By Counterforce Health Team in Voydeya (danicopan) —

How to Get Voydeya (Danicopan) Covered by Cigna in Georgia: Complete Appeals Guide with Forms and Deadlines

Quick Answer: Getting Voydeya Covered by Cigna in Georgia

Cigna requires prior authorization for Voydeya (danicopan) with strict documentation of PNH diagnosis by flow cytometry, ongoing C5 inhibitor therapy, and evidence of extravascular hemolysis. If denied, you have 180 days for internal appeal, then 60 days for Georgia external review. Start today: Call Cigna at 1-800-882-4462 for peer-to-peer review, gather your flow cytometry results and hemoglobin labs, and prepare a medical necessity letter showing inadequate response to C5 inhibitor monotherapy.

Table of Contents

  1. Understanding Your Denial Letter
  2. Common Fixable Issues
  3. First-Level Internal Appeal
  4. Peer-to-Peer Review Process
  5. Second-Level and External Review in Georgia
  6. Medical Necessity Letter Templates
  7. Tracking Your Appeal
  8. Strengthening Your Case
  9. If Your Appeal Fails
  10. Costs and Financial Assistance
  11. FAQ

Understanding Your Denial Letter

When Cigna denies coverage for Voydeya (danicopan), the denial letter contains critical information that determines your next steps. Here's how to decode it:

Key Elements to Find:

  • Denial reason code (medical necessity, step therapy, non-formulary status, or missing documentation)
  • Appeal deadline (typically 180 days for internal appeals)
  • Required documentation for reconsideration
  • Pharmacy vs. medical benefit classification
Note: Voydeya is typically managed through Express Scripts/Accredo as a specialty drug, so denials often come from the pharmacy benefit manager rather than Cigna directly.

Most Common Denial Reasons for Voydeya:

  1. No documented C5 inhibitor therapy - Missing proof of eculizumab or ravulizumab treatment
  2. Insufficient evidence of extravascular hemolysis - Labs don't show persistent anemia or elevated reticulocytes
  3. Missing REMS documentation - Vaccination records not submitted
  4. Non-specialist prescriber - Requires hematology/oncology specialist

Common Fixable Issues

Before filing a formal appeal, check if your denial stems from easily correctable problems:

Issue Quick Fix Timeline
Missing flow cytometry results Submit PNH diagnosis confirmation 1-2 business days
Incomplete vaccination records Provide meningococcal/pneumococcal documentation 1-2 business days
Wrong diagnosis code Ensure ICD-10 D59.5 (PNH) is used Same day
Missing C5 inhibitor documentation Submit treatment history and dosing records 2-3 business days

Resubmission Process:

  1. Call Cigna provider services at 1-800-882-4462
  2. Request to resubmit with additional documentation
  3. Use CoverMyMeds portal or fax updated PA request

First-Level Internal Appeal

Step-by-Step Appeal Process

1. Gather Required Documentation (Days 1-3)

  • Original denial letter
  • Complete medical records from past 12 months
  • PNH flow cytometry results showing GPI-deficient cells
  • C5 inhibitor treatment history and response
  • Recent hemoglobin and reticulocyte counts
  • Vaccination records per REMS requirements

2. Prepare Medical Necessity Letter (Days 4-5)

  • Document inadequate response to C5 inhibitor monotherapy
  • Include specific lab values showing extravascular hemolysis
  • Reference FDA labeling for approved indication
  • Attach supporting literature if available

3. Submit Appeal (Day 6)

  • Use Cigna's online provider portal (preferred)
  • Or fax to number provided in denial letter
  • Include cover letter summarizing key points

4. Follow Up (Days 7-14)

  • Confirm receipt within 2 business days
  • Response typically within 15-30 days for standard review
  • 72 hours for expedited review if urgent medical need

Peer-to-Peer Review Process

Scheduling a Peer-to-Peer Call:

  • Phone: 1-800-882-4462 (Cigna Health Services)
  • Who can request: Only the prescribing physician
  • Best timing: Within 5 days of initial denial
  • Preparation time: Usually scheduled within 24-48 hours

Preparation Checklist for Providers

Clinical Talking Points:

  • Patient's PNH clone size and affected cell lineages
  • Duration and dosing of current C5 inhibitor therapy
  • Objective evidence of ongoing extravascular hemolysis (Hgb ≤9.5 g/dL, reticulocytes >120 × 10⁹/L)
  • Transfusion requirements or functional impairment
  • Safety monitoring plan and REMS compliance

Documentation to Have Ready:

  • Flow cytometry report with specific percentages
  • Trend of hemoglobin values over past 6 months
  • C5 inhibitor dosing and administration records
  • Any adverse events or complications from current therapy
From our advocates: Hematologists report that emphasizing the specific FDA indication for "add-on therapy" rather than requesting monotherapy significantly improves approval rates. Clearly stating that Voydeya will be used alongside, not instead of, the C5 inhibitor addresses a common misconception that leads to denials.

Second-Level and External Review in Georgia

Internal Second-Level Appeal

If your first appeal is denied, Cigna offers a second internal review:

  • Timeline: Request within 180 days of original denial
  • Process: Reviewed by different medical director
  • Response time: 30 days for standard, 72 hours for expedited

Georgia External Review Process

Eligibility Requirements:

  • Completed all internal appeal levels
  • Denial based on medical necessity, experimental/investigational determination, or similar clinical criteria
  • Not a purely contractual exclusion

Filing Process:

  1. Deadline: 60 days from final internal denial letter
  2. Contact: Georgia Department of Insurance Consumer Services at 1-800-656-2298
  3. Forms: Complete Georgia External Review Request Form
  4. Cost: Free to consumers

Required Documentation:

  • Final internal denial letter from Cigna
  • All medical records and clinical notes
  • Completed external review application
  • Provider's statement of medical necessity

Timeline:

  • Standard review: 30 business days
  • Expedited review: 72 hours (requires physician certification of urgent need)
  • Decision: Binding on Cigna if overturned

Medical Necessity Letter Templates

Core Elements for Voydeya Appeals

Patient Information Section:

Patient: [Name], DOB: [XX/XX/XXXX]
Insurance ID: [Policy Number]
Diagnosis: Paroxysmal Nocturnal Hemoglobinuria (ICD-10: D59.5)
Prescriber: [Hematologist Name and Credentials]

Clinical Rationale Template:

This patient has confirmed PNH by flow cytometry showing [X]% GPI-deficient 
erythrocytes and [Y]% deficient granulocytes. Despite [duration] of optimized 
C5 inhibitor therapy with [eculizumab/ravulizumab] at [dose/frequency], the 
patient continues to experience clinically significant extravascular hemolysis 
as evidenced by:

- Hemoglobin: [value] g/dL (below 9.5 g/dL threshold)
- Reticulocyte count: [value] × 10⁹/L (above 120 × 10⁹/L threshold)
- Transfusion requirements: [frequency/units over timeframe]
- Functional impact: [specific symptoms affecting daily activities]

Voydeya (danicopan) is FDA-approved specifically as add-on therapy to C5 
inhibitors for adults with PNH experiencing extravascular hemolysis, which 
precisely matches this patient's clinical presentation.

Safety and Monitoring Section:

The patient has completed all required vaccinations per REMS protocol:
- Meningococcal (MenACWY and MenB): [dates]
- Pneumococcal: [date]
- Haemophilus influenzae type b: [date]

Regular monitoring will include CBC, comprehensive metabolic panel, and 
clinical assessment for signs of infection every [frequency].

Tracking Your Appeal

Appeal Log Template

Date Action Contact/Reference Outcome Next Step
[Date] Initial denial received Denial #[number] Coverage denied Gather documentation
[Date] Called for peer-to-peer 1-800-882-4462 Scheduled for [date] Prepare clinical summary
[Date] Submitted internal appeal Portal confirmation #[number] Pending review Follow up in 15 days

Key Contacts for Georgia

  • Cigna Provider Services: 1-800-882-4462
  • Georgia DOI Consumer Services: 1-800-656-2298
  • Georgians for a Healthy Future: Consumer assistance organization
  • Georgia Legal Services: For Medicaid/PeachCare appeals

Strengthening Your Case

Evidence-Based Arguments

1. Clinical Guidelines Support:

  • Reference FDA labeling showing specific indication for extravascular hemolysis
  • Cite published treatment algorithms supporting combination therapy
  • Include quality of life impact assessments

2. Prior Therapy Documentation:

  • Detailed C5 inhibitor trial history with specific doses and durations
  • Documentation of inadequate response or persistent symptoms
  • Any adverse events or contraindications to dose escalation

3. Functional Impact:

  • Fatigue scores or validated assessment tools
  • Work/school absence records
  • Healthcare utilization (ER visits, hospitalizations)

Win-Rate Boosters

Tip: Appeals are successful in approximately 82% of Medicare Advantage cases when proper documentation is provided. Commercial plans show similar overturn rates for rare disease therapies when clinical criteria are clearly met.

Most Effective Strategies:

  • Submit lab trends showing persistent anemia despite C5 therapy
  • Include transfusion records with specific dates and units
  • Document REMS compliance proactively
  • Request expedited review if clinically appropriate

If Your Appeal Fails

Alternative Coverage Options

1. Formulary Exception Request

  • Submit if Voydeya is non-formulary
  • Requires demonstration that formulary alternatives are ineffective
  • Timeline: 72 hours for urgent requests

2. Step Therapy Override

  • Document medical contraindications to required first-line therapy
  • Provide evidence of prior trial and failure
  • Include provider attestation of medical necessity

3. Manufacturer Support Programs

  • Alexion Access Navigator: Patient assistance and copay support
  • Bridge therapy during appeals process
  • Financial hardship programs

Costs and Financial Assistance

Coverage Landscape

  • Estimated annual cost: $50,000-$100,000 for Voydeya alone (plus ongoing C5 inhibitor costs)
  • Cigna formulary status: Specialty tier (verify current placement)
  • Prior authorization: Required for all plans

Financial Support Options:

  1. Manufacturer copay assistance: Available for commercially insured patients
  2. Foundation grants: Patient Access Network, HealthWell Foundation
  3. State programs: Georgia may have rare disease assistance (verify eligibility)

At Counterforce Health, we help patients and clinicians navigate these complex approval processes by analyzing denial letters, identifying the specific criteria that need to be addressed, and drafting targeted appeals that align with each insurer's requirements. Our platform streamlines the documentation process and improves approval rates for specialty medications like Voydeya.

FAQ

How long does Cigna prior authorization take in Georgia? Standard PA decisions: 15 business days. Expedited reviews: 72 hours if urgent medical need is documented.

What if Voydeya is non-formulary on my Cigna plan? Request a formulary exception with documentation that covered alternatives are ineffective or contraindicated.

Can I request an expedited appeal? Yes, if your physician certifies that waiting poses serious risk to your health. Include "Physician Certification for Expedited Review" form.

Does step therapy apply if I've tried C5 inhibitors outside Georgia? Yes, document all prior therapies regardless of where they were tried. Include medical records and provider notes.

What happens if I miss the 60-day external review deadline? Contact Georgia DOI immediately at 1-800-656-2298. Limited options may be available depending on circumstances.

Who can help me with the appeals process in Georgia? Georgians for a Healthy Future provides free consumer assistance. For Medicaid appeals, contact Georgia Legal Services.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always consult with your healthcare provider and insurance company for the most current information regarding your specific situation. For additional help with insurance issues in Georgia, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

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