By Counterforce Health Team in Cresemba (isavuconazole) —

How to Get Cresemba (isavuconazole) Covered by Humana in North Carolina: Prior Authorization Guide and Appeal Process

Answer Box: Getting Cresemba Covered by Humana in North Carolina

Cresemba (isavuconazole) requires prior authorization from Humana and is typically placed on Tier 4 (Specialty) with higher cost-sharing. To get approval: 1) Confirm your diagnosis of invasive aspergillosis or mucormycosis with culture/biopsy results, 2) Submit Humana's coverage determination form with detailed medical necessity documentation, and 3) If denied, file an appeal within 65 days. North Carolina residents can also request external review through Smart NC if internal appeals fail.

Table of Contents

Humana Plan Types & Coverage Implications

Humana offers several plan types in North Carolina, each with different coverage rules for Cresemba:

Medicare Advantage Plans: These HMO and PPO plans follow Medicare Part B and Part D rules. Cresemba falls under Part D (prescription drug coverage) and requires prior authorization across most Humana Medicare Advantage plans.

Employer Group Plans: Coverage varies by employer contract. Some may have different formulary tiers or utilization management requirements than standard Medicare plans.

Individual/ACA Plans: Less common in North Carolina, but follow commercial insurance rules with potentially different prior authorization criteria.

Note: Humana's PA denial rate for Medicare Advantage averages around 3.5% (2023), among the lowest of major insurers, but denials often stem from incomplete documentation rather than clinical inappropriateness.

Cresemba Formulary Status & Tier Placement

Based on 2024-2025 Humana formularies, Cresemba (isavuconazonium sulfate) is typically covered but placed on Tier 4 (Specialty) with mandatory prior authorization. This means:

  • Higher cost-sharing: 25-33% coinsurance rather than fixed copays
  • Prior authorization required: No coverage without pre-approval
  • Specialty pharmacy requirement: May need to be filled through designated specialty pharmacies

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Must get approval before filling Plan formulary, PA flag Humana PA Resources
Tier 4 Placement 25-33% coinsurance 2025 Drug Guide Humana Formulary
Specialty Pharmacy Limited to network specialty providers Member ID card or customer service Humana Pharmacy Network
Medical Necessity Must meet clinical criteria PA form requirements Coverage determination forms

Prior Authorization Requirements

Humana requires prior authorization for Cresemba across all plan types. The process involves:

Who Can Submit

  • The prescribing physician
  • The patient or authorized representative
  • Pharmacy on behalf of the patient

Required Documentation

Based on Humana's clinical policies and standard antifungal PA requirements:

  1. Confirmed diagnosis of invasive aspergillosis or mucormycosis
  2. Diagnostic evidence: Culture results, histopathology, or imaging
  3. Clinical justification: Why Cresemba is preferred over alternatives
  4. Prior therapy history: What was tried and why it failed

Submission Methods

  • Online: Through Humana's provider portal
  • Fax: Numbers vary by plan type (check member ID card)
  • Phone: Customer service can initiate PA requests
  • Mail: Coverage determination forms to plan address

Medical Necessity Documentation

Strong medical necessity letters significantly improve approval odds. Include these elements:

Diagnosis Requirements

  • Specific diagnosis: "Proven invasive pulmonary aspergillosis" or "probable mucormycosis"
  • ICD-10 codes: B44.0 (invasive aspergillosis), B46.9 (mucormycosis)
  • Site of infection: Pulmonary, sinus, disseminated, CNS

Clinical Evidence

  • Imaging results: CT showing nodules, halo sign, or tissue invasion
  • Microbiology: Positive cultures with species identification
  • Histopathology: Tissue showing hyphal invasion (if biopsy performed)
  • Biomarkers: Galactomannan or beta-D-glucan levels

Treatment Rationale

Document why Cresemba is medically necessary:

  • Voriconazole intolerance: Visual disturbances, hepatotoxicity, QT prolongation
  • Drug interactions: Contraindications with other medications
  • Treatment failure: Prior antifungal ineffective
  • Guideline support: IDSA/ECMM recommendations for first-line therapy
Clinician Corner: Include specific lab values, imaging dates, and culture results. Reference IDSA aspergillosis guidelines or ECMM mucormycosis recommendations to strengthen clinical justification.

Step-by-Step: Fastest Path to Approval

  1. Verify formulary status (Patient/Clinic)
    • Check your specific Humana plan's 2025 formulary
    • Confirm Cresemba tier placement and PA requirement
    • Timeline: 15 minutes
  2. Gather diagnostic documentation (Clinic)
    • Culture results, imaging reports, biopsy findings
    • Prior antifungal therapy records
    • Timeline: 1-2 hours
  3. Complete PA submission (Prescriber)
    • Use Humana's coverage determination form
    • Include comprehensive medical necessity letter
    • Timeline: 30-60 minutes
  4. Submit via fastest channel (Clinic)
    • Electronic portal preferred for tracking
    • Fax for urgent cases with delivery confirmation
    • Timeline: Same day
  5. Follow up on decision (Patient/Clinic)
    • Standard review: 72 hours maximum
    • Expedited review: 24 hours for urgent cases
    • Timeline: 1-3 business days
  6. If approved, coordinate specialty pharmacy (Patient)
    • Transfer prescription to approved specialty provider
    • Set up patient portal and delivery
    • Timeline: 1-2 business days
  7. If denied, file appeal immediately (Patient/Prescriber)
    • Submit redetermination request within 65 days
    • Include additional supporting evidence
    • Timeline: Appeal decision within 7 days

Appeals Process in North Carolina

If Humana denies your Cresemba request, North Carolina offers robust appeal rights:

Internal Appeals (Humana)

  • First Level: Redetermination request
  • Deadline: 65 days from denial notice
  • Decision timeframe: 7 days for Part D appeals
  • Who can file: Patient, representative, or prescriber

External Review (North Carolina)

If internal appeals fail, North Carolina's external review system provides independent oversight:

  • Administered by: Smart NC (NC Department of Insurance)
  • Deadline: 120 days after final internal denial
  • Decision timeframe: 45 days standard, 72 hours expedited
  • Cost: Free to patients
  • Binding: Insurer must comply with favorable decisions

Smart NC Contact Information

From Our Advocates: A North Carolina patient with invasive aspergillosis initially faced denial for Cresemba due to "insufficient documentation of voriconazole failure." After working with Smart NC to compile detailed treatment history and infectious disease consult notes, the external review overturned the denial within 30 days, emphasizing the importance of thorough documentation and state-level advocacy resources.

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
"Not medically necessary" Provide guideline support IDSA/ECMM citations, ID consult
"Step therapy not met" Document voriconazole failure/intolerance Treatment records, toxicity reports
"Diagnosis not confirmed" Submit additional testing Cultures, biopsy, biomarkers
"Alternative available" Clinical comparison Drug interaction tables, contraindications
"Incomplete information" Resubmit with all elements Comprehensive PA packet

Cost-Sharing and Financial Assistance

Expected Costs

  • Tier 4 coinsurance: 25-33% of drug cost
  • Wholesale cost: ~$394/vial IV, ~$1,620/14 capsules
  • Patient responsibility: Varies by deductible and out-of-pocket maximum

Financial Assistance Options

  • Astellas Patient Support: astellasaccess.com
  • Copay assistance programs: For eligible commercial insurance patients
  • Foundation grants: Various rare disease foundations
  • Medicare Extra Help: For qualifying Medicare beneficiaries

Note: This information is educational only. Consult with your healthcare team about treatment costs and insurance coverage.

When to Contact North Carolina Regulators

Contact the North Carolina Department of Insurance if:

  • Humana fails to meet appeal deadlines
  • You're denied external review eligibility
  • There are procedural violations in the review process

NC Department of Insurance

  • Phone: 919-807-6750
  • Website: ncdoi.gov
  • Complaint portal: Online complaint system available

FAQ

How long does Humana prior authorization take for Cresemba in North Carolina? Standard PA decisions: 72 hours maximum. Expedited reviews: 24 hours for urgent cases. Submit complete documentation to avoid delays.

What if Cresemba is not on my Humana formulary? Request a formulary exception using the coverage determination process. Your prescriber must provide medical necessity documentation explaining why covered alternatives are inappropriate.

Can I get expedited review for Cresemba PA? Yes, if your prescriber certifies that delays would seriously jeopardize your health. Expedited reviews receive 24-hour decisions versus 72-hour standard timeframes.

Does North Carolina external review cover Humana denials? Yes, Smart NC handles external reviews for state-regulated plans, including most Humana products. Self-funded employer plans may be excluded unless they opt into the state system.

What happens if I start Cresemba before PA approval? You'll be responsible for full out-of-pocket costs. However, if you have a transition fill eligibility (new to plan or drug became restricted), you may get a 31-day supply while PA is processed.

Can my infectious disease specialist help with the appeal? Absolutely. ID specialists often provide the strongest medical necessity documentation, especially for complex cases involving drug resistance or multiple treatment failures.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeal processes for prescription medications. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that turn insurance denials into approvals. We specialize in high-cost specialty medications like Cresemba, providing the clinical documentation and procedural expertise needed to secure coverage.

Whether you're facing an initial PA requirement or appealing a denial, Counterforce Health can help streamline the process and improve your chances of success through our comprehensive understanding of payer policies and medical necessity requirements.

Sources & Further Reading

Disclaimer: This article provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual circumstances, plan terms, and medical necessity. Always consult with your healthcare provider about treatment options and work directly with your insurance company for coverage determinations. Information about appeals processes reflects general procedures that may vary by plan type and individual circumstances.

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