By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (Lumasiran) Covered by Blue Cross Blue Shield in New Jersey: Complete PA Guide with Appeals Process

Answer Box: Getting Oxlumo Covered by Blue Cross Blue Shield in New Jersey

Oxlumo (lumasiran) requires prior authorization from Blue Cross Blue Shield in New Jersey for primary hyperoxaluria type 1 (PH1). Your fastest path to approval:

  1. Confirm PH1 diagnosis with AGXT genetic testing or liver biopsy showing AGT enzyme deficiency
  2. Have a specialist (nephrologist, urologist, or geneticist) submit PA request via Horizon's provider portal with baseline urinary oxalate levels
  3. If denied, use New Jersey's IHCAP external review program (68% success rate for specialty drugs)

Start today: Contact your specialist to gather genetic testing results and baseline lab work. Horizon BCBS typically decides within 14 days.

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Requirements
  5. Cost-Share Dynamics
  6. Submission Process
  7. Common Approval Patterns
  8. Appeals Playbook for New Jersey
  9. FAQ
  10. Sources & Further Reading

Plan Types & Coverage Implications

Horizon Blue Cross Blue Shield dominates New Jersey's insurance market with ~39% market share. Your specific plan type affects how Oxlumo coverage works:

  • HMO plans: Require referrals to specialists; your PCP must refer you to a nephrologist or geneticist before PA submission
  • PPO/EPO plans: Allow direct specialist access; you can schedule with a nephrologist without referral
  • Medicaid/NJ FamilyCare: Follow similar PA criteria but may have additional state-specific requirements
  • Medicare Advantage: Subject to federal Medicare Part B or Part D rules depending on administration setting
Note: All Horizon plans require prior authorization for Oxlumo regardless of plan type, but referral requirements differ.

Formulary Status & Tier Placement

Oxlumo is classified as Tier 4 (Specialty) on Horizon BCBS formularies, meaning:

  • High-cost specialty drug requiring specialty pharmacy dispensing
  • Prior authorization mandatory before any coverage
  • No generic alternatives available
  • Step therapy may apply depending on your specific plan

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before coverage Horizon Provider Portal Horizon BCBS PA List
Formulary Tier Tier 4 (Specialty) Horizon Formulary 2024 Formulary
Specialty Pharmacy Must use approved network Horizon Care@Home: 1-855-243-3321 Provider Manual
Diagnosis Code E72.53 (Primary hyperoxaluria) ICD-10 coding manual CMS Guidelines
HCPCS Code J0224 (Oxlumo injection) Medicare billing codes CMS Fee Schedule

Prior Authorization Requirements

Horizon BCBS requires comprehensive documentation for Oxlumo PA approval:

Clinical Documentation Checklist

✓ Confirmed PH1 Diagnosis

  • AGXT genetic testing showing biallelic pathogenic variants, OR
  • Liver biopsy demonstrating absent/reduced AGT enzyme activity

✓ Baseline Laboratory Values

  • Urinary oxalate levels (24-hour urine collection preferred)
  • Serum creatinine and eGFR (must be ≥30 mL/min/1.73 m²)
  • Complete metabolic panel

✓ Specialist Requirements

  • Prescription from nephrologist, urologist, geneticist, or gastroenterologist
  • Clinical notes documenting PH1 severity and treatment goals

✓ Additional Documentation

  • No previous liver transplant for PH1
  • Weight-based dosing calculation
  • Planned administration schedule (loading doses monthly x3, then quarterly maintenance)
Clinician Corner: Your medical necessity letter should address FDA-approved indication (lowering urinary oxalate in PH1), baseline oxalate levels, kidney function status, and why conservative management alone is insufficient. Include references to FDA prescribing information and relevant nephrology guidelines.

Specialty Pharmacy Requirements

Oxlumo must be dispensed through Horizon's approved specialty pharmacy network:

  • Primary partner: Horizon Care@Home (1-855-243-3321)
  • Alternative networks: Accredo, CVS Specialty, Express Scripts Specialty
  • Administration: Healthcare provider-administered subcutaneous injection
  • Storage: Requires refrigeration; specialty pharmacy coordinates delivery timing

Patient Setup Process

  1. Prescription routing: Your doctor submits PA and prescription simultaneously
  2. Specialty pharmacy enrollment: Care@Home contacts you within 24-48 hours
  3. Benefits verification: Pharmacy confirms coverage and copay
  4. Delivery coordination: Scheduled around your clinic appointments
  5. Clinical support: Pharmacy provides injection training materials

Cost-Share Dynamics

Annual list price: Approximately $493,000, with actual costs varying by weight-based vial requirements.

Typical Patient Responsibility

  • Tier 4 specialty copay: Often 25-40% coinsurance after deductible
  • Out-of-pocket maximum: New Jersey ACA plans cap annual costs (2024: $9,450 individual/$18,900 family)
  • Manufacturer support: Alnylam offers copay assistance program (verify eligibility at Alnylam Act)
Important: This is educational information only. Contact Horizon member services at the number on your insurance card for specific cost estimates.

Submission Process

Step-by-Step: Fastest Path to Approval

1. Gather Documentation (Patient + Clinic)

  • Insurance card and member ID
  • AGXT genetic testing results
  • Recent urinary oxalate levels
  • Current kidney function labs

2. Specialist Consultation (Clinic)

  • Schedule with nephrologist, urologist, or geneticist
  • Obtain clinical assessment and treatment plan
  • Request medical necessity letter

3. Prior Authorization Submission (Clinic)

  • Submit via Horizon Provider Portal
  • Include all required documentation
  • Use correct codes: J0224 (HCPCS), E72.53 (ICD-10)

4. Specialty Pharmacy Setup (Patient)

  • Await PA approval (typically 14 days)
  • Enroll with Horizon Care@Home
  • Schedule first administration

5. Monitor Status (Patient + Clinic)

  • Track PA status through provider portal
  • Follow up if no response within 14 days
  • Prepare appeal documentation if needed

Common Approval Patterns

Strong submissions typically include:

  • Genetic confirmation: Clear AGXT mutation documentation, not just clinical suspicion
  • Quantified oxalate levels: Specific baseline measurements, not general "elevated" notes
  • Specialist endorsement: Detailed treatment rationale from appropriate subspecialist
  • Functional assessment: eGFR documentation showing adequate kidney function
  • Weight-based dosing: Proper vial count calculations for patient's weight

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
"No confirmed PH1 diagnosis" Submit genetic testing or liver biopsy AGXT gene test results
"Insufficient baseline data" Provide quantified oxalate levels 24-hour urine oxalate measurement
"Non-specialist prescriber" Transfer care or obtain consultation Nephrologist/urologist assessment
"Inadequate kidney function" Document eGFR ≥30 mL/min/1.73 m² Recent comprehensive metabolic panel

Appeals Playbook for New Jersey

New Jersey offers excellent appeal protections through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals (Required First)

Timeline: 180 days from denial date Process:

  1. Submit written appeal to Horizon BCBS
  2. Include additional clinical documentation
  3. Request peer-to-peer review if available
  4. Expect decision within 30 days (15 for urgent)

External Review via IHCAP

Success rate: 68% for specialty drugs Timeline: Must file within 4 months of final internal denial Process:

  1. Complete internal appeals first
  2. File online at njihcap.maximus.com or call 888-866-6205
  3. Submit all medical records and denial letters
  4. Independent physician reviewers make binding decision
  5. Decision within 45 days (expedited: 48 hours for urgent cases)

No cost to you - insurer pays all review fees.

From our advocates: We've seen successful IHCAP appeals for Oxlumo when families included comprehensive genetic testing documentation and detailed medical necessity letters from pediatric nephrologists. The key was demonstrating that conservative oxalate reduction measures were insufficient and that the patient met all FDA-approved criteria. While outcomes vary, thorough preparation significantly improves chances.

When to Escalate Further

Contact NJ Department of Banking and Insurance (1-800-446-7467) if:

  • IHCAP process delays exceed stated timelines
  • Insurer fails to comply with IHCAP decision
  • You need help understanding your appeal rights

FAQ

How long does Horizon BCBS prior authorization take in New Jersey? Standard review: 14 days. Expedited review available for urgent medical necessity (verify timeline with Horizon).

What if Oxlumo is non-formulary on my specific plan? Request formulary exception with medical necessity documentation. All Horizon plans we reviewed include Oxlumo as Tier 4 specialty.

Can I request expedited appeals? Yes, for urgent medical situations. Available for both internal appeals and IHCAP external review.

Does step therapy apply if I failed treatments outside New Jersey? Document all prior therapies regardless of location. Out-of-state treatment failures count toward step therapy requirements.

What happens if my PA is approved but then denied at renewal? Renewals require documented clinical response (reduced urinary oxalate, stable kidney function). Maintain regular monitoring labs.

Can my doctor file appeals on my behalf? Yes, with your written consent. Providers can file both internal appeals and IHCAP external reviews for patients.

Counterforce Health Support

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to the plan's own rules. For complex cases like Oxlumo, where genetic testing and specialty documentation are critical, having expert appeal support can significantly improve your chances of approval.

If you're facing a denial for Oxlumo in New Jersey, Counterforce Health can help you navigate both Horizon's internal appeals process and New Jersey's IHCAP external review system with documentation that meets payer-specific requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by specific plan and may change. Always verify current requirements with your insurance plan and consult healthcare providers for medical decisions. For official New Jersey insurance regulations and consumer protections, visit the NJ Department of Banking and Insurance website.

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