By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Humana in North Carolina: Complete Appeals Guide with Templates

Answer Box: Getting Givlaari (givosiran) Covered by Humana in North Carolina

Humana requires prior authorization for Givlaari (givosiran) for acute hepatic porphyria. To get approved: (1) Have your specialist document ≥2 attacks in the past 6 months plus elevated ALA/PBG levels, (2) Submit PA through Humana's provider portal with complete clinical documentation, (3) If denied, appeal within 65 days using Medicare Advantage procedures. Start today: Call Humana at the number on your insurance card to confirm PA requirements for your specific plan.

Table of Contents

Humana's Coverage Policy for Givlaari

Humana Medicare Advantage plans require prior authorization for Givlaari (givosiran), a monthly injection that reduces acute hepatic porphyria (AHP) attacks. The medication costs approximately $575,000 annually, making it one of the most expensive specialty drugs on the market.

Plan Types Affected:

  • Medicare Advantage (Parts C and D)
  • Dual Eligible Special Needs Plans (D-SNPs)
  • Medicare Part D Prescription Drug Plans
Note: Medicare Advantage Private Fee-for-Service (PFFS) members may not require PA, but Humana requests notification. Always verify with your specific plan.

Where to Find Your Policy: Use Humana's Prior Authorization Search Tool with your member ID to check current requirements.

Medical Necessity Requirements

Indication Requirements

Givlaari is FDA-approved for adults (≥18 years) with acute hepatic porphyria to reduce attack frequency. All four AHP subtypes qualify:

  • Acute intermittent porphyria (AIP)
  • Variegate porphyria (VP)
  • Hereditary coproporphyria (HCP)
  • ALA-dehydratase deficiency porphyria (ADP)

Required Diagnostics

Biochemical Confirmation:

  • Elevated urinary porphobilinogen (PBG) ≥4x upper limit of normal during attacks
  • Elevated 5'-aminolevulinic acid (ALA) during symptomatic periods
  • Tests must be from within the past 12 months

Genetic Testing:

  • Pathogenic mutation in HMBS, PPOX, CPOX, or ALAD genes
  • Required for definitive subtype identification

Attack History Documentation

Humana typically requires ≥2 documented porphyria attacks in the past 6 months with evidence of:

  • Hospitalization or urgent care visits
  • IV hemin administration
  • Characteristic symptoms (severe abdominal pain, neuropathy, psychiatric symptoms)

Alternative Qualifying Criteria:

  • Current use of prophylactic hemin due to frequent attacks
  • Single severe attack with CNS/PNS complications (seizures, paralysis, respiratory failure)

Specialist Prescriber Requirements

The prescriber must be or have consulted with a specialist experienced in porphyria management:

  • Hepatologist
  • Hematologist
  • Neurologist
  • Gastroenterologist with documented porphyria expertise

Step-by-Step: Fastest Path to Approval

1. Verify PA Requirements (Patient/Clinic)

  • Log into Humana provider portal
  • Search "Givlaari" or "givosiran" with patient's plan information
  • Timeline: Immediate verification

2. Gather Required Documentation (Clinic)

  • ALA/PBG lab results (past 12 months)
  • Genetic testing results
  • Attack history with dates and treatments
  • Current weight for dosing calculations
  • Timeline: 1-3 business days

3. Complete Specialist Evaluation (Patient)

  • Schedule appointment with hepatologist, hematologist, or neurologist
  • Obtain written consultation note supporting Givlaari therapy
  • Timeline: 1-4 weeks depending on availability

4. Submit PA Request (Clinic)

  • Use Humana's electronic PA system for fastest processing
  • Include all documentation in initial submission
  • Timeline: Same day submission possible

5. Humana Review Process

  • Standard decision: Up to 30 days for Medicare Advantage
  • Expedited review: 72 hours if medically urgent
  • Timeline: Variable based on request type

6. Follow Up and Appeal if Needed

  • Check decision via provider portal
  • If denied, file Level 1 appeal within 65 days
  • Timeline: Begin immediately upon denial

7. Coordinate Specialty Pharmacy (If Approved)

  • Humana will direct to preferred specialty pharmacy
  • Complete enrollment and delivery scheduling
  • Timeline: 3-7 business days

Common Denial Reasons & How to Fix Them

Denial Reason Documentation to Include Source
Insufficient attack history Detailed attack log with dates, symptoms, treatments, hospitalizations Clinical criteria examples
Missing biochemical confirmation Recent ALA/PBG levels during symptomatic period; genetic testing results Porphyria diagnostic guidelines
Non-specialist prescriber Consultation note from hepatologist, hematologist, or neurologist Prescriber requirements
Concurrent hemin prophylaxis Attestation that prophylactic hemin will be discontinued Policy restrictions
Inadequate baseline documentation Provider attestation of baseline attack frequency and hemin requirements Documentation requirements

Appeals Process for Humana in North Carolina

Level 1: Internal Appeal

  • Deadline: 65 days from denial notice
  • Method: Humana provider portal, mail, or phone
  • Timeline: 30 days for standard; 72 hours for expedited
  • Required: Denial letter, additional clinical documentation, specialist letter

Level 2: Independent Review Entity (IRE)

  • Automatic: Humana forwards if Level 1 is denied
  • Timeline: 30 days for standard; 72 hours for expedited
  • Process: Independent medical review by CMS-contracted entity

Expedited Appeals

Available when delay would seriously jeopardize health or ability to regain function:

  • Submit expedited request with Level 1 appeal
  • Physician attestation of urgency required
  • Decision within 72 hours

Script for Requesting Expedited Review: "My patient has acute hepatic porphyria with frequent attacks requiring hospitalization. Delay in starting Givlaari therapy poses serious risk of life-threatening complications including respiratory paralysis and seizures. I request expedited review based on medical urgency."

When North Carolina External Review Doesn't Apply

Important: North Carolina's Smart NC external review program does not apply to Medicare Advantage plans like Humana. Medicare Advantage appeals are governed by federal CMS regulations, not state insurance laws.

For Humana Medicare Advantage denials:

  • Follow CMS Medicare appeals process through IRE
  • Contact Medicare at 1-800-MEDICARE for guidance
  • Consider Medicare Ombudsman if appeals are unsuccessful

Smart NC applies only to:

  • Fully insured commercial plans
  • NC State Health Plan
  • Individual market plans

If you have a fully insured Humana commercial plan (not Medicare), you may be eligible for North Carolina's external review after exhausting internal appeals.

Cost Support and Patient Assistance

Alnylam Assist Program

  • Copay assistance for eligible patients
  • Free drug program for uninsured patients meeting income requirements
  • Case management support
  • Contact: alnylamassist.com or 1-833-256-9526

Foundation Assistance

  • Patient Advocate Foundation
  • Good Days (formerly Chronic Disease Fund)
  • HealthWell Foundation
  • Eligibility: Varies by foundation; typically income-based
Tip: Apply for manufacturer assistance before starting therapy. Processing can take 2-4 weeks, and retroactive coverage may not be available.

Clinician Corner: Medical Necessity Letter

Essential Components for Humana PA

Patient Information:

  • Demographics, Humana member ID, plan type
  • Current weight (for 2.5 mg/kg dosing calculation)

Diagnosis Documentation:

  • Specific AHP subtype with ICD-10 code
  • Biochemical confirmation (ALA/PBG levels with dates)
  • Genetic testing results if available

Clinical History:

  • Detailed attack frequency (past 6-12 months)
  • Previous treatments including hemin use
  • Hospitalizations and emergency department visits
  • Impact on functional status and quality of life

Treatment Rationale:

  • Why Givlaari is medically necessary
  • Contraindications to alternative therapies
  • Expected clinical outcomes

Monitoring Plan:

  • Hepatic function monitoring
  • Renal function assessment
  • Attack frequency tracking

Supporting Evidence to Cite

Include references to:

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps clinicians draft point-by-point rebuttals aligned to payer policies, pulling the right citations and weaving them into appeals with required clinical facts. For complex cases like Givlaari denials, Counterforce Health can streamline the appeals process and improve approval rates.

FAQ

How long does Humana's prior authorization take for Givlaari? Standard PA decisions take up to 30 days for Medicare Advantage plans. Expedited reviews are completed within 72 hours when medical urgency is documented. Electronic submissions through the provider portal typically process faster than fax or mail.

What if Givlaari is non-formulary on my Humana plan? Non-formulary drugs can still be covered through the formulary exception process. Your doctor must demonstrate medical necessity and that formulary alternatives are inappropriate. The same clinical criteria apply.

Can I request an expedited appeal if Humana denies Givlaari? Yes, if delay would seriously jeopardize your health. Your physician must attest to the medical urgency. Common qualifying situations include frequent hospitalizations for acute attacks or progressive neurological complications.

Does step therapy apply to Givlaari? Most Humana policies require documentation of previous treatments (typically hemin) but don't mandate specific step therapy protocols. Having tried and failed other therapies strengthens your case but isn't always required.

What happens if I'm currently on prophylactic hemin? You must discontinue prophylactic hemin when starting Givlaari, as concurrent use is not approved. Document your current hemin regimen as evidence of disease severity, but plan to transition to Givlaari monotherapy.

How do I find a porphyria specialist in North Carolina? Contact the American Porphyria Foundation for specialist referrals, or ask your primary care physician for referrals to hepatology, hematology, or neurology practices with porphyria experience.

What if my appeal is denied at all levels? Consider working with patient advocacy organizations or legal counsel experienced in Medicare appeals. Counterforce Health also provides specialized support for complex specialty drug appeals, helping patients navigate the appeals process with targeted, evidence-based strategies.

Can I get Givlaari covered if I live in North Carolina but have insurance from another state? Coverage depends on your specific insurance policy, not your residence. Follow the appeals procedures for your insurance company. North Carolina's external review process only applies to state-regulated plans.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your insurance company and consult healthcare professionals for medical decisions. For personalized assistance with insurance appeals, consider contacting patient advocacy organizations or specialists in healthcare coverage like Counterforce Health.

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