By Counterforce Health Team in Oxlumo (lumasiran) —

How Long Does It Take to Get Oxlumo (Lumasiran) Approved by Cigna in New Jersey? Complete Timeline Guide

Answer Box: Getting Oxlumo (Lumasiran) Approved by Cigna in New Jersey

Timeline: Cigna typically reviews Oxlumo (lumasiran) prior authorization requests within 1-3 business days through Express Scripts. First step: Have your nephrologist or urologist submit genetic confirmation of PH1 (AGXT gene mutations), baseline urinary oxalate levels, and clinical documentation. If denied: New Jersey's IHCAP external review provides binding decisions within 7 days (urgent) or 45 days (standard). Start today by gathering your genetic testing results and 24-hour urine oxalate measurements.

Table of Contents

  1. What Affects Oxlumo Approval Timing
  2. Pre-Submission Preparation (0-2 Days)
  3. Submission to Initial Review (1-5 Days)
  4. Additional Information Requests
  5. Decision Window & Reading Approval Letters
  6. If Denied: Appeal Timeline in New Jersey
  7. Renewal Cycles & Reauthorization
  8. Timeline Visual & Milestones
  9. Time-Saving Tips for Faster Approval

What Affects Oxlumo Approval Timing

Several factors determine how quickly Cigna approves Oxlumo (lumasiran) in New Jersey:

Benefit Type Impact:

  • Commercial plans: Standard 1-3 day review through Express Scripts
  • Medicare Advantage: May require additional CMS compliance checks
  • Self-funded employer plans: Follow federal timelines rather than New Jersey state requirements

Complexity of Criteria: Cigna requires specific documentation for Oxlumo approval:

  • Biallelic pathogenic variants in the AGXT gene
  • Urinary oxalate ≥ 0.5 mmol/24h/1.73 m² or elevated oxalate:creatinine ratio
  • Prescription by nephrologist or urologist
  • No prior liver transplant for PH1

Documentation Completeness: Complete submissions with all required elements process fastest. Missing genetic testing results or baseline oxalate levels trigger automatic requests for additional information, adding 3-7 days to the timeline.

Note: New Jersey law (effective 2025) requires insurers to decide non-urgent prior authorizations within 9 days, providing additional consumer protection beyond federal minimums.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist:

✓ Genetic Testing Results

  • AGXT gene sequencing showing biallelic pathogenic variants
  • Laboratory report with interpretation
  • If unavailable, liver enzyme analysis showing reduced AGT activity

✓ Baseline Laboratory Values

  • 24-hour urinary oxalate excretion (preferred)
  • Spot urinary oxalate-to-creatinine ratio (alternative)
  • Baseline eGFR ≥ 30 mL/min/1.73 m²
  • Plasma oxalate level if available

✓ Clinical Documentation

  • Specialist consultation notes (nephrologist or urologist)
  • Diagnosis confirmation with ICD-10 codes
  • Treatment history and rationale
  • Current weight for dosing calculations

✓ Insurance Information

  • Current Cigna member ID and group number
  • Benefit verification showing specialty drug coverage
  • Prior authorization form (obtain from Cigna provider portal)

Coding Requirements:

  • Diagnosis: E72.53 (Primary hyperoxaluria)
  • HCPCS: J3490 (unclassified drug) or specific code when available
  • Administration: 96372 (subcutaneous injection)

Submission to Initial Review (1-5 Days)

New Jersey Turnaround Requirements: Under 2025 New Jersey regulations, Cigna must respond to prior authorization requests within:

  • Urgent requests: 72 hours
  • Standard requests: 9 calendar days (or 12 days if submitted by paper)

What Reviewers Check First:

  1. Genetic Confirmation: AGXT gene mutation documentation
  2. Specialist Involvement: Prescription from nephrologist/urologist
  3. Clinical Necessity: Baseline urinary oxalate levels meeting thresholds
  4. Exclusion Criteria: No prior liver transplant documented
  5. Dosing Appropriateness: Weight-based calculations per FDA labeling

Express Scripts Review Process: Cigna processes Oxlumo requests through Express Scripts specialty pharmacy management, typically completing reviews within 5.7 hours on average, though up to 3 business days is standard for complex cases.

Additional Information Requests

If Cigna requests additional information, you have 3 business days to respond under New Jersey's 2025 prior authorization law.

Common Information Requests:

  • Clarification of genetic testing methodology
  • Additional urinary oxalate measurements
  • Specialist consultation notes
  • Prior therapy documentation (if step therapy applies)

How to Respond Quickly:

  • Use Cigna's provider portal for electronic submission
  • Include cover letter referencing original PA request number
  • Submit all requested documents in a single submission
  • Follow up by phone if urgent
Tip: Incomplete responses restart the review clock. Submit all requested information together rather than piecemeal.

Decision Window & Reading Approval Letters

Typical Outcomes:

Approved (60-70% of complete submissions):

  • Coverage duration: Typically 6-12 months
  • Quantity limits: Based on weight-based dosing requirements
  • Site of care: Healthcare provider administration required
  • Renewal requirements: Evidence of clinical response

Denied - Common Reasons:

  • Insufficient genetic confirmation of PH1
  • Urinary oxalate levels below threshold
  • Non-specialist prescriber
  • Prior liver transplant documented
  • Missing baseline laboratory values

Partial Approval:

  • May approve with modified dosing schedule
  • Could require step therapy with conservative management first
  • Might limit to specific administration sites

If Denied: Appeal Timeline in New Jersey

New Jersey provides robust appeal rights through both internal Cigna appeals and the state's Independent Health Care Appeals Program (IHCAP).

Internal Cigna Appeals

Stage 1 - Informal Review:

  • Timeline: 72 hours (urgent), 10 days (standard)
  • Deadline to file: 180 days from denial
  • Required documents: Denial letter, medical records, physician statement
  • Submit via: Cigna member services or provider portal

Stage 2 - Formal Panel Review:

  • Timeline: 72 hours (urgent), 30 days (standard)
  • Triggers automatically after Stage 1 denial for group plans
  • Enhanced review: Clinical panel including relevant specialists

New Jersey IHCAP External Review

After exhausting Cigna's internal process, New Jersey residents can access binding external review:

IHCAP Timeline:

  • Preliminary review: 5 business days to confirm eligibility
  • Urgent decisions: 7 business days
  • Standard decisions: 45 days maximum
  • Filing deadline: 4 months from final internal denial

How to File IHCAP Appeal:

  • Contact: 1-888-393-1062 (IHCAP hotline)
  • Submit via: Maximus NJ IHCAP portal or mail
  • Cost: Free to patients (insurer pays review fees)
  • Decision: Binding on Cigna if overturned

Required IHCAP Documents:

  • Final denial letter from Cigna
  • Complete medical records
  • Physician letter explaining medical necessity
  • Genetic testing results
  • Baseline and follow-up laboratory values
From our advocates: We've seen cases where patients received IHCAP approval for Oxlumo after Cigna denied coverage based on urinary oxalate thresholds. The key was submitting comprehensive genetic documentation and specialist letters explaining the progressive nature of PH1, even when oxalate levels were borderline. While outcomes vary, thorough documentation significantly improves success rates.

Renewal Cycles & Reauthorization

Standard Reauthorization Schedule:

  • Initial approval: 6-12 months
  • Renewal requirements: Evidence of clinical response
  • Timeline for resubmission: 30 days before expiration

Required Renewal Documentation:

  • Updated urinary oxalate levels showing reduction from baseline
  • Current weight for dosing verification
  • Specialist assessment of clinical response
  • Continued genetic confirmation (usually not required if previously approved)
  • eGFR monitoring results

What Speeds Renewal:

  • Documented oxalate reduction ≥ 30% from baseline
  • Stable or improved renal function
  • No safety concerns or adverse events
  • Consistent specialist oversight

Timeline Visual & Milestones

Milestone Timeline Key Requirements
Documentation Gathering 0-2 days Genetic testing, baseline labs, specialist notes
Prior Authorization Submission Day 0 Complete Cigna PA form with all supporting documents
Initial Review 1-3 days Express Scripts clinical review
Additional Information (if needed) +3-7 days Patient has 3 days to respond
Final Decision 1-9 days total Approval, denial, or partial approval
Internal Appeal (if denied) 10-30 days Two-stage Cigna review process
IHCAP External Review 7-45 days Independent medical review (binding)

Time-Saving Tips for Faster Approval

Portal Usage:

  • Submit through Cigna provider portal rather than fax for faster processing
  • Use electronic attachments for supporting documentation
  • Monitor portal for real-time status updates

Bundled Evidence Strategy:

  • Submit all required documents simultaneously
  • Include cover letter summarizing key clinical points
  • Reference specific Cigna policy criteria in submission

Direct Specialty Routing:

  • Ensure prescription routes directly to Express Scripts/Accredo
  • Coordinate with Alnylam Assist program for additional support
  • Confirm specialty pharmacy benefits before submission

Proactive Communication:

  • Call Cigna specialty pharmacy line for urgent cases: [verify current number with Cigna]
  • Request peer-to-peer review if initial denial seems inappropriate
  • Maintain regular contact with prescribing specialist throughout process

Counterforce Health: Streamlining Your Appeal Process

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeal processes for specialty medications like Oxlumo. The platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals tailored to each payer's requirements. By automating much of the documentation and research process, Counterforce Health can significantly reduce the time and effort required to secure coverage for rare disease treatments.

FAQ: Common Questions About Oxlumo Coverage in New Jersey

How long does Cigna prior authorization take for Oxlumo in New Jersey? Standard review takes 1-3 business days through Express Scripts, with New Jersey law requiring decisions within 9 days maximum.

What if Oxlumo is non-formulary on my Cigna plan? Request a formulary exception with medical necessity documentation. Cigna must review non-formulary requests using the same clinical criteria.

Can I request an expedited appeal in New Jersey? Yes, both Cigna internal appeals and IHCAP external reviews offer expedited timelines (72 hours and 7 days respectively) for urgent cases.

Does step therapy apply to Oxlumo for PH1? Generally no, as Oxlumo is first-line therapy for genetically confirmed PH1. However, some plans may require documentation of conservative management attempts.

What happens if I move from another state to New Jersey? New Jersey's 2025 law requires insurers to honor existing prior authorizations for 60 days when switching plans, preventing therapy interruption.

Who can prescribe Oxlumo for Cigna coverage? Cigna requires prescription by or consultation with a nephrologist or urologist. Primary care physicians typically cannot initiate coverage requests.

How much does Oxlumo cost if not covered? Annual list price averages $493,000, with individual vial costs around $60,099. Patient assistance programs may be available through Alnylam Assist.

What genetic testing is required for Cigna approval? AGXT gene sequencing showing biallelic pathogenic variants, or liver enzyme analysis demonstrating reduced AGT activity if genetic testing is unavailable.

Sources & Further Reading

This guide provides educational information about insurance coverage processes and should not replace professional medical or legal advice. Coverage decisions depend on individual circumstances and specific benefit plans. For personalized guidance, consult your healthcare provider and insurance representative. Counterforce Health offers additional resources for navigating complex prior authorization and appeal processes.

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