By Counterforce Health Team in Oxlumo (lumasiran) —

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

Answer Box: Getting Oxlumo Covered by UnitedHealthcare in Texas

Oxlumo (lumasiran) requires prior authorization from UnitedHealthcare for primary hyperoxaluria type 1 (PH1). No step therapy is required—approval focuses on confirmed PH1 diagnosis and specialist prescribing. The fastest path: (1) Ensure genetic testing confirms AGXT mutations, (2) Have a nephrologist or geneticist submit PA through the UnitedHealthcare provider portal with baseline urinary oxalate levels, (3) If denied, file internal appeal within 60 days. Texas residents have strong external review rights through independent review organizations if internal appeals fail.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Oxlumo prescriptions UnitedHealthcare Oxlumo Policy
Diagnosis Confirmed PH1 via genetic testing (AGXT mutations) FDA labeling, genetic testing report
Prescriber Nephrologist, geneticist, or urologist UnitedHealthcare policy
Age Requirement 2 years or older FDA labeling
Kidney Function eGFR ≥ 30 mL/min/1.73 m² (no peritoneal dialysis) UnitedHealthcare policy
No Step Therapy Direct approval if criteria met UnitedHealthcare policy
Appeal Deadline 60 days for internal appeal (Texas) Texas Insurance Code

Step-by-Step: Fastest Path to Approval

1. Confirm PH1 Diagnosis (Patient + Specialist)

Who does it: Nephrologist, geneticist, or urologist
Document needed: Genetic testing report showing pathogenic AGXT mutations
Timeline: 2-4 weeks for genetic testing results
Source: AGXT genetic testing requirements

2. Gather Baseline Labs (Specialist)

Who does it: Ordering physician
Document needed: 24-hour urinary oxalate levels, eGFR, plasma oxalate if available
Timeline: 1-2 weeks
Key requirement: Document elevated urinary oxalate consistent with PH1

3. Submit Prior Authorization (Specialist Office)

Who does it: Prescriber or clinic staff
How to submit: UnitedHealthcare provider portal or fax
Documents to include: PA form, genetic testing report, lab values, clinic notes
Timeline: UnitedHealthcare has 7 days to respond for Part B drugs
Source: UnitedHealthcare PA procedures

4. Track Status (Patient + Clinic)

Who does it: Both patient and clinic staff
How: Provider portal or member services phone line
Timeline: Check within 3-5 business days of submission

5. If Approved: Coordinate Delivery

Who does it: Specialty pharmacy (typically OptumRx)
Timeline: 1-2 weeks for first shipment setup
Note: Oxlumo requires healthcare provider administration

6. If Denied: Prepare Appeal (see Appeals section below)

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
"PH1 diagnosis not confirmed" Submit complete genetic testing report showing two pathogenic AGXT mutations. Include metabolic evidence (elevated urinary oxalate).
"Prescribed by non-specialist" Transfer prescription to nephrologist, geneticist, or urologist. Include specialist consultation notes.
"Insufficient kidney function" Submit recent eGFR showing ≥30 mL/min/1.73 m². Document that patient is not on peritoneal dialysis.
"Missing baseline oxalate levels" Provide 24-hour urinary oxalate collection results showing elevation consistent with PH1.
"Not medically necessary" Submit detailed letter of medical necessity outlining PH1 complications, treatment goals, and FDA approval status.

Appeals Playbook for UnitedHealthcare in Texas

Internal Appeal Process

Timeline: File within 60 days of denial notice
Decision timeframe:

  • Standard: 30 days for medical services, 7 days for Part B drugs
  • Expedited: 72 hours if delay would jeopardize health

How to file:

  • Online: UnitedHealthcare member or provider portal
  • Phone: Member services (number on insurance card)
  • Mail/Fax: Address provided in denial letter

Required documents:

  • Original denial letter
  • Medical necessity letter from prescriber
  • Supporting clinical documentation
  • Any new evidence not previously submitted

External Review (Independent Review Organization)

If internal appeal is denied, Texas law provides access to independent external review.

Timeline: Request within 4 months of final internal denial
Decision timeframe:

  • Standard: 20 days
  • Expedited: 5 days for urgent cases

How to request: UnitedHealthcare must provide IRO request form with final denial
Cost: Free to patient (insurer pays IRO fees)
Binding: IRO decision is final and binding on UnitedHealthcare

Texas Department of Insurance IRO hotline: 1-866-554-4926

From our advocates: We've seen cases where patients submitted genetic testing reports that didn't clearly state "pathogenic" mutations. Always ensure your genetic testing report explicitly confirms PH1 diagnosis with clear interpretation of AGXT variants. This simple documentation improvement can turn denials into approvals.

Medical Necessity Letter Template

[Date]
[UnitedHealthcare Medical Director]
[Address from denial letter]

RE: Appeal for Prior Authorization - Oxlumo (lumasiran)
Patient: [Name], DOB: [Date], Member ID: [Number]
Diagnosis: Primary Hyperoxaluria Type 1 (ICD-10: E72.53)

Dear Medical Director,

I am appealing the denial of prior authorization for Oxlumo (lumasiran) for my patient with confirmed primary hyperoxaluria type 1 (PH1).

CLINICAL BACKGROUND:
[Patient name] has genetically confirmed PH1 with [specific AGXT mutations]. Baseline 24-hour urinary oxalate was [value] μmol/1.73 m²/day ([date]), significantly elevated above normal ranges.

FDA APPROVAL STATUS:
Oxlumo is FDA-approved to lower urinary and plasma oxalate levels in pediatric and adult patients with PH1. There are no alternative FDA-approved therapies with the same mechanism of action.

MEDICAL NECESSITY:
Without treatment, PH1 leads to progressive kidney damage, recurrent kidney stones, and systemic oxalosis. Early intervention with Oxlumo can prevent irreversible complications.

PRESCRIBER QUALIFICATIONS:
I am a [specialty] with expertise in rare kidney diseases and PH1 management.

SUPPORTING DOCUMENTATION:
- Genetic testing report confirming PH1
- Baseline urinary oxalate levels
- Current eGFR showing adequate kidney function
- Clinical notes documenting PH1 complications

Please approve this medically necessary therapy to prevent disease progression.

Sincerely,
[Prescriber name, credentials]
[Contact information]

Patient Assistance Programs

Alnylam Assist® programs can help with Oxlumo costs and coverage gaps:

Copay Assistance

  • Eligibility: Commercial insurance patients
  • Benefit: Covers out-of-pocket costs
  • How to apply: Healthcare provider submits Alnylam Assist Start Form

Bridge Therapy

  • Purpose: Temporary coverage during PA delays or insurance changes
  • Duration: Until permanent coverage established
  • Process: Case manager assessment after Start Form submission

Patient Assistance Program (PAP)

  • Eligibility: Uninsured or underinsured patients meeting income criteria
  • Benefit: Free medication
  • Application: Through healthcare provider and Alnylam case manager

Getting started: Ask your doctor to submit an Alnylam Assist Start Form

Counterforce Health helps patients and clinicians navigate these complex prior authorization requirements by analyzing denial letters and crafting targeted, evidence-based appeals that address each payer's specific criteria.

When to Escalate: Texas Department of Insurance

If UnitedHealthcare fails to follow proper procedures or you need help understanding your rights:

Texas Department of Insurance
Consumer Help Line: 1-800-252-3439
Website: tdi.texas.gov

Office of Public Insurance Counsel (OPIC)
Help Line: 1-877-611-6742
Assists with appeals and insurance disputes

When to contact:

  • Missed appeal deadlines by insurer
  • Procedural violations
  • Questions about external review process
  • Need help understanding denial reasons

FAQ: Common Questions

Q: How long does UnitedHealthcare prior authorization take in Texas?
A: Standard PA decisions are made within 7 days for Part B drugs like Oxlumo. Expedited requests are decided within 72 hours if delay would jeopardize health.

Q: What if Oxlumo is not on UnitedHealthcare's formulary?
A: Oxlumo may be covered as a non-formulary drug with prior authorization. The lack of formulary status doesn't mean automatic denial if medical necessity is established.

Q: Can I request an expedited appeal?
A: Yes, if waiting for standard appeal timelines would seriously jeopardize your health. Both you and your provider can request expedited review.

Q: Does UnitedHealthcare require step therapy for Oxlumo?
A: No. UnitedHealthcare's policy does not require trying other therapies first for PH1 patients meeting diagnostic criteria.

Q: What happens if my internal appeal is denied?
A: You can request external review by an Independent Review Organization (IRO) through the Texas Department of Insurance. This review is binding on UnitedHealthcare.

Q: How much does Oxlumo cost without insurance?
A: The annual list price is approximately $493,000. However, Alnylam Assist programs may provide significant financial support for eligible patients.

Q: Can I switch to a different UnitedHealthcare plan for better Oxlumo coverage?
A: Coverage criteria are generally consistent across UnitedHealthcare plans. Focus on meeting existing PA requirements rather than changing plans.

Q: What if I move from Texas to another state?
A: Appeal rights and timelines may differ by state. Contact your new state's insurance department for specific procedures.

The appeals process can feel overwhelming, but Texas provides strong patient protections and multiple levels of review. Counterforce Health specializes in turning insurance denials into successful approvals by crafting appeals that directly address each payer's specific requirements and evidence standards.

Sources & Further Reading

Disclaimer: This information is for educational purposes and should not replace professional medical advice. Always consult with your healthcare provider and insurance company for the most current coverage policies and requirements. Coverage decisions may vary based on individual circumstances and plan details.

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