CurrentAvMedPolicy N/A

Arikayce (amikacin liposome inhalation) prior authorization

Defines prior authorization and step-edit requirements for Arikayce for members with MAC lung disease; applies to prescribers and AvMed pharmacy staff processing PA requests.

Policy Summary

PayerAvMed

PolicyArikayce (amikacin liposome inhalation) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals for Arikayce are for 6 months and reauthorization may be approved for 12 months when renewal criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

28 vialsQuantity limit

>=18Minimum age

Coverage Criteria for Arikayce

inv-01: Initial Therapy

Covered when ALL of the following are met

Age: Patient is 18 years of age or older>=18 years

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

Prescriber signature and documentation required

Diagnosis - Clinical findings: Member has ONE of: pulmonary symptoms OR nodular/cavitary opacities on chest radiograph OR HRCT showing multifocal bronchiectasis with multiple small nodules

Chart notes required

Policy Summary

PayerAvMed

PolicyArikayce (amikacin liposome inhalation) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals for Arikayce are for 6 months and reauthorization may be approved for 12 months when renewal criteria are met.

SourceLink

On This Page

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Diagnosis - Microbiological findings: Member has ONE of: positive culture from at least two separate expectorated sputum samples OR bronchoscopic culture positive for nontuberculosis mycobacterium (NTM) OR lung biopsy showing granulomatous inflammation or positive AFB staining with positive culture for NTM

Chart/lab documentation required

Prior treatment failure: Documentation of at least 2 positive sputum cultures despite at least 6 months of multidrug guideline-based therapy (macrolide, rifampin, ethambutol)>=6 months

Attach lab results

Recent culture: Documentation of positive sputum cultures within the past 60 days<=60 days

Exclusion of other diagnoses: Tuberculosis and lung malignancy have been ruled out

Combination therapy: Member will continue Arikayce in combination with guideline-based therapy (macrolide, rifampin, ethambutol)

Concomitant GBT will be verified through pharmacy paid claims

inv-02: Reauthorization

Reauthorization covered when ALL of the following are met

Microbiologic response: Either at least 3 consecutive negative monthly sputum cultures in the first 6 months OR at least 2 consecutive negative monthly sputum cultures in the last 2 months of therapy3 negative in 6 months OR 2 negative in last 2 months

Labs must be submitted

Duration and limits: Renewal allowed up to 12 months after converting to negative sputum status; treatment beyond the first reauthorization (after 18 months) requires documentation of a positive sputum culture to continue treatment<=12 months per renewal

Arikayce will not be approved when used in combination with an intravenous aminoglycoside (for example, amikacin or streptomycin).

Arikayce is not approved for treatment of MAC isolates that demonstrate amikacin resistance defined as a minimum inhibitory concentration of MIC >64 µg/mL.

Initial Authorization Criteria

inv-13: Initial Authorization

Initial authorization requirements

Age and prescriber: Patient >=18 years and medication prescribed by or in consultation with an infectious disease specialist or pulmonologist>=18 years

Prescriber signature and supporting documentation required

Diagnosis confirmation: Clinical and microbiological criteria for MAC must be met: required clinical finding plus required microbiologic finding as specified

See documented clinical and microbiologic findings; submit chart notes and labs

Prior therapy: At least 6 months of guideline-based multidrug therapy without sustained culture conversion>=6 months

Attach lab results documenting at least 2 positive sputum cultures despite therapy

Continuation / Reauthorization Criteria

inv-14: Continuation Therapy

Criteria for continued use

Microbiologic response for continuation: At least 3 consecutive negative monthly sputum cultures in the first 6 months OR at least 2 consecutive negative monthly sputum cultures in the last 2 months of therapy3 negative in 6 months OR 2 negative in last 2 months

Laboratory results must be submitted

Drug Strength, Quantity, and Resistance Thresholds

Drug strength/quantityNDCCovered

590mg/8.4ml

Arikayce vial strength and volume

amikacin MIC resistance threshold

Amikacin resistance thresholdMAC isolates with amikacin resistance defined as minimum inhibitory concentration (MIC) >64 µg/mL

ConsequenceNot approved for Arikayce if MAC isolate MIC >64 µg/mL

Source contextListed as a contraindication/exclusion for approval in the policy's exclusions and not medically necessary sections

Step Therapy Requirements

Step	Requirement	Notes
1	Member must have failed or been refractory to multidrug guideline-based therapy (GBT) prior to Arikayce initiation	Failure defined as at least 2 positive sputum cultures despite >=6 months of GBT (macrolide + rifampin + ethambutol). Prior therapies will be verified via pharmacy paid claims or chart notes.

Quantity Limits

Arikayce quantity limit

Quantity limit28 vials per 28 days (one vial = 590 mg/8.4 mL)

Dose formArikayce vial strength: 590 mg/8.4 mL

Route and frequencyInhalation route once daily (one vial daily)

SupplyProvided by specialty pharmacy (PropriumRx indicated)

Provider Requirements and Submission Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for Arikayce (amikacin liposome inhalation suspension). Initial approval duration: 6 months. Reauthorization may be approved for up to 12 months when renewal criteria are met. Submit requests to the pharmacy prior-authorization fax at 1-305-671-0200. If information provided is incomplete, incorrect, or illegible, the authorization process can be delayed or denied.

Initial authorization: 6 months
Reauthorization: up to 12 months (must meet renewal criteria)
Fax: 1-305-671-0200

Step Therapy

Combination and Step Requirements

Arikayce must be used in combination with guideline-based multidrug background therapy (GBT) — specifically a macrolide (clarithromycin or azithromycin), rifampin, and ethambutol. Prior authorization requires documentation that Arikayce will be continued in combination with GBT; pharmacy paid claims will be checked to verify concomitant background therapy.

Combination therapy required: macrolide + rifampin + ethambutol
Background therapy will be verified via pharmacy paid claims

Documentation Required

Required Documentation

Prescriber must sign and clearly print name on the prior authorization request (preprinted stamps not valid). Provide complete documentation to support each criterion checked, including chart notes, laboratory results, diagnostics (e.g., chest radiograph or HRCT), sputum culture results, and prior treatment history. Documentation must include: clinical findings, microbiological confirmation, at least 2 positive sputum cultures despite ≥6 months of guideline-based therapy, and sputum culture results within the past 60 days when applicable.

Prescriber signature required (no preprinted stamps)
Submit chart notes, lab results, diagnostics, and sputum culture results
Document prior guideline-based therapy (≥6 months) and prior therapies (pharmacy claims may be reviewed)

Denial Risk

Triggers for Denial

Requests may be denied if information is incomplete, incorrect, or illegible; if required chart notes, labs, diagnostics, or sputum culture results are missing; or if the patient fails to meet all clinical and microbiological criteria (including confirmed MAC diagnosis, prior GBT failure, or contraindications such as amikacin-resistant isolates or concurrent IV aminoglycoside use). Use of samples to initiate therapy does not meet preauthorization criteria.

Incomplete/illegible request information may delay or cause denial
Missing supporting documentation (chart notes, labs, diagnostics, sputum cultures) can lead to denial
Denial triggers: lack of confirmed MAC diagnosis, insufficient prior GBT (≥6 months), MAC isolates with amikacin resistance (MIC >64 µg/mL), or concurrent IV aminoglycoside use

Site of Care / Dispensing

Note

Home/outpatient inhalation (specialty pharmacy supply)

Arikayce is administered via inhalation and is supplied through a specialty pharmacy for outpatient/home use.

Background

Mycobacterium avium complex (MAC) lung disease is managed with guideline-based multidrug therapy; inhaled amikacin (Arikayce) is intended as an add-on for refractory MAC. This policy excludes use of Arikayce when the member is concurrently receiving an intravenous aminoglycoside or when the MAC isolate shows amikacin resistance (defined as MIC >64 µg/mL).

Definitions

Guideline-based therapy (GBT)

DefinitionGuideline-based therapy (GBT): multidrug background therapy for MAC that may include a macrolide (clarithromycin or azithromycin), rifampin, and ethambutol

Role with ArikayceArikayce must be continued in combination with GBT (macrolide + rifampin + ethambutol) — verification via pharmacy paid claims or chart notes

Prior therapy requirementAt least 6 months of multidrug GBT without sustained culture conversion is required before Arikayce initiation