By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (Lumasiran) Covered by Humana in Washington: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Oxlumo (Lumasiran) Covered by Humana in Washington

Oxlumo requires prior authorization from Humana for primary hyperoxaluria type 1 (PH1). The fastest path to approval: (1) Confirm PH1 diagnosis with genetic testing showing AGXT mutations or liver enzyme analysis, (2) Document elevated urinary oxalate levels (>0.7 mmol/24h in adults), and (3) Submit PA request through a specialist (nephrologist, endocrinologist, or geneticist). First step today: Contact your prescribing physician to gather genetic test results and recent urinary oxalate measurements. If denied, Washington residents can appeal through an Independent Review Organization (IRO) with decisions in 15-20 days for standard cases or 72 hours for urgent reviews.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Oxlumo prescriptions Humana provider portal or fax 800-555-2546 Humana Medicare Policy
PH1 Diagnosis Confirmed by AGXT genetic testing or liver enzyme analysis Genetic testing lab report or specialist consultation FDA Access Data
Elevated Oxalate Urinary oxalate >0.7 mmol/24h (adults) or age-specific norms Recent lab results within 6 months Clinical Guidelines
Specialist Prescriber Nephrologist, endocrinologist, geneticist, or urologist Prescription or consultation notes Humana Coverage Criteria
No Liver Transplant Oxlumo not covered if prior liver transplant for PH1 Medical history documentation Coverage Policy
Appeals Deadline 65 days from denial notice for Medicare Advantage Denial letter from Humana CMS Guidelines

Step-by-Step: Fastest Path to Approval

1. Confirm PH1 Diagnosis (Patient + Clinician)

What's needed: Genetic testing showing biallelic AGXT mutations or liver biopsy confirming AGT enzyme deficiency. Timeline: 2-4 weeks if testing needed How to submit: Include genetic lab report or specialist consultation notes with PA request

2. Document Elevated Urinary Oxalate (Clinician)

What's needed: 24-hour urine collection showing oxalate >0.7 mmol/24h in adults or elevated oxalate:creatinine ratio Timeline: 1-2 days for collection, 3-5 days for results How to submit: Recent lab values (within 6 months) attached to PA form

3. Secure Specialist Involvement (Patient)

What's needed: Prescription from or consultation with nephrologist, endocrinologist, geneticist, or urologist Timeline: 1-3 weeks for referral appointment How to submit: Specialist must submit PA or provide supporting consultation notes

4. Submit Prior Authorization (Clinician)

What's needed: Completed PA form with all supporting documentation Timeline: Submit via Humana provider portal or fax to verify current number Expected decision: 30 days standard, 72 hours expedited for urgent cases

5. Monitor PA Status (Patient + Clinician)

What's needed: Track submission through Humana member portal or provider system Timeline: Check every 5-7 business days Next steps: If approved, coordinate with specialty pharmacy; if denied, initiate appeal immediately

Understanding Primary Hyperoxaluria Type 1 Documentation

Primary hyperoxaluria type 1 is caused by mutations in the AGXT gene, leading to deficiency of the AGT enzyme and excessive oxalate production. Humana requires definitive diagnostic proof before approving Oxlumo coverage.

Required Diagnostic Evidence

  • Genetic Testing: Biallelic pathogenic variants in AGXT gene (over 190 known mutations)
  • Alternative: Liver enzyme analysis showing absent or reduced AGT activity
  • Supporting Labs: Elevated urinary oxalate excretion, plasma oxalate >20 μmol/L, or abnormal oxalate:creatinine ratios
Clinician Corner: Medical necessity letters should reference FDA labeling for Oxlumo, specify the patient's AGXT mutation status, include baseline urinary oxalate levels, and document any prior conservative management attempts (dietary oxalate restriction, increased fluid intake, citrate supplementation).

From our advocates: We've seen cases where initial PA requests were denied because genetic testing was ordered by a primary care physician rather than a specialist. Having a nephrologist or geneticist involved from the start—even just for a consultation—significantly improves approval odds, as it demonstrates appropriate specialist evaluation of this rare condition.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"PH1 not confirmed" Submit genetic testing report showing AGXT mutations Lab report from certified genetic testing facility
"Urinary oxalate not elevated" Provide recent 24-hour urine collection results Lab values showing oxalate >0.7 mmol/24h (adults)
"Non-specialist prescriber" Add specialist consultation or transfer prescription Nephrologist/endocrinologist consultation notes
"Prior therapies not tried" Document conservative management attempts Chart notes showing dietary counseling, citrate therapy
"Not medically necessary" Emphasize disease progression risk and FDA approval Specialist letter citing clinical guidelines and prognosis

Appeals Process: Internal to IRO

Internal Appeal with Humana (First Level)

Deadline: 65 days from denial notice for Medicare Advantage How to file: Submit written appeal via Humana member portal or mail to address on denial letter Timeline: 30 days for standard review, 72 hours for expedited Required documents: Original PA request, denial letter, additional supporting evidence

Peer-to-Peer Review

When available: Often offered during internal appeal process Who participates: Prescribing specialist and Humana medical director Key talking points: Confirmed PH1 diagnosis, disease severity, consequences of delayed treatment, FDA approval status Outcome: Can result in immediate approval if medical necessity is established

External Review through Washington IRO

If Humana upholds the denial, Washington residents can request an Independent Review Organization (IRO) review through the Washington State Office of the Insurance Commissioner.

Timeline for IRO Review:

  • Expedited cases: 72 hours (for urgent medical situations)
  • Standard cases: 15-20 days for fully-insured plans, 45 days for self-insured plans
  • Patient submission time: 5 business days to provide additional information to IRO

How to Request IRO Review:

  1. Complete Humana's internal appeal process first
  2. Submit external review request to Washington OIC within 180 days of final internal denial
  3. Include all medical records, specialist letters, and treatment justification
  4. The IRO will be selected based on expertise in rare diseases and nephrology

IRO Decision: Binding on Humana—if overturned, the insurer must cover Oxlumo treatment.

Costs and Patient Support Options

Oxlumo's average annual list price is approximately $493,000, making patient assistance programs crucial for many families.

Manufacturer Support

  • Alnylam Assist: Comprehensive support program including insurance navigation, copay assistance, and free drug programs for eligible patients
  • Contact: Visit Alnylam Assist website or call their patient support line
  • Eligibility: Varies by insurance type and household income

Additional Resources

  • National Organization for Rare Disorders (NORD): Patient assistance programs for rare disease medications
  • HealthWell Foundation: Copay assistance for eligible patients with specific insurance types
  • Washington State Pharmacy Assistance: Programs for Medicare beneficiaries and low-income residents

When to Escalate to Washington State Regulators

Contact the Washington State Office of the Insurance Commissioner if:

  • Humana fails to respond to appeals within required timeframes
  • You believe the denial violates Washington state insurance laws
  • The IRO process isn't followed properly
  • You need help navigating the external review process

Consumer Advocacy Line: 1-800-562-6900 Online complaint portal: Available on the OIC website for formal complaints

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies, identifying denial reasons, and crafting evidence-backed rebuttals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements for medications like Oxlumo, providing targeted appeal strategies that align with each insurer's specific criteria and procedural requirements.

FAQ: Humana and Oxlumo in Washington

How long does Humana prior authorization take for Oxlumo in Washington? Standard PA decisions take up to 30 days, while expedited requests (for urgent medical situations) are decided within 72 hours. Submit complete documentation to avoid delays.

What if Oxlumo is non-formulary on my Humana plan? You can request a formulary exception based on medical necessity. This requires the same documentation as a PA request plus justification for why formulary alternatives aren't appropriate.

Can I request an expedited appeal if my PH1 is worsening? Yes, if delaying treatment would seriously jeopardize your health. Your specialist must document the urgency and submit supporting clinical evidence.

Does Washington's external review process cost anything? No, the IRO review process is free to patients. The insurance commissioner covers the cost of independent medical review.

What happens if both Humana and the IRO deny coverage? The IRO decision is final for the insurance appeal process. Your next options would be seeking legal counsel or exploring alternative funding through patient assistance programs.

How often does Oxlumo need reauthorization? Most insurers require annual reauthorization with documentation of continued medical necessity and treatment response (reduced urinary oxalate levels).

Can I use Oxlumo if I've had a liver transplant for PH1? Generally no—most insurance policies, including Humana's, exclude coverage for patients who have already received liver transplantation for PH1.

What documentation do I need to keep during the appeals process? Maintain copies of all correspondence, denial letters, appeal submissions, medical records, lab results, and specialist consultations. Counterforce Health's platform can help organize and track these documents throughout the appeals process.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and should not be considered medical or legal advice. Insurance coverage decisions depend on individual policy terms and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For additional help with appeals and prior authorization, contact the Washington State Office of the Insurance Commissioner at 1-800-562-6900.

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