By Counterforce Health Team in Voydeya (danicopan) —

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

Answer Box: Getting Voydeya (Danicopan) Covered by Aetna CVS Health in New Jersey

Voydeya (danicopan) is not on Aetna's standard formularies for 2024, requiring a formulary exception request with comprehensive clinical documentation. The fastest path to approval involves: (1) Your hematologist submits a detailed prior authorization form with evidence of extravascular hemolysis despite C5 inhibitor therapy, (2) Include flow cytometry confirming PNH diagnosis and lab values showing inadequate response to eculizumab/ravulizumab alone, (3) If denied, file an internal appeal within 180 days, then pursue New Jersey's binding external review through IHCAP. Start by having your specialist complete Aetna's prior authorization form today.

Table of Contents

Plan Types & Coverage Implications

Understanding your specific Aetna plan type is crucial for accessing Voydeya (danicopan), as referral requirements and network restrictions vary significantly.

HMO Plans: Require a primary care physician (PCP) referral to see a hematologist. You'll need your PCP to coordinate the referral before pursuing Voydeya coverage. All care must stay within Aetna's network.

PPO Plans: Offer the most flexibility—you can see any hematologist (in or out-of-network) without a referral. This is advantageous for rare disease care where specialists may be limited.

EPO Plans: Allow direct access to in-network specialists without referrals, but coverage is limited to network providers only. This gives you specialist access without the PCP bottleneck, provided your hematologist is in-network.

Note: All plan types require prior authorization for specialty drugs like Voydeya, regardless of referral requirements.

Formulary Status & Tier Placement

Voydeya (danicopan) does not appear on Aetna's 2024 formularies, including the Advanced Control, Standard, and Medicare D-SNP plans. This means it's considered non-covered by default and requires a formulary exception request rather than standard prior authorization.

Coverage at a Glance

Requirement Status Action Needed Source
Formulary Listed No Formulary exception required Aetna 2024 Formulary
Prior Authorization Yes Clinical documentation mandatory Aetna PA Forms
Step Therapy Likely Must document C5 inhibitor failure Policy varies by plan
Specialist Required Yes Board-certified hematologist Standard for PNH treatments

Prior Authorization Requirements

Since Voydeya isn't formulary-covered, your hematologist must submit a comprehensive formulary exception with these critical elements:

Required Clinical Documentation

Patient Information:

  • Full name, date of birth, Aetna member ID and group number
  • Complete contact information

Prescriber Details:

  • Board-certified hematologist's name, NPI, DEA number
  • Specialty certification and contact information
  • Provider signature and date

Clinical Evidence:

  • Confirmed PNH diagnosis with flow cytometry results
  • Evidence of extravascular hemolysis while on C5 inhibitor therapy
  • Laboratory values: hemoglobin, reticulocyte count, LDH, bilirubin (with dates)
  • Treatment timeline showing C5 inhibitor therapy (eculizumab or ravulizumab) with doses and duration
  • Documentation of inadequate response to C5 inhibitor monotherapy
  • Medical necessity attestation from hematologist

REMS Program Requirements:

  • Vaccination documentation (meningococcal, pneumococcal, Hib)
  • REMS enrollment confirmation (verify current requirements)

Specialty Pharmacy Setup

Aetna members must use CVS Specialty Pharmacy for Voydeya dispensing. The enrollment process requires coordination between your hematologist and the specialty pharmacy.

Step-by-Step Enrollment Process

  1. Prescriber Enrollment: Your hematologist completes the CVS Specialty enrollment form for danicopan
  2. Prescription Submission: Submit via e-prescribe (NCPDP ID 1466033), fax (1-800-323-2445), or phone (1-800-237-2767)
  3. Insurance Verification: CVS Specialty verifies coverage using BIN code 610502 for Aetna claims
  4. Patient Setup: Complete patient enrollment via CVS Specialty portal or phone
  5. Prior Authorization Processing: CVS Specialty coordinates PA submission with your hematologist
Tip: Expect delays if prior authorization isn't approved before prescription submission. Start the PA process early.

Cost-Share Dynamics

With Voydeya's estimated annual cost of $50,000-$100,000 (plus ongoing C5 inhibitor costs), understanding your plan's cost-sharing structure is essential.

Typical Aetna Specialty Tier Cost-Sharing:

  • Deductible may apply before coverage begins
  • Coinsurance typically 20-40% for specialty tiers
  • Out-of-pocket maximums provide annual protection

Financial Assistance Options:

  • Alexion patient support programs
  • Copay assistance cards (verify eligibility restrictions)
  • State pharmaceutical assistance programs in New Jersey
  • Foundation grants for rare disease patients

Submission Process

Fastest Path to Approval

  1. Gather Documentation (1-2 days): Collect flow cytometry results, recent labs showing EVH, C5 inhibitor treatment records
  2. Complete PA Form (1 day): Your hematologist fills out Aetna's prior authorization form
  3. Submit Request (same day): Via Availity portal, Novologix, or fax to 1-888-267-3277
  4. Track Status (ongoing): Follow up within 48 hours if no acknowledgment received
  5. Provide Additional Info (as needed): Respond to requests within 2 business days
  6. Receive Decision (24-48 hours standard, 72 hours expedited): Review approval or denial letter carefully
  7. Appeal if Denied (within 180 days): Follow New Jersey appeal process outlined below

Appeals Strategy for New Jersey

New Jersey offers one of the nation's strongest external review programs through the Independent Health Care Appeals Program (IHCAP), providing binding decisions that override insurer denials.

Appeal Timeline & Process

Step Deadline Decision Timeline Action Required
Internal Appeal (Level 1) 180 days from denial 30-45 days (72h expedited) Written appeal with clinical rationale
Internal Appeal (Level 2) 60 days from Level 1 denial 30 days Additional documentation if available
External Review (IHCAP) 180 days from final denial 45 days Submit to Maximus Federal Services

Key Contacts:

  • IHCAP Hotline: 1-888-393-1062
  • NJ Department of Banking and Insurance: 1-800-446-7467
  • Aetna Member Services: 1-800-238-6279

Strengthening Your Appeal

For Internal Appeals:

  • Reference specific policy language about medical necessity
  • Include peer-reviewed literature supporting danicopan use in PNH
  • Provide detailed timeline of C5 inhibitor therapy and ongoing symptoms
  • Request peer-to-peer review with a hematologist

For External Review:

  • Emphasize that IHCAP decisions are binding on Aetna
  • Include all previous correspondence and medical records
  • Have your hematologist write a detailed letter addressing the denial rationale

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documentation Needed
"Not medically necessary" Demonstrate EVH despite C5 inhibitor Lab values, transfusion records, symptom diary
"Experimental/investigational" Reference FDA approval and indication FDA label, clinical guidelines
"Not on formulary" Request formulary exception Medical necessity letter, prior failures
"Step therapy required" Document C5 inhibitor inadequacy Treatment timeline, response measurements
"Missing REMS documentation" Provide vaccination records Immunization history, REMS enrollment

When to Escalate

Contact New Jersey regulators if:

  • Aetna misses decision deadlines
  • You're denied access to the appeals process
  • The insurer requests inappropriate documentation
  • You suspect bad faith claim handling

New Jersey Department of Banking and Insurance:

  • Consumer Hotline: 1-800-446-7467
  • Online complaints: nj.gov/dobi

FAQ

How long does Aetna prior authorization take in New Jersey? Standard decisions typically take 24-48 hours for complete submissions. Expedited reviews (when delay would jeopardize health) are completed within 72 hours.

What if Voydeya is denied as non-formulary? Request a formulary exception with detailed medical necessity documentation. If denied, appeal through Aetna's internal process, then pursue external review via IHCAP.

Can I request an expedited appeal? Yes, if your hematologist attests that delay would cause serious harm to your health. Both Aetna's internal appeals and IHCAP offer expedited timelines.

Does step therapy apply if I've tried C5 inhibitors outside New Jersey? Yes, document all prior therapies regardless of where they were prescribed. Include medical records showing treatment failure or inadequate response.

What happens if IHCAP overturns Aetna's denial? The decision is binding—Aetna must provide coverage. This is mandated by New Jersey statute and cannot be appealed by the insurer.

Are there financial assistance programs for Voydeya? Alexion offers patient support programs, and copay assistance may be available. Check eligibility restrictions, as some programs exclude government insurance beneficiaries.

From our advocates: We've seen successful appeals when families compile a comprehensive "treatment timeline" showing exactly how the patient responded to each C5 inhibitor dose adjustment, including specific lab values and quality-of-life impacts. This concrete evidence of ongoing extravascular hemolysis despite optimized therapy often resonates with medical reviewers more than general statements about treatment failure.

Counterforce Health: Streamlining Your Appeal

Counterforce Health helps patients and clinicians turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each payer's specific requirements, pulling the right clinical evidence and regulatory citations to strengthen your case.

For complex cases like Voydeya coverage, where formulary exceptions require extensive documentation, having the right evidence organized and presented according to Aetna's specific criteria can make the difference between approval and denial. We help ensure your appeal addresses every requirement while meeting New Jersey's procedural standards.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For assistance with insurance appeals and coverage issues, contact the New Jersey Department of Banking and Insurance at 1-800-446-7467.

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