How to Get Voydeya (Danicopan) Covered by Humana in Virginia: Prior Authorization Guide with Appeals Process
Quick Answer: Getting Voydeya Covered by Humana in Virginia
Voydeya (danicopan) requires prior authorization from Humana and is typically placed on Tier 5 (specialty) with ~33% coinsurance. The fastest path to approval: (1) Confirm your hematologist has documented PNH via flow cytometry and evidence of extravascular hemolysis despite C5 inhibitor therapy, (2) ensure meningococcal vaccinations are complete and REMS enrollment is documented, and (3) submit the complete PA packet via Humana's provider portal or fax to 1-877-486-2621. If denied, you have 7 days to appeal, and Virginia's external review process provides an independent second opinion within 45 days (72 hours for urgent cases).
Table of Contents
- What This Guide Covers
- Before You Start: Verify Your Coverage
- Gather What You Need
- Submit the Prior Authorization Request
- Follow-Up and Tracking
- Typical Timelines in Virginia
- If You're Asked for More Information
- If Your Request is Denied
- Virginia External Review Process
- Renewal and Re-Authorization
- Cost and Savings Options
- Frequently Asked Questions
What This Guide Covers
This guide helps patients with paroxysmal nocturnal hemoglobinuria (PNH) and their healthcare providers navigate Humana's prior authorization process for Voydeya (danicopan) in Virginia. Voydeya is an oral Factor D inhibitor approved as add-on therapy to C5 inhibitors (eculizumab or ravulizumab) for treating extravascular hemolysis in adults with PNH.
Who this helps:
- PNH patients experiencing extravascular hemolysis despite C5 inhibitor therapy
- Hematologists and specialty clinics managing PNH
- Caregivers navigating insurance appeals
- Specialty pharmacies coordinating coverage
With proper documentation and persistence, many patients successfully obtain coverage. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.
Before You Start: Verify Your Coverage
Confirm Your Plan Type
Check if you have:
- Humana Medicare Advantage (Part C with Part D)
- Humana Medicare Part D standalone
- Humana commercial/employer plan
Why this matters: Voydeya is processed through the pharmacy benefit (Part D), not medical benefit, regardless of your plan type.
Verify Network Status
Ensure your prescribing hematologist is in-network with your Humana plan. Out-of-network providers can still submit prior authorizations, but your cost-sharing will be higher.
Confirm Formulary Placement
Check Humana's drug list to see Voydeya's tier placement. Most specialty medications like Voydeya are placed on Tier 5 (Specialty) with approximately 33% coinsurance after meeting your deductible.
Gather What You Need
Medical Documentation Required
Essential clinical evidence:
- PNH diagnosis confirmation: Flow cytometry results showing GPI-deficient cell populations (ICD-10: D59.5)
- Current C5 inhibitor therapy: Documentation of ongoing eculizumab (Soliris) or ravulizumab (Ultomiris) with dose, frequency, and duration
- Evidence of extravascular hemolysis: Recent labs showing at least one of:
- Hemoglobin ≤9.5 g/dL
- Reticulocyte count ≥120 × 10⁹/L
- Transfusion requirements
- Treatment history: Prior complement inhibitor trials and documented inadequate response
- REMS compliance: Proof of meningococcal (MenACWY and MenB) and pneumococcal vaccinations completed ≥2 weeks before treatment
REMS and Safety Requirements
Voydeya requires enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program. Your prescriber must:
- Be REMS-certified
- Document patient counseling on infection risks
- Provide safety card and emergency contact information
- Confirm vaccination status per CDC guidelines for complement inhibitor therapy
Note: Voydeya cannot be used as monotherapy for PNH—it must be prescribed alongside a C5 inhibitor.
Submit the Prior Authorization Request
Submission Methods
Provider portal: Log into Humana's provider portal (Availity) for electronic submission Fax: Submit to 1-877-486-2621 for medication prior authorizations Phone: Call provider services for urgent requests
Required Forms and Information
Include in your submission packet:
- Completed Humana prior authorization form
- Clinical summary with diagnosis, treatment history, and medical necessity rationale
- Recent laboratory results (hemoglobin, reticulocytes, LDH)
- Flow cytometry report confirming PNH diagnosis
- Documentation of current C5 inhibitor therapy
- Vaccination records and REMS enrollment confirmation
- Insurance card copy and member ID
Medical Necessity Letter Checklist
Your hematologist should address:
- Problem statement: Persistent anemia/transfusion dependence despite optimized C5 inhibition
- Prior treatments: Specific C5 inhibitor used, dose, duration, and clinical response
- Clinical rationale: Why danicopan is medically necessary for this patient
- Monitoring plan: How treatment response will be assessed
- Safety considerations: Vaccination status and infection monitoring protocol
Follow-Up and Tracking
When to Follow Up
- Day 3: Confirm receipt of submission
- Day 10: Check status if no response received
- Day 20: Escalate if approaching deadline
Sample Call Script
"Hi, I'm calling to check the status of a prior authorization request for Voydeya (danicopan) for [patient name], member ID [number]. The request was submitted on [date]. Can you provide the current status and reference number?"
Document: Date, time, representative name, reference numbers, and any additional requirements mentioned.
Typical Timelines in Virginia
Standard Prior Authorization
- Medicare Part D: 72 hours for standard requests
- Commercial plans: Up to 15 business days
- Expedited requests: 24-72 hours with physician certification of urgency
Appeal Timelines
- Level 1 appeal: 7 days for Medicare Part D standard appeals
- Expedited appeals: 72 hours
- Virginia external review: 45 days standard, 72 hours expedited
If You're Asked for More Information
Common Requests
Additional lab work: More recent hemoglobin, reticulocyte counts, or transfusion records Specialist consultation: Confirmation from hematology that patient meets criteria Treatment trial documentation: Detailed records of C5 inhibitor response and duration Vaccination verification: Updated immunization records or REMS compliance documentation
Response Strategy
Respond promptly with requested information. Use this opportunity to strengthen your case by including additional supporting evidence like:
- Peer-reviewed literature on extravascular hemolysis in PNH
- Clinical guidelines supporting combination therapy
- Patient quality of life assessments
If Your Request is Denied
Common Denial Reasons and Solutions
| Denial Reason | Solution |
|---|---|
| Not on C5 inhibitor | Document current eculizumab/ravulizumab therapy |
| No evidence of EVH | Submit recent labs showing anemia, high reticulocytes, or transfusion needs |
| Missing vaccinations | Provide updated immunization records |
| Non-specialist prescriber | Include hematology consultation or referral |
| Incomplete REMS documentation | Submit REMS enrollment confirmation |
Level 1 Appeal Process
Timeline: File within 60 days of denial notice for Medicare plans Required documents:
- Original denial letter
- Additional clinical documentation
- Updated medical necessity letter addressing denial reasons
- Any new supporting literature or guidelines
Submission: Use same methods as initial request (portal, fax, or mail)
Peer-to-Peer Review
Request a peer-to-peer review where your hematologist can discuss the case directly with Humana's medical director. This is often effective for complex rare disease cases.
Virginia External Review Process
If Humana upholds their denial after internal appeals, Virginia offers an independent external review through the State Corporation Commission Bureau of Insurance.
Eligibility and Timeline
- When to file: Within 120 days of final denial
- Required form: Form 216-A (External Review Request)
- Cost: Free to consumers
- Decision timeline: 45 days standard, 72 hours for expedited cases
How to Submit
Contact information:
- Phone: 1-877-310-6560
- Email: [email protected]
- Fax: (804) 371-9915
- Mail: SCC Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
Required Documents
- Form 216-A external review request
- All denial letters from Humana
- Medical records supporting the request
- Insurance card copy
Tip: Contact the Bureau of Insurance before submitting to ensure you have all required documentation.
Renewal and Re-Authorization
When to Resubmit
Most prior authorizations require annual renewal. Calendar renewal 60-90 days before expiration to avoid treatment interruption.
Documentation for Renewal
Include evidence of:
- Continued medical necessity
- Treatment response (hemoglobin improvement, reduced transfusions)
- Ongoing safety monitoring
- Updated vaccination status if required
Cost and Savings Options
Manufacturer Support
Alexion/AstraZeneca offers patient assistance programs. Visit the manufacturer's website or call their patient support line for eligibility requirements.
Copay Assistance
Check for copay cards or foundation grants that may help with out-of-pocket costs for specialty tier medications.
Alternative Funding
Virginia residents may qualify for state pharmaceutical assistance programs or charitable foundations supporting rare disease treatments.
Frequently Asked Questions
How long does Humana prior authorization take in Virginia? Standard requests: 72 hours for Medicare Part D, up to 15 days for commercial plans. Expedited requests: 24-72 hours with physician certification.
What if Voydeya is not on my formulary? Request a formulary exception with clinical documentation showing medical necessity. This follows the same process as prior authorization.
Can I get expedited review if I'm already on C5 inhibitors? Yes, if your physician certifies that delay would seriously jeopardize your health due to ongoing hemolysis and transfusion dependence.
Does step therapy apply to Voydeya? Step therapy may require trying and failing other PNH treatments first, but documented failure of C5 inhibitor monotherapy typically satisfies this requirement.
What happens if my appeal is denied? You can request Virginia external review through the State Corporation Commission, which provides an independent medical review at no cost.
How much will Voydeya cost with Humana coverage? As a Tier 5 specialty drug, expect approximately 33% coinsurance after meeting your deductible. The exact amount depends on your specific plan.
From Our Advocates
"We've seen many PNH patients successfully appeal Voydeya denials by focusing on the documentation of extravascular hemolysis. The key is showing clear evidence that despite optimal C5 inhibitor therapy, the patient continues to experience clinically significant anemia or transfusion dependence. Including recent transfusion records and reticulocyte counts alongside a compelling medical necessity letter from the hematologist often makes the difference in approval."
Counterforce Health specializes in helping patients and providers navigate complex prior authorization processes for specialty medications like Voydeya. Our platform analyzes denial letters, identifies specific coverage criteria, and helps craft targeted appeals that address each payer's unique requirements, turning denials into approvals through evidence-backed advocacy.
Sources and Further Reading
- Humana Prior Authorization Information
- Virginia SCC Bureau of Insurance External Review
- Voydeya Prescribing Information and REMS
- CDC Meningococcal Vaccination Guidelines
- Humana Medicare Part D Drug Lists
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for the most current coverage requirements and medical recommendations. Coverage policies and procedures may change; verify current requirements with your specific plan.
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