How to Get Voydeya (Danicopan) Covered by Blue Cross Blue Shield in Ohio: Decision Tree & Appeals Guide
Answer Box: Quick Coverage Path
Voydeya (danicopan) requires prior authorization from Blue Cross Blue Shield plans in Ohio. To qualify, you need: (1) confirmed PNH by flow cytometry, (2) current treatment with a C5 inhibitor (Soliris/Ultomiris), (3) documented extravascular hemolysis despite C5 therapy, and (4) up-to-date vaccinations. First step today: Call the member services number on your BCBS Ohio card to confirm PA requirements and get the submission portal link. Most approvals take 7-15 business days with complete documentation.
Table of Contents
- How to Use This Decision Tree
- Eligibility Triage: Do You Qualify?
- If "Likely Eligible": Documentation Checklist
- If "Possibly Eligible": Tests to Request
- If "Not Yet": Alternatives and Exception Requests
- If Denied: Ohio Appeals Path
- Coverage Requirements at a Glance
- Common Denial Reasons & How to Fix Them
- Costs and Financial Assistance
- FAQ
How to Use This Decision Tree
This guide helps patients and clinicians navigate Voydeya (danicopan) coverage with Blue Cross Blue Shield plans in Ohio, including Anthem BCBS. Voydeya is an oral Factor D inhibitor approved in 2024 as add-on therapy to C5 inhibitors for adults with paroxysmal nocturnal hemoglobinuria (PNH) who have extravascular hemolysis.
Start here: Answer the questions in the eligibility triage below to determine your approval likelihood and next steps.
Note: BCBS Ohio includes multiple plan types (commercial, Medicare Advantage, Medicaid managed care). Requirements may vary slightly by product line, but the core clinical criteria remain consistent.
Eligibility Triage: Do You Qualify?
✅ Likely Eligible if ALL apply:
- Confirmed PNH diagnosis by flow cytometry showing GPI-deficient red blood cells
- Currently on C5 inhibitor (eculizumab/Soliris or ravulizumab/Ultomiris) for ≥3 months
- Documented extravascular hemolysis despite C5 therapy:
- Persistent anemia (Hb <10-11 g/dL) with transfusion needs, OR
- Elevated reticulocyte count (>100 × 10⁹/L) with low/normal LDH
- Up-to-date vaccinations against meningococcal, pneumococcal, and Hib
- Prescribed by hematologist or blood disorder specialist
⚠️ Possibly Eligible if MOST apply:
- PNH diagnosis confirmed but C5 inhibitor therapy <3 months
- On C5 inhibitor but unclear documentation of breakthrough hemolysis
- Missing recent lab work or vaccination records
- Prescribed by non-specialist (can be resolved with consultation)
❌ Not Yet if ANY apply:
- No confirmed PNH diagnosis by flow cytometry
- Not currently on a C5 inhibitor (Voydeya cannot be used as monotherapy)
- No evidence of extravascular hemolysis on current C5 therapy
- Active serious bacterial infection or vaccination contraindications
If "Likely Eligible": Documentation Checklist
Your hematologist should gather these documents before submitting the prior authorization:
Clinical Documentation
- Flow cytometry report confirming PNH with percentage of GPI-deficient cells
- C5 inhibitor treatment records showing:
- Current medication (eculizumab or ravulizumab)
- Dosing schedule and infusion logs
- Duration of therapy (minimum 3 months preferred)
- Recent laboratory results (within 30 days):
- Complete blood count with reticulocyte count
- LDH, total and direct bilirubin
- Haptoglobin levels
- Pre-transfusion hemoglobin if applicable
Safety Documentation
- Vaccination records showing completion of:
- Meningococcal (serogroups A, C, W, Y, and B)
- Pneumococcal (PCV13 and PPSV23)
- Haemophilus influenzae type B
- REMS enrollment confirmation (prescriber must be certified)
Submission Path
- Call BCBS Ohio at the number on your insurance card to confirm:
- Prior authorization requirement
- Correct submission portal or fax number
- Expected review timeline
- Submit via provider portal (typically Anthem provider portal or designated specialty pharmacy)
- Track status through portal or by calling pharmacy services
If "Possibly Eligible": Tests to Request
Work with your hematologist to strengthen your case:
Additional Testing
- Extended hemolysis panel if recent labs are incomplete:
- Repeat CBC with differential and reticulocytes
- LDH, bilirubin fractionation, haptoglobin
- Consider C3 deposition testing on red blood cells
- Transfusion documentation if you've needed blood transfusions:
- Dates, number of units, pre-transfusion hemoglobin levels
- Hospital records showing transfusion for PNH-related anemia
Timeline to Reapply
- 2-4 weeks after completing additional testing
- Immediately if vaccination status is the only missing element
- 3 months if C5 inhibitor therapy duration is insufficient (document ongoing hemolysis in the meantime)
If "Not Yet": Alternatives and Exception Requests
Alternative Treatments to Discuss
While working toward Voydeya approval, consider these options with your hematologist:
| Treatment | Mechanism | Coverage Notes |
|---|---|---|
| Empaveli (pegcetacoplan) | C3 inhibitor | May be preferred by some plans as monotherapy |
| Fabhalta (iptacopan) | Factor B inhibitor | Oral option, may have different PA criteria |
| Optimized C5 inhibitor dosing | Increase dose/frequency | Less costly, may improve EVH |
Exception Request Strategy
If you don't meet standard criteria, your doctor can request a formulary exception by demonstrating:
- Unique clinical circumstances making standard alternatives inappropriate
- Compelling medical necessity for Voydeya specifically
- Supporting literature for off-label or exceptional use
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned with each plan's specific policies.
If Denied: Ohio Appeals Path
Ohio residents have strong appeal rights through the Ohio Department of Insurance external review process.
Level 1: Internal Appeal with BCBS
- Deadline: 60 days from denial notice
- Timeline: 15 business days for standard review, 72 hours if expedited
- How to file: Via member portal, provider portal, or written request
- Required documents:
- Original denial letter
- Updated clinical documentation
- Medical necessity letter addressing each denial reason
Level 2: Peer-to-Peer Review
- Request immediately after denial by calling the number on the denial letter
- Prepare: One-page clinical summary and key supporting evidence
- Duration: Typically 15-30 minutes with plan medical director
- Document: Date, reviewer name, and discussion points
External Review (Ohio Department of Insurance)
- Deadline: 180 days from final internal denial
- Timeline: 30 days for standard review, 72 hours if expedited
- Cost: Free to patients
- Contact: Ohio Department of Insurance at 1-800-686-1526
- Decision: Binding on BCBS if overturned
From our advocates: We've seen strong success rates with Voydeya appeals when the clinical documentation clearly demonstrates ongoing extravascular hemolysis despite optimized C5 inhibitor therapy. The key is connecting lab values to real-world symptoms like fatigue and transfusion needs—this resonates with both plan medical directors and independent review organizations.
Coverage Requirements at a Glance
| Requirement | What It Means | Where to Find It |
|---|---|---|
| Prior Authorization | Required for all BCBS Ohio plans | Anthem Ohio PA lookup |
| Specialty Pharmacy | Must use in-network specialty pharmacy | BCBS member services |
| REMS Enrollment | Prescriber must be REMS-certified | Voydeya REMS program |
| Vaccination Requirement | Current meningococcal, pneumococcal, Hib | FDA label requirements |
| Specialist Prescriber | Hematologist or blood disorder specialist | BCBS policy (verify with plan) |
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn |
|---|---|
| "Not on C5 inhibitor" | Submit eculizumab/ravulizumab prescription records and infusion logs |
| "Insufficient EVH evidence" | Provide serial labs showing persistent anemia and elevated reticulocytes despite C5 therapy |
| "Missing vaccinations" | Submit immunization records or specialist letter documenting medical contraindication |
| "Non-specialist prescriber" | Have hematologist co-sign or transfer prescription |
| "Experimental/investigational" | Cite FDA approval in 2024 and reference clinical trial data |
Costs and Financial Assistance
Voydeya's estimated annual cost ranges from $50,000-$100,000, in addition to ongoing C5 inhibitor therapy costs.
Financial Support Options
- Alexion OneSource: Manufacturer support program - contact information
- Copay assistance: Available for commercially insured patients (verify with the source linked above)
- Foundation grants: Search patient assistance foundations for PNH support
- Medicare Extra Help: For Part D beneficiaries meeting income requirements
Organizations like Counterforce Health can help navigate both coverage approvals and financial assistance programs, ensuring patients access the medications they need while minimizing out-of-pocket costs.
FAQ
How long does BCBS Ohio prior authorization take for Voydeya? Standard PA decisions typically take 7-15 business days. Urgent requests can be processed within 72 hours if delay would seriously jeopardize health.
What if Voydeya is not on my BCBS formulary? You can request a formulary exception by demonstrating medical necessity and failure/intolerance of formulary alternatives. Your hematologist must provide detailed clinical justification.
Can I request an expedited appeal in Ohio? Yes. Both internal appeals and external reviews can be expedited if delay would pose serious health risks. Mark requests as "urgent" and provide clinical justification.
Does step therapy apply if I've failed treatments outside Ohio? Treatment history from other states is generally accepted. Provide complete documentation of prior therapies, doses, durations, and reasons for discontinuation.
What counts as medical necessity for Voydeya? Medical necessity requires confirmed PNH with extravascular hemolysis despite adequate C5 inhibitor therapy, where Voydeya would provide clinical benefit not achievable with formulary alternatives.
Who can prescribe Voydeya in Ohio? Most BCBS plans require prescription by or consultation with a hematologist or blood disorder specialist. Primary care physicians may need specialist co-signature.
Sources & Further Reading
- Voydeya FDA Prescribing Information
- Anthem Ohio Prior Authorization Lookup
- Ohio Department of Insurance Appeals Process
- Voydeya Patient Support Resources
- Ohio External Review FAQs
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and individual circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For assistance with appeals and coverage issues, contact the Ohio Department of Insurance at 1-800-686-1526.
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