By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (Lumasiran) Covered by Aetna (CVS Health) in Illinois: Complete Guide to Prior Authorization and Appeals

Answer Box: Getting Oxlumo Covered by Aetna (CVS Health) in Illinois

Aetna (CVS Health) covers Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) with prior authorization. To get approval: (1) Your nephrologist or geneticist submits a precertification request with confirmed PH1 diagnosis (genetic testing showing AGXT mutation or enzyme analysis), baseline urinary oxalate levels, and eGFR ≥30 mL/min/1.73 m². (2) Standard approval takes 30-45 days; expedited requests get decisions within 72 hours. (3) If denied, you have 180 days to appeal internally, then 30 days for Illinois external review. Download the Aetna Oxlumo precertification form and call (866) 752-7021 to start.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline Expectations
  4. Medical Necessity Criteria
  5. Cost Considerations
  6. Denials and Appeals in Illinois
  7. Renewal Requirements
  8. Specialty Pharmacy Coordination
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Oxlumo Covered by Aetna (CVS Health)?

Yes, Aetna considers Oxlumo (lumasiran) medically necessary for primary hyperoxaluria type 1 (PH1) patients, but prior authorization is required for all commercial medical plans. The drug may be covered under your medical benefit (provider-administered) or pharmacy benefit through CVS Specialty, depending on your specific plan.

Coverage at a Glance

Requirement Details Where to Find It Source
Prior Authorization Required for all plans Aetna provider portal Aetna Policy
Formulary Status May require exception if non-preferred Member portal or ID card 2024 Formulary Guide
Specialist Required Nephrologist or geneticist PA form requirements Precert Form
Diagnosis Code ICD-10 E72.53 (primary hyperoxaluria) Clinical documentation Aetna Policy

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm Your Coverage (Patient/Family)
    • Call Aetna member services (number on your ID card)
    • Ask: "Is Oxlumo covered under medical or pharmacy benefit?"
    • Request your plan's formulary status and copay information
  2. Gather Required Documentation (Clinic)
    • Genetic testing results showing AGXT mutation OR liver enzyme analysis
    • Baseline urinary oxalate measurements
    • eGFR ≥30 mL/min/1.73 m² lab results
    • Complete medical history and prior treatments
  3. Submit Precertification Request (Prescriber)
  4. Track Your Request (Patient/Clinic)
    • Standard timeline: 30-45 days for medical benefit
    • Expedited: 72 hours with urgency documentation
    • Check status via Aetna provider portal
  5. Coordinate Specialty Pharmacy (If Approved)
    • CVS Specialty typically handles fulfillment
    • Confirm shipping address and administration scheduling
    • Verify patient assistance program enrollment
Clinician Corner: Medical Necessity Letter Checklist

Your prior authorization will be stronger with these elements:Confirmed PH1 diagnosis: Include genetic test results or enzyme analysis reportBaseline measurements: Document urinary oxalate levels and kidney functionTreatment rationale: Explain why Oxlumo is appropriate per FDA labelingMonitoring plan: Outline follow-up labs and response assessmentGuideline support: Reference nephrology society recommendations when available

Timeline Expectations

Standard Processing Times

Request Type Aetna Timeline Success Rate Notes
Medical Benefit PA 30-45 days 60-70% with complete submissions Most common pathway
Pharmacy Benefit PA 14 days 95% if eligibility clear Via CVS Caremark
Expedited/Urgent 72 hours Similar to standard Requires urgency documentation
Appeal (Internal) 45 business days 10-15% overturn rate Can request expedited
External Review (IL) 5 business days after IRO assignment 52% overturn rate Binding decision

Pro tip: About 85% of approvals happen within 24-48 hours when documentation is complete and criteria are clearly met.

Medical Necessity Criteria

What Aetna Requires for Initial Approval

All of the following must be documented:

  • Confirmed PH1 diagnosis via molecular genetic testing showing AGXT mutation OR liver enzyme analysis demonstrating absent/reduced alanine:glyoxylate aminotransferase (AGT) activity
  • Prescription by or consultation with a relevant specialist (nephrologist or geneticist)
  • Baseline laboratory values: eGFR ≥30 mL/min/1.73 m² and urinary oxalate measurements
  • No concurrent use with nedosiran (Rivfloza)
  • Appropriate ICD-10 coding: E72.53 (primary hyperoxaluria)

Common Denial Reasons & How to Address Them

Denial Reason How to Fix Documentation Needed
Insufficient PH1 proof Submit genetic testing AGXT mutation analysis or enzyme study
Non-specialist prescriber Add consultation note Nephrologist or geneticist evaluation
Missing baseline labs Complete testing eGFR, urinary oxalate, creatinine
Experimental/investigational Cite FDA approval FDA label, indication section

Cost Considerations

Understanding Your Out-of-Pocket Costs

Oxlumo's annual list price is approximately $493,000, making cost-sharing a significant concern for many patients.

Commercial Insurance Options:

  • Alnylam Assist Copay Program: May reduce costs for eligible patients with commercial insurance
  • Medical benefit coinsurance: Typically 20-30% of allowed amount
  • Deductibles: May apply before coverage begins

Medicaid Coverage:

  • Illinois Medicaid managed care plans (Meridian, Molina) cover Oxlumo with prior authorization
  • Minimal or no patient cost-sharing for approved treatments
  • Manufacturer copay cards cannot be used with government insurance
Note: Contact Alnylam Assist at 1-833-256-2748 to verify your eligibility for patient assistance programs and benefits verification support.

Denials and Appeals in Illinois

Your Appeal Rights in Illinois

Illinois provides strong patient protection through the Health Carrier External Review Act. Here's your pathway if Aetna denies coverage:

Internal Appeal Process:

  • Deadline: 180 days from denial notice
  • Timeline: 15 business days for pre-service requests
  • Expedited: 24 hours for urgent cases
  • Contact: Use appeal instructions in your denial letter

External Review (Independent):

  • Deadline: 30 days after final internal denial (shorter than many states)
  • Timeline: 5 business days once Independent Review Organization (IRO) receives all materials
  • Cost: Free to patients; Illinois insurers pay IRO fees
  • Decision: Binding on Aetna

Illinois Resources:

  • Illinois Department of Insurance Consumer Hotline: (877) 527-9431
  • Illinois Attorney General Health Care Helpline: (1-877-305-5145)
  • External Review Forms: Illinois DOI website

Appeals Playbook for Aetna in Illinois

  1. Internal Appeal (First Level)
    • Submit within 180 days of denial
    • Include all medical records supporting PH1 diagnosis
    • Address each denial reason specifically
    • Request expedited review if delay risks health
  2. External Review (If Internal Appeal Denied)
    • File within 30 days of final adverse determination
    • Submit to Illinois Department of Insurance
    • IRO will be board-certified physician with relevant expertise
    • Decision typically completed within 30 days total

From our advocates: We've seen cases where patients initially denied for "insufficient genetic confirmation" were approved on appeal after submitting comprehensive AGXT testing results with a detailed specialist letter explaining the mutation's clinical significance. The key is directly addressing each criterion cited in the denial letter.

Renewal Requirements

When to Reauthorize

Aetna typically approves Oxlumo for 12-month periods with renewal required 30-45 days before expiration.

Renewal Documentation:

  • Updated urinary oxalate reduction measurements
  • Stable or improved eGFR results
  • Prescriber attestation of continued clinical benefit
  • Ongoing specialist involvement
  • No significant safety concerns

Timeline for Renewal:

  • Submit 30-45 days before current authorization expires
  • Faster processing (14-30 days) with stable clinical data
  • Continue current therapy while renewal is pending

Specialty Pharmacy Coordination

Working with CVS Specialty

Most Aetna plans route Oxlumo through CVS Specialty for fulfillment and administration coordination.

What to Expect:

  • Benefits verification and prior authorization support
  • Coordination with your infusion center or clinic
  • Patient education and injection training if applicable
  • Insurance appeals assistance if needed

Key Contacts:

  • CVS Specialty: Check your specific plan materials for direct number
  • Alnylam Assist: 1-833-256-2748 for manufacturer support

Troubleshooting Common Issues

When Things Go Wrong

Portal Access Problems:

  • Use Aetna member portal at Aetna.com
  • Call member services if login issues persist
  • Providers can access via Aetna provider portal

Missing Forms or Documentation:

  • Download current Oxlumo precert form
  • Verify fax number: (888) 267-3277
  • Confirm receipt with phone follow-up: (866) 752-7021

Delays in Processing:

  • Standard requests: Follow up after 30 days
  • Expedited requests: Follow up after 3 business days
  • Request expedited processing if clinical urgency develops

Frequently Asked Questions

How long does Aetna prior authorization take for Oxlumo in Illinois? Standard medical benefit requests take 30-45 days, while pharmacy benefit requests through CVS Caremark typically process within 14 days. Expedited requests are decided within 72 hours.

What if Oxlumo is non-formulary on my Aetna plan? Submit a formulary exception request with your prior authorization, documenting medical necessity and lack of suitable alternatives. Most PH1 cases qualify for exceptions.

Can I request an expedited appeal in Illinois? Yes, if delay would seriously jeopardize your health. Your prescriber must certify the urgency, and Aetna must decide within 72 hours for expedited appeals.

Does step therapy apply to Oxlumo for PH1? Typically no, since Oxlumo is often first-line therapy for PH1. However, some plans may require documentation of conservative management attempts.

What genetic testing confirms PH1 for insurance? AGXT gene sequencing showing pathogenic mutations, or liver enzyme analysis demonstrating absent/reduced AGT activity. The Alnylam Act program offers no-charge testing for eligible patients.

How do I escalate if Aetna isn't following Illinois timelines? Contact the Illinois Department of Insurance at (877) 527-9431 to file a complaint. They can investigate delays and ensure compliance with state appeal laws.

Getting the coverage you need for rare diseases like PH1 can feel overwhelming, but you don't have to navigate this process alone. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify exactly why coverage was denied, then drafts point-by-point rebuttals aligned to your plan's own rules. We pull the right medical evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—and weave them into appeals that meet procedural requirements while tracking deadlines and required documentation.

For immediate assistance with your Oxlumo prior authorization or appeal, consider reaching out to Counterforce Health for expert guidance tailored to your specific situation and Aetna plan requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with insurance appeals and coverage issues in Illinois, contact the Illinois Department of Insurance at (877) 527-9431.

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