By Counterforce Health Team in Voydeya (danicopan) —

How to Get Voydeya (Danicopan) Covered by Aetna CVS Health in California: Complete Appeals Guide

Answer Box: Getting Voydeya Covered by Aetna CVS Health in California

Voydeya (danicopan) requires prior authorization from Aetna CVS Health and must be obtained through CVS Specialty Pharmacy. The fastest path to approval: 1) Have your hematologist submit a comprehensive PA request with PNH diagnosis by flow cytometry, evidence of extravascular hemolysis despite C5 inhibitor therapy, and vaccination documentation. 2) If denied, file an internal appeal within 60 days. 3) If still denied, request California's Independent Medical Review (IMR) through the DMHC for a binding decision within 45 days. Start today: Call your doctor to begin the PA process and ensure all required documentation is ready.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline Requirements
  4. Medical Necessity Criteria
  5. Cost Information
  6. Common Denial Reasons & Solutions
  7. Appeals Process in California
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. FAQ

Coverage Basics

Is Voydeya Covered by Aetna CVS Health?

Voydeya (danicopan) is classified as a specialty medication that requires prior authorization through Aetna CVS Health's utilization management process. The drug is available through CVS Specialty Pharmacy with an "ACS" (Available from CVS Specialty Pharmacy) designation in their formularies.

Coverage varies by plan type:

  • Commercial plans: Typically Tier 3 or 4 specialty tier
  • Medicare Advantage: Higher specialty tier with coinsurance
  • Medicaid managed care: Subject to state-specific criteria

Which Plans Cover Voydeya?

All Aetna CVS Health plans can potentially cover Voydeya, but coverage depends on:

  • Meeting prior authorization criteria
  • Using CVS Specialty Pharmacy for dispensing
  • Obtaining the medication for FDA-approved indications only
Note: Voydeya is approved only as add-on therapy to C5 inhibitors (eculizumab or ravulizumab) for extravascular hemolysis in PNH patients—never as monotherapy.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient + Clinic)
    • Insurance card with member ID
    • PNH diagnosis confirmed by flow cytometry
    • Evidence of extravascular hemolysis on C5 inhibitor therapy
    • Vaccination records (meningococcal, pneumococcal, Hib)
    • Timeline: 1-2 days
  2. Submit PA Request (Prescriber)
    • Online: Availity portal (fastest)
    • Fax: 1-866-249-6155 (pharmacy specialty drugs)
    • Phone: 1-855-240-0535 (8 AM-6 PM CT, Mon-Fri)
    • Timeline: Same day submission possible
  3. Aetna Review Process (Automated)
    • Initial screening for completeness
    • Clinical review by pharmacy team
    • Timeline: 72 hours for standard, 24 hours for urgent
  4. Decision Notification (Aetna to Patient/Provider)
    • Approval: Coverage effective immediately
    • Denial: Written explanation with appeal rights
    • Timeline: Within review timeframe above
  5. If Approved: Specialty Pharmacy Setup (Patient)
    • CVS Specialty Pharmacy contacts patient
    • Coordinate delivery and administration training
    • Timeline: 24-48 hours after approval

Timeline Requirements

Standard Review Times

According to California insurance regulations, Aetna must make coverage determinations within specific timeframes:

  • Standard (Non-Urgent): 72 hours from complete request
  • Expedited/Urgent: 24 hours for exigent circumstances
  • Automatic Approval: If no decision within timeframe, request is deemed approved

When to Request Expedited Review

Request urgent review if the patient has:

  • Severe anemia requiring immediate intervention
  • Active bleeding or hemolytic crisis
  • Hospitalization related to PNH complications
  • Risk of serious adverse health consequences from delay

Medical Necessity Criteria

Coverage Requirements Table

Requirement What It Means Documentation Needed
PNH Diagnosis Confirmed by flow cytometry Lab report showing GPI-deficient cells
C5 Inhibitor Therapy Currently on eculizumab or ravulizumab Prescription history, infusion records
Extravascular Hemolysis Evidence of ongoing EVH despite C5 therapy LDH levels, hemoglobin, reticulocyte count
Specialist Prescriber Hematologist or PNH specialist Provider credentials, NPI verification
Vaccination Status Required immunizations current Vaccination records per REMS program
REMS Enrollment Risk evaluation and mitigation strategy Prescriber and patient enrollment confirmation

Clinician Corner: Medical Necessity Letter Checklist

When preparing your letter of medical necessity, include:

Clinical History:

  • PNH diagnosis date and flow cytometry results
  • Current C5 inhibitor therapy and duration
  • Evidence of breakthrough extravascular hemolysis
  • Transfusion history and frequency
  • Previous treatment failures or intolerances

Laboratory Evidence:

  • Recent LDH levels (elevated despite C5 inhibitor)
  • Hemoglobin trends showing persistent anemia
  • Reticulocyte count indicating ongoing hemolysis
  • Bilirubin levels (indirect)

Treatment Rationale:

  • Why Voydeya is medically necessary as add-on therapy
  • Expected clinical benefits (reduced transfusions, improved hemoglobin)
  • Monitoring plan for safety and efficacy
  • Alternative treatments considered and why unsuitable

Supporting Citations:

Cost Information

Understanding Your Costs

Voydeya's placement in specialty tiers means higher out-of-pocket costs:

Typical Cost-Sharing:

  • Specialty tier copays: $100-500+ per month
  • Coinsurance: 25-40% of drug cost after deductible
  • Annual out-of-pocket maximum applies

Financial Assistance Options:

  1. Manufacturer Support
    • Alexion Access Navigator program
    • Copay assistance for eligible commercial patients
    • Patient assistance programs for uninsured/underinsured
  2. Foundation Grants
    • National Organization for Rare Disorders (NORD)
    • Patient Advocate Foundation
    • HealthWell Foundation
  3. State Programs
    • California's Healthy Families Program
    • Medi-Cal coverage for eligible patients

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Not on C5 inhibitor Provide current prescription records Infusion logs, prescription history
Insufficient EVH evidence Submit comprehensive lab panel LDH, hemoglobin, reticulocyte count over time
Missing vaccinations Update immunization status Current vaccination records per REMS
Non-specialist prescriber Transfer to hematologist Referral to PNH specialist
Experimental/investigational Cite FDA approval FDA label, approval letter
Step therapy not met Document C5 inhibitor trial Treatment history, response data

Scripts for Common Situations

Patient Phone Script for Aetna: "Hello, I'm calling about prior authorization status for Voydeya, danicopan, for my paroxysmal nocturnal hemoglobinuria. My member ID is [number]. Can you tell me the status of my request submitted on [date] and what additional information might be needed?"

Clinic Staff Script for Peer-to-Peer: "I'm requesting a peer-to-peer review for [patient name] regarding Voydeya coverage denial. The patient has confirmed PNH with ongoing extravascular hemolysis despite optimal C5 inhibitor therapy. When can we schedule a clinical discussion with your medical director?"

Appeals Process in California

Internal Appeal (First Level)

Timeline: Must file within 60 days of denial notice Process:

  1. Submit written appeal to address on denial letter
  2. Include all supporting clinical documentation
  3. Request expedited review if medically urgent
  4. Decision deadline: 30 days (standard), 72 hours (urgent)

Required Elements:

  • Copy of original denial letter
  • Updated medical necessity letter
  • New clinical evidence (if available)
  • Patient impact statement

California Independent Medical Review (IMR)

If your internal appeal is denied, California offers a powerful external review process through the Department of Managed Health Care (DMHC).

Eligibility: Denials based on medical necessity, experimental/investigational determinations, or emergency services disputes

How to File:

  • Online: healthhelp.ca.gov
  • Phone: 888-466-2219 (DMHC Help Center)
  • Mail: Submit IMR application with supporting documents

Timeline:

  • Standard IMR: 45 days for decision
  • Expedited IMR: 7 days (often within 72 hours for urgent cases)
  • No cost: California covers all IMR fees

Success Rate: IMR has shown 55-72% success rates for specialty oncology drugs, indicating strong potential for rare disease medications when properly documented.

From our advocates: "We've seen several PNH patients succeed with California IMR appeals by focusing on the clear FDA approval for extravascular hemolysis and providing comprehensive lab trends showing ongoing hemolysis despite C5 inhibitor therapy. The key is demonstrating that Voydeya addresses a specific, measurable medical need that current therapy isn't meeting."

Binding Decision

IMR decisions are legally binding on Aetna CVS Health. If the independent medical experts determine Voydeya is medically necessary, Aetna must authorize coverage and cannot appeal the decision.

Specialty Pharmacy Requirements

Why CVS Specialty Pharmacy?

Voydeya requires special handling due to:

  • REMS program requirements
  • Patient education needs
  • Monitoring for serious infections
  • Coordination with C5 inhibitor therapy

Setting Up Specialty Pharmacy Services

What to Expect:

  1. CVS Specialty contacts you within 24-48 hours of approval
  2. Insurance verification and copay assistance enrollment
  3. Medication counseling and safety education
  4. Scheduled delivery coordination
  5. Ongoing refill management and clinical monitoring

Contact Information:

  • CVS Specialty Pharmacy: Check your approval letter for direct number
  • Patient portal access for refill management
  • 24/7 clinical support for urgent questions

Troubleshooting Common Issues

Portal and System Problems

Availity Portal Down:

  • Use backup fax submission: 1-866-249-6155
  • Call provider line: 1-855-240-0535
  • Submit via paper form if electronic systems unavailable

Missing Forms:

  • Download current PA forms from Aetna provider portal
  • Verify form version matches current year requirements
  • Contact provider services if forms are outdated

Documentation Issues

Incomplete Medical Records:

  • Request comprehensive chart notes from all PNH specialists
  • Obtain complete flow cytometry reports with GPI analysis
  • Gather infusion logs from C5 inhibitor treatments
  • Document all prior therapies and outcomes

Lab Results Missing:

  • Ensure LDH, hemoglobin, and reticulocyte counts are recent (within 30 days)
  • Include trends over time showing persistent hemolysis
  • Add indirect bilirubin and haptoglobin if available

FAQ

How long does Aetna CVS Health prior authorization take in California? Standard reviews must be completed within 72 hours, urgent reviews within 24 hours. If Aetna doesn't respond within these timeframes, the request is automatically approved under California law.

What if Voydeya is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. If denied, the California IMR process can review non-formulary denials when the medication is FDA-approved and medically necessary.

Can I request an expedited appeal in California? Yes, both internal appeals and IMR can be expedited if there's risk of serious adverse health consequences from delay. Expedited internal appeals must be decided within 72 hours, expedited IMR within 7 days.

Does step therapy apply if I've tried treatments outside California? Yes, prior therapy documentation from any state counts toward step therapy requirements. Provide complete treatment records regardless of where care was received.

What happens if my doctor isn't a PNH specialist? Many payers require hematologist or PNH specialist prescribing. If your current doctor isn't specialized, request a referral to a hematologist familiar with PNH treatment.

How do I prove extravascular hemolysis is ongoing? Provide lab trends showing elevated LDH, low hemoglobin, high reticulocyte count, and transfusion requirements despite optimized C5 inhibitor therapy. Include multiple time points to show persistence.

Can I appeal if I'm denied for not having required vaccinations? Update your vaccination status first, then request reconsideration. If vaccinations are contraindicated, provide medical documentation of contraindications and alternative infection prevention measures.

What if my appeal is successful but coverage is still delayed? Contact the DMHC Help Center at 888-466-2219 if Aetna doesn't implement an approved appeal decision promptly. California regulators can intervene to enforce compliance.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for patients, clinicians, and specialty pharmacies. Our platform analyzes denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that align with each payer's specific requirements. For complex cases like Voydeya coverage, we help identify the exact denial basis and draft point-by-point rebuttals using FDA labeling, peer-reviewed studies, and specialty guidelines.

When navigating Aetna CVS Health's prior authorization process, having the right documentation and appeal strategy can make the difference between approval and denial. Counterforce Health helps ensure your submission meets all procedural requirements while tracking deadlines and required attachments, giving patients and providers the best chance for coverage approval.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits and medical circumstances. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For assistance with appeals and coverage issues in California, contact the DMHC Help Center at 888-466-2219.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.