By Counterforce Health Team in Upstaza (eladocagene exuparvovec) —

How to Get Upstaza (Eladocagene Exuparvovec) Approved by Cigna in New Jersey: Complete Timeline Guide

Quick Answer: Getting Upstaza Approved by Cigna in New Jersey

Cigna requires prior authorization for Upstaza (eladocagene exuparvovec) with genetic testing confirmation of AADC deficiency. Under New Jersey's new 2025 law, Cigna must decide within 3 business days for standard requests or 24 hours for urgent cases. If denied, you have 180 days for internal appeals and 4 months for external review through New Jersey's IHCAP program. Start by having your neurologist submit complete documentation via EviCore by Evernorth or call 1-800-882-4462.

Table of Contents

  1. What Affects Approval Timing
  2. Pre-Submission Preparation (Days 1-2)
  3. Initial Review Process (Days 3-5)
  4. Additional Information Requests
  5. Decision Timeline & Outcomes
  6. If Denied: Appeals Process
  7. Renewal Requirements
  8. Timeline Visual Summary
  9. Time-Saving Tips
  10. FAQ

What Affects Approval Timing

Several factors determine how quickly Cigna approves Upstaza coverage in New Jersey:

Benefit Structure: Cigna typically manages specialty drugs like Upstaza through Express Scripts/Accredo specialty pharmacy, requiring coordination between medical and pharmacy benefits.

Diagnostic Complexity: AADC deficiency requires genetic testing showing biallelic DDC gene mutations plus CSF neurotransmitter analysis or plasma AADC enzyme activity assay. Incomplete testing delays approval.

Documentation Quality: Complete clinical information submitted upfront prevents the common cycle of additional information requests that can add 3-7 days per round.

Note: Gene therapies face heightened scrutiny due to their multimillion-dollar cost and one-time administration nature.

Pre-Submission Preparation (Days 1-2)

Essential Documentation Checklist

Before submitting your prior authorization, gather these required documents:

Diagnostic Evidence:

  • Genetic test results confirming DDC gene mutations
  • CSF neurotransmitter profile showing low 5-HIAA, HVA, and MHPG levels
  • Plasma AADC enzyme activity assay results
  • Blood level measurement of 3-O-methyldopa (3-OMD)

Clinical Documentation:

  • Specialist consultation notes from pediatric neurologist or movement disorder specialist
  • Documentation of failed standard AADC therapies with dates and outcomes
  • Current functional assessment showing inability to meet gross motor milestones
  • Treatment plan from certified gene therapy facility

Administrative Requirements:

  • Patient age verification (18 months to 65 years per FDA approval)
  • Confirmation of no prior gene therapy treatment
  • Insurance verification and benefit check

Verification Steps

  1. Check formulary status: Log into myCigna.com and use "Price a Medication" tool to identify PA requirements
  2. Confirm network facility: Verify your chosen treatment center is Cigna-contracted and certified for gene therapy
  3. Review benefit limits: Check for lifetime maximums or specific exclusions

Initial Review Process (Days 3-5)

New Jersey State Requirements

Under New Jersey's 2025 prior authorization law, Cigna must:

  • Approve or deny standard PA requests within 3 business days
  • Process urgent requests within 24 hours
  • Request additional information only once, with 3-day response deadline

Submission Methods

Electronic Prior Authorization (Preferred):

  • EviCore by Evernorth: Select "Pharmacy Drugs (Express Scripts Coverage)" for Cigna PA requests
  • CoverMyMeds: Universal platform for medication PAs
  • MyAccredoPatients.com: Direct submission to Accredo specialty pharmacy

Phone Submission: Call 1-800-882-4462 if electronic options unavailable

What Reviewers Check First

Cigna's initial review focuses on:

  1. FDA indication alignment: Treatment of AADC deficiency in eligible age range
  2. Diagnostic confirmation: Genetic testing and enzyme activity results
  3. Prescriber credentials: Neurologist or specialist consultation
  4. Facility certification: Gene therapy center accreditation
  5. Prior therapy documentation: Evidence of failed standard treatments

Additional Information Requests

If Cigna requests additional information, you have 3 business days under New Jersey law to respond. Common requests include:

Missing Information Required Response Where to Find
Genetic test details Complete DDC gene mutation report Genetic testing laboratory
Enzyme activity levels Plasma AADC assay results Specialty lab or neurologist
Prior treatment history Detailed medication trial log with dates Medical records
Facility certification Gene therapy center accreditation proof Treatment facility
Tip: Respond to information requests immediately. Delays reset the review timeline and can lead to automatic denials.

Decision Timeline & Outcomes

Typical Decision Timeframes

With Complete Documentation:

  • Standard requests: 2-3 business days
  • Urgent requests: 24 hours
  • Complex cases requiring specialist review: Up to 5 business days

Common Approval Conditions:

  • Treatment at specified network facility
  • Completion of required pre-operative assessments
  • Post-operative monitoring compliance
  • Lifetime limit of one infusion

Reading Your Approval Letter

Approved requests will specify:

  • Covered NDC/J-codes for billing
  • Authorized treatment facility
  • Required pre-authorization for related services
  • Appeal rights if conditions change

If Denied: Appeals Process

Cigna Internal Appeals

You have 180 calendar days from denial to file internal appeals:

Level 1 Internal Appeal:

  • Timeline: 30 days for medical necessity decisions
  • Submit via: CignaforHCP.com or call member services
  • Required: Denial letter, medical records, physician letter

Level 2 Internal Appeal (Required for HMO/PPO):

  • Timeline: Up to 60 days
  • Automatic physician review for medical necessity denials

New Jersey External Review (IHCAP)

After exhausting Cigna's internal process, file with New Jersey's Independent Health Care Appeals Program:

Filing Requirements:

  • Deadline: 4 months from final internal denial
  • Fee: $25 (waivable for financial hardship)
  • Submit to: Maximus Federal Services (njihcap.maximus.com)

Timeline:

  • Preliminary review: 5 business days
  • Final decision: 45 days standard, 48 hours expedited
  • Cigna compliance: 10 business days if overturned

Required Documents:

  • All denial letters from Cigna
  • Complete medical records
  • Physician necessity letter
  • Signed medical release forms
Important: IHCAP decisions are binding on Cigna and must be followed.

Renewal Requirements

Upstaza is a one-time gene therapy with no renewal requirements. However, you may need separate authorizations for:

  • Pre-operative assessments and imaging
  • Anesthesia and surgical facility fees
  • Post-operative monitoring and follow-up care
  • Related medications for procedure support

Each component may have different PA requirements and timelines.

Timeline Visual Summary

Phase Days Key Actions Potential Delays
Preparation 1-2 Gather documentation, verify benefits Missing test results
Submission 1 Submit via portal or phone Portal technical issues
Initial Review 3-5 Cigna medical review Incomplete documentation
Additional Info 1-3 Respond to requests Provider delays
Decision 1-2 Approval/denial issued Complex case review
Internal Appeal 30-60 If denied, file appeal Missing appeal forms
External Review 45 IHCAP final decision Incomplete submission

Total Timeline: 7-10 days for straightforward approvals, 60-120 days if appeals needed.

Time-Saving Tips

  1. Use Electronic Portals: EviCore and CoverMyMeds provide faster processing than phone or fax
  2. Submit Complete Packages: Include all required documentation upfront to avoid information requests
  3. Verify Network Status: Confirm facility and provider network participation before submission
  4. Track Submission: Monitor portal status and respond immediately to requests
  5. Prepare Appeals Early: If denial seems likely, gather appeal documentation during initial review

Counterforce Health Support

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform ingests denial letters, plan policies, and clinical notes to identify the denial basis and draft point-by-point rebuttals aligned to the plan's own rules. For complex gene therapy cases like Upstaza, they pull appropriate citations from FDA labeling, peer-reviewed studies, and specialty guidelines while ensuring all required clinical facts are included.

FAQ

How long does Cigna PA take for Upstaza in New Jersey? Under New Jersey's 2025 law, Cigna must decide within 3 business days for standard requests or 24 hours for urgent cases with complete documentation.

What if Upstaza is non-formulary on my Cigna plan? You can request a formulary exception with medical necessity documentation. Express Scripts manages most Cigna specialty drug decisions.

Can I request an expedited review? Yes, if delay would jeopardize health or ability to regain function. Urgent requests must be decided within 24 hours under New Jersey law.

Does step therapy apply to gene therapy? Typically yes - you must document failure or contraindication to standard AADC deficiency treatments before gene therapy approval.

What happens if I'm denied twice by Cigna? After completing both internal appeal levels, you can file with New Jersey's IHCAP external review program within 4 months.

Who can help with my appeal in New Jersey? Contact NJ DOBI Consumer Hotline at 1-800-446-7467 or IHCAP at 1-888-393-1062 for guidance.

Are there cost assistance programs for Upstaza? Check with PTC Therapeutics for manufacturer assistance programs and contact patient advocacy organizations for additional support options.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance processes and should not be considered medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For personalized assistance with complex appeals, consider working with specialists like Counterforce Health who focus on evidence-based insurance advocacy.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.