By Counterforce Health Team in Voydeya (danicopan) —

How to Get Voydeya (Danicopan) Covered by Humana in New Jersey: Coding, Appeals, and Prior Authorization Guide

Answer Box: Getting Voydeya (Danicopan) Covered by Humana in New Jersey

Voydeya (danicopan) requires prior authorization from Humana Medicare Advantage in New Jersey. The fastest path to approval: (1) Ensure proper ICD-10 coding (D59.5 for PNH), (2) Submit complete prior authorization with evidence of extravascular hemolysis despite C5 inhibitor therapy, and (3) Include required vaccination documentation per REMS program. If denied, file Level 1 appeal within 65 days—Humana must respond within 7 days for Part D drug appeals. For urgent cases, request expedited review (24-72 hour decision). Start today: Contact your hematologist to gather flow cytometry results, current lab values, and C5 inhibitor treatment history.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit Paths

Voydeya (danicopan) is an oral complement Factor D inhibitor that always falls under pharmacy benefits (Medicare Part D), not medical benefits (Part B). This distinction is crucial for proper billing and coverage determination.

Key Coverage Requirements:

  • Indication: Add-on therapy to C5 inhibitors (eculizumab or ravulizumab) for extravascular hemolysis in adults with PNH
  • Prescriber: Typically requires hematology specialist or documented consultation
  • REMS Program: Patient must be enrolled with required vaccinations (meningococcal, pneumococcal, Hib)
Note: Unlike infused complement inhibitors that may qualify for Part B coverage, Voydeya's oral self-administration route means it's processed through Part D pharmacy benefits exclusively.

ICD-10 Mapping for PNH and EVH Documentation

Primary Diagnosis Code: D59.5 (Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli])

This single code covers both intravascular and extravascular hemolysis associated with PNH. There's no separate ICD-10 code specifically for EVH—document the clinical distinction in your notes rather than coding.

Supporting Documentation Requirements:

  • Flow cytometry results confirming GPI-anchored protein deficiency
  • Laboratory evidence of hemolysis (LDH, bilirubin, haptoglobin, reticulocyte count)
  • Documentation of inadequate response to C5 inhibitor monotherapy
  • Evidence of ongoing transfusion requirements or symptomatic anemia

Secondary Codes When Applicable:

  • I82.0: Portal vein thrombosis (if present)
  • D61.9: Aplastic anemia (if concurrent bone marrow failure)
  • N18.X: Chronic kidney disease (if PNH-related nephropathy)

Product Coding: HCPCS, NDC, and Units

HCPCS/J-Code: Currently J8499 ("Prescription drug, oral, non-chemotherapeutic, NOS") until a specific code is assigned.

Common NDC Numbers:

  • 25682-043-04: 42 tablet blister pack
  • 25682-043-92: 200 mg dose package (3x/day carton)
  • 25682-046-92: 150 mg dose package (3x/day carton)

Billing Unit Calculation:

  • Standard dosing: 150 mg three times daily = 3 tablets per day
  • 30-day supply = 90 tablets = 90 billing units
  • May increase to 200 mg TID based on response (120 units per 30 days)
Tip: Always verify the NDC matches the actual strength dispensed. Billing errors often occur when the wrong NDC is used for dose adjustments.

Clean Prior Authorization Request

A complete Humana prior authorization should include these elements in order:

Patient Information Section:

  • Member ID and plan details
  • Prescribing physician (hematology specialist preferred)
  • Pharmacy information (specialty pharmacy typically required)

Clinical Documentation:

Diagnosis: Paroxysmal nocturnal hemoglobinuria (ICD-10: D59.5)
Confirmed by: Flow cytometry on [date] showing [specific results]
Current C5 inhibitor: [eculizumab/ravulizumab], dose, frequency
Evidence of EVH: [labs showing persistent anemia, high reticulocytes, transfusion requirements]
Prior therapies tried: [list with dates and outcomes]
Vaccination status: [meningococcal, pneumococcal, Hib - dates]

Medical Necessity Statement: "Patient continues to experience extravascular hemolysis despite optimized C5 inhibitor therapy, as evidenced by [specific lab values]. Voydeya is indicated as add-on therapy per FDA labeling to address C3-mediated EVH."

Counterforce Health helps clinicians create targeted, evidence-backed prior authorization requests by analyzing payer-specific requirements and drafting point-by-point rebuttals aligned to plan policies. Their platform ingests denial letters and clinical notes to identify the exact approval criteria needed.

Common Coding Pitfalls to Avoid

Unit Conversion Errors:

  • ❌ Billing by milligrams instead of tablets
  • ❌ Using wrong NDC for dose strength
  • ✅ Bill each tablet as 1 unit regardless of strength

Mismatched Codes:

  • ❌ Attempting to bill under Part B with provider administration codes
  • ❌ Using investigational drug codes for FDA-approved indication
  • ✅ Use J8499 with appropriate NDC until specific HCPCS assigned

Missing Documentation:

  • ❌ Submitting without flow cytometry confirmation
  • ❌ No evidence of C5 inhibitor background therapy
  • ✅ Include complete diagnostic workup and treatment history

Humana Verification and Resources

Before submitting, verify current requirements:

  1. Check formulary status: Humana Medicare Drug List
  2. Review prior authorization requirements: Access Humana's provider portal for current PA forms
  3. Confirm specialty pharmacy network: Voydeya typically requires specialty dispensing
  4. Verify member eligibility: Ensure Part D coverage includes specialty tier medications
Important: Humana's prior authorization requirements can change annually. Always use the most current forms and criteria for the plan year.

Appeals Process for New Jersey

New Jersey Humana Medicare Advantage appeals follow federal timelines, NOT state IHCAP rules.

Level 1: Redetermination

  • Deadline: 65 days from denial
  • Decision timeline: 7 days (Part D), 30 days (Part C)
  • Submit via: Humana member portal, phone, or mail
  • Required: Denial notice, medical necessity letter, supporting documentation

Level 2: Independent Review Entity (IRE)

  • Deadline: 65 days from Level 1 denial
  • Decision timeline: 30 days
  • Review entity: CMS-contracted IRE (usually Maximus)
  • Success rate: ~50% of external reviews favor the patient

Expedited Appeals

  • When to use: Delay could harm health
  • Timeline: 24 hours (Part D), 72 hours (Part C)
  • Requirement: Physician documentation of urgency
Note: Medicare Advantage plans are NOT subject to New Jersey's IHCAP external review program. You must use the federal appeals process.

Appeals Success Strategies:

  • Include peer-reviewed literature supporting add-on complement inhibition
  • Document specific lab values showing inadequate C5 inhibitor response
  • Emphasize FDA-approved indication and specialist recommendation

For patients who need help navigating complex appeals, Counterforce Health specializes in turning insurance denials into targeted appeals by identifying the specific denial basis and crafting evidence-backed rebuttals.

Pre-Submission Audit Checklist

Before submitting your Voydeya prior authorization:

✅ Diagnosis Confirmation

  • ICD-10 D59.5 documented
  • Flow cytometry results attached
  • PNH diagnosis date clearly stated

✅ Treatment History

  • Current C5 inhibitor documented (drug, dose, duration)
  • Evidence of inadequate response (labs, transfusion records)
  • Previous complement inhibitor trials listed

✅ Safety Requirements

  • REMS enrollment confirmed
  • Vaccination records attached (meningococcal, pneumococcal, Hib)
  • Prescriber credentials verified (hematology specialist)

✅ Coding Accuracy

  • Correct NDC for prescribed strength
  • J8499 HCPCS code used
  • Billing units calculated correctly (tablets, not mg)

✅ Administrative Details

  • Member ID and plan information complete
  • Specialty pharmacy identified
  • Prior authorization form fully completed

FAQ

How long does Humana prior authorization take for Voydeya in New Jersey? Standard prior authorization decisions are made within 14 days. For urgent requests with proper documentation, expedited reviews can be completed within 24-72 hours.

What if Voydeya is non-formulary on my Humana plan? Request a formulary exception by demonstrating medical necessity. Include documentation that formulary alternatives (other complement inhibitors) are inappropriate or have failed.

Can I request a peer-to-peer review with Humana? Yes, if initially denied, your physician can request a peer-to-peer discussion with Humana's medical director. This often resolves clinical questions before formal appeals.

Does step therapy apply if I'm already on a C5 inhibitor? Voydeya is only indicated as add-on therapy, so concurrent C5 inhibitor use is required, not step therapy. Document ongoing EVH despite optimized C5 therapy.

What happens if I miss the 65-day appeal deadline? Contact Humana immediately to request deadline extension due to good cause (illness, hospitalization, etc.). Some exceptions may be granted with proper documentation.

How much will Voydeya cost with Humana Medicare Advantage? As a specialty tier medication, expect 25-40% coinsurance after deductible. Annual out-of-pocket costs vary by plan but may reach several thousand dollars before catastrophic coverage begins.

From our advocates: We've seen many successful Voydeya appeals when clinicians include specific hemoglobin trends and reticulocyte counts showing persistent EVH despite optimized C5 inhibitor therapy. The key is demonstrating that the patient meets FDA labeling criteria with objective lab data, not just clinical symptoms. This composite experience reflects common patterns but doesn't guarantee individual outcomes.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance plan for personalized guidance. For specific questions about New Jersey insurance regulations, contact the NJ Department of Banking and Insurance at 1-800-446-7467.

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