By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (Lumasiran) Covered by UnitedHealthcare in California: Complete Guide with Forms and Appeal Scripts

Answer Box: Getting Oxlumo Covered by UnitedHealthcare in California

UnitedHealthcare requires prior authorization for Oxlumo (lumasiran) to treat primary hyperoxaluria type 1 (PH1) in California, with no step therapy required. You need genetic testing confirming AGXT mutations, baseline urinary oxalate levels, and a specialist prescriber (nephrologist/geneticist/urologist).

Fastest approval path:

  1. Gather genetic testing report and baseline urinary oxalate measurements
  2. Have your specialist submit PA via UnitedHealthcare provider portal
  3. If denied, file internal appeal within 180 days, then California DMHC Independent Medical Review (IMR)

Start today: Contact your specialist to confirm you have genetic testing results and request PA submission.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Deadlines
  4. Medical Necessity Criteria
  5. Costs and Copays
  6. Denials and Appeals
  7. Renewals and Reauthorization
  8. Specialty Pharmacy Setup
  9. Troubleshooting Common Issues
  10. FAQ

Coverage Basics

Is Oxlumo Covered by UnitedHealthcare?

Yes, UnitedHealthcare covers Oxlumo (lumasiran) as a specialty tier medication under medical benefits for confirmed primary hyperoxaluria type 1 (PH1). The drug requires prior authorization across all UnitedHealthcare plan types in California, including commercial, Medicare Advantage, and managed Medicaid plans.

Which Plans Include Coverage?

Oxlumo is covered under:

  • UnitedHealthcare commercial HMO and PPO plans
  • UnitedHealth Medicare Advantage plans
  • UnitedHealthcare Community Plan (Medicaid)
  • Plans managed through OptumRx pharmacy benefits

The medication is not typically listed on standard formularies due to its specialty administration requirements but is covered when medically necessary criteria are met.

Note: Coverage details may vary by specific plan. Verify your benefits by calling UnitedHealthcare member services at 1-877-842-3210.

Prior Authorization Process

Who Submits the Prior Authorization?

Your specialist must submit the prior authorization request. UnitedHealthcare requires prescribing by:

  • Nephrologist
  • Geneticist
  • Urologist

Primary care physicians cannot typically prescribe Oxlumo for initial approval.

How to Submit

Fastest method: Electronic submission via the UnitedHealthcare provider portal

Alternative methods:

  • Fax: (verify current fax number with UnitedHealthcare)
  • Phone: Provider services line for urgent cases

Required Documentation

Document Requirement Notes
Genetic testing report AGXT mutation confirmation Must state "pathogenic" mutations
Baseline urinary oxalate 24-hour collection >0.514 mmol/24hr/1.73m² Within 90 days of request
eGFR results ≥30 mL/min/1.73m² Recent kidney function
Medical records Specialist clinic notes Documenting PH1 diagnosis
ICD-10 code E72.53 (Primary hyperoxaluria) For billing accuracy

Timing and Deadlines

How Long Does Prior Authorization Take?

  • Standard review: 7 business days
  • Expedited review: 72 hours (when health would be jeopardized by delay)
  • Complex cases: Up to 14 days with additional documentation requests

When to Request Expedited Review

Request expedited processing if:

  • Patient has rapidly declining kidney function
  • Urgent need to prevent stone formation or kidney damage
  • Current treatment failures requiring immediate intervention

To request expedited review: Have your provider specify "urgent" on the PA request and provide clinical justification for the timeline.

Medical Necessity Criteria

Primary Requirements

UnitedHealthcare approves Oxlumo when all criteria are met:

  1. Confirmed PH1 diagnosis via genetic testing showing pathogenic AGXT mutations
  2. Age 2 years or older
  3. Preserved kidney function (eGFR ≥30 mL/min/1.73m²)
  4. No liver transplant history
  5. Elevated urinary oxalate above normal range
  6. Specialist prescribing (nephrology/genetics/urology)

Step Therapy Requirements

Good news: UnitedHealthcare does not require step therapy for Oxlumo when the above criteria are met. You do not need to fail vitamin B6 or other treatments first, though documentation of prior therapies may strengthen your case.

Clinician Corner: Medical Necessity Letter

For Healthcare Providers: Include these elements in your medical necessity letter:Problem statement: "Patient has genetically confirmed PH1 with AGXT mutations leading to excessive oxalate production"Clinical rationale: "Oxlumo's siRNA mechanism directly targets HAO1 to reduce oxalate synthesis, addressing the root cause"Baseline measurements: Include specific urinary oxalate levels and eGFR valuesTreatment goals: "Prevent progression to ESRD and reduce stone formation risk"FDA indication: Reference FDA approval for PH1 in patients ≥2 years

Costs and Copays

What Will I Pay?

Oxlumo costs vary significantly by plan type:

Commercial plans:

  • Specialty tier: typically 20-33% coinsurance
  • Monthly out-of-pocket: $100-$500+ depending on plan design
  • Annual maximum: subject to plan out-of-pocket limits

Medicare Advantage:

  • Follows Part B rules: 20% coinsurance after deductible
  • May qualify for Low-Income Subsidy (Extra Help) programs
Important: Manufacturer copay assistance may be available. Contact Alnylam Assist at 1-833-256-2526 to check eligibility.

Financial Assistance Options

  1. Alnylam Patient Assistance Program: Free drug for eligible uninsured/underinsured patients
  2. Copay assistance cards: May reduce out-of-pocket costs for commercially insured patients
  3. California state programs: Medi-Cal for income-eligible residents

Denials and Appeals

Common Denial Reasons

Denial Reason How to Address
Insufficient genetic documentation Submit complete genetic testing report with clear AGXT mutation results
Missing baseline labs Provide 24-hour urinary oxalate collection results
Non-specialist prescriber Transfer care to nephrologist, geneticist, or urologist
Incomplete medical records Submit comprehensive clinic notes documenting PH1 diagnosis

Appeals Process in California

Internal Appeals with UnitedHealthcare

  1. File within 180 days of denial notice
  2. Submit via:
    • UnitedHealthcare member portal
    • Mail to address on denial letter
    • Fax (verify current number)
  3. Include:
    • Copy of denial letter
    • Additional medical evidence
    • Updated medical necessity letter

California Independent Medical Review (IMR)

If UnitedHealthcare upholds the denial, California residents can request an Independent Medical Review through the Department of Managed Health Care (DMHC).

California IMR Process:

  • No cost to patients
  • File within 6 months of final internal denial
  • Standard timeline: 45 days for decision
  • Expedited: 7 days for urgent cases
  • Success rate: Approximately 55-68% of medical necessity denials are overturned

To file IMR:

  1. Call DMHC Help Center: 888-466-2219
  2. Submit online at healthhelp.ca.gov
  3. Mail completed form with medical records
California Advantage: The state's Independent Medical Review system is binding on insurers and has high overturn rates for specialty medications when medical necessity is well-documented.

Renewals and Reauthorization

When to Renew

Start reauthorization 60-90 days before your current approval expires. UnitedHealthcare typically approves Oxlumo for up to 12 months.

Renewal Requirements

Documentation needed:

  • Response monitoring: ≥30% reduction in urinary oxalate from baseline
  • Updated labs: Recent urinary oxalate and eGFR within 3 months
  • Specialist letter: Confirming continued medical necessity
  • Adherence records: Documentation of consistent treatment

Renewal Timeline

  • Submit: 60-90 days before expiration
  • Processing: 5-7 business days for standard renewal
  • Track status: Via provider portal or member services

Specialty Pharmacy Setup

Why Specialty Pharmacy?

Oxlumo requires:

  • Cold storage and special handling
  • Provider administration (subcutaneous injection)
  • Coordination between clinic and pharmacy
  • Insurance verification and benefits investigation

OptumRx Specialty Network

UnitedHealthcare typically requires use of OptumRx specialty pharmacy network for Oxlumo. Setup takes 1-2 weeks and includes:

  1. Benefits verification
  2. Prior authorization confirmation
  3. Delivery scheduling to provider office
  4. Patient education and support services

Contact OptumRx Specialty: 1-855-427-4682

Troubleshooting Common Issues

Portal Access Problems

Provider portal down:

  • Call UnitedHealthcare provider services
  • Submit via fax as backup
  • Document submission attempts

Missing forms:

  • Download current PA forms from uhcprovider.com
  • Verify you're using 2024 versions
  • Contact provider relations for assistance

Communication Delays

No response within timeline:

  • Follow up with member services: 1-877-842-3210
  • Request case escalation
  • Document all communication attempts

Missing documentation requests:

  • Respond within requested timeframe
  • Submit via multiple methods if urgent
  • Keep copies of all submissions

FAQ

How long does UnitedHealthcare prior authorization take for Oxlumo in California?

Standard prior authorization takes 7 business days. Expedited requests (when health would be jeopardized) are processed within 72 hours. Complex cases may take up to 14 days.

What if Oxlumo is listed as non-formulary on my plan?

Oxlumo can still be covered through medical necessity exceptions even if not on your plan's standard formulary. Submit a prior authorization request with complete documentation—UnitedHealthcare covers FDA-approved medications when medically necessary criteria are met.

Can I request an expedited appeal in California?

Yes. Both UnitedHealthcare internal appeals and California DMHC Independent Medical Reviews offer expedited processing for urgent cases. Standard IMR takes 45 days; expedited IMR decisions are made within 7 days.

Does step therapy apply if I've failed treatments outside California?

No. UnitedHealthcare does not require step therapy for Oxlumo when genetic testing confirms PH1. Previous treatment failures from any location can be documented to support medical necessity but are not required.

What happens if my specialist isn't in-network with UnitedHealthcare?

You may still receive coverage through out-of-network exceptions for specialty care when no in-network provider is available. Contact UnitedHealthcare to request a network adequacy review and potential exception.

How do I check my prior authorization status?

Check status via:

  • UnitedHealthcare member portal online
  • Provider portal (for your doctor)
  • Member services: 1-877-842-3210
  • Reference your PA tracking number from submission

When should I contact California insurance regulators?

Contact the DMHC Help Center (888-466-2219) if:

  • UnitedHealthcare doesn't respond within required timelines
  • You need help filing an Independent Medical Review
  • You believe your plan is not following California insurance laws
  • You need assistance with the appeals process

Getting Additional Support

Navigating insurance approvals for specialty medications like Oxlumo can be complex, especially when facing denials or delays. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters, identifies the specific denial basis, and drafts point-by-point rebuttals aligned to each plan's own rules, incorporating the right clinical evidence and procedural requirements for your specific situation.

Whether you're dealing with prior authorization requirements, appeal deadlines, or complex medical necessity documentation, having expert support can significantly improve your chances of approval and reduce the time to access your medication.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on individual medical circumstances and specific plan benefits. Always consult with your healthcare provider about treatment options and work directly with your insurance plan for coverage determinations. For assistance with California insurance issues, contact the DMHC Help Center at 888-466-2219.

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