By Counterforce Health Team in Arikayce (amikacin liposome inhalation) —

How to Get Arikayce Covered by Cigna in California: Prior Authorization Requirements and Appeal Process

Answer Box: Getting Arikayce Covered by Cigna in California

Cigna requires prior authorization for Arikayce (amikacin liposome inhalation) with strict criteria: adults ≥18 with MAC lung disease, positive cultures after ≥6 months of multidrug therapy, and amikacin susceptibility testing. Submit PA through Cigna/Express Scripts portal with sputum culture results, treatment history, and specialist consultation. If denied, file internal appeal within 180 days, then request California's Independent Medical Review (IMR) through DMHC for binding external review. Start today: Gather your culture results and contact your pulmonologist or infectious disease specialist to initiate the PA request.

Table of Contents

  1. Cigna's Coverage Criteria for Arikayce
  2. Prior Authorization Requirements
  3. Step Therapy and Medical Exceptions
  4. Required Diagnostics and Documentation
  5. Appeals Process in California
  6. Common Denial Reasons and Solutions
  7. Costs and Patient Assistance
  8. FAQ

Cigna's Coverage Criteria for Arikayce

Cigna covers Arikayce (amikacin liposome inhalation suspension) exclusively for refractory Mycobacterium avium complex (MAC) lung disease in adults. The medication requires prior authorization across all Cigna plan types, including those managed through Express Scripts specialty pharmacy networks.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Age limit Adults ≥18 years old Date of birth verification Cigna PA Policy
Prior authorization Required for all plans PA form submission Cigna PA Policy
Diagnosis Refractory MAC lung disease only Positive MAC cultures Cigna PA Policy
Treatment failure ≥6 months multidrug therapy Treatment history documentation Cigna PA Policy
Specialist requirement Infectious disease or pulmonology Provider credentials Cigna PA Policy
Combination therapy Must use with multidrug regimen Current medication list Cigna PA Policy

Prior Authorization Requirements

Initial Approval Criteria

Cigna approves Arikayce for one-year durations when all of the following criteria are met:

  1. Patient is ≥18 years old
  2. Positive MAC sputum culture collected within the past 3 months
  3. Treatment failure after ≥6 consecutive months of background multidrug regimen (typically macrolide + ethambutol + rifamycin)
  4. Amikacin susceptibility confirmed by laboratory testing
  5. Combination use with continued multidrug regimen
  6. Specialist oversight by infectious disease or pulmonology physician

Fastest Path to Approval: Step-by-Step

  1. Gather documentation (Patient/Clinic): Collect sputum culture results, susceptibility testing, and 6+ months of treatment records
  2. Specialist consultation (Patient): Ensure prescriber is infectious disease or pulmonology specialist
  3. Submit PA request (Clinic): Use Cigna provider portal or Express Scripts authorization system
  4. Include required documents (Clinic): Culture results, treatment history, specialist letter
  5. Track submission (Clinic): Follow up within 72 hours if no acknowledgment received
  6. Receive determination (All): Standard review completed within 14 days
  7. Fill prescription (Patient): Use designated specialty pharmacy if approved
Tip: Submit PA requests early in the week to avoid weekend processing delays. Cigna typically processes specialty drug authorizations within 72 hours for complete submissions.

Step Therapy and Medical Exceptions

Arikayce doesn't require traditional step therapy since it's indicated only for treatment-refractory cases. However, Cigna requires documented evidence of treatment failure with standard MAC therapy.

Required Prior Treatments

Before approving Arikayce, Cigna requires documentation of:

  • Macrolide therapy: Azithromycin or clarithromycin for ≥6 months
  • Ethambutol: Standard dosing for ≥6 months
  • Rifamycin: Rifampin or rifabutin for ≥6 months
  • Persistent positive cultures: MAC isolation despite adequate therapy

Medical Exception Pathways

If standard 6-month documentation is incomplete, physicians can request exceptions by demonstrating:

  • Intolerance to standard therapy: Documented adverse effects requiring discontinuation
  • Contraindications: Medical conditions preventing standard drug use
  • Rapid disease progression: Clinical deterioration requiring immediate intervention

Required Diagnostics and Documentation

Laboratory Requirements

Test Timing Purpose Documentation
MAC sputum culture Within 3 months Confirm active infection Lab report with organism identification
Amikacin susceptibility Recent (≤6 months) Verify drug effectiveness MIC values or susceptibility report
Baseline audiometry Before treatment Monitor ototoxicity risk Hearing test results
Renal function Within 30 days Monitor nephrotoxicity Creatinine, BUN levels

Clinical Documentation Checklist

  • Diagnosis confirmation: ICD-10 codes for MAC lung disease
  • Treatment history: Detailed medication list with doses, durations, and outcomes
  • Culture results: Serial sputum cultures showing persistent MAC positivity
  • Specialist consultation: Letter from infectious disease or pulmonology physician
  • Monitoring plan: Proposed schedule for audiometry and renal function tests

Appeals Process in California

California residents have robust appeal rights through both Cigna's internal process and the state's Independent Medical Review (IMR) system.

Internal Appeals with Cigna

Timeline: 180-day window from denial date Process: Submit written appeal with supporting documentation Determination: First-level review within 30 days, second-level within 60 days

California Independent Medical Review (IMR)

California's IMR system provides binding external review with high success rates for specialty drug appeals.

Success rates: 45-70% overturn rate for specialty drugs when medical necessity is well-documented Timeline:

  • Standard review: 45 days
  • Expedited review: 72 hours for urgent cases Cost: Free to patients Eligibility: Available after internal appeal completion or 30-day wait

How to Apply:

  • Online: DMHC website
  • Phone: 1-888-466-2219
  • Deadline: 6 months from final internal denial
Note: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and drafts point-by-point rebuttals using payer-specific criteria and clinical evidence.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
"Not meeting 6-month criterion" Submit complete treatment timeline Pharmacy records, prescription history
"Insufficient culture documentation" Provide recent MAC-positive results Laboratory reports within 3 months
"Missing specialist requirement" Obtain ID or pulmonology consultation Specialist letter with credentials
"Lack of combination regimen" Document concurrent multidrug therapy Current medication list with doses
"Monitoring gaps" Establish baseline testing Audiometry, renal function results

Clinician Corner: Medical Necessity Letter

When writing medical necessity letters for Arikayce, include:

  1. Patient background: Age, diagnosis, disease duration
  2. Treatment failure: Specific medications tried, durations, outcomes
  3. Clinical rationale: Why Arikayce is appropriate now
  4. Guideline support: Reference ATS/ERS/ESCMID/IDSA guidelines
  5. Monitoring plan: Proposed audiometry and renal function schedule
  6. Treatment goals: Expected outcomes and duration

Costs and Patient Assistance

Arikayce costs approximately $1,500-$1,600 per vial without insurance coverage. Several assistance programs can help reduce out-of-pocket expenses:

Manufacturer Support

  • Insmed Patient Assistance Program: Income-based free drug program
  • Commercial copay assistance: Up to $10,000 annually for eligible patients
  • Information: Visit Arikayce.com or call 1-844-4-ARIKAYCE

California-Specific Resources

  • Covered California: Premium tax credits for marketplace plans
  • Medi-Cal: Expanded Medicaid coverage for low-income residents
  • State pharmaceutical assistance: Various county-level programs available

FAQ

How long does Cigna PA take in California? Standard prior authorization requests are processed within 72 hours for complete submissions. Expedited reviews for urgent cases are completed within 24 hours.

What if Arikayce is non-formulary on my plan? Request a formulary exception through Cigna's standard process. Physicians can certify medical necessity, and decisions are made within one business day for standard requests.

Can I request an expedited appeal? Yes, if your condition may seriously jeopardize your life or health. Expedited appeals are completed within 24 hours of receipt.

Does step therapy apply if I failed treatments outside California? Treatment failure documentation from any location is acceptable as long as it meets the 6-month minimum requirement with appropriate multidrug therapy.

What happens if my internal appeal is denied? You can request California's Independent Medical Review (IMR) within 6 months of the final internal denial. IMR decisions are binding on the insurance company.

How do I know if my plan is regulated by DMHC or CDI? Most HMOs and managed care plans are under DMHC oversight. Check your member handbook or call the plan directly. Both agencies offer similar external review processes.

When navigating insurance coverage challenges, patients and clinicians can benefit from specialized support. Counterforce Health helps transform insurance denials into successful appeals by analyzing payer policies and crafting evidence-based rebuttals that align with each plan's specific criteria.

Sources & Further Reading

This article is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For assistance with California insurance appeals, contact the DMHC Help Center at 1-888-466-2219.

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