By Counterforce Health Team in Voydeya (danicopan) —

How to Get Voydeya (Danicopan) Covered by UnitedHealthcare in New York: Complete Guide to Approval and Appeals

Answer Box: Getting Voydeya Covered in New York

Yes, UnitedHealthcare covers Voydeya (danicopan) in New York with prior authorization. The fastest path: 1) Confirm you're on a C5 inhibitor (eculizumab/ravulizumab), 2) Have your doctor submit PA through UnitedHealthcare's provider portal with PNH diagnosis and evidence of extravascular hemolysis, 3) If denied, file internal appeal within 180 days. New York residents have strong external appeal rights through the Department of Financial Services. Voydeya is dispensed exclusively through Onco360 specialty pharmacy, not Optum.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Step Therapy Requirements
  5. Costs and Financial Support
  6. Denials and Appeals
  7. Specialty Pharmacy Requirements
  8. Troubleshooting Common Issues
  9. New York-Specific Rights
  10. Frequently Asked Questions

Coverage Basics

Is Voydeya Covered by UnitedHealthcare?

Voydeya (danicopan) is covered by UnitedHealthcare plans in New York, but requires prior authorization through OptumRx. The drug must be used as add-on therapy to a C5 inhibitor (eculizumab or ravulizumab) for treating extravascular hemolysis in adults with paroxysmal nocturnal hemoglobinuria (PNH).

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans UHC Provider Portal UHC PA Requirements
Step Therapy Must try C5 inhibitor first Plan formulary documents UHC Step Therapy Policy
Specialty Pharmacy Onco360 only Voydeya prescribing info Onco360 Partnership
Diagnosis Required PNH confirmed by flow cytometry Medical records UHC PA Form

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm PNH Diagnosis (Patient/Provider)
    • Flow cytometry results showing PNH clone
    • ICD-10 code documentation
    • Timeline: Same day
  2. Document C5 Inhibitor Use (Provider)
    • Current prescription for eculizumab or ravulizumab
    • Evidence of ongoing extravascular hemolysis despite C5 therapy
    • Timeline: 1-2 days to gather
  3. Submit Prior Authorization (Provider)
    • Use UHC Provider Portal electronic submission
    • Include medical necessity letter and supporting documentation
    • Timeline: 15 minutes online submission
  4. Await Decision (All parties)
    • Standard review: 72 hours for most requests
    • Expedited review: 24 hours if urgent
    • Timeline: 1-3 business days
  5. Obtain Prescription (Patient)
    • Contact Onco360 directly for fulfillment
    • Complete REMS program requirements
    • Timeline: 3-5 business days
Tip: Submit PA requests electronically when possible. UnitedHealthcare's automated PreCheck system can approve requests in seconds if all criteria are clearly met from electronic health records.

Medical Necessity Documentation

Your doctor's prior authorization request should include:

  • PNH diagnosis with flow cytometry results
  • Current C5 inhibitor therapy (drug name, dose, duration)
  • Evidence of extravascular hemolysis (persistent anemia, high reticulocyte count, transfusion requirements)
  • Vaccination status (meningococcal, pneumococcal, Haemophilus influenzae type b)
  • Treatment goals and expected clinical outcomes

Timing and Urgency

Standard Timelines

  • Prior authorization review: 72 hours for standard requests
  • Expedited review: 24 hours for urgent clinical needs
  • Appeal decisions: 30 days for internal appeals, 60 days for external appeals in New York
  • Prescription fulfillment: 3-5 business days through Onco360

When to Request Expedited Review

Request expedited processing if:

  • Patient has severe anemia requiring immediate intervention
  • Transfusion dependence is worsening
  • Current therapy is failing rapidly
  • Clinical deterioration is documented

Step Therapy Requirements

UnitedHealthcare requires step therapy for PNH treatments, meaning patients must try preferred therapies first unless contraindicated.

Required First-Line Therapies

  1. Eculizumab (Soliris) - Must document trial and response
  2. Ravulizumab (Ultomiris) - Alternative first-line option

Exceptions to Step Therapy

Step therapy can be bypassed if:

  • Patient has documented intolerance to C5 inhibitors
  • Medical contraindications exist
  • Previous therapy failed within the last 365 days (with claims history)
  • Urgent clinical need exists
Note: New enrollees without recent claims for C5 inhibitors will typically need to complete step therapy requirements unless exceptions apply.

Costs and Financial Support

UnitedHealthcare Coverage

Voydeya's annual cost ranges from $50,000-$100,000, plus the cost of concurrent C5 inhibitor therapy. Your out-of-pocket costs depend on your specific plan's:

  • Deductible requirements
  • Coinsurance percentages
  • Annual out-of-pocket maximums
  • Specialty drug tier placement

Patient Assistance Programs

Alexion OneSource Program provides:

  • Copay assistance for commercially insured patients
  • Benefits investigation and prior authorization support
  • Clinical education and adherence support
  • Financial counseling services
Important: Government insurance beneficiaries (Medicare, Medicaid) cannot use manufacturer copay assistance programs due to federal regulations.

Counterforce Health helps patients navigate insurance denials and appeals by creating targeted, evidence-backed appeals that align with payer policies. Their platform can significantly improve approval chances by identifying specific denial reasons and crafting point-by-point rebuttals using the right clinical evidence and procedural requirements.

Additional Financial Resources

  • Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA) through Optum Financial
  • State pharmaceutical assistance programs
  • Patient advocacy foundation grants
  • Hospital charity care programs

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Not on C5 inhibitor Provide current prescription Pharmacy records, prescription copy
Insufficient EVH evidence Submit lab values, transfusion records CBC, reticulocyte count, transfusion logs
Missing vaccinations Complete REMS requirements Vaccination records, provider attestation
Non-specialist prescriber Transfer to hematologist Specialist referral, consultation notes

Appeals Playbook for New York

Internal Appeals (UnitedHealthcare)

  1. Timeline: 180 days from denial date
  2. Submission: Online portal, fax, or mail
  3. Required documents:
    • Original denial letter
    • Additional medical evidence
    • Provider letter of support
  4. Decision timeline: 30 days (expedited: 72 hours)

External Appeals (New York DFS)

  1. Eligibility: After completing internal appeals
  2. Timeline: 4 months from final internal denial
  3. Cost: $25 fee (waived for financial hardship)
  4. Submission: NY DFS External Appeal Portal
  5. Success rate: 38-55% overall; higher for rare disease cases with strong documentation
From our advocates: We've seen PNH patients succeed in external appeals by including peer-reviewed studies showing Voydeya's efficacy in reducing transfusion requirements when added to C5 inhibitors. The key is demonstrating that the combination therapy addresses an unmet medical need that C5 inhibition alone cannot meet.

Appeal Script Templates

For calling UnitedHealthcare: "I'm calling to appeal the denial of Voydeya for my PNH. The denial letter dated [DATE] stated [REASON]. I have additional medical evidence showing [SPECIFIC CLINICAL NEED]. Can you help me submit an expedited internal appeal?"

For provider peer-to-peer requests: "I'm requesting a peer-to-peer review for Voydeya approval. My patient has documented extravascular hemolysis despite optimal C5 inhibitor therapy, with [SPECIFIC LAB VALUES]. The combination therapy is medically necessary per FDA labeling and clinical guidelines."

Specialty Pharmacy Requirements

Onco360 Exclusive Distribution

Voydeya is only available through Onco360 specialty pharmacy, not through Optum Specialty Pharmacy or retail pharmacies. This exclusive arrangement is mandated by the manufacturer, Alexion.

Patient Transfer Process

If you currently use Optum Specialty Pharmacy for other medications:

  1. Your doctor must send a new prescription directly to Onco360
  2. Onco360 handles insurance verification and prior authorization coordination
  3. You'll receive onboarding support, clinical education, and delivery coordination
  4. Your other specialty medications can remain with Optum

Onco360 Services Include

  • Benefits investigation and prior authorization support
  • Clinical support and medication education
  • REMS program coordination
  • Home delivery and adherence monitoring
  • 24/7 pharmacist availability

Troubleshooting Common Issues

Portal and System Problems

UnitedHealthcare Provider Portal Issues:

  • Clear browser cache and try different browser
  • Contact provider services: 1-800-842-3211
  • Use alternative submission methods (fax, phone) if portal is down

Missing Forms or Documentation:

  • Download current PA forms from UHC Provider Resources
  • Request patient records from previous providers
  • Obtain lab results directly from testing facilities

Communication Breakdowns

Between Provider and Onco360:

  • Ensure prescription includes all required clinical information
  • Verify correct prescriber DEA and NPI numbers
  • Confirm patient insurance information is current

Between Patient and Insurance:

  • Keep detailed records of all phone calls and reference numbers
  • Request written confirmation of verbal approvals
  • Escalate to supervisor if representatives provide conflicting information

New York-Specific Rights

Strong Consumer Protections

New York provides robust insurance appeal rights through the Department of Financial Services:

  • External appeal right for experimental/investigational denials
  • Expedited appeals for urgent medical needs (72-hour decisions)
  • Binding decisions that insurers must honor
  • Fee refunds if appeals are successful

Additional Resources

Community Health Advocates (CHA)

New York State Department of Financial Services

  • External appeal applications and guidance
  • Consumer complaint portal
  • Insurance company oversight and enforcement

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in New York? Standard PA decisions are issued within 72 hours. Expedited requests for urgent medical needs receive decisions within 24 hours.

What if Voydeya is non-formulary on my plan? Non-formulary drugs can still be covered through medical exception processes. Submit a prior authorization with strong medical necessity documentation.

Can I request an expedited appeal if my initial PA is denied? Yes, if your condition is urgent or rapidly deteriorating, you can request expedited internal and external appeals with shortened timelines.

Does step therapy apply if I've already failed C5 inhibitors outside New York? Previous treatment failures should be documented and typically satisfy step therapy requirements regardless of where the treatment occurred.

How do I know if my UnitedHealthcare plan covers specialty drugs? Check your Summary of Benefits and Coverage (SBC) or call the number on your insurance card. Most UHC plans cover specialty drugs with prior authorization.

What happens if Onco360 can't fill my prescription? Contact your prescriber and UnitedHealthcare immediately. Alternative arrangements may be possible through medical exceptions or temporary supplies.

Are there income limits for Alexion's patient assistance programs? Specific income limits vary by program. Contact Alexion OneSource directly to determine eligibility and available support options.

How often does Voydeya require reauthorization? Most prior authorizations are approved for 12 months, after which renewal requires evidence of continued clinical benefit and safety monitoring.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, payer policies, and clinical notes to create targeted rebuttals backed by the right evidence. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes more effectively. Learn more about their services.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Insurance policies and coverage criteria may change. Verify all information with official sources before making treatment decisions.

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