Do You Qualify for Voydeya (danicopan) Coverage by Blue Cross Blue Shield in New York? Decision Tree & Next Steps
Answer Box: Your Fastest Path to Voydeya Coverage
If you have paroxysmal nocturnal hemoglobinuria (PNH) with extravascular hemolysis despite C5 inhibitor therapy, you likely qualify for Voydeya (danicopan) coverage through Blue Cross Blue Shield in New York. The fastest approval path requires: (1) Current C5 inhibitor therapy (Soliris/Ultomiris), (2) Evidence of ongoing hemolysis (hemoglobin ≤9.5 g/dL and reticulocyte count ≥120 × 10⁹/L), and (3) Complete REMS vaccination requirements. First step today: Contact your hematologist to initiate the VOYDEYA REMS program enrollment and gather your recent lab results showing extravascular hemolysis markers.
Table of Contents
- How to Use This Guide
- Eligibility Triage: Do You Qualify?
- If "Likely Eligible": Document Checklist
- If "Possibly Eligible": Tests to Request
- If "Not Yet": Alternative Approaches
- If Denied: Appeal Path Chooser
- New York External Appeals: Your Safety Net
- Resources & Next Steps
How to Use This Guide
This decision tree helps patients and clinicians determine the best path forward for Voydeya coverage through Blue Cross Blue Shield plans in New York. Start with the eligibility triage below to understand where you stand, then follow the specific action steps for your situation.
Note: Blue Cross Blue Shield operates through 33 independent plans. While this guide covers general BCBS policies, always verify specific requirements with your local New York plan.
Eligibility Triage: Do You Qualify?
Primary Requirements Checklist
Answer these questions to determine your eligibility tier:
✅ Diagnosis confirmed?
- PNH diagnosed by flow cytometry showing GPI-deficient cells
- ICD-10 code D59.5 documented in medical records
✅ Currently on C5 inhibitor therapy?
- Stable on Soliris (eculizumab) OR Ultomiris (ravulizumab) for ≥6 months
- No plans to discontinue C5 inhibitor (Voydeya is add-on only, never monotherapy)
✅ Evidence of extravascular hemolysis despite C5 therapy?
- Hemoglobin ≤9.5 g/dL AND absolute reticulocyte count ≥120 × 10⁹/L
- Ongoing transfusion requirements or persistent anemia symptoms
✅ Prescriber qualified?
- Board-certified hematologist or documented consultation
- Willing to enroll in VOYDEYA REMS program
✅ Vaccination requirements met?
- Meningococcal (A, C, W, Y, B), pneumococcal, and Hib vaccines current
- Administered ≥2 weeks before planned Voydeya start date
Your Eligibility Result
If you answered YES to all 5 questions: → Likely Eligible - Proceed to document checklist If you answered YES to 3-4 questions: → Possibly Eligible - Additional testing needed
If you answered YES to ≤2 questions: → Not Yet - Consider alternatives first
If "Likely Eligible": Document Checklist
Required Documentation Package
| Document Type | What to Include | Where to Find It |
|---|---|---|
| PNH Confirmation | Flow cytometry report, ICD-10 D59.5 diagnosis | Hematologist records |
| C5 Inhibitor History | 6+ months treatment records, current dosing | Infusion center logs |
| Extravascular Hemolysis Labs | Hemoglobin, reticulocyte count, LDH, bilirubin | Recent lab results (≤30 days) |
| REMS Documentation | Prescriber enrollment, vaccination records | VOYDEYA REMS portal |
| Medical Necessity Letter | Hematologist attestation of need | Provider documentation |
Submission Path: Step-by-Step
Step 1: REMS Enrollment (1-2 days)
- Prescriber enrolls at voydeyarems.com
- Verify vaccination status; administer if needed ≥2 weeks before treatment
Step 2: Prior Authorization Submission (Same day)
- Submit via Blue Cross provider portal or fax
- Include complete document package above
- Request expedited review if medically urgent
Step 3: Follow-Up (5-10 days)
- Standard review: 5-14 business days
- Expedited review: 24-48 hours for urgent cases
- Track status via provider portal
From our advocates: Patients who submit complete documentation packages with clear evidence of extravascular hemolysis markers typically see faster approvals. Having your hematologist highlight the specific lab values that meet coverage criteria can make the difference between a quick approval and additional information requests.
If "Possibly Eligible": Tests to Request
Missing Documentation to Gather
If missing recent labs, request:
- Complete blood count with reticulocyte count
- Comprehensive metabolic panel
- LDH, total/direct bilirubin, haptoglobin
- Flow cytometry confirmation (if >1 year old)
If C5 inhibitor history incomplete, obtain:
- Infusion records showing consistent therapy
- Documentation of any dose adjustments
- Evidence of intravascular hemolysis control
Timeline to re-apply: 2-4 weeks after obtaining missing documentation
What to Track While Waiting
Monitor symptoms that support medical necessity:
- Transfusion requirements
- Fatigue scores or functional assessments
- Breakthrough hemolysis episodes
- Quality of life impacts
If "Not Yet": Alternative Approaches
Prepare for Exception Requests
If not on C5 inhibitor:
- Discuss starting Soliris or Ultomiris first
- Document any contraindications to C5 therapy
- Consider clinical trial options
If hemolysis markers don't meet thresholds:
- Track trends over time (may worsen)
- Document functional impacts and symptoms
- Gather evidence of transfusion burden
Alternative therapies to discuss:
- Fabhalta (iptacopan) - oral Factor B inhibitor
- Empaveli (pegcetacoplan) - C3 inhibitor option
- Optimized C5 inhibitor dosing
If Denied: Appeal Path Chooser
Blue Cross Blue Shield Internal Appeals
Level 1: Standard Internal Appeal
- Deadline: 180 days from denial notice
- Processing time: 30 days standard, 72 hours expedited
- Required documents: Denial letter, additional medical evidence, physician letter
When to request expedited review:
- Serious health risk from treatment delay
- Physician attestation of urgent medical need
- Documented clinical deterioration
Common Denial Reasons & Fixes
| Denial Code | Reason | How to Overturn |
|---|---|---|
| Medical Necessity | Insufficient evidence of EVH | Submit recent labs showing Hgb ≤9.5 + retic count ≥120 × 10⁹/L |
| Step Therapy | Must try alternatives first | Document C5 inhibitor therapy ≥6 months, contraindications to other agents |
| REMS Requirements | Missing vaccination/enrollment | Complete REMS enrollment, submit vaccination records |
| Non-Formulary | Drug not on formulary | Request formulary exception with medical necessity documentation |
Peer-to-Peer Review Strategy
Before formal appeal, request peer-to-peer review:
- Hematologist discusses case directly with Blue Cross medical director
- Often resolves denials faster than formal appeals
- No additional paperwork required
New York External Appeals: Your Safety Net
New York provides strong consumer protections through the Department of Financial Services External Appeal program.
When External Appeals Apply
Eligible denial types:
- "Not medically necessary" determinations
- "Experimental/investigational" designations
- Out-of-network coverage disputes
Filing Process & Timelines
| Appeal Type | Filing Deadline | Processing Time | Best For |
|---|---|---|---|
| Standard External | 4 months from internal denial | 30 days | Non-urgent cases |
| Expedited External | 4 months from internal denial | 72 hours | Serious health risk |
| Urgent Drug Appeal | 4 months from internal denial | 24 hours | Rare disease emergencies |
How to file:
- Complete DFS External Appeal form
- Include patient consent, denial notice, supporting medical evidence
- Submit online via DFS Portal (preferred)
- Pay $25 fee (waived for financial hardship, refunded if you win)
For help filing: Contact Community Health Advocates at 888-614-5400 for free assistance.
Important: External appeal decisions are binding on Blue Cross Blue Shield. If you win, they must cover the treatment and refund your filing fee.
Resources & Next Steps
Essential Contacts & Forms
Blue Cross Blue Shield New York:
- Member services: Check your insurance card for plan-specific number
- Provider portal: Verify current PA submission process
- Appeals: Submit via member portal or certified mail
New York State Resources:
- DFS External Appeals: File binding external reviews
- Community Health Advocates: 888-614-5400 (free appeal assistance)
- External Appeal Database: Search past decisions
REMS Program:
- VOYDEYA REMS enrollment: Required prescriber registration
- Voydeya HCP resources: Clinical support materials
Coverage Assistance Programs
Manufacturer Support:
- Alexion patient services: Check voydeya.com for copay assistance
- Prior authorization support through manufacturer
Foundation Grants:
- PAN Foundation: Paroxysmal Nocturnal Hemoglobinuria fund
- NORD Patient Assistance: Premium and copay support programs
Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned to each payer's specific requirements, pulling the right clinical evidence and procedural details to maximize approval chances.
Checklist: What to Gather Before You Start
Before initiating your Voydeya prior authorization, collect:
- Insurance card with member/group numbers
- Complete PNH diagnosis records (flow cytometry)
- C5 inhibitor treatment history (≥6 months)
- Recent labs showing extravascular hemolysis markers
- Vaccination records (meningococcal, pneumococcal, Hib)
- Hematologist contact information and NPI number
- Prior therapy documentation (failures, contraindications)
Timeline expectations: Complete applications typically receive decisions within 5-14 business days. Incomplete submissions may take 30+ days due to additional information requests.
For complex cases or if you've experienced multiple denials, Counterforce Health specializes in crafting comprehensive appeals that address payer-specific criteria and maximize approval odds through targeted medical evidence and proper procedural compliance.
Sources & Further Reading
- FDA Voydeya Prescribing Information: Official labeling and safety requirements
- VOYDEYA REMS Program: Required prescriber enrollment and patient safety information
- New York DFS External Appeals: Binding external review process and forms
- Community Health Advocates: Free assistance with insurance appeals in New York
- Voydeya Clinical Resources: Healthcare provider support materials and coverage information
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For questions about New York insurance regulations, contact the Department of Financial Services at (800) 342-3736.
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