By Counterforce Health Team in Givlaari (givosiran) —

Givlaari (Givosiran) Approval with Humana in Illinois: Complete Guide to Coverage, Appeals, and Costs

Answer Box: Getting Givlaari Covered by Humana in Illinois

Givlaari (givosiran) requires prior authorization for all Humana Medicare Advantage plans in Illinois. Your fastest path to approval: 1) Have your hematologist or hepatologist submit a PA request through the Humana provider portal with documented AHP diagnosis (elevated ALA/PBG levels), ≥2 qualifying attacks in the past 6 months, and evidence of hemin trial/failure. 2) If denied, file an expedited appeal within 65 days for urgent cases (72-hour decision). 3) Illinois residents can request external review within 4 months of final denial through the Illinois Department of Insurance.

First step today: Verify your Humana plan covers specialty drugs and gather your attack history documentation.

Table of Contents

Coverage Basics

Is Givlaari Covered by Humana?

Yes, Givlaari is covered under Humana Medicare Advantage plans, but it requires prior authorization and is typically dispensed through specialty pharmacy. The medication is listed on Humana's 2025 Medicare Prior Authorization List and remains subject to medical necessity review.

Which Humana Plans Cover Givlaari?

  • Medicare Advantage (Part C): Covered with prior authorization
  • Medicare Part D: Covered as a specialty medication
  • Commercial plans: Coverage varies by specific plan design

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans Humana provider portal PA List 2025
Specialty Pharmacy Must use designated pharmacy Humana Specialty Pharmacy Member services
Medical Necessity AHP diagnosis + attack history Clinical documentation Coverage policy
Step Therapy May require hemin trial first Prior therapy records Medical policy

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Clinic)
    • Check Humana ID card for Medicare Advantage confirmation
    • Timeline: Same day
    • Source: Humana member portal
  2. Gather Documentation (Clinic)
    • AHP diagnosis with elevated ALA/PBG levels
    • Attack history (≥2 attacks in past 6 months)
    • Prior hemin use or contraindications
    • Timeline: 1-2 business days
  3. Submit PA Request (Prescriber)
    • Use Humana provider portal (fastest method)
    • Alternative: CoverMyMeds, fax to 502-508-9300
    • Timeline: Same day submission
  4. Track Status (Patient/Clinic)
    • Monitor through provider portal
    • Call member services if needed
    • Timeline: Check within 24-48 hours
  5. Receive Decision (All parties)
    • Standard: 72 hours for most requests
    • Expedited: 24 hours for urgent cases
    • Timeline: Per CMS regulations

Who Submits the Prior Authorization?

Your prescribing physician (hematologist, hepatologist, or neurologist) must submit the PA request. Patients cannot submit directly, but you can:

  • Ask your doctor's office about submission status
  • Call Humana member services to verify receipt
  • Request expedited review if medically urgent

Timing and Deadlines

How Long Does Humana PA Take?

  • Standard requests: 72 hours (3 business days)
  • Expedited requests: 24 hours when urgent medical need is documented
  • Complex cases: Up to 14 days if additional clinical information is needed

What If It's Urgent?

For urgent situations where delaying treatment could seriously harm your health, your prescriber can request expedited review. This requires:

  • Clinical statement explaining medical urgency
  • Documentation that delay risks serious harm
  • Submission through standard PA channels with "expedited" designation

Coverage Criteria

Medical Necessity Requirements

Humana typically approves Givlaari when these criteria are met:

Requirement Documentation Needed
Confirmed AHP Diagnosis Lab confirmation of elevated urine ALA/PBG during symptomatic periods OR genetic testing confirming AHP mutation
Attack History ≥2 documented attacks in past 6 months requiring medical intervention (ER visits, hemin administration, hospitalizations)
Specialist Prescriber Hematologist, hepatologist, neurologist, or physician experienced in AHP management
Prior Therapy Evidence of hemin use, trigger avoidance attempts, or documented contraindications to hemin

What Counts as Step Therapy?

Step therapy may require trying hemin prophylaxis first. You can bypass this requirement with:

  • Hemin failure: ≥1-3 months of prophylactic hemin with continued attacks
  • Contraindications: Documented allergy or severe adverse reactions to hemin
  • Access issues: Inability to receive IV hemin due to vascular access problems
Clinician Corner: When writing medical necessity letters, include specific attack frequency (number per month), severity scores if available, impact on daily functioning, prior hemin doses and outcomes, and current weight for dosing calculations (2.5 mg/kg monthly).

Costs and Financial Assistance

Understanding Your Costs

Givlaari costs vary significantly based on your specific Humana plan:

  • Deductible: Up to $590 maximum for Medicare Part D (2025)
  • Copay/Coinsurance: Typically 25-33% for specialty tier medications
  • Out-of-pocket maximum: $2,000 annual limit for Medicare Part D

Financial Assistance Options

  1. Medicare Prescription Payment Plan: Spread costs monthly (available 2025)
  2. Extra Help: Low-income Medicare beneficiaries may qualify for reduced costs
  3. Alnylam Assist: Patient assistance program (verify Medicare eligibility restrictions)

To check your exact costs, use the Medicare Plan Finder with your Illinois ZIP code and search for Givlaari.

Denials and Appeals

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Insufficient attack history Provide detailed attack logs, ER records Medical records showing ≥2 attacks in 6 months
Missing biochemical confirmation Submit ALA/PBG lab results or genetic testing Lab reports during symptomatic periods
Non-specialist prescriber Transfer to hematologist/hepatologist Specialist consultation notes
Lack of hemin trial Document contraindications or failures Prior therapy records, adverse event notes

Appeals Process for Illinois Residents

Internal Appeals (First Level)

  • Deadline: 65 days from denial notice
  • Timeline: 7 days standard, 72 hours expedited
  • How to file: Call 1-800-451-4651 or submit through member portal
  • Required: Denial letter, supporting clinical documentation

External Review (Illinois-Specific)

Note: Illinois external review decisions are binding on Humana if overturned in your favor.

Renewals and Reauthorization

When to Reauthorize

  • Initial approval: Typically 6 months
  • Renewal: 12 months if showing positive response
  • Required documentation: Attack reduction data, continued medical necessity

What Changes Trigger Reauthorization?

  • Dose adjustments
  • Change in prescriber
  • New insurance plan year
  • Loss of response (increased attack frequency)

Specialty Pharmacy Requirements

Why Was My Prescription Transferred?

Givlaari must be dispensed through Humana's contracted specialty pharmacy network due to:

  • Special handling and storage requirements
  • Patient education and monitoring needs
  • Cost management for high-price medications

What to Expect

  • Delivery: Direct to home or clinic
  • Coordination: Pharmacy contacts you for scheduling
  • Monitoring: Regular check-ins for side effects and response

Troubleshooting Common Issues

Portal Problems

  • Portal down: Call provider services directly at 1-800-457-4708
  • Missing forms: Contact Humana to resend denial letters or PA forms
  • Status unclear: Allow 24-48 hours after submission before following up

Communication Issues

  • No response from clinic: Contact patient advocate or case manager
  • Humana not responding: File complaint with Illinois Department of Insurance: 877-527-9431

Counterforce Health specializes in helping patients navigate complex prior authorization and appeals processes for specialty medications like Givlaari. Their platform can help identify specific denial reasons and draft targeted appeals that address payer requirements point-by-point.

Frequently Asked Questions

How long does Humana PA take in Illinois? Standard prior authorization decisions are made within 72 hours. Expedited requests for urgent medical situations receive decisions within 24 hours.

What if Givlaari is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and that preferred alternatives are ineffective or contraindicated.

Can I request an expedited appeal? Yes, if waiting for a standard decision could seriously harm your health. Your prescriber must provide a supporting statement explaining the medical urgency.

Does step therapy apply if I failed hemin outside Illinois? Yes, prior therapy failures from any location count toward step therapy requirements, as long as documentation is available.

What if I can't afford my copay? Check eligibility for Medicare Extra Help, manufacturer patient assistance programs, or state pharmaceutical assistance programs.

How do I file an external review in Illinois? Download the form from the Illinois Department of Insurance website and submit within 4 months of your final internal appeal denial.

Can I switch Humana plans during open enrollment? Yes, during Medicare Open Enrollment (October 15 - December 7), you can compare plans and switch to one with better Givlaari coverage.

What happens if Humana doesn't respond to my appeal on time? The case automatically escalates to the next level of review. Contact Counterforce Health or Medicare at 1-800-MEDICARE for assistance with escalation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions. Insurance coverage policies change frequently; verify current requirements with Humana and consult official policy documents. For personalized assistance with coverage appeals, consider working with patient advocacy services or legal aid organizations in Illinois.

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