How to Get Elfabrio (Pegunigalsidase Alfa) Covered by Cigna in Pennsylvania: Complete Prior Authorization and Appeals Guide
Answer Box: Getting Elfabrio Covered by Cigna in Pennsylvania
Cigna requires prior authorization for Elfabrio (pegunigalsidase alfa-iwxj) in Pennsylvania through Express Scripts/Accredo specialty pharmacy. Submit the Elfabrio CCRD PA form with confirmed Fabry disease diagnosis (deficient α-galactosidase A enzyme <4% normal OR pathogenic GLA gene variant), age 18+, and specialist prescriber. Standard approval takes 2-5 business days via CoverMyMeds or Cigna portal. If denied, Pennsylvania's new external review program overturns ~50% of denials within 45 days. Start today: Verify your Cigna coverage type and gather enzyme/genetic test results from your specialist.
Table of Contents
- Before You Start: Coverage Verification
- What You Need to Gather
- Submit Your Prior Authorization Request
- Follow-Up and Timeline Expectations
- If You're Asked for More Information
- If Your Request is Denied
- Pennsylvania External Review Process
- Renewal and Re-Authorization
- Cost Assistance Options
- Frequently Asked Questions
Before You Start: Coverage Verification
Check Your Plan Type
Not all Cigna plans are eligible for Pennsylvania's external review process. If your employer offers a self-funded plan, it may not qualify for state-level appeals. Contact your HR department or check your insurance card for plan details.
Verify Elfabrio Coverage
Elfabrio falls under Cigna's medical benefit (not pharmacy) since it's administered by IV infusion. Check your plan's formulary status at cigna.com/ifp-drug-lists or call member services.
Confirm Your Specialty Pharmacy
Cigna typically routes specialty drugs through Express Scripts/Accredo. Verify your specialty pharmacy benefits and whether you need to use a specific network.
What You Need to Gather
Required Clinical Documentation
| Requirement | Details | Where to Get It |
|---|---|---|
| Fabry Disease Confirmation | α-galactosidase A enzyme activity <4% normal (males) OR pathogenic/likely pathogenic GLA gene variant (females/uncertain cases) | Genetics lab results, enzyme assay reports |
| Age Verification | Must be 18+ years (pediatric safety not established) | Medical records, ID |
| Specialist Prescriber | Genetics, cardiology, nephrology, neurology, or lysosomal storage disease specialist | Provider credentials, referral documentation |
| Current Weight | For 1 mg/kg dosing calculation | Recent clinic visit notes |
| Symptom Documentation | Acroparesthesias, angiokeratomas, kidney/heart involvement | Clinical notes within 90 days |
| Prior Therapy Records | If applicable, previous ERT trials or Galafold use | Treatment history, prior authorization records |
Forms You'll Need
- Elfabrio CCRD PA form from Cigna's provider portal
- Recent clinic notes (within 90 days)
- Medical necessity letter from prescriber
- Enzyme/genetic test results
Tip: Request all test results and clinic notes before starting the PA process. Missing documentation is the most common cause of delays.
Submit Your Prior Authorization Request
Submission Methods (Fastest to Slowest)
- CoverMyMeds (preferred) - Electronic submission with real-time status updates
- SureScripts/EHR integration - Direct from provider's electronic health record
- Cigna provider portal - Online submission with document upload
- Phone/Fax - Call 1-800-882-4462 for urgent requests or fax (verify current number)
Clean Request Packet Checklist
- Completed Elfabrio CCRD PA form with all required fields
- Enzyme assay results showing <4% normal activity (males) or genetic testing (females)
- Specialist's medical necessity letter explaining Fabry disease diagnosis and treatment rationale
- Current patient weight and dosing calculation (1 mg/kg every 2 weeks)
- Recent clinic notes documenting symptoms and disease progression
- Prior therapy documentation (if patient tried other treatments)
- ICD-10 code E75.21 (Fabry disease) clearly documented
Site of Care Considerations
Elfabrio requires administration at an infusion center or physician's office due to monitoring requirements for infusion reactions. Initial 4-6 doses must be given over 3-4 hours with 2-hour post-infusion observation. Include your planned infusion site in the PA request.
Follow-Up and Timeline Expectations
Standard Timeline
- Electronic submission (CoverMyMeds): 2-5 business days
- Portal/fax submission: 3-7 business days
- Expedited/urgent requests: 24-72 hours (call Cigna directly)
When to Follow Up
Call Cigna at 1-800-882-4462 if you haven't received a decision within the expected timeframe. Have your reference number, patient ID, and prescriber information ready.
From our advocates: We've seen cases where incomplete enzyme testing documentation delayed approval by 1-2 weeks. One patient's PA was initially rejected because the genetic testing didn't clearly state "pathogenic variant," but was quickly approved once the genetics lab provided a clarifying letter.
If You're Asked for More Information
Common Additional Requests
- Detailed genetic variant interpretation - Contact the testing lab for a clinical summary
- Specialist consultation notes - May need recent evaluation from Fabry disease specialist
- Dosing justification - Provide current weight and confirm 1 mg/kg calculation
- Site of care medical necessity - Explain why infusion center is required for safety
Medical Necessity Letter Template Points
Your specialist's letter should address:
- Confirmed Fabry disease diagnosis with specific test results
- Clinical symptoms and organ involvement
- Why Elfabrio is medically necessary for this patient
- Any contraindications to alternative therapies
- Treatment goals and monitoring plan
If Your Request is Denied
Common Denial Reasons and Solutions
| Denial Reason | How to Address |
|---|---|
| Incomplete diagnosis confirmation | Submit enzyme assay <4% normal OR genetic testing with pathogenic variant interpretation |
| Age requirement not met | Confirm patient is 18+ with documentation |
| Non-specialist prescriber | Transfer prescription to qualified specialist or obtain specialist consultation |
| Step therapy required | Document Galafold ineligibility (non-amenable mutation) or failure/intolerance |
| Dosing concerns | Provide current weight, confirm 1 mg/kg calculation, address any dose adjustments |
Cigna Internal Appeals Process
- First-level appeal: Submit within 180 days of denial
- Second-level appeal: Available if first-level is denied
- Expedited appeals: Available if delay could jeopardize health
- Peer-to-peer review: Request physician-to-physician discussion
Submit appeals through the Cigna provider portal or call 1-800-882-4462.
Pennsylvania External Review Process
When External Review Applies
After exhausting Cigna's internal appeals, Pennsylvania residents can request an independent external review through the Pennsylvania Insurance Department. This state-supervised process has overturned approximately 50% of denials in its first year.
Timeline and Submission
- Deadline: 4 months from your final internal denial letter
- Standard review: 45 days for decision
- Expedited review: 72 hours if condition is worsening
- Submission: Online portal at pa.gov or by mail/fax
What Happens if You Win
If the independent review organization overturns Cigna's denial, Cigna must immediately provide coverage and reimburse any out-of-pocket costs you paid during the appeal process.
Getting Help
Contact the Pennsylvania Insurance Department Consumer Services Bureau at 1-877-881-6388 for assistance with the external review process.
Renewal and Re-Authorization
Typical Approval Period
Elfabrio prior authorizations are typically approved for 12 months. Set a calendar reminder 60-90 days before expiration to begin the renewal process.
Renewal Documentation
- Updated clinic notes showing treatment response
- Current weight for dosing verification
- Any changes in clinical status
- Continued medical necessity from prescriber
What Speeds Renewal
- Documented clinical improvement or disease stabilization
- No significant adverse events
- Adherence to prescribed dosing schedule
- Updated specialist evaluation
Cost Assistance Options
Manufacturer Support
Chiesi Global Rare Diseases offers Chiesi Total Care patient support services, including:
- Insurance navigation assistance
- Copay support programs (verify eligibility)
- Prior authorization support
- Infusion site coordination
Contact Chiesi Total Care for current program details and eligibility requirements.
Additional Resources
- Patient Advocate Foundation: Copay relief programs for qualifying patients
- HealthWell Foundation: Grants for rare disease treatments
- National Fabry Disease Foundation: Patient support and resources
Frequently Asked Questions
Q: How long does Cigna prior authorization take for Elfabrio in Pennsylvania? A: Standard electronic submissions typically take 2-5 business days. Portal or fax submissions may take 3-7 business days.
Q: What if Elfabrio is non-formulary on my plan? A: Request a formulary exception with clinical justification. Document why alternatives like Fabrazyme or Galafold are unsuitable for your specific case.
Q: Can I request an expedited appeal if denied? A: Yes, expedited appeals are available if treatment delay could jeopardize your health. Call Cigna directly at 1-800-882-4462 to request expedited review.
Q: Does step therapy apply if I haven't tried other Fabry treatments? A: Cigna may require Galafold trial first for patients with amenable GLA mutations. Document if your mutation is non-amenable or if you have contraindications to oral therapy.
Q: What's the success rate for appeals in Pennsylvania? A: Pennsylvania's external review program has approximately a 50% overturn rate for denials, significantly higher than national averages.
Q: Can Elfabrio be given at home? A: Initial infusions require infusion center administration due to monitoring needs for infusion reactions. Maintenance infusions may continue at infusion centers based on individual tolerance.
Getting specialized help with complex prior authorizations and appeals can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to create point-by-point rebuttals aligned with each payer's specific requirements. Their platform pulls the right medical evidence and weaves it into appeals that meet procedural requirements while tracking deadlines and required documentation.
If you're facing a complex Elfabrio denial or need help navigating Cigna's prior authorization process, consider reaching out to Counterforce Health for specialized support in building a strong case for coverage.
Sources & Further Reading
- Cigna Elfabrio Prior Authorization Form
- Pennsylvania External Review Process
- Cigna Appeals and Disputes
- Elfabrio Prescribing Information (FDA)
- Chiesi Total Care Patient Support
Disclaimer: This guide is for informational purposes only and does not constitute medical advice. Coverage decisions depend on individual plan benefits, clinical circumstances, and payer policies. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with Pennsylvania insurance issues, contact the Pennsylvania Insurance Department at 1-877-881-6388.
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