By Counterforce Health Team in Voydeya (danicopan) —

The Requirements Checklist to Get Voydeya (danicopan) Covered by UnitedHealthcare in Ohio: Forms, Appeals, and Success Tips

Answer Box: Getting Voydeya Covered by UnitedHealthcare in Ohio

Who's eligible: Adults with paroxysmal nocturnal hemoglobinuria (PNH) experiencing extravascular hemolysis despite C5 inhibitor therapy (eculizumab/ravulizumab). Fastest path: Submit prior authorization via OptumRx Healthcare Professionals Portal with complete clinical documentation. First step today: Gather flow cytometry results, current C5 inhibitor records, recent labs (hemoglobin, reticulocyte count), and vaccination documentation. If denied, you have 180 days for internal appeals, then external review through Ohio's Department of Insurance.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Checklist
  4. Coding & Documentation Requirements
  5. Submission Process
  6. Specialty Pharmacy Requirements
  7. After Submission: What to Expect
  8. Appeals Process in Ohio
  9. Common Denial Reasons & How to Fix Them
  10. Printable Checklist
  11. FAQ

Who Should Use This Guide

This checklist is designed for patients with PNH and their healthcare teams seeking UnitedHealthcare coverage for Voydeya (danicopan) in Ohio. You'll need this if:

  • You're currently on a C5 inhibitor (Soliris/Ultomiris) but still experiencing breakthrough anemia or transfusion needs
  • Your doctor has recommended adding Voydeya to your current PNH treatment
  • You've received a denial and need to understand the appeal process
  • You're preparing a prior authorization submission

Expected outcome: With complete documentation, most requests are decided within 24 hours. Appeals have varying success rates, but thorough clinical documentation significantly improves approval odds.

Member & Plan Basics

Coverage Requirements

  • Active UnitedHealthcare coverage with pharmacy benefits through OptumRx
  • Prior authorization required for all specialty medications including Voydeya
  • Step therapy applies: Must document C5 inhibitor use first
  • Specialty pharmacy dispensing only through OptumRx-designated facilities
Note: Self-funded employer plans follow federal ERISA rules but often use similar processes. Confirm your plan type by checking your member ID card or calling member services.

Clinical Criteria Checklist

Primary Requirements

✓ Confirmed PNH Diagnosis

  • Flow cytometry results showing GPI-deficient cell percentage
  • ICD-10 code D59.5 documentation

✓ Current C5 Inhibitor Therapy

  • Must be on eculizumab (Soliris) OR ravulizumab (Ultomiris)
  • Document drug name, dose, frequency, and duration
  • Cannot request Voydeya as monotherapy

✓ Evidence of Extravascular Hemolysis (EVH)

  • Hemoglobin ≤9.5 g/dL despite C5 therapy
  • Elevated reticulocyte count (≥120 x 10⁹/L)
  • Transfusion history or ongoing transfusion requirements
  • Supporting labs: LDH, indirect bilirubin, haptoglobin

✓ Safety Requirements

  • Current vaccinations: meningococcal, pneumococcal, Haemophilus influenzae type b
  • REMS program enrollment documentation
  • No contraindications to complement inhibition

Clinical Documentation Standards

Your prescriber's letter of medical necessity should include:

  • Specific flow cytometry percentages and dates
  • Timeline of C5 inhibitor therapy and response
  • Recent laboratory values demonstrating ongoing hemolysis
  • Functional impact of persistent anemia
  • Treatment goals and expected outcomes

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, payer-specific documentation that addresses each plan's unique requirements and denial patterns.

Coding & Documentation Requirements

Essential Codes

  • ICD-10: D59.5 (Paroxysmal nocturnal hemoglobinuria)
  • HCPCS J-codes: Document current C5 inhibitor (J1300 for eculizumab, J1303 for ravulizumab)
  • NDC numbers: Include for all medications when billing

Required Documentation Elements

  • Prescriber attestation on letterhead
  • Flow cytometry report (original lab results)
  • Medication history with dates and outcomes
  • Recent complete blood count and reticulocyte count
  • Vaccination records
  • REMS enrollment confirmation

Submission Process

Step-by-Step Submission

1. Access the Portal Submit via OptumRx Healthcare Professionals Portal or compatible ePA platforms like CoverMyMeds.

2. Complete Required Fields

  • Patient demographics and member ID
  • Prescriber NPI and contact information
  • Diagnosis code (D59.5)
  • Current medications and dosing
  • Clinical justification narrative

3. Attach Supporting Documents

  • Letter of medical necessity
  • Flow cytometry results
  • Recent lab reports
  • Vaccination records
  • Prior medication trial documentation

4. Submit and Track

  • Record confirmation number
  • Note submission date and method
  • Set calendar reminders for follow-up

Urgent Requests

For urgent clinical situations, call 1-800-711-4555 to request expedited review. Document the clinical urgency clearly in your submission.

Specialty Pharmacy Requirements

UnitedHealthcare requires Voydeya to be dispensed through OptumRx-designated specialty pharmacies only. After prior authorization approval:

  1. Prescription routing: Send prescription to assigned specialty pharmacy
  2. Patient enrollment: Specialty pharmacy will contact patient for enrollment
  3. Coordination: Pharmacy verifies authorization before dispensing
  4. Ongoing support: Specialty pharmacy provides adherence monitoring and patient education
Tip: Don't send prescriptions to retail pharmacies—they cannot dispense specialty medications covered under this benefit.

After Submission: What to Expect

Standard Timeline

  • Initial review: Most requests decided within 24 hours of complete submission
  • Electronic approvals: Some qualifying requests approved in under 1 minute through automated systems
  • Additional information requests: 3-5 business days for response

Status Monitoring

  • Check status through provider portal
  • Document all communications with confirmation numbers
  • Save copies of approval letters and any conditions

What to Record

  • Submission confirmation number
  • Review timeline and any deadlines
  • Names of representatives contacted
  • Any additional requirements or conditions

Appeals Process in Ohio

If your initial request is denied, Ohio law provides robust appeal rights through multiple levels.

Internal Appeals (Required First)

Level 1: Reconsideration

Level 2: Formal Appeal

  • Deadline: After reconsideration denial
  • Method: Electronic submission required as of June 2025
  • Documentation: Include all denial letters and additional clinical evidence

External Review (After Internal Appeals)

Ohio residents have the right to independent external review through the Ohio Department of Insurance.

Eligibility Requirements:

  • Completed all internal UnitedHealthcare appeal levels
  • Denial based on medical necessity or experimental treatment
  • Request filed within 180 days of final internal denial

How to Request:

  1. Complete Ohio external review request form
  2. Submit to UnitedHealthcare (they forward to Ohio DOI)
  3. Independent medical experts review your case
  4. Decision is binding on the insurer

Timeline:

  • Standard reviews: 30 days
  • Expedited reviews: 72 hours for urgent cases
Important: Ohio's external review applies to state-regulated plans. Self-funded employer plans may have different processes but often provide similar independent review options.

Getting Help in Ohio

  • Ohio Department of Insurance Consumer Hotline: 1-800-686-1526
  • UHCAN Ohio: Consumer advocacy and navigation assistance
  • OSHIIP: Medicare-specific help for seniors

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Not on C5 inhibitor Provide current therapy records Prescription history, infusion records, pharmacy claims
Insufficient EVH evidence Submit comprehensive lab package Recent CBC, reticulocyte count, LDH, bilirubin, transfusion records
Missing vaccinations Provide vaccination records Current immunization status, dates of required vaccines
Non-specialist prescriber Hematologist consultation Referral letter, specialist attestation, care coordination notes
Incomplete flow cytometry Submit original lab report Full flow cytometry analysis with GPI-deficient cell percentages

When working with Counterforce Health, their platform automatically identifies the specific denial basis and creates targeted rebuttals using the payer's own policy language, significantly improving appeal success rates.

Printable Checklist

Before You Start

□ Active UnitedHealthcare coverage confirmed
□ Member ID and group number available
□ Prescriber NPI and contact information
□ Current C5 inhibitor documentation

Clinical Requirements

□ Flow cytometry results (with percentages)
□ Recent hemoglobin ≤9.5 g/dL
□ Elevated reticulocyte count ≥120 x 10⁹/L
□ Transfusion history documented
□ Current vaccination records
□ REMS enrollment confirmed

Submission Package

□ Prior authorization form completed
□ Letter of medical necessity on letterhead
□ All supporting lab reports attached
□ Prescription with correct dosing
□ Submission confirmation received

After Submission

□ Confirmation number recorded
□ Follow-up date scheduled
□ Appeal deadlines noted (if needed)
□ Specialty pharmacy contact information

FAQ

How long does UnitedHealthcare prior authorization take for Voydeya in Ohio? Most requests are decided within 24 hours of complete submission. Urgent requests can be reviewed within 24 hours by calling 1-800-711-4555.

What if Voydeya isn't on my formulary? Voydeya requires prior authorization regardless of formulary status. Non-formulary medications may have additional requirements but can still be covered with appropriate documentation.

Can I request an expedited appeal in Ohio? Yes, for urgent medical situations where delays could seriously endanger your health. Both UnitedHealthcare and Ohio's external review process offer expedited timelines.

Does step therapy apply if I tried C5 inhibitors in another state? Yes, your medication history travels with you. Provide documentation of previous trials and outcomes regardless of where treatment occurred.

What's the success rate for Voydeya appeals? While specific rates aren't publicly available, Medicare Advantage appeals overall have approximately 82% full or partial overturn rates. Thorough clinical documentation significantly improves odds.

Who can prescribe Voydeya? While any licensed physician can prescribe, payers often prefer specialists familiar with PNH management. Hematologists or PNH specialists typically have higher approval rates.

What if my employer plan is self-funded? Self-funded plans follow federal ERISA rules but often use similar processes. Contact your plan administrator to confirm specific procedures and appeal rights.

How do I find out if my plan covers specialty pharmacy benefits? Check your Summary of Benefits and Coverage (SBC) or call member services. Most UnitedHealthcare plans include specialty pharmacy coverage through OptumRx.

Disclaimer: This guide provides general information about insurance processes and should not replace professional medical or legal advice. Coverage policies vary by plan and individual circumstances. Always verify current requirements with your specific plan and consult healthcare providers for medical decisions.

Sources & Further Reading

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