How to Get Voydeya (Danicopan) Covered by Cigna in Washington: Prior Authorization, Appeals & Approval Timeline
Answer Box: Getting Voydeya (Danicopan) Covered by Cigna in Washington
Voydeya (danicopan) is on Cigna's formulary but requires prior authorization for patients with paroxysmal nocturnal hemoglobinuria (PNH). To get approved in Washington:
- Ensure you meet criteria: Must have PNH confirmed by flow cytometry and documented extravascular hemolysis while on a C5 inhibitor (Soliris/Ultomiris) for ≥6 months
- Complete REMS enrollment: Both patient and prescriber must enroll in the Voydeya REMS program and ensure meningococcal vaccination
- Submit PA through Accredo: Your hematologist submits prior authorization with clinical documentation to Cigna's specialty pharmacy partner
If denied, Washington residents have strong appeal rights including external review through an Independent Review Organization (IRO) within 180 days.
Table of Contents
- Plan Types & Network Requirements
- Formulary Status & Tier Placement
- Prior Authorization Requirements
- Specialty Pharmacy Process
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & Solutions
- Appeals Process in Washington
- Cost-Share & Financial Assistance
- FAQ
- Sources & Further Reading
Plan Types & Network Requirements
Your Cigna plan type affects how you access hematology specialists and specialty drugs in Washington:
HMO Plans:
- Require primary care physician (PCP) referral to see a hematologist
- Must use in-network providers only
- Specialty drugs covered only through approved network pharmacies
PPO Plans:
- No referral needed for hematology specialists
- Can see out-of-network providers (higher costs)
- Largest network flexibility for specialty care
EPO Plans:
- No referral required for in-network hematologists
- Must stay in-network (except emergencies)
- Direct specialist access with network restrictions
Tip: Use Cigna's provider directory to verify your hematologist is in-network before starting the PA process.
Formulary Status & Tier Placement
Voydeya (danicopan) is included on Cigna's National Formulary for 2024 as a specialty medication requiring prior authorization. The drug is typically placed on a higher formulary tier due to its:
- High cost (estimated $50,000-$100,000 annually)
- Specialty indication for rare disease (PNH)
- Required combination with C5 inhibitor therapy
- REMS program requirements
Alternative agents on Cigna formularies include:
- Fabhalta (iptacopan) - oral Factor B inhibitor
- Empaveli (pegcetacoplan) - C3 inhibitor
- Soliris (eculizumab) - C5 inhibitor
- Ultomiris (ravulizumab) - C5 inhibitor
Prior Authorization Requirements
Cigna requires documentation of specific clinical criteria before approving Voydeya:
Coverage Requirements
Requirement | Documentation Needed | Source |
---|---|---|
PNH diagnosis | Flow cytometry showing GPI-anchored protein deficiency in ≥2 cell lineages | Cigna PA Policy |
Extravascular hemolysis | Lab evidence: Hemoglobin ≤9.5 g/dL and reticulocyte count ≥120 × 10⁹/L while on C5 inhibitor | FDA Label |
C5 inhibitor therapy | ≥6 months stable dosing of eculizumab or ravulizumab | Cigna PA Policy |
REMS enrollment | Patient and prescriber enrolled in Voydeya REMS program | Voydeya REMS |
Vaccination status | Current meningococcal, pneumococcal, and Hib vaccines | Voydeya REMS |
Clinician Corner: Medical Necessity Letter
Your hematologist's letter should include:
- Problem statement: "Patient has PNH with clinically significant extravascular hemolysis despite 6+ months of optimized C5 inhibitor therapy"
- Prior treatments: Document C5 inhibitor type, duration, dosing, and persistent symptoms
- Clinical rationale: Reference FDA approval for add-on therapy to C5 inhibitors
- Laboratory evidence: Include recent hemoglobin, reticulocyte count, LDH, and bilirubin
- Monitoring plan: Outline safety monitoring per REMS requirements
Specialty Pharmacy Process
Cigna routes Voydeya through Accredo specialty pharmacy, part of the Express Scripts network. The process involves:
- Prescription submission: Hematologist sends prescription to Accredo
- Patient intake: Accredo contacts patient for insurance verification and education
- Prior authorization: Accredo coordinates PA submission with clinical documentation
- REMS compliance: Verification of enrollment and vaccination requirements
- Fulfillment: Direct shipment to patient with clinical support
Contact Accredo directly: 877-826-7657 or through the myCigna portal.
Step-by-Step: Fastest Path to Approval
- Confirm eligibility (Patient): Verify Cigna coverage and hematologist network status
- Complete REMS enrollment (Patient & Prescriber): Enroll at voydeyarems.com and ensure current vaccinations
- Gather documentation (Clinic): Collect flow cytometry, recent labs, C5 inhibitor history, and vaccination records
- Submit PA (Prescriber): Send prescription and clinical documentation to Accredo with PA request
- Track status (Patient): Monitor PA progress through myCigna or by calling Accredo
- Appeal if denied (Patient/Prescriber): Submit internal appeal within 180 days with additional evidence
- Request external review (Patient): If internal appeal fails, file for IRO review within 180 days
Expected timeline: Initial PA decision within 30 days; appeals within 30 days; external review within 15 days (72 hours if expedited).
Common Denial Reasons & Solutions
Denial Reason | Solution | Required Documentation |
---|---|---|
Not on C5 inhibitor | Provide proof of current eculizumab/ravulizumab therapy | Pharmacy records, infusion logs |
Insufficient hemolysis evidence | Submit comprehensive lab panel | Hemoglobin, reticulocytes, LDH, bilirubin |
Missing REMS enrollment | Complete enrollment before resubmission | REMS confirmation letter |
Non-specialist prescriber | Transfer to hematology/oncology | Specialist consultation notes |
Incomplete vaccination | Update immunizations per REMS | Vaccination records |
From our advocates: "We've seen patients get approved after initial denials by ensuring their hematologist includes transfusion history and fatigue scores in the appeal. The combination of objective labs and quality-of-life impact often makes the difference in overturning medical necessity denials."
Appeals Process in Washington
Washington provides robust consumer protections for insurance appeals:
Internal Appeals (Cigna)
- Deadline: 180 days from denial notice
- Timeline: Decision within 30 days
- Submission: Mail, fax, or online through myCigna
- Required: Appeal form, medical records, denial letter
External Review (IRO)
- Eligibility: After internal appeal denial for medical necessity disputes
- Deadline: 180 days from final internal denial
- Timeline: 15 days standard, 72 hours expedited
- Authority: Washington Office of the Insurance Commissioner
- Outcome: Binding decision on insurer
Key advantage: Washington's external review process uses independent medical experts who can override Cigna's medical necessity determinations.
Need help? Contact the Washington OIC Consumer Advocacy line at 1-800-562-6900.
Cost-Share & Financial Assistance
Specialty medications like Voydeya typically involve:
- High deductibles (often $1,000-$8,000 annually)
- Coinsurance of 20-40% after deductible
- Out-of-pocket maximums ($8,050-$18,200 for 2024)
Financial assistance options:
- Alexion Patient Support: Copay assistance and financial counseling through the manufacturer
- Washington State programs: Apple Health (Medicaid) for eligible residents
- Foundation grants: Patient advocate foundations for rare disease medications
Note: Copay assistance programs may not count toward your deductible or out-of-pocket maximum under some plans.
FAQ
How long does Cigna prior authorization take for Voydeya in Washington? Cigna must respond within 30 calendar days for standard PA requests. Expedited reviews (for urgent medical situations) are processed within 72 hours.
What if Voydeya is denied as "not medically necessary"? Submit an internal appeal with additional clinical documentation. If upheld, request external review through Washington's IRO process, which has binding authority over medical necessity determinations.
Can I get an expedited appeal if I'm having breakthrough hemolysis? Yes. Request expedited review if delay could seriously jeopardize your health. Provide documentation of worsening symptoms or lab values.
Does step therapy apply to Voydeya in Washington? Step therapy requirements vary by plan. Some may require trying other PNH medications first, but exceptions are available with clinical justification.
What happens if my hematologist is out-of-network? Coverage depends on your plan type. PPO plans provide out-of-network benefits at higher cost-sharing. HMO/EPO plans typically don't cover out-of-network care except for emergencies.
How do I find the current Cigna formulary for my plan? Check your plan documents or visit Cigna's formulary lookup tool with your plan information.
About Counterforce Health: Counterforce Health helps patients and clinicians turn insurance denials into successful appeals by creating evidence-backed, payer-specific rebuttal letters. The platform analyzes denial reasons and crafts targeted responses using the right clinical citations and procedural requirements for each insurer's workflow.
When navigating complex prior authorizations like Voydeya, having expert support can make the difference between approval and prolonged treatment delays. Counterforce Health's approach aligns clinical evidence with payer policies to improve approval rates and reduce administrative burden on both patients and providers.
Sources & Further Reading
- Cigna Voydeya Prior Authorization Policy (PDF)
- Washington Insurance Appeals Guide (PDF)
- Voydeya REMS Program
- FDA Voydeya Prescribing Information
- Washington Office of the Insurance Commissioner
- Cigna Member Services
- Accredo Specialty Pharmacy
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current information with Cigna, your healthcare provider, and the Washington Office of the Insurance Commissioner. For medical decisions, consult with your hematologist or healthcare team.
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