By Counterforce Health Team in Oxlumo (lumasiran) —

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

Quick Answer: Aetna CVS Health covers Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) as a specialty tier medication requiring prior authorization. You'll need genetic testing confirming PH1, a specialist prescriber, and completion of Aetna's precertification form. If denied, Washington residents can appeal through internal review and then external review by an Independent Review Organization (IRO). Start by having your specialist submit the precertification form to (866) 752-7021.

Table of Contents

Coverage Overview and Requirements

Aetna CVS Health covers Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) as a specialty tier medication requiring prior authorization. The drug is not on standard formulary tiers but is available through Aetna's specialty pharmacy network when medical necessity criteria are met.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Must get approval before treatment Aetna Precertification List Aetna 2025
Specialty Tier 20-40% coinsurance (not flat copay) Your plan documents Plan-specific
Specialist Prescriber Nephrology or genetics specialist required Aetna Medical Policy Policy 0983
Genetic Testing AGXT mutation or liver enzyme analysis Aetna Medical Policy Policy 0983
CVS Specialty Pharmacy Must use approved specialty pharmacy Your approval letter Post-approval

Step-by-Step: Fastest Path to Approval

  1. Confirm PH1 Diagnosis (Patient + Specialist)
    • Obtain genetic testing for AGXT mutations or liver enzyme analysis showing reduced AGT activity
    • Document urinary oxalate levels and stone history
    • Timeline: 2-4 weeks for genetic testing results
  2. Find a Specialist (Patient)
    • Ensure your prescriber is a nephrology or genetics specialist
    • HMO plans require specialist referral; PPO plans allow direct access
    • Timeline: 1-2 weeks to schedule
  3. Complete Precertification Form (Specialist)
  4. Gather Supporting Documentation (Specialist + Patient)
    • Prior therapy records showing treatment failures or contraindications
    • Complete clinical notes with diagnosis codes
    • Current lab results and imaging
    • Timeline: 1-3 days to compile
  5. Submit Complete Application (Specialist)
    • Ensure all form fields are completed
    • Include all supporting documentation
    • Request expedited review if medically urgent
    • Timeline: 15 business days for standard review, 72 hours for expedited
  6. Follow Up (Patient + Specialist)
    • Aetna acknowledges receipt within 5 business days
    • Call if no acknowledgment received
    • Timeline: 5 business days for acknowledgment
  7. Coordinate Specialty Pharmacy (If Approved)
    • CVS Specialty will contact you within 3-5 business days
    • Schedule first dose administration
    • Timeline: 1-2 weeks to first dose

Prior Authorization Process

Medical Necessity Criteria

Aetna considers Oxlumo medically necessary when all of the following criteria are met:

  • Confirmed PH1 diagnosis demonstrated by either:
    • Genetic testing showing AGXT gene mutations, or
    • Liver enzyme analysis showing absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity
  • Specialist prescriber: Prescription from nephrology or genetics specialist
  • No concurrent use: Patient will not use Oxlumo with nedosiran (Rivfloza)
  • Complete precertification form: All fields on Aetna's form must be completed

Review Timelines

Standard Review: Up to 15 business days from complete submission Expedited Review: Within 72 hours for urgent cases involving:

  • Progressive kidney function decline
  • Recurrent kidney stone formation
  • Severe hyperoxaluria with complications
Tip: Request expedited review by noting urgency on the precertification form and calling (866) 752-7021 to explain the medical situation.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documents Needed
No PH1 confirmation Submit genetic testing or liver enzyme analysis AGXT genetic test results or AGT activity analysis
Non-specialist prescriber Transfer care to nephrology or genetics specialist Referral documentation and specialist consultation notes
Incomplete form Resubmit with all fields completed Complete Aetna precertification form
Insufficient clinical documentation Provide comprehensive medical records Prior therapy records, stone analysis, urinary oxalate levels
"Experimental/investigational" Cite FDA approval and clinical guidelines FDA approval letter and treatment guidelines

Appeals Process in Washington

If Aetna denies your Oxlumo request, Washington state provides strong appeal protections, including independent external review.

Internal Appeals (Required First Step)

Level 1 - Standard Appeal

  • Deadline: 180 days from denial date
  • Timeline: 30 days for decision (15 days for urgent)
  • How to file: Call member services or submit written appeal

Level 2 - Peer-to-Peer Review (if available)

  • Your specialist can request a clinical discussion with Aetna's medical director
  • Often resolves complex cases without formal appeal
  • Request through (866) 752-7021

External Review (Independent Review Organization)

Washington residents have the right to external review by an Independent Review Organization (IRO) after completing internal appeals.

Key Benefits:

  • Independent specialist review: IRO assigns reviewers with direct experience in rare diseases
  • Binding decision: If IRO overturns denial, Aetna must provide coverage
  • No cost to you: Washington prohibits fees for external review
  • Strong success rates: Many rare disease denials are overturned when proper documentation is provided

How to Request External Review:

  1. Complete Aetna's internal appeals first
  2. File external review request within 180 days of final internal denial
  3. Contact Washington Office of the Insurance Commissioner at (800) 562-6900
  4. Submit via insurance.wa.gov appeals process

Timeline:

  • Standard external review: 30 days
  • Expedited review (medical urgency): 72 hours
Note: Washington's 2025 Specialist Care Access Act requires IROs to assign reviewers with direct experience in the specific rare disease area, improving outcomes for complex cases.

Costs and Financial Assistance

Aetna CVS Health Cost Structure

Specialty Tier Coinsurance: Typically 20-40% of drug cost (not a flat copay) Annual Out-of-Pocket Maximum: Specialty tier costs count toward your plan's maximum Required Pharmacy: Must use CVS Specialty or approved specialty pharmacy

With Oxlumo's annual cost around $493,000, even a 20% coinsurance creates substantial out-of-pocket expenses.

Alnylam Assist Copay Program

Eligibility: Patients with commercial insurance (not Medicare/Medicaid) Process: Your healthcare provider submits a Start Form to Alnylam Assist Timeline: Case manager contacts you within 2 business days Coverage: Reduces copay/coinsurance for eligible patients

How to Access:

  1. Ask your prescribing specialist to submit the Start Form
  2. Alnylam Case Manager will assess eligibility automatically
  3. If eligible, copay support begins with first dose

Learn more at Alnylam Assist.

Additional Financial Resources

  • Patient Assistance Program: For uninsured patients, Alnylam provides Oxlumo at no cost if eligible
  • Gap Coverage: Temporary assistance during insurance transitions
  • Independent foundations: Organizations like Counterforce Health help patients navigate complex prior authorization and appeals processes, turning denials into targeted, evidence-backed appeals

Clinician Corner: Medical Necessity Documentation

Essential Elements for Approval

Diagnosis Documentation:

  • Genetic testing results showing AGXT mutations (preferred)
  • Liver biopsy with AGT enzyme activity analysis (if genetic testing unavailable)
  • ICD-10 codes: E74.8 (other specified disorders of carbohydrate metabolism)

Clinical History:

  • Detailed stone history with composition analysis
  • Urinary oxalate levels (24-hour collection preferred)
  • Kidney function assessment (eGFR, creatinine)
  • Prior treatment attempts and outcomes

Supporting Evidence:

  • FDA prescribing information for indication
  • Relevant clinical guidelines from nephrology societies
  • Documentation of contraindications to alternative treatments

Medical Necessity Letter Template

Your letter should address:

  1. Problem statement: Confirmed PH1 diagnosis with supporting test results
  2. Prior treatments: Conservative measures tried and outcomes
  3. Clinical rationale: Why Oxlumo is medically necessary for this patient
  4. Guideline support: FDA approval and clinical evidence
  5. Monitoring plan: How you'll assess treatment response
Tip: Include specific urinary oxalate levels and percentage reduction goals in your documentation. Aetna often looks for quantifiable treatment targets.

FAQ

How long does Aetna CVS Health prior authorization take in Washington? Standard review takes up to 15 business days from complete submission. Expedited review for urgent cases is completed within 72 hours. Aetna acknowledges receipt within 5 business days.

What if Oxlumo is non-formulary on my plan? Oxlumo requires prior authorization but is covered when medical necessity criteria are met. Non-formulary status doesn't prevent coverage—it just requires the PA process and typically results in specialty tier cost-sharing.

Can I request an expedited appeal in Washington? Yes, for medically urgent situations involving progressive kidney decline, recurrent stones, or severe complications. Both Aetna's internal appeals and Washington's external review process offer expedited timelines (72 hours).

Does step therapy apply to Oxlumo? Aetna's policy doesn't require specific step therapy, but you'll need to document that conservative oxalate-reduction measures are insufficient. This includes dietary modifications and other supportive care attempts.

What happens if my appeal is denied? After exhausting Aetna's internal appeals, you can request external review through Washington's IRO process. The IRO's decision is binding on Aetna. If the IRO overturns the denial, Aetna must provide coverage.

How much will Oxlumo cost with Aetna CVS Health? Cost depends on your specific plan's specialty tier coinsurance (typically 20-40%). With Oxlumo's high list price, even 20% coinsurance creates significant out-of-pocket costs, making manufacturer assistance programs essential.

Can I use Oxlumo with other PH1 medications? Aetna's policy specifically prohibits concurrent use of Oxlumo with nedosiran (Rivfloza). Using these medications together will result in denial.

What if I don't have a specialist? Aetna requires prescription from a nephrology or genetics specialist. If you don't have one, ask your primary care provider for a referral. HMO plans require referrals; PPO plans typically allow direct specialist access.

When to Escalate

Contact the Washington Office of the Insurance Commissioner if:

  • Aetna doesn't respond within required timeframes
  • You believe your appeal wasn't properly reviewed
  • You need help navigating the external review process

Contact Information:

The OIC can provide template letters, explain your rights, and help ensure proper appeal procedures are followed.

From our advocates: We've seen many PH1 patients initially denied for Oxlumo get approved on appeal when proper genetic testing documentation and specialist support letters were provided. The key is comprehensive documentation showing clear PH1 diagnosis and medical necessity—don't give up after an initial denial.

Navigating insurance coverage for rare disease medications like Oxlumo requires persistence and proper documentation, but Washington's strong consumer protections provide multiple pathways to approval. Counterforce Health specializes in helping patients turn insurance denials into successful appeals by providing targeted, evidence-backed documentation that meets payers' specific requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about treatment decisions and contact your insurance company or state insurance department for the most current policies and procedures. Coverage policies and appeal processes may change; verify current requirements with official sources.

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