How to Get Oxlumo (Lumasiran) Covered by Cigna in Washington: Complete Prior Authorization and Appeals Guide
Answer Box: To get Oxlumo (lumasiran) covered by Cigna in Washington, you need genetic confirmation of PH1 (AGXT mutation), elevated urinary oxalate levels, and a nephrology/urology specialist prescription. Submit through Express Scripts with complete documentation. If denied, use Cigna's internal appeal within 180 days, then Washington's external IRO review for a binding decision. Start by gathering genetic testing, lab results, and specialist notes today.
Table of Contents
- Cigna's Coverage Policy Overview
- Medical Necessity Requirements
- Step Therapy and Exceptions
- Quantity and Frequency Limits
- Required Diagnostics and Documentation
- Specialty Pharmacy Requirements
- Supporting Evidence Guidelines
- Appeals Process in Washington
- Common Denial Reasons and Solutions
- Cost Assistance Options
- FAQ
Cigna's Coverage Policy Overview
Cigna covers Oxlumo (lumasiran) through Express Scripts specialty pharmacy management for confirmed primary hyperoxaluria type 1 (PH1) cases. The drug requires prior authorization across all Cigna plan types—commercial PPO, HMO, and Medicare Advantage plans in Washington.
Plan Types and Application:
- Commercial plans: Standard PA through Express Scripts
- Medicare Advantage: Additional CMS compliance requirements
- Self-funded employer plans: Federal (not Washington state) appeal timelines apply
You can find Cigna's official Oxlumo coverage policy in their specialty pharmacy guidelines, which outlines all medical necessity criteria and documentation requirements.
Medical Necessity Requirements
Cigna requires comprehensive documentation to establish medical necessity for Oxlumo coverage:
Core Requirements Table
Requirement | Documentation Needed | Source |
---|---|---|
PH1 Diagnosis | Genetic AGXT mutation report OR liver biopsy showing AGT deficiency | FDA labeling |
Elevated Oxalate | 24-hour urine oxalate ≥0.5-0.7 mmol/24h/1.73m² OR oxalate:creatinine ratio above normal | Cigna policy |
Specialist Prescriber | Nephrology, urology, or genetics specialist prescription/consultation | Express Scripts criteria |
Kidney Function | eGFR ≥30 mL/min/1.73m² documented | Clinical guidelines |
No Prior Transplant | Medical record confirmation of no previous liver transplant | Cigna policy |
Genetic Testing Requirements
The genetic confirmation must show biallelic pathogenic variants in the AGXT gene. Acceptable testing includes:
- Comprehensive PH1 genetic panel
- Targeted AGXT sequencing
- Whole exome sequencing with PH1 focus
If genetic testing is unavailable, liver biopsy demonstrating alanine-glyoxylate aminotransferase (AGT) enzyme deficiency serves as an alternative diagnostic method.
Step Therapy and Exceptions
Cigna typically does not require step therapy for Oxlumo since it's the only FDA-approved siRNA therapy specifically for PH1. However, they may require documentation of:
Conservative Management Attempts:
- Dietary oxalate restriction
- Increased fluid intake
- Pyridoxine (vitamin B6) supplementation trials
- Citrate supplementation
Medical Exception Pathways: If your case involves atypical circumstances, document contraindications or ineffectiveness of conservative measures. Include specialist notes explaining why immediate Oxlumo therapy is medically necessary.
Quantity and Frequency Limits
Oxlumo dosing follows FDA-approved weight-based protocols with specific quantity limits:
Dosing Schedule
Patient Weight | Loading Dose (Monthly × 3) | Maintenance Dose |
---|---|---|
<10 kg | 6 mg/kg monthly | 3 mg/kg monthly |
10-20 kg | 6 mg/kg monthly | 6 mg/kg quarterly |
≥20 kg | 3 mg/kg monthly | 3 mg/kg quarterly |
Renewal Requirements:
- 12-month authorization periods
- Must demonstrate ≥30% reduction in urinary oxalate from baseline
- Ongoing specialist monitoring documentation required
Required Diagnostics and Documentation
Essential Lab Values
- 24-hour urine oxalate: Must exceed 0.5 mmol/24h/1.73m² (some policies require ≥0.7)
- Spot urine oxalate:creatinine ratio: Above age-specific upper limit
- Plasma oxalate: ≥20 μmol/L if available
- eGFR: ≥30 mL/min/1.73m² within 30 days of submission
Clinical Documentation Checklist
- Genetic testing report with AGXT mutations
- Specialist consultation notes
- Current weight for dosing calculations
- ICD-10 code E72.53 (Primary hyperoxaluria)
- Insurance verification with member/group numbers
- Prior therapy documentation (if applicable)
Specialty Pharmacy Requirements
Cigna routes Oxlumo through Express Scripts specialty pharmacy network. The medication requires:
Administration Requirements:
- Healthcare provider administration (subcutaneous injection)
- Use HCPCS code J3490 (unclassified drug) or specific NDC
- Administration code 96372 for subcutaneous injection
Site of Care:
- Physician office
- Outpatient infusion center
- Specialty clinic
- Home healthcare (with qualified nurse)
Supporting Evidence Guidelines
Primary Evidence Sources
Include these key citations in your medical necessity letter:
- FDA prescribing information for approved indication
- Clinical trial data showing efficacy in PH1 patients
- Specialist society guidelines (when available)
Medical Necessity Letter Template
Your specialist should include:
- Patient presentation: PH1 diagnosis, symptom severity, kidney function
- Prior treatments: Conservative measures tried and outcomes
- Clinical rationale: Why Oxlumo is appropriate now
- Monitoring plan: How response will be assessed
- Dosing justification: Weight-based calculations per FDA labeling
Appeals Process in Washington
Washington provides robust appeal rights through multiple levels:
Internal Appeals
- First Level: Submit within 180 days of denial
- Timeline: Cigna must respond within 30 days (commercial), 60 days (Medicare)
- Expedited: 72 hours for urgent cases
- Required: Medical records, specialist letters, lab results
External Review (IRO)
If internal appeals fail, Washington's Independent Review Organization (IRO) process provides binding decisions:
- Eligibility: After exhausting internal appeals
- Timeline: 180 days from final internal denial to request IRO
- Process: Submit through Washington Office of Insurance Commissioner
- Cost: Free to patients (insurer pays all fees)
- Decision Timeline: 15-20 days standard, 72 hours expedited
- Outcome: Binding on Cigna if IRO approves coverage
From our advocates: "We've seen Washington IRO panels consistently support rare disease medication appeals when the genetic diagnosis is clear and specialist documentation is thorough. The key is presenting a complete clinical picture that demonstrates medical necessity beyond the insurer's initial assessment."
Washington-Specific Resources
- Consumer Help: Call OIC at 1-800-562-6900
- Appeal Templates: Available on OIC website
- IRO Process: Detailed guidance at Washington insurance commissioner resources
Common Denial Reasons and Solutions
Denial Reason | Solution | Required Documentation |
---|---|---|
"Not medically necessary" | Provide specialist letter emphasizing PH1 severity and lack of alternatives | Genetic testing, urinary oxalate levels, specialist consultation |
"Experimental/investigational" | Reference FDA approval and clinical evidence | FDA label, published studies, clinical guidelines |
"Step therapy required" | Document contraindications to conservative measures | Medical records showing intolerance or ineffectiveness |
"Non-formulary drug" | Request formulary exception | Comparative analysis showing no formulary alternatives |
"Quantity exceeds limit" | Justify weight-based dosing per FDA protocol | Patient weight, dosing calculations, FDA prescribing information |
Cost Assistance Options
Manufacturer Support
- Alnylam Assist: Patient support program offering copay assistance
- Eligibility: Commercial insurance patients may qualify for reduced copays
- Contact: Visit Alnylam Assist website for applications
Additional Resources
- Patient advocacy organizations: Rare disease foundations may offer grants
- State programs: Washington Apple Health (Medicaid) coverage options
- Hospital financial assistance: Many facilities offer charity care programs
FAQ
How long does Cigna prior authorization take for Oxlumo in Washington? Standard review takes 1-3 business days through Express Scripts. Complex cases may take up to 30 days for commercial plans.
What if Oxlumo is not on Cigna's formulary? Request a formulary exception by demonstrating medical necessity and lack of formulary alternatives for PH1 treatment.
Can I get expedited approval for urgent cases? Yes, if delay would seriously jeopardize your health. Request expedited review and provide documentation of urgency.
Does Washington require step therapy for Oxlumo? Cigna may require documentation of conservative management attempts, but formal step therapy is uncommon given Oxlumo's unique indication.
What happens if my appeal is denied? After exhausting Cigna's internal appeals, you can request Washington's external IRO review, which provides binding decisions.
How do I prove my child meets weight-based dosing requirements? Provide current weight documentation and dosing calculations per FDA labeling to justify vial quantities.
Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Oxlumo. Our platform helps patients and clinicians navigate prior authorization requirements by analyzing denial letters, identifying specific coverage criteria, and generating targeted appeals with the right clinical evidence and procedural documentation.
If you're facing a Cigna denial for Oxlumo in Washington, Counterforce Health can help you build a comprehensive appeal that addresses the specific denial reasons and meets Washington's external review requirements.
Sources & Further Reading
- Cigna Oxlumo Coverage Policy
- FDA Oxlumo Prescribing Information
- Washington Office of Insurance Commissioner Appeals
- Alnylam Assist Patient Support
- Express Scripts Specialty Pharmacy
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always consult with your healthcare provider and insurance company for the most current requirements and procedures specific to your situation.
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