By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (lumasiran) Covered by UnitedHealthcare in Florida: Complete Guide with Forms, Appeals, and Timelines

Answer Box: UnitedHealthcare requires prior authorization for Oxlumo (lumasiran) in Florida, with approval typically requiring: (1) confirmed PH1 diagnosis via AGXT genetic testing, (2) specialist prescriber (nephrologist/geneticist), (3) elevated urinary oxalate levels, and (4) eGFR ≥30 mL/min/1.73 m². First step today: Have your nephrologist or geneticist submit a complete PA through the UHC Provider Portal with genetic test results, baseline oxalate levels, and medical necessity letter. Standard review takes 7-14 business days.

Table of Contents

Policy Overview: How UnitedHealthcare Covers Oxlumo in Florida

UnitedHealthcare covers Oxlumo (lumasiran) as a specialty tier medication under the medical benefit for Florida residents with confirmed primary hyperoxaluria type 1 (PH1). Coverage applies across UnitedHealthcare's major plan types in Florida:

  • Commercial plans (employer-sponsored and individual marketplace)
  • Medicare Advantage
  • Community Plan (Medicaid)

All plan types require prior authorization through OptumRx, UnitedHealthcare's pharmacy benefit manager. The drug must be sourced through OptumRx Specialty Pharmacy to ensure benefits apply and proper cold-chain handling.

Note: Florida follows federal ACA standards for appeals and external review, giving you strong protections if coverage is initially denied.

Medical Necessity Requirements

Core Eligibility Criteria

UnitedHealthcare's approval hinges on meeting all of these requirements:

Diagnosis Requirements:

  • Confirmed primary hyperoxaluria type 1 (PH1) with ICD-10 code E72.53
  • Genetic confirmation showing pathogenic or likely pathogenic AGXT gene mutations
  • Documentation from a genetics clinic or genetic testing lab

Clinical Requirements:

  • Age ≥2 years (consistent with FDA labeling)
  • eGFR ≥30 mL/min/1.73 m²
  • Not on peritoneal dialysis
  • No prior liver transplant
  • Elevated urinary oxalate consistent with PH1 (typically >0.7 mmol/24h or elevated oxalate:creatinine ratio)

Prescriber Requirements:

  • Must be prescribed by a specialist:
    • Nephrologist
    • Medical geneticist
    • Urologist with PH1 experience

Primary care physicians are typically not accepted for initial approval.

Coverage at a Glance

Requirement What UnitedHealthcare Needs Where to Find It Timeline
Prior Authorization Complete PA form via provider portal UHC Provider Portal 7-14 business days
Genetic Testing AGXT pathogenic variants Genetics lab report Before PA submission
Specialist Prescriber Nephrology/genetics/urology Provider NPI verification At PA submission
Baseline Labs 24-hour urinary oxalate, eGFR Recent lab results Within 90 days
Specialty Pharmacy OptumRx sourcing required Automatic routing After PA approval

Step Therapy and Exceptions

Unlike many specialty medications, UnitedHealthcare typically does not require step therapy for Oxlumo in confirmed PH1 cases, recognizing it as a first-line treatment for this rare genetic condition.

However, documentation should include:

  • Conservative measures tried (increased fluid intake, dietary oxalate reduction, citrate supplementation)
  • Pyridoxine (vitamin B6) trial if genotype suggests potential responsiveness
  • Clinical rationale for why standard supportive care alone is insufficient

If step therapy is unexpectedly required, exceptions can be requested based on:

  • Medical contraindication to required drugs
  • Previous failure of required therapies
  • Risk of serious adverse outcome from delay

Quantity Limits and Renewal Criteria

Initial Approval

  • Loading phase: Monthly dosing for first 3 months (weight-based vial calculation)
  • Maintenance phase: Quarterly dosing thereafter
  • Approval period: Typically 6-12 months initially

Renewal Requirements

UnitedHealthcare renewal criteria typically include:

  • ≥30% reduction in urinary oxalate from baseline
  • Stable or improved kidney function
  • Good adherence to dosing schedule
  • Continued specialist management
  • No significant safety concerns
Tip: Start collecting renewal documentation 60 days before your approval expires to avoid treatment gaps.

Required Diagnostics and Documentation

Essential Laboratory Tests

Genetic Testing:

  • AGXT gene sequencing showing pathogenic variants
  • Report must explicitly state "pathogenic" or "likely pathogenic"
  • Variants of uncertain significance may require additional documentation

Biochemical Confirmation:

  • 24-hour urinary oxalate (preferred): >0.7 mmol/24h suggests PH
  • Spot urine oxalate:creatinine ratio (if 24-hour not feasible): above age-adjusted upper limit
  • Plasma oxalate (if eGFR <30): >20 µmol/L supports PH diagnosis

Kidney Function Assessment:

  • Serum creatinine and calculated eGFR
  • Urinalysis
  • Imaging (ultrasound or CT) documenting nephrocalcinosis or stones if present

Documentation Timeline

  • Genetic testing: Can be from any time (permanent result)
  • Urinary oxalate: Within 90 days of PA submission
  • Kidney function: Within 30 days preferred
  • Clinical notes: Recent specialist evaluation within 60 days

Site of Care and Specialty Pharmacy Rules

Specialty Pharmacy Requirement

Oxlumo must be sourced through OptumRx Specialty Pharmacy for UnitedHealthcare benefits to apply. The specialty pharmacy:

  • Handles prior authorization support
  • Coordinates cold-chain shipping to administration site
  • Provides patient support services
  • Manages benefits verification

Administration Sites

Preferred sites of care:

  • Physician office (nephrologist, geneticist, or urologist)
  • Freestanding infusion center
  • Hospital-based specialty clinic

Hospital outpatient departments may require additional justification:

  • Medical instability requiring hospital resources
  • Previous severe reactions requiring emergency capability
  • No appropriate alternative sites available
Important: Coordinate with OptumRx Specialty Pharmacy at 1-800-711-4555 to ensure proper sourcing and delivery logistics.

Evidence to Support Approval

Medical Necessity Letter Components

Your specialist's medical necessity letter should include:

  1. Clinical Summary
    • PH1 diagnosis with genetic confirmation
    • Disease severity and complications
    • Impact on kidney function and quality of life
  2. Treatment History
    • Conservative measures attempted
    • Previous therapies and outcomes
    • Why alternatives are insufficient
  3. Rationale for Oxlumo
    • FDA approval for PH1
    • Expected clinical benefits
    • Treatment goals (oxalate reduction targets)
  4. Supporting Evidence
    • Cite FDA labeling for approved indication
    • Reference clinical trial data if relevant
    • Include relevant clinical guidelines

Key Supporting Documents

  • AGXT genetic testing report
  • Baseline urinary oxalate measurements
  • Kidney function tests and imaging
  • Specialist consultation notes
  • Documentation of conservative therapy trials

Appeals Process for Florida Residents

Internal Appeals with UnitedHealthcare

Timeline to File:

  • 180 days from denial notice to file internal appeal

Review Timelines:

  • Standard review: 30 days for future treatment decisions
  • Expedited review: 72 hours for urgent cases (must have physician certification of urgency)

How to File:

  • Preferred: UnitedHealthcare Provider Portal
  • Alternative: Mail or fax to address on denial letter
  • Include: Complete medical records, specialist letter, genetic testing, lab results

External Review Through Florida DFS

If UnitedHealthcare's internal appeal is denied:

Eligibility:

  • Must complete internal appeal process first
  • Applies to "medical necessity" and "experimental/investigational" denials

Timeline:

  • 4 months (120 days) from final internal denial to request external review

How to File:

  • Contact Florida Department of Financial Services
  • Request external review form and instructions
  • Submit complete documentation package

Review Timeline:

  • Standard: 45 days for decision
  • Expedited: 72 hours for urgent cases
  • No cost to patient
Florida Resource: Contact the Insurance Consumer Helpline at 1-877-MY-FL-CFO (1-877-693-5236) for assistance with appeals.

Common Denial Reasons and Solutions

Denial Reason Solution Documentation Needed
"Prescriber not qualified specialist" Resubmit with nephrologist/geneticist Specialist consultation note, NPI verification
"Diagnosis not confirmed" Provide genetic testing results AGXT pathogenic variant report
"Insufficient kidney function" Document current eGFR ≥30 Recent lab results, nephrology note
"Missing baseline oxalate" Submit urinary oxalate measurements 24-hour urine or spot ratio results
"Not medically necessary" Enhanced medical necessity letter Detailed clinical rationale, guidelines
"Site of care not appropriate" Justify administration setting Medical stability assessment

Sample Appeal Language

"This appeal requests reconsideration of the denial for Oxlumo (lumasiran) for [Patient Name] with genetically confirmed primary hyperoxaluria type 1. The patient meets all UnitedHealthcare criteria: (1) confirmed PH1 via AGXT genetic testing, (2) specialist prescriber (nephrology), (3) elevated urinary oxalate levels, and (4) adequate kidney function. Oxlumo is FDA-approved specifically for PH1 and represents the only targeted therapy to reduce hepatic oxalate production in this rare genetic condition."

Costs and Patient Assistance

UnitedHealthcare Coverage

  • Specialty tier copay typically applies
  • Deductible may need to be met first
  • Out-of-pocket maximum provides annual cost protection

Manufacturer Support

Alnylam Assist Program:

  • Copay assistance for eligible commercially insured patients
  • Free drug program for uninsured patients meeting income criteria
  • Reimbursement support and prior authorization assistance

Contact: 1-833-ALNYLAM (1-833-256-9526)

Additional Resources

  • National Organization for Rare Disorders (NORD): Patient assistance programs
  • HealthWell Foundation: Copay assistance for rare diseases
  • Patient Access Network (PAN) Foundation: Disease-specific funds

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in Florida? Standard review typically takes 7-14 business days. Expedited review for urgent cases can be completed within 72 hours with physician certification of medical urgency.

What if Oxlumo is not on my formulary? Oxlumo is typically covered under the medical benefit as a specialty drug, not the pharmacy formulary. Your specialist can request a formulary exception if needed.

Can I request an expedited appeal? Yes, if delay in treatment could seriously jeopardize your health. Your physician must certify the urgency, and review will be completed within 72 hours.

Do I need to try other treatments first? UnitedHealthcare typically does not require step therapy for Oxlumo in confirmed PH1 cases, but documentation of conservative measures is helpful.

What if my primary care doctor wants to prescribe Oxlumo? UnitedHealthcare requires a specialist prescriber (nephrologist, geneticist, or urologist). Ask for a referral to establish specialist care.

How do I find an in-network specialist in Florida? Use the UnitedHealthcare provider directory online or call member services. Look specifically for nephrologists or medical geneticists with rare disease experience.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies specific coverage criteria, and generates comprehensive appeal packages that address payer requirements point-by-point.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on your specific plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For assistance with insurance appeals, consider consulting with Counterforce Health or other qualified advocates.

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