By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (Lumasiran) Covered by Aetna CVS Health in California: Complete Guide with Forms and Appeals

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

Eligibility: Aetna CVS Health covers Oxlumo for primary hyperoxaluria type 1 (PH1) with confirmed AGXT gene mutation or liver enzyme deficiency. Fastest approval path: Submit the Aetna Oxlumo precertification form with genetic test results and specialist documentation. First step today: Contact your prescriber to order AGXT genetic testing if not already completed, and request they initiate prior authorization via (866) 752-7021. If denied, California's Independent Medical Review (IMR) through the DMHC provides strong appeal rights with no patient fees.

Table of Contents

Plan Types & Coverage Implications

Aetna CVS Health operates multiple plan types in California, each with different referral and authorization patterns:

HMO Plans: Require referrals from your primary care physician to see specialists. For Oxlumo, you'll typically need a nephrology or genetics referral before the specialist can prescribe and submit prior authorization.

PPO Plans: Allow direct access to specialists without referrals. You can schedule directly with a nephrologist or genetic specialist who can prescribe Oxlumo and handle the prior authorization process.

Medicaid (Medi-Cal) Plans: Aetna Better Health of California follows enhanced Medicaid criteria that may have additional documentation requirements but generally mirror commercial policies for rare disease treatments.

Note: Regardless of plan type, Oxlumo requires prior authorization and specialty pharmacy dispensing through CVS Specialty.

Formulary Status & Specialty Pharmacy

Oxlumo is classified as a specialty medication on Aetna's formulary, meaning it's not available through retail pharmacies. Here's how coverage works:

Specialty Drug List: Oxlumo appears on Aetna's 2025 specialty drug list with prior authorization required for all plans.

Dispensing: CVS Specialty Pharmacy handles distribution, storage, and patient coordination. The medication is shipped directly to the healthcare provider's office for subcutaneous administration.

Alternative Agents: Aetna's policy acknowledges Rivfloza (nedosiran) as an alternative PH1 treatment, but explicitly prohibits using Oxlumo in combination with nedosiran.

Prior Authorization Requirements

Aetna requires comprehensive documentation to approve Oxlumo. Here are the key requirements:

Requirement Documentation Needed Where to Find It
PH1 Diagnosis AGXT genetic test or liver enzyme analysis Genetics lab, nephrology clinic
Prescriber Specialist (nephrology, genetics preferred) Provider directory
Clinical History Urinary oxalate levels, stone analysis Lab results, imaging reports
Prior Authorization Form Completed Aetna form Aetna website

Genetic Testing Requirements: The AGXT gene test must show a pathogenic mutation, or liver enzyme analysis must demonstrate absent/reduced alanine:glyoxylate aminotransferase activity.

No Numeric Thresholds: Unlike some insurers, Aetna doesn't require specific urinary oxalate levels at baseline, focusing instead on confirmed PH1 diagnosis and clinical need.

Step-by-Step: Fastest Path to Approval

  1. Confirm PH1 Diagnosis (Patient + Prescriber)
    • Order AGXT genetic testing if not completed
    • Gather urinary oxalate results and stone composition analysis
    • Timeline: 2-3 weeks for genetic testing
  2. Specialist Consultation (Patient)
    • See nephrology or genetics specialist
    • Obtain prescription and treatment plan
    • Timeline: 1-2 weeks for appointment
  3. Submit Prior Authorization (Prescriber)
  4. Aetna Review Process (Insurance)
  5. CVS Specialty Coordination (Patient + Pharmacy)
    • Enrollment in specialty pharmacy program
    • Delivery coordination to provider office
    • Timeline: 3-5 business days after approval
  6. Treatment Initiation (Patient + Prescriber)
    • First dose administered at healthcare facility
    • Ongoing monitoring and documentation
    • Timeline: Weight-based dosing per FDA label
  7. Continuation Authorization (Prescriber)
    • Submit renewal with clinical response data
    • Document urinary oxalate reduction or improved kidney function
    • Timeline: Before 12-month approval expires

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit genetic test results and specialist letter AGXT mutation report, clinical notes
"Experimental/investigational" Provide FDA approval documentation FDA label, clinical guidelines
"Non-formulary status" Request formulary exception Specialist attestation, prior therapy failures
"Insufficient documentation" Resubmit with complete records All required forms, genetic testing, clinical history
From our advocates: We've seen Aetna denials overturned when providers include both the genetic testing report and a detailed letter explaining why conservative management (hydration, dietary changes) isn't sufficient for this patient's specific mutation type. The key is connecting the genetic findings to the clinical need for targeted therapy.

California Appeals Process

California provides robust appeal rights through the Department of Managed Health Care (DMHC). Here's your roadmap:

Internal Appeal (Grievance)

  • File with Aetna within 180 days of denial
  • Standard timeline: 30 days for decision
  • Expedited timeline: 72 hours for urgent cases

Independent Medical Review (IMR)

  • Available through DMHC after internal appeal
  • No cost to patients
  • Timeline: 45 days standard, 7 days expedited
  • Success rates vary by case type and documentation quality

Required Documentation for Appeals:

  • Original denial letter
  • Complete medical records
  • Specialist letters supporting medical necessity
  • Peer-reviewed literature on PH1 and Oxlumo efficacy
  • FDA labeling and clinical trial data

DMHC Contact Information:

Cost-Share Considerations

Oxlumo's high cost (approximately $493,000 annually at launch) means understanding your plan's specialty drug benefits is crucial:

Typical Cost-Sharing Patterns:

  • Specialty tier coinsurance: 20-40% of drug cost
  • Annual out-of-pocket maximums: $8,700-$9,450 for individual coverage (2024 ACA limits)
  • Deductible application varies by plan design

Financial Assistance Options:

  • Alnylam Act Program: Manufacturer copay assistance
  • State pharmaceutical assistance programs
  • Nonprofit rare disease foundations
Important: This information is educational only. Consult your plan documents or member services for specific cost-sharing details.

When to Escalate to State Regulators

Contact California regulators if Aetna isn't following proper procedures:

DMHC Oversight (for HMO and most PPO plans):

  • Delays beyond required timelines
  • Failure to provide appeal rights
  • Inadequate medical review processes
  • File complaint at dmhc.ca.gov

California Department of Insurance (for some PPO/indemnity plans):

  • Consumer Hotline: (800) 927-4357
  • Similar external review rights available

Documentation to Include:

  • All correspondence with Aetna
  • Timeline of delays or procedural violations
  • Medical records supporting your case
  • Evidence of financial or health impacts

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex insurance approvals by turning denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify the specific basis for rejection, then drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. For medications like Oxlumo, we help ensure that genetic testing results, specialist documentation, and FDA labeling are properly presented to meet Aetna's exact criteria while tracking California's appeal deadlines and procedural requirements.

FAQ

How long does Aetna prior authorization take for Oxlumo in California? Standard review takes up to 15 business days, while expedited review for urgent cases is completed within 72 hours. Submit requests well before the planned start date.

What if Oxlumo is denied as "not medically necessary"? Request peer-to-peer review with an Aetna medical director, then file an internal appeal with additional genetic testing documentation and specialist letters. California's IMR provides a final external review option.

Can I get expedited approval if my kidney function is declining? Yes. Document rapidly declining eGFR or urgent clinical need in the prior authorization request. Aetna must respond to expedited requests within 72 hours.

Does step therapy apply to Oxlumo in California? Aetna's policy doesn't require trying other medications first, but you cannot use Oxlumo with nedosiran (Rivfloza). Focus on documenting PH1 diagnosis rather than prior therapy failures.

What genetic testing is required for approval? AGXT gene sequencing showing pathogenic mutations, or liver enzyme analysis demonstrating reduced alanine:glyoxylate aminotransferase activity. Both are accepted by Aetna.

How much will Oxlumo cost with Aetna coverage? Costs vary significantly by plan design. Specialty tier coinsurance typically ranges from 20-40% of the drug cost, but manufacturer assistance and annual out-of-pocket maximums may limit your exposure.

Can I appeal to California state regulators if Aetna denies my claim? Yes. After completing Aetna's internal appeal process, you can file for Independent Medical Review through the DMHC at no cost. This provides binding external review by independent medical experts.

What happens if I move from California to another state? Appeal rights and timelines vary by state. Contact Counterforce Health or your new state's insurance department to understand local procedures and requirements.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage and appeal processes. It is not medical advice, legal counsel, or a guarantee of coverage outcomes. Always consult your healthcare providers about treatment decisions and contact your insurance plan directly to verify current policies and procedures. For personalized assistance with complex appeals, consider consulting with healthcare advocates or legal professionals specializing in insurance matters.

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