How to Get Upstaza (Eladocagene Exuparvovec) Covered by Cigna in Pennsylvania: Complete Forms, Appeals, and Contact Guide
Answer Box: Getting Upstaza Covered by Cigna in Pennsylvania
Cigna requires prior authorization for Upstaza (eladocagene exuparvovec) through Express Scripts/Accredo, with specific criteria including genetic confirmation of AADC deficiency and failed standard therapies. Submit via CoverMyMeds portal or call 800-753-2851 with genetic testing, severity assessment, and certified neurosurgical center details. If denied, Pennsylvania's new external review program offers strong appeal rights—about 50% of appeals are overturned. Start today: Verify your plan coverage through myCigna, gather genetic testing results, and contact your prescriber to initiate the prior authorization process.
Table of Contents
- Start Here: Verify Your Plan and Coverage
- Required Forms and Documentation
- Submission Portals and Processes
- Fax Numbers and Mailing Addresses
- Specialty Pharmacy Setup
- Support Phone Lines
- Pennsylvania Appeals and External Review
- Common Denial Reasons and Solutions
- When to Contact Regulators
Start Here: Verify Your Plan and Coverage
Before beginning the prior authorization process, confirm your specific Cigna plan details through the myCigna portal or by calling the customer service number on your insurance card.
Key Coverage Information:
- Upstaza (eladocagene exuparvovec) is covered under Cigna Coverage Policy IP0725 for AADC deficiency
- All gene therapies require prior authorization across Cigna plans
- Specialty pharmacy management through Express Scripts/Accredo is mandatory
- Treatment must occur at a certified neurosurgical center
Note: Cigna uses the brand name Kebilidi in their policy documents, which is the same medication as Upstaza (eladocagene exuparvovec).
Required Forms and Documentation
Prior Authorization Requirements
Essential Documentation Checklist:
- Genetic testing confirming biallelic DDC gene mutations
- Plasma AADC enzyme activity results (decreased levels)
- CSF neurotransmitter analysis (5-HIAA, HVA, 3-MT)
- Documentation of failed standard therapies (dopamine agonists, MAO inhibitors, or pyridoxine)
- Certified treatment center verification
- Age confirmation (≥18 months with skull maturity imaging)
Medical Necessity Letter Components
Your prescriber's medical necessity letter should include:
- Confirmed AADC deficiency diagnosis with genetic evidence
- Severity of symptoms (developmental delays, motor dysfunction)
- Prior treatment history and limitations of supportive care
- Rationale for gene therapy intervention
- Post-treatment monitoring plan
Counterforce Health helps patients navigate complex prior authorization requirements by analyzing denial letters and crafting targeted appeals with the right clinical evidence. Their platform identifies specific denial reasons and creates point-by-point rebuttals aligned to each payer's policies, saving time for both patients and providers.
Submission Portals and Processes
Primary Submission Methods
1. CoverMyMeds Portal (Recommended)
- Fastest processing method
- Real-time status tracking
- Secure document upload capability
- Access through Cigna provider portal
2. Accredo Direct Submission
- Call: 800-753-2851
- Dedicated gene therapy support team
- 72-hour standard review timeline
- 24-hour expedited review for urgent cases
3. Gene Therapy Program Team
- Phone: 855-678-0051
- Email: [email protected]
- Specialized rare disease support
Submission Timeline Expectations
| Review Type | Processing Time | When to Use |
|---|---|---|
| Standard | 72 hours | Non-urgent cases |
| Expedited | 24 hours | Delay risks neurological harm |
| Peer-to-peer | Upon request | After initial denial |
Fax Numbers and Mailing Addresses
Gene Therapy Prior Authorization
- Fax: 833-910-1625
- Mail: Cigna Precertification Department, 1640 Dallas Parkway, Plano, TX 75093
Internal Appeals
- Mail: Cigna National Appeals Unit, P.O. Box 188011, Chattanooga, TN 37422
Tip: Include a cover sheet with patient Cigna ID, prescriber NPI, and urgency level. Mark "GENE THERAPY - AADC DEFICIENCY" prominently.
Specialty Pharmacy Setup
Accredo Enrollment Process
Step 1: Prescriber Initiation
- E-prescribe to Accredo (fastest method)
- Fax prescription with prior auth approval
- Call 888-327-9791 for fax instructions
Step 2: Patient Enrollment
- Call Accredo: 877-826-7657
- Provide insurance information and prescriber details
- Schedule delivery coordination
Step 3: Transfer from Current Pharmacy
- Request new prescription from your prescriber (recommended)
- Use myCigna electronic transfer for eligible medications
- Call Express Scripts: 1-800-835-3784 for assistance
Note: Controlled substances and expired prescriptions cannot be automatically transferred and require new prescriptions.
Support Phone Lines
Patient Support Numbers
| Service | Phone Number | Hours | What They Help With |
|---|---|---|---|
| Cigna Customer Service | Number on ID card | 24/7 | Coverage questions, claim status |
| Express Scripts | 1-800-835-3784 | 24/7 | Prescription transfers, pharmacy benefits |
| Accredo | 877-826-7657 | 24/7 | Specialty medication support |
| Gene Therapy Team | 855-678-0051 | Business hours | Prior auth, case management |
Questions to Ask Customer Service
When calling Cigna, have this information ready:
- Your member ID number
- Prescriber's name and NPI
- Medication name (Upstaza or Kebilidi)
- Prior authorization reference number (if applicable)
Sample Script: "I need to check the prior authorization status for Upstaza for AADC deficiency. My member ID is [number] and the prescriber is [name]. Can you tell me what documentation is still needed?"
Pennsylvania Appeals and External Review
Internal Appeal Process
Level 1 Internal Appeal
- Deadline: 180 days from denial date
- Processing time: 30 days for medical necessity appeals
- Submit to: Cigna National Appeals Unit (address above)
Level 2 Internal Appeal
- Deadline: 60 days from Level 1 decision
- Different medical director reviews case
- Final internal review before external options
Pennsylvania External Review
Pennsylvania's Independent External Review Program launched in January 2024 with strong patient success rates.
Key Statistics:
- 50% of external appeals overturned in first year
- 517 external appeals filed in 2024
- 259 cases ruled in favor of patients
External Review Process:
- Complete all internal appeals first
- File within 4 months of final denial
- Submit through Pennsylvania Insurance Department portal
- Standard review: 45 days
- Expedited review: 72 hours (urgent cases)
Appeals Support Resources
Pennsylvania Insurance Department
- Consumer Services: Available through pa.gov
- Free assistance with complex appeals
- External review guidance and forms
Pennsylvania Health Law Project
- Consumer Assistance Program
- Free help for low-income individuals
- Specialized rare disease advocacy
Common Denial Reasons and Solutions
| Denial Reason | Solution Strategy | Required Documentation |
|---|---|---|
| Experimental/Investigational | Cite FDA approval (August 2024) | FDA approval announcement, Cigna policy IP0725 |
| Not medically necessary | Emphasize no disease-modifying alternatives | Medical necessity letter, literature review |
| Step therapy required | Request override with prescriber attestation | Clinical rationale for immediate treatment |
| Facility requirements | Verify certified treatment center | Center accreditation documentation |
| Insufficient genetic evidence | Provide complete genetic testing | Biallelic DDC mutations, enzyme activity |
Medical Necessity Appeal Strategy
When appealing a medical necessity denial, Counterforce Health's platform can help identify the specific denial basis and craft targeted rebuttals using FDA labeling, peer-reviewed studies, and specialty guidelines that align with Cigna's own coverage criteria.
Key Appeal Points:
- AADC deficiency is a rare, progressive disorder
- No other disease-modifying treatments available
- Gene therapy offers potential for functional improvement
- Meets all Cigna coverage criteria per policy IP0725
When to Contact Regulators
Pennsylvania Insurance Department Complaints
Contact the Pennsylvania Insurance Department if:
- Cigna fails to respond within required timeframes
- Internal appeals process is not followed properly
- You need assistance understanding your rights
Filing a Complaint:
- Online portal available at pa.gov
- Include all correspondence and denial letters
- Document timeline of appeals process
Federal Options
For Medicare Advantage plans, additional appeal rights may apply through CMS. Contact 1-800-MEDICARE for guidance on federal appeal processes.
Frequently Asked Questions
Q: How long does Cigna prior authorization take for Upstaza? A: Standard review is 72 hours, with expedited 24-hour review available if delay risks neurological harm.
Q: What if Upstaza is non-formulary on my plan? A: Request a formulary exception through Cigna's non-covered medication process, emphasizing the lack of disease-modifying alternatives.
Q: Can I request an expedited appeal in Pennsylvania? A: Yes, both Cigna internal appeals and Pennsylvania external reviews offer expedited timelines for urgent medical situations.
Q: Does step therapy apply to gene therapies? A: Cigna's policy requires documentation of failed standard therapies (dopamine agonists, MAO inhibitors, or pyridoxine) before approving gene therapy.
Q: What happens if my external review is successful? A: Cigna must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal process.
Sources and Further Reading
- Cigna Coverage Policy IP0725 - Kebilidi Gene Therapy
- Pennsylvania External Review Program
- Cigna Prior Authorization Requirements
- Express Scripts Specialty Pharmacy
- Cigna Gene Therapy Program
This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions are made by your insurance plan based on your specific policy terms and medical circumstances. For personalized assistance with your coverage appeal, consult with your healthcare provider or contact the Pennsylvania Insurance Department's consumer services.
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