By Counterforce Health Team in Voydeya (danicopan) —

Blue Cross Blue Shield Texas Coverage Criteria for Voydeya (Danicopan): What Counts as "Medically Necessary"?

Answer Box: Getting Voydeya Covered by Blue Cross Blue Shield Texas

Blue Cross Blue Shield of Texas (BCBSTX) requires prior authorization for Voydeya (danicopan) with specific medical necessity criteria: confirmed PNH diagnosis by flow cytometry, documented extravascular hemolysis on stable C5 inhibitor therapy (≥6 months), and completed vaccinations against encapsulated bacteria. Submit PA through your plan's pharmacy benefit portal with lab results, vaccination records, and specialist documentation. If denied, you have 180 days to file an internal appeal, followed by external review through Texas Department of Insurance within 4 months.

First step today: Check your plan's formulary at bcbstx.com and contact the pharmacy benefit number on your ID card for current PA criteria.

Table of Contents

  1. Policy Overview
  2. Indication Requirements
  3. Step Therapy & Exceptions
  4. Required Diagnostics
  5. REMS & Vaccination Requirements
  6. Specialty Pharmacy Requirements
  7. Evidence to Support Medical Necessity
  8. Appeals Process in Texas
  9. Common Denial Reasons & Solutions
  10. Quick Reference Checklist
  11. FAQ

Policy Overview

Blue Cross Blue Shield of Texas, as part of Health Care Service Corporation (HCSC), does not publish a specific 2024 medical policy for Voydeya. Instead, coverage is governed through the pharmacy benefit with plan-specific formulary requirements and general prior authorization processes.

Plan Types Affected:

  • Fully insured commercial plans (individual, small group, large group)
  • Some Administrative Services Only (ASO) groups
  • Texas Department of Insurance regulated products

Where to Find Current Criteria: Since Voydeya is an oral medication, check your specific plan's drug formulary rather than medical PA code lists. Use the BCBSTX provider portal or call the pharmacy benefit number on your member ID card.

Note: Self-funded ERISA plans may have different requirements and appeal processes than state-regulated Texas plans.

Indication Requirements

Voydeya has a narrow FDA-approved indication that forms the foundation of medical necessity criteria:

FDA-Approved Use:

  • Add-on to C5 inhibitor (eculizumab or ravulizumab)
  • Treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH)
  • Not approved as monotherapy for PNH

Key Clinical Elements:

  • Patient must be ≥18 years old
  • Confirmed PNH diagnosis
  • Currently receiving stable C5 inhibitor therapy
  • Evidence of clinically significant EVH despite C5 blockade

Most payers require documentation that Voydeya will be used exactly as FDA-labeled—any deviation typically requires additional justification and may face coverage challenges.

Step Therapy & Exceptions

While BCBSTX hasn't published specific step therapy requirements for Voydeya, common payer patterns suggest these likely criteria:

Typical Step Therapy Requirements:

  1. Stable C5 inhibitor therapy for ≥6 months (eculizumab or ravulizumab)
  2. Optimized dosing of current C5 inhibitor
  3. Documentation of persistent EVH despite adequate C5 blockade

Medical Exception Pathways: Texas law provides step therapy protections when:

  • Required step drug will likely cause adverse reaction
  • Expected to be ineffective based on clinical characteristics
  • Patient previously tried and failed the required drug
  • Delay would cause irreparable harm

Exception Timeline: BCBSTX must respond to step therapy exceptions within 72 hours for standard requests, 24 hours for urgent cases.

Required Diagnostics

Medical necessity documentation typically requires specific laboratory and diagnostic evidence:

PNH Diagnosis Documentation

Flow Cytometry Requirements:

  • High-sensitivity flow cytometry showing GPI-deficient cells
  • Clone size typically ≥5% in granulocytes or monocytes
  • Documentation of ≥2 cell lineages affected
  • Must include FLAER-based analysis for white blood cells

Clinical Laboratory Evidence:

  • Recent hemoglobin ≤9.5-10 g/dL
  • Absolute reticulocyte count ≥120 × 10^9/L or >2.5%
  • LDH elevation (supporting hemolysis)
  • Transfusion history if applicable

C5 Inhibitor Documentation

Required Elements:

  • Current drug name, dose, and frequency
  • Duration on stable regimen (≥6 months documentation)
  • Evidence of appropriate dosing per FDA labeling
  • Prior dose optimizations or interval adjustments
Tip: Include a timeline showing C5 inhibitor therapy duration and any dose changes to demonstrate stability.

REMS & Vaccination Requirements

Voydeya has an FDA Risk Evaluation and Mitigation Strategy (REMS) program focused on infection prevention that affects coverage approval:

Required Vaccinations (≥2 weeks before first dose):

  • Meningococcal: All serogroups A, C, W, Y, and B
  • Pneumococcal: Per ACIP recommendations for complement inhibitor patients
  • Haemophilus influenzae type b: If not previously vaccinated

Documentation Requirements:

  • Vaccine names, dates, and lot numbers
  • Confirmation of ACIP-compliant scheduling
  • If vaccines given <2 weeks before start: antibacterial prophylaxis plan

REMS Compliance:

  • Prescriber must be REMS-certified
  • Pharmacy must verify vaccination status before dispensing
  • Patient counseling documentation required

Counterforce Health helps patients and providers navigate these complex REMS requirements by organizing vaccination records and ensuring proper documentation for insurance submissions.

Specialty Pharmacy Requirements

Most BCBSTX plans require Voydeya to be dispensed through contracted specialty pharmacies:

Typical Requirements:

  • Use of plan-approved specialty pharmacy network
  • Prior authorization approval before shipping
  • Coordination with REMS-certified pharmacy
  • Home delivery or infusion center shipping

Out-of-Network Considerations: Using non-contracted specialty pharmacies typically results in denial unless a network adequacy exception is granted. Document if preferred pharmacy is not REMS-certified or cannot provide required services.

Evidence to Support Medical Necessity

Strong medical necessity letters should reference established guidelines and peer-reviewed evidence:

Key References to Include:

  • FDA prescribing information for indication-specific use
  • Clinical trial data showing efficacy in EVH reduction
  • Hematology society guidelines on PNH management
  • Published literature on complement inhibition strategies

Clinical Rationale Framework:

  1. Problem: Persistent EVH despite optimized C5 therapy
  2. Prior treatments: Document C5 inhibitor optimization attempts
  3. Clinical impact: Transfusion requirements, quality of life, hemolysis markers
  4. Rationale: Why Voydeya's Factor D inhibition addresses unmet need
  5. Monitoring plan: Lab follow-up and safety assessments

Appeals Process in Texas

Texas provides robust appeal rights for insurance denials through a two-step process:

Internal Appeal (Required First Step)

Timeline: 180 days from denial to file internal appeal Decision deadline: 30 days for pre-service requests Required elements:

  • Written appeal with denial letter
  • Medical records and clinical documentation
  • Physician letter of medical necessity
  • Supporting literature and guidelines

External Review (Independent Review Organization)

Eligibility: Medical necessity, appropriateness, or experimental/investigational denials Timeline: 4 months from final internal denial to request external review Process: Submit TDI Form LHL009 to BCBSTX Decision timeline: 20 days for standard, 5 days for urgent cases

Cost: Insurer pays IRO fees for commercial plans

Important: Self-funded ERISA plans follow federal appeals processes, not Texas IRO procedures.

For assistance with appeals, contact:

  • Texas Department of Insurance: 1-800-252-3439
  • Office of Public Insurance Counsel: 1-877-611-6742

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Required Documentation
Not on formulary Request formulary exception Medical necessity letter, clinical trial data
Missing PA Submit complete prior authorization All required clinical elements
Insufficient EVH documentation Provide recent labs Hemoglobin, reticulocyte count, transfusion records
REMS non-compliance Complete vaccination requirements Vaccine records, REMS certification
Step therapy required Request medical exception Prior C5 therapy documentation, failure evidence
Experimental/investigational Cite FDA approval FDA labeling, published efficacy data

Quick Reference Checklist

Before Submitting PA:

  • Confirmed PNH diagnosis by flow cytometry (≥5% clone)
  • Stable C5 inhibitor ≥6 months with dosing details
  • Recent labs: Hgb ≤10 g/dL, reticulocyte count ≥120 × 10^9/L
  • Complete vaccination records (meningococcal, pneumococcal, Hib)
  • REMS prescriber certification
  • Medical necessity letter with guideline citations
  • Transfusion history (if applicable)
  • Specialty pharmacy coordination

For Appeals:

  • Original denial letter and EOB
  • All clinical documentation from PA
  • Updated physician letter addressing denial reasons
  • Published literature supporting use
  • Timeline showing urgency (if expedited)

FAQ

How long does BCBSTX prior authorization take? Standard PA decisions are typically made within 15 business days. Expedited reviews for urgent cases may be completed in 72 hours or less.

What if Voydeya is not on my formulary? You can request a formulary exception through the prior authorization process. Include medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I appeal if my plan is through my employer? Yes, but self-funded ERISA plans follow federal appeal procedures rather than Texas IRO processes. Check with your HR department about your specific plan type.

Do I need a hematologist to prescribe Voydeya? While not always required, specialist involvement strengthens PA requests. Many payers prefer or require hematology consultation for PNH treatments.

What happens if I start Voydeya before PA approval? Claims will likely be denied. Always obtain prior authorization before starting therapy unless it's a true emergency situation.

How often do I need to renew authorization? Most plans require annual reauthorization with documentation of continued benefit and ongoing combination with C5 inhibitor therapy.

This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change over time. Always verify current requirements with your specific insurance plan and consult healthcare providers for medical decisions.

Need help with complex prior authorization appeals? Counterforce Health specializes in turning insurance denials into successful approvals by crafting evidence-backed appeals that align with each plan's specific criteria and Texas appeal procedures.

Sources & Further Reading

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