CurrentColorado Rocky Mountain Health PlansPolicy N/A

Arikayce (amikacin liposome inhalation suspension) prior authorization

Defines prior authorization and medical necessity criteria for Arikayce in adults with refractory Mycobacterium avium complex (MAC) lung disease for Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyArikayce (amikacin liposome inhalation suspension) prior authorization

Policy CodePolicy N/A

Change TypeMinor/No material change

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionSubmit medical records documenting recent positive MAC respiratory cultures, prior multidrug background regimen of ≥6 consecutive months, and amikacin MIC <64 mcg/mL; ensure specialist prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6initial authorization duration

6prior multidrug therapy duration

<=12max therapy if cultures positive

<64amikacin susceptibility threshold

Specialistspecialist prescriber

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Coverage Criteria for Arikayce (amikacin liposome inhalation suspension)

Initial Therapy

Covered when ALL of the following are met for initial authorization:

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

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

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

Initial Authorization: Patient will continue to receive a multidrug background regimen (≥2 agents)

Initial Authorization: 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: In vitro susceptibility testing (within 6 months) documents the MAC isolate is susceptible to amikacin with MIC < 64 mcg/mLMIC < 64 mcg/mL

Initial Authorization: Prescribed by or in consultation with an infectious disease specialist or pulmonologist

Continuation / Reauthorization

Reauthorization covered when EITHER of the following:

Reauthorization Option 1: Documentation that the patient has achieved negative respiratory cultures

Reauthorization Option 2: (a) Patient has not achieved negative respiratory cultures while on Arikayce AND (b) Physician attestation that patient has demonstrated clinical benefit while on Arikayce AND (c) In vitro susceptibility testing of most recent (within 6 months) positive culture documents MAC isolate susceptible to amikacin with MIC < 64 mcg/mL AND (d) Patient has not received greater than 12 months of Arikayce therapy with continued positive respiratory culturesMIC < 64 mcg/mL; <= 12 months

Use of Arikayce is not recommended for patients with non‑refractory Mycobacterium avium complex (MAC) lung disease. This policy reserves Arikayce for adults with refractory MAC lung disease who have failed to achieve negative sputum cultures after an adequate multidrug background regimen and have limited or no alternative treatment options.

Key Coding and Therapy Parameters

amikacin MIC susceptibility

Amikacin MIC susceptibility thresholdIn vitro susceptibility testing of a recent (within 6 months) positive culture documents MAC isolate susceptible to amikacin with MIC < 64 mcg/mL.

Timing of susceptibility testingMust be from most recent positive culture within 6 months.

Use for initial and reauthorizationRequired for both initial authorization and reauthorization when cultures are positive.

prior multidrug therapy duration

Minimum prior multidrug therapy durationPatient must have received a multidrug background regimen containing at least two agents for a minimum of 6 consecutive months within the past 12 months.

Required agents in background regimen

Provider Actions, Authorization Steps, and Documentation

Prior Authorization

Prior Authorization Required — Initial Authorization

Initial authorization required. Submit documentation showing diagnosis, recent positive MAC respiratory culture, prior multidrug background therapy, continued background therapy, amikacin susceptibility, and specialist prescriber. Authorization issued for 6 months.

Diagnosis: refractory Mycobacterium avium complex (MAC) lung disease
Respiratory culture positive for MAC within the previous 6 months (medical records: chart notes, labs)
Documentation of prior multidrug background regimen containing at least two agents (macrolide, ethambutol, rifamycin) for ≥ 6 consecutive months within the past 12 months; prescription claims may supplement
Patient will continue to receive a multidrug background regimen
In vitro susceptibility testing of a recent (within 6 months) positive culture showing MAC isolate susceptible to amikacin (MIC < 64 mcg/mL)
Prescribed by or in consultation with an infectious disease specialist or pulmonologist

Background and Indication

Arikayce (amikacin liposome inhalation suspension) is indicated under accelerated approval for adults with refractory Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial regimen for patients who have not achieved negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen. The accelerated approval is based on achieving sputum culture conversion — defined as three consecutive negative monthly sputum cultures by Month 6 — and clinical benefit has not yet been fully established; therefore Arikayce is reserved for patients with limited or no alternative treatment options.

Definitions

Refractory MAC lung disease

Definition of refractory MAC lung diseaseMAC lung disease in patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy.

Clinical context for Arikayce useArikayce is reserved for adults with limited or no alternative treatment options and has been studied in this refractory population only.

Not recommended for non-refractory diseaseUse of Arikayce is not recommended for patients with non-refractory MAC lung disease.

Sputum culture conversion

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

Regulatory basis for approvalAccelerated approval of Arikayce is based on achieving sputum culture conversion by Month 6.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyArikayce (amikacin liposome inhalation suspension) prior authorization

Policy CodePolicy N/A

Change TypeMinor/No material change

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

SourceLink

On This Page

Examples include a macrolide (e.g., azithromycin, clarithromycin), ethambutol, and a rifamycin (e.g., rifampin, rifabutin).

Documentation sourcesPrescription claims history may be used in conjunction with medical records to document medication use, dose, and duration.

initial authorization length

Initial authorization lengthAuthorization will be issued for 6 months.

State and plan considerationsState mandates, federal regulatory requirements, and member-specific benefit plan coverage may affect coverage duration.

Reauthorization timingReauthorization decisions reference clinical response and documented criteria within the authorization period.

maximum therapy with continued positive cultures for reauthorization

Maximum Arikayce duration with continued positive culturesPatient must not have received greater than 12 months of Arikayce therapy with continued positive respiratory cultures to qualify for reauthorization under the continued-positive-cultures pathway.

Context for reauthorization optionThis limit applies when patient has not achieved negative respiratory cultures and reauthorization is sought based on physician attestation of clinical benefit.

Requirement concurrent with background regimenPatient must continue to receive a multidrug background regimen (≥2 agents) during therapy and reauthorization period.

Documentation Required

Reauthorization Criteria

Reauthorization allowed only when criteria met: either documented sputum culture conversion OR continued benefit with limits and required documentation. Provide medical records and susceptibility testing as noted.

If negative respiratory cultures achieved: submit documentation of culture conversion
If cultures remain positive: submit physician attestation of clinical benefit while on Arikayce
If cultures remain positive: in vitro susceptibility testing of most recent (within 6 months) positive culture documents MAC susceptible to amikacin (MIC < 64 mcg/mL)
If cultures remain positive: patient has not received > 12 months of Arikayce therapy with continued positive respiratory cultures
Submission of medical records documenting continued receipt of a multidrug background regimen containing at least two agents (macrolide, ethambutol, rifamycin)
Prescribed by or in consultation with an infectious disease specialist or pulmonologist

Step Therapy

Step Therapy / Sequencing

Arikayce is reserved as step therapy for adults with refractory MAC who have failed to achieve negative sputum cultures after a minimum of 6 consecutive months of multidrug background therapy. Use is limited to patients with limited or no alternative treatment options.

Indication limited to adults with refractory MAC lung disease (failure to achieve negative sputum cultures after ≥ 6 months of multidrug background regimen)
Reserve for patients with limited or no alternative treatment options
Not recommended for non-refractory MAC lung disease

Documentation Required

Required Documentation

Required documentation must be submitted with the prior authorization request to establish medical necessity and avoid delays or denial.

Medical records (chart notes, laboratory values) documenting respiratory cultures positive for MAC within the previous 6 months
Records documenting prior multidrug background regimen: agents, doses, and dates showing at least two agents for ≥ 6 consecutive months
Documentation that the patient will continue to receive a multidrug background regimen
Documentation that the patient has not achieved negative sputum cultures after ≥ 6 months of background therapy (for initial auth)
In vitro susceptibility results for recent positive culture showing amikacin MIC < 64 mcg/mL
For reauthorization, documentation of negative cultures OR (if cultures remain positive) physician attestation of clinical benefit and susceptibility data
Prescriber specialty or consultation notes (infectious disease specialist or pulmonologist)

Denial Risk

Triggers for Denial

Denial risks include missing or insufficient documentation, lack of prior multidrug therapy, absence of recent positive MAC respiratory cultures, or exceeding therapy duration limits without meeting continuation criteria.

Failure to provide medical records documenting a respiratory culture positive for MAC within the previous 6 months
Lack of documentation of prior multidrug background therapy (≥ 2 agents for ≥ 6 consecutive months)
No documentation that the patient will continue on a multidrug background regimen
For reauthorization: absence of documentation of negative cultures OR (if cultures remain positive) missing physician attestation of clinical benefit or missing susceptibility testing
Patient has received > 12 months of Arikayce therapy with continued positive respiratory cultures (reauthorization not supported)

Clinical benefit caveatClinical benefit has not yet been fully established despite conversion-based approval.