CurrentColorado Rocky Mountain Health PlansPolicy 2026 P 2161-8

Arikayce (amikacin liposome inhalation suspension) prior authorization / medical necessity

Payer clinical policy governing prior authorization and medical necessity criteria for Arikayce in adults with refractory Mycobacterium avium complex (MAC) lung disease; applies to Colorado Rocky Mountain Health Plans pharmacy management programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyArikayce prior authorization / medical necessity

Policy CodePolicy 2026 P 2161-8

Change TypeAnnual review — no material changes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit medical records showing recent positive respiratory cultures for MAC, prior multidrug background regimen of ≥6 months, and amikacin MIC <64 mcg/mL to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization duration

6 monthsrequired prior multidrug duration

<64amikacin MIC threshold

6 monthssputum conversion window

6 months

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Coverage Criteria for Arikayce (amikacin liposome inhalation suspension)

Initial Therapy

Initial Authorization — Covered when ALL of the following are met

Initial Authorization: Patient has diagnosis of refractory Mycobacterium avium complex (MAC) lung disease

Microbiologic documentation: Submission of medical records documenting respiratory cultures positive for MAC within the previous 6 months6 months

Prior therapy: Patient has been receiving a multidrug background regimen containing at least two agents (macrolide, ethambutol, rifamycin) for a minimum of 6 consecutive months within the past 12 months>=6 months

Ongoing background regimen: Patient will continue to receive a multidrug background regimen

Failure to convert: Documentation that the patient has not achieved negative sputum cultures after receipt of a multidrug background regimen for a minimum of 6 consecutive months6 months

Susceptibility: In vitro susceptibility testing of recent (within 6 months) positive culture documents MAC isolate susceptible to amikacin with MIC <64 mcg/mLMIC <64 mcg/mL

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

Reauthorization

Reauthorization — Covered when ALL of the following are met (alternate path: negative cultures)

Reauthorization option: Either documentation of negative respiratory cultures OR all criteria in the alternate path below

Continued positive cultures with benefit: Patient has not achieved negative respiratory cultures while on Arikayce AND physician attestation that patient has demonstrated clinical benefit while on Arikayce

Repeat susceptibility: Most recent (within 6 months) positive culture susceptibility documents amikacin MIC <64 mcg/mLMIC <64 mcg/mL

Duration limit: Patient has not received greater than 12 months of Arikayce therapy with continued positive respiratory cultures

Use of Arikayce is not recommended for patients with non-refractory MAC lung disease. The policy follows the drug’s approved indication and evidence base, which studied Arikayce only in patients who failed to achieve negative sputum cultures after at least 6 consecutive months of a multidrug background regimen; therefore patients who have not met that refractory definition are outside the intended population for therapy.

Arikayce should be reserved for adults who have limited or no alternative treatment options. The approval is under accelerated approval with only limited clinical safety and effectiveness data; accordingly, Arikayce is indicated for a narrow, specific population (adults with refractory MAC lung disease) and is not intended as routine therapy when alternative effective options exist.

Laboratory and Susceptibility Thresholds

amikacin MIC threshold — < 64 mcg/mL

Amikacin MIC thresholdIn vitro susceptibility: MAC isolate susceptible to amikacin with MIC < 64 mcg/mL

Timing of testingMost recent positive culture susceptibility must be within 6 months

Reauthorization requirementRepeat susceptibility with MIC <64 mcg/mL required for continued coverage when cultures remain positive

prior multidrug regimen duration — >= 6 consecutive months within past 12 months

Required prior multidrug regimen duration>= 6 consecutive months within the past 12 months

Background regimen compositionAt least two agents including macrolide (e.g., azithromycin, clarithromycin), ethambutol, or rifamycin (e.g., rifampin, rifabutin)

Provider Requirements, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Arikayce (amikacin liposome inhalation) requires prior authorization. Approval for initial therapy is issued for 6 months and reauthorization approvals are issued for 6 months. State mandates, federal requirements, and member-specific benefits may further affect coverage.

Initial and reauthorization approvals are limited to 6-month intervals.
Reauthorization beyond 12 months is not allowed for patients with continued positive respiratory cultures.

Step Therapy

Step therapy / Positioning

Step therapy / Positioning: Arikayce is reserved for adults with refractory Mycobacterium avium complex (MAC) lung disease who have limited or no alternative treatment options. Use is limited to patients who did not achieve negative sputum cultures after at least 6 consecutive months of a multidrug background regimen containing at least two agents (macrolide, ethambutol, rifamycin). Reserve Arikayce for refractory MAC; it is not recommended for non-refractory MAC.

Refractory MAC defined as failure to achieve negative sputum cultures after ≥6 consecutive months of multidrug therapy.

Background and Indications

Arikayce (amikacin liposome inhalation suspension) is indicated under accelerated approval for the treatment of Mycobacterium avium complex (MAC) lung disease in adults who have not achieved 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 three consecutive monthly negative sputum cultures by Month 6. Clinical benefit has not been fully established, and the drug has been studied only in patients meeting the definition of refractory MAC lung disease.

Key Definitions

3 consecutive negative monthly sputum cultures by Month 6 — Sputum culture conversion definition

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

Regulatory basisAccelerated approval endpoint for Arikayce is achievement of sputum culture conversion by Month 6

Clinical contextConversion endpoint reflects microbiologic response but clinical benefit has not been fully established

Failure to achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen — Refractory MAC lung disease definition

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

Indication scope

Documentation Required

Required Documentation

Required Documentation: Submit complete medical records to support the diagnosis of refractory MAC and the need for Arikayce. Include clinical notes, laboratory results, and medication history. Provide documentation at initial authorization and at each reauthorization.

Recent respiratory cultures positive for MAC within the previous 6 months (culture reports).
Documentation that the patient has not achieved negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen (chart notes, serial culture results).
Evidence of prior multidrug background regimen containing at least two agents (prescription claims, medication administration records, chart notes) within the past 12 months.
Plan to continue a multidrug background regimen while on Arikayce.
In vitro susceptibility testing of a recent (within 6 months) positive MAC isolate showing amikacin MIC < 64 mcg/mL.
For reauthorization: either documentation of negative respiratory cultures (sputum culture conversion) OR physician attestation of clinical benefit plus continued susceptibility (amikacin MIC < 64 mcg/mL) if cultures remain positive.
Prescriber specialty: documentation that the medication is prescribed by or in consultation with an infectious disease specialist or pulmonologist.