By Counterforce Health Team in Voydeya (danicopan) —

How to Get Voydeya (Danicopan) Covered by Blue Cross Blue Shield in Pennsylvania: Appeals, Alternatives & Exception Paths

Quick Answer: Getting Voydeya Covered by Blue Cross Blue Shield in Pennsylvania

Voydeya (danicopan) is typically not on Pennsylvania Blue Cross formularies as of 2025, requiring a non-formulary exception request. Your fastest path: (1) Have your hematologist submit a prior authorization with documented extravascular hemolysis despite C5 inhibitor therapy, (2) Include vaccination records and REMS compliance, (3) If denied, appeal within 180 days citing medical necessity. Pennsylvania's new external review program overturns about 53% of denials. Start today by calling your Blue Cross member services number to confirm your plan's specialty pharmacy requirements.

Table of Contents

When Formulary Alternatives Make Sense

Since Voydeya (danicopan) is not listed on major Pennsylvania Blue Cross formularies including Capital Blue Cross, Highmark, and Independence Blue Cross, you'll likely face a non-formulary exception process.

Alternatives make sense when:

  • Your insurance requires step therapy before approving Voydeya
  • You need immediate treatment while appealing a Voydeya denial
  • Clinical contraindications exist for add-on complement therapy
  • Cost considerations favor established C5 inhibitors

Key consideration: Voydeya is specifically indicated as an add-on to C5 inhibitor therapy for extravascular hemolysis in PNH patients. It's not meant to replace your current C5 inhibitor but to work alongside it.

Typical PNH Treatment Alternatives

Pennsylvania Blue Cross plans typically cover these PNH therapies with prior authorization:

C5 Inhibitors (First-Line, Covered)

  • Eculizumab (Soliris): IV infusion every 2 weeks, controls intravascular hemolysis
  • Ravulizumab (Ultomiris): IV infusion every 8 weeks, longer-acting C5 inhibitor

Newer Complement Inhibitors

  • Pegcetacoplan (Empaveli): C3 inhibitor, may address both intra- and extravascular hemolysis
  • Iptacopan (Fabhalta): Oral Factor B inhibitor, potential alternative to IV therapies
Note: Coverage for newer agents like Empaveli and Fabhalta varies by plan and may also require exception requests.

Pros and Cons of Each Option

Treatment Formulary Status Administration Coverage Considerations
Soliris (eculizumab) Usually covered IV every 2 weeks Requires specialty pharmacy; established PA criteria
Ultomiris (ravulizumab) Usually covered IV every 8 weeks Less frequent dosing; may be preferred by some plans
Empaveli (pegcetacoplan) Variable Subcutaneous twice weekly May require exception; addresses extravascular hemolysis
Voydeya (danicopan) Not on formulary Oral 3x daily Requires exception; add-on therapy only

Access Considerations

  • Specialty pharmacy requirement: All PNH treatments must be dispensed through plan-designated specialty pharmacies like Accredo for Capital Blue Cross
  • Prior authorization required: All options need clinical documentation and specialist attestation
  • 30-day supply limits: Specialty drugs are limited to monthly fills for safety monitoring

Non-Formulary Exception Strategy

When to Request an Exception

Request a non-formulary exception for Voydeya when you have:

  • Documented extravascular hemolysis despite optimized C5 inhibitor therapy
  • Evidence of persistent anemia, elevated reticulocytes, and transfusion dependence
  • Completed required vaccinations (meningococcal, pneumococcal, Haemophilus influenzae type b)
  • REMS program enrollment documentation

Evidence That Helps Your Case

Clinical Documentation Checklist:

  • Flow cytometry confirming PNH diagnosis with GPI-deficient clone percentage
  • Serial lab values showing persistent anemia (Hb <10-12 g/dL) on C5 inhibitor
  • Elevated reticulocyte count indicating ongoing hemolysis
  • Transfusion records demonstrating continued blood product dependence
  • Indirect hyperbilirubinemia and low haptoglobin levels
  • Specialist (hematologist) attestation letter citing FDA labeling for Voydeya's indication

Switching and Coordination Logistics

Provider Coordination Steps

  1. Confirm current therapy status: Document current C5 inhibitor dose, frequency, and response
  2. Submit comprehensive PA: Use Highmark's Availity Essentials or IBX's PEAR portal
  3. Specialty pharmacy coordination: Contact plan's designated specialty pharmacy for logistics
  4. REMS enrollment: Ensure patient is enrolled in Voydeya REMS program before approval

Patient Action Items

  • Obtain current insurance card and confirm member ID
  • Gather vaccination records for meningococcal, pneumococcal, and Hib vaccines
  • Request copies of recent lab results from your hematologist
  • Keep detailed records of transfusion dates and units received

Re-trying for Voydeya Later

What to Document During Alternative Therapy

If you start with a covered alternative while appealing for Voydeya, document:

  • Treatment response: Serial hemoglobin, LDH, reticulocyte counts every 4-6 weeks
  • Quality of life impacts: Fatigue levels, functional status, work/activity limitations
  • Breakthrough symptoms: Any episodes of hemolysis, dark urine, or complications
  • Transfusion requirements: Dates, units, and clinical circumstances

When to Resubmit

Consider resubmitting a Voydeya request if:

  • Alternative therapy shows inadequate response after 3-6 months
  • New clinical evidence emerges supporting add-on complement inhibition
  • Your plan's formulary changes (typically reviewed annually)
  • Pennsylvania external review precedent strengthens your case

Appeals Playbook for Pennsylvania

Internal Appeals Process

Timeline: Must appeal within 180 days of denial for commercial plans

  1. Level 1 Internal Appeal
    • Submit written request to address on denial letter
    • Include new clinical information and specialist letters
    • Decision timeline: 15 days standard, 72 hours expedited
  2. Level 2 Internal Appeal (if available)
    • Request peer-to-peer review with plan medical director
    • Provide additional evidence and guideline citations

Pennsylvania External Review (New 2024)

If internal appeals fail, Pennsylvania's Independent External Review Program offers significant hope:

  • Success rate: 53% of appeals are overturned in favor of patients
  • Cost: Free to consumers
  • Timeline: 4 months to request after final internal denial; decision within 60 days
  • Scope: Covers medical necessity denials for commercial (non-self-funded) plans

To Request External Review:

  1. Complete insurer's internal appeal process first
  2. Submit request via PA Insurance Department online portal
  3. Include all supporting documentation within 15 days of assignment
  4. Await independent medical reviewer decision (binding on insurer)

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit evidence of extravascular hemolysis Labs showing persistent anemia, reticulocytes, transfusion records
"Not on concomitant C5 inhibitor" Clarify add-on indication Current prescription for Soliris/Ultomiris with dosing
"Missing vaccination requirements" Provide immunization records Meningococcal, pneumococcal, Hib vaccination dates
"Non-specialist prescriber" Transfer to hematologist Specialist referral and attestation letter
"Step therapy not completed" Request exception for contraindications Medical reasons why alternatives are inappropriate

Cost Savings and Support Options

Manufacturer Support

  • Alexion Patient Services: Provides insurance navigation and financial assistance
  • Voydeya Copay Program: May reduce out-of-pocket costs for eligible commercial patients
  • Contact: voydeya.com for current program details

Foundation Assistance

  • Patient Access Network Foundation: Rare disease copay assistance
  • HealthWell Foundation: Specialty drug support programs
  • National Organization for Rare Disorders (NORD): Patient assistance programs
Tip: Apply for foundation assistance while your appeal is pending—approval can take several weeks.

FAQ

How long does Blue Cross Blue Shield PA take in Pennsylvania? Standard prior authorizations are decided within 15 days. Expedited reviews (for urgent cases) are completed within 72 hours. Highmark and IBX both follow these timelines.

What if Voydeya is non-formulary on my plan? Request a non-formulary exception with comprehensive clinical documentation. If denied, appeal through internal processes, then Pennsylvania's external review program, which overturns about 53% of denials.

Can I request an expedited appeal for Voydeya? Yes, if delay would seriously jeopardize your health. Provide documentation that immediate access is medically necessary due to severe ongoing hemolysis or complications.

Does step therapy apply if I've tried other treatments outside Pennsylvania? Medical records from other states should be accepted. Provide comprehensive documentation of prior therapies, outcomes, and reasons for discontinuation.

How do I know if my employer plan is self-funded? Check your Summary Plan Description or ask HR. Self-funded plans are exempt from Pennsylvania's external review process and follow federal ERISA appeal procedures instead.

What's the difference between Voydeya and other PNH treatments? Voydeya is specifically an add-on to C5 inhibitors for patients with extravascular hemolysis. Unlike Empaveli or Fabhalta, it's not intended as monotherapy but works alongside your current C5 inhibitor.

From our advocates: We've seen several Pennsylvania patients successfully appeal Voydeya denials by focusing on the specific add-on indication and providing serial lab values showing inadequate response to C5 inhibitor alone. The key is demonstrating that standard C5 therapy isn't controlling extravascular hemolysis, not that it's completely ineffective. This targeted approach has helped clarify the medical necessity for combination therapy.

At Counterforce Health, we help patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed requests. Our platform analyzes denial letters and plan policies to identify the specific basis for denial, then drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. For complex cases like Voydeya appeals, having the right documentation aligned to your plan's criteria can make the difference between approval and denial.

For additional support with your Voydeya appeal, Counterforce Health can help ensure your request meets Pennsylvania Blue Cross requirements and includes all necessary clinical documentation for the best chance of approval.

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 about treatment decisions and contact your insurance plan directly for current coverage policies. For assistance with appeals in Pennsylvania, contact the Pennsylvania Insurance Department Consumer Services at 1-877-881-6388.

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