Prescribed by or in consultation with an infectious disease specialist or a pulmonologist.

Authorization will be issued for 6 months.

Reauthorization / Continuation Therapy — Reauthorization

Covered when EITHER of the following conditions is met:

Reauthorization Option 1: Documentation that the patient has achieved negative respiratory cultures while on Arikayce.

Authorization will be issued for 6 months.

Reauthorization Option 2: a) Patient has not achieved negative respiratory cultures while on Arikayce; b) Physician attestation that patient has demonstrated clinical benefit while on Arikayce; c) In vitro susceptibility testing of most recent (within 6 months) positive culture documents that the MAC isolate is susceptible to amikacin with a MIC of < 64 mcg/mL; d) Patient has not received greater than 12 months of Arikayce therapy with continued positive respiratory cultures; e) Submission of medical records documenting that the patient continues to receive a multidrug background regimen containing at least two of: macrolide, ethambutol, rifamycin; f) Prescribed by or in consultation with an infectious disease specialist or pulmonologist.Arikayce therapy ≤ 12 months when cultures remain positive

Authorization will be issued for 6 months.

Use of Arikayce is not recommended for patients with non-refractory MAC lung disease. The policy limits coverage to patients meeting the indication for refractory disease — i.e., those who have not achieved negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen. Requests for members without documentation of refractory MAC (per the definition above) should not be approved.

Key Clinical Thresholds and Coding-related Values

amikacin MIC susceptibility threshold

Amikacin MIC susceptibility threshold< 64 mcg/mL

Supporting contextIn vitro susceptibility testing of recent (within 6 months) positive culture must document MAC isolate susceptible to amikacin with MIC < 64 mcg/mL.

Reauthorization requirementMost recent (within 6 months) positive culture with available susceptibility testing must show MIC < 64 mcg/mL.

minimum prior multidrug regimen duration

Minimum prior multidrug regimen duration≥ 6 consecutive months

Regimen timingReceived within the past 12 months (must have been receiving the regimen for a minimum of 6 consecutive months within the past 12 months).

Required agentsMultidrug background regimen must contain at least two agents (e.g., macrolide, ethambutol, rifamycin).

Provider Requirements and Documentation

Prior Authorization

Initial Authorization Requirements

Initial authorization requires documentation of a confirmed diagnosis of refractory Mycobacterium avium complex (MAC) lung disease and supporting records. Submit recent positive respiratory culture results for MAC within the prior 6 months, evidence of prior therapy with a multidrug background regimen (see details), and confirmation that the patient will continue the multidrug background regimen while receiving Arikayce. Authorization length: 6 months.

Required: recent positive respiratory cultures for MAC within 6 months
Required: documentation that patient will continue a multidrug background regimen during Arikayce therapy
Required: prescriber is an infectious disease specialist or pulmonologist (or consultation)
Authorization duration: 6 months

Denial Risk

Prior Regimen Requirement

The patient must have received and failed a multidrug background regimen containing at least two agents for a minimum of 6 consecutive months within the past 12 months. The regimen must include at least two of the following: macrolide (e.g., azithromycin or clarithromycin), ethambutol, or a rifamycin (e.g., rifampin, rifabutin). Also document that sputum cultures have not converted to negative after this ≥6-month regimen.

Minimum prior regimen: ≥6 consecutive months within past 12 months
Required agents: at least two of macrolide, ethambutol, rifamycin
Documentation: lack of negative sputum cultures after the ≥6-month regimen

Documentation Required

Required Documentation

Provide medical records (e.g., chart notes, laboratory values) and prescription claims history as applicable to document: recent positive respiratory cultures for MAC (within 6 months); prior multidrug background regimen (agents, doses, start/stop dates) demonstrating ≥6 months of therapy; continued background regimen during Arikayce therapy; and in vitro susceptibility testing of the most recent positive culture showing MAC susceptibility to amikacin with MIC < 64 mcg/mL. For continuation requests, include physician attestation of clinical benefit and total duration of prior Arikayce therapy (must not exceed 12 months with continued positive cultures).

Submit: culture reports showing MAC-positive respiratory culture within 6 months
Submit: medication records/prescription claims showing ≥6 months of a multidrug background regimen with at least two agents
Submit: susceptibility testing showing amikacin MIC < 64 mcg/mL (within 6 months)
For continuation: physician attestation of clinical benefit and total Arikayce duration (≤12 months if cultures remain positive)

Denial Risk

Denial-risk / Missing Documentation Conditions

Failure to provide required documentation will risk denial. Missing or incomplete items include absence of a MAC-positive respiratory culture within the prior 6 months, lack of documentation of a prior ≥6-month multidrug background regimen containing at least two specified agents, no evidence that the patient will continue background therapy, missing susceptibility testing demonstrating amikacin MIC < 64 mcg/mL, or absent specialist prescriber/consultation documentation.

Denial risk if no MAC-positive culture within prior 6 months
Denial risk if no documentation of ≥6 months prior multidrug background regimen with required agents
Denial risk if no evidence of continued background regimen during Arikayce therapy
Denial risk if no susceptibility testing showing amikacin MIC < 64 mcg/mL
Denial risk if prescriber is not an infectious disease specialist or pulmonologist and no consultation documented

Key Definitions

Refractory MAC lung disease

DefinitionPatients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy.

Indication contextArikayce has been studied and is indicated for use in this refractory MAC lung disease population; not recommended for non-refractory disease.

Authorization relevanceInitial authorization requires documentation that the patient has not achieved negative sputum cultures after this minimum 6-month regimen.

Sputum culture conversion

DefinitionSputum culture conversion is defined as 3 consecutive negative monthly sputum cultures by Month 6.

Regulatory basisThe accelerated approval for Arikayce is based on achieving sputum culture conversion (3 consecutive negative monthly cultures) by Month 6.

Clinical implicationSputum culture conversion is the primary measured endpoint for evaluating response to therapy in the indication.

OpenPayer

Arikayce (amikacin liposome inhalation suspension) prior authorization

Coverage Criteria for Arikayce (amikacin liposome inhalation suspension)

Key Clinical Thresholds and Coding-related Values

Provider Requirements and Documentation

Background and Indication

Key Definitions