CurrentCignaPolicy IP0383

Amikacin liposome inhalation suspension (Arikayce) coverage

Defines medical necessity, reauthorization, duration, and non-covered uses for Arikayce (amikacin liposome inhalation suspension) for Cigna-administered health benefit plans, affecting prescribers and reviewers.

Policy Summary

PayerCigna

PolicyAmikacin liposome inhalation suspension (Arikayce) coverage

Policy CodePolicy IP0383

Change TypeRevised criteria (material)

Effective DateJan 15, 2025

Next Review Date

Key ActionSubmit prior authorization showing age ≥18, completion of ≥6 months of a background multidrug regimen, a positive sputum culture for MAC, and documentation that Arikayce will be used with a background regimen.

SourceLink

POLICY UPDATE CHANGES

Replaced requirement of 'refractory MAC lung disease defined as not achieving negative sputum cultures after a minimum of 6 consecutive months of a background multidrug regimen' with criteria that the patient has completed ≥ 6 consecutive months of a background multidrug regimen and has a positive sputum culture for Mycobacterium avium complex.

≥6 mominimum background regimen

up to 12 moinitial approval

up to 12 moreauthorization

29% vs 8.9%culture conversion (Month 6)

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Coverage Criteria

Mycobacterium avium Complex (MAC) Lung Disease

Covered when ALL of the following are met

MAC Initial Coverage: Patient is age 18 years or older; Patient has completed ≥ 6 consecutive months of a background multidrug regimen (typical components include a macrolide such as azithromycin or clarithromycin, ethambutol, and a rifamycin such as rifampin or rifabutin); Patient has a positive sputum culture for Mycobacterium avium complex (any positive sputum culture taken after completion of ≥ 6 months of background therapy fulfills this criterion); The MAC isolate is susceptible to amikacin; Arikayce will be used in conjunction with a background multidrug regimen; Medication is prescribed by a pulmonologist, infectious diseases physician, or a physician who specializes in the treatment of Mycobacterium avium complex lung infections.

All listed conditions must be met.

Cystic Fibrosis

Covered when BOTH of the following are met

Cystic Fibrosis Indication: Patient has cystic fibrosis with Pseudomonas aeruginosa identified in airway culture; Medication is prescribed by, or in consultation with, a pulmonologist or a physician who specializes in the treatment of cystic fibrosis.

Both conditions must be met.

Reauthorization Criteria - MAC

Reauthorization covered when BOTH of the following are met

MAC Reauthorization: Arikayce will be used in conjunction with a background multidrug regimen; AND one of the following: (i) the patient has not achieved negative sputum cultures for Mycobacterium avium complex, OR (ii) the patient has achieved negative sputum cultures for Mycobacterium avium complex for less than 12 months and will continue Arikayce to complete 12 months of therapy following the negative sputum culture.

Both A and one of B(i)/B(ii) must be satisfied.

Reauthorization Criteria - Cystic Fibrosis

Reauthorization covered when

CF Reauthorization: Patient continues to meet the initial cystic fibrosis medical necessity criteria and there is documentation of beneficial response to therapy.

Documentation of benefit required for continued coverage.

Any use of Arikayce (amikacin liposome inhalation suspension) for indications other than those specified in this policy is considered experimental, investigational, or unproven and may be denied. This includes any off‑label or unlisted clinical uses until sufficient published evidence becomes available to support coverage.

Arikayce is not recommended for initial treatment of Mycobacterium avium complex (MAC) pulmonary disease and should be reserved for adults with limited or no other treatment options. The agent received accelerated approval for use in adults who remain culture‑positive after ≥ 6 consecutive months of a guideline‑based background multidrug regimen, and guidance advises reserving liposomal amikacin for patients who have failed prior therapy rather than as first‑line therapy.

Clinical practice guidelines do not recommend liposomal amikacin for the initial treatment of MAC pulmonary disease. Instead, the guidelines recommend adding liposomal amikacin to guideline‑based therapy only for patients who have failed to achieve culture conversion after ≥ 6 months of appropriate multidrug therapy; resistance testing (amikacin MIC breakpoints) should guide cessation of therapy when indicated.

Coding and Microbiology Thresholds

amikacin liposome MIC resistance breakpoint

Amikacin liposome (Arikayce) MIC resistance breakpoint≥ 128 mcg/mL

Clinical action on breakpointMIC ≥ 128 mcg/mL for amikacin liposome indicates resistance and would lead to cessation of therapy per guidelines

Source guideline contextBreakpoint cited by ATS/ERS/ESCMID/IDSA 2020 guidelines for NTM pulmonary disease

parenteral amikacin MIC resistance breakpoint

Parenteral amikacin MIC resistance breakpoint≥ 64 mcg/mL

Clinical action on breakpointMIC ≥ 64 mcg/mL for parenteral amikacin indicates resistance and would lead to cessation of therapy per guidelines

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are up to 12 months; reauthorization approvals are up to 12 months.

Initial approval duration: up to 12 months
Reauthorization approval duration: up to 12 months

Step Therapy

Step Therapy / Sequencing

Arikayce is reserved for adults who have limited or no alternative treatment options and should be used in patients who have not achieved clinical goals (failure to convert sputum culture) after ≥ 6 consecutive months of a guideline-based background multidrug regimen. Use for initial treatment of non-refractory MAC lung disease is not recommended.

Reserve for adults (≥18 years) with limited or no alternative treatment options
Background multidrug regimen typically includes a macrolide, ethambutol, and a rifamycin
Intended for patients who have not achieved negative sputum cultures after ≥6 months of background MDR therapy

Definitions

Background multidrug regimen

Typical agentsMacrolide (azithromycin or clarithromycin), ethambutol, and a rifamycin (rifampin or rifabutin)

Role in policyPatients must complete ≥ 6 consecutive months of a background multidrug regimen before Arikayce is considered

Guideline noteMost guideline regimens are three-drug combinations; select regimens may be two drugs (macrolide + ethambutol) for certain patients

Culture conversion

DefinitionAchieving three consecutive monthly negative sputum cultures

Use as efficacy endpointCulture conversion by Month 6 was the surrogate efficacy endpoint in pivotal trial

Background

Arikayce is indicated for treatment of Mycobacterium avium complex (MAC) lung disease in adults who have limited or no alternative treatment options, and only as part of combination therapy for patients who do not achieve negative sputum cultures after at least 6 consecutive months of a background multidrug regimen (typically a macrolide, ethambutol, and a rifamycin). Its approval was based on sputum culture conversion (three consecutive monthly negative cultures) by Month 6, but available safety and efficacy data are limited; therefore, Arikayce should be reserved for patients without other viable treatment alternatives and is not recommended for non‑refractory cases.