By Counterforce Health Team in Givlaari (givosiran) —

Do You Qualify for Givlaari (givosiran) Coverage by UnitedHealthcare in Illinois? Decision Tree & Next Steps

Answer Box: Your Fastest Path to Givlaari Coverage in Illinois

Yes, you can get Givlaari (givosiran) covered by UnitedHealthcare in Illinois if you meet specific criteria: age 18+, confirmed acute hepatic porphyria with elevated urinary ALA/PBG levels, and documented attack history (≥2 attacks in past 6 months). UnitedHealthcare requires prior authorization via OptumRx with biochemical confirmation and evidence of hemin trial/failure. First step today: Gather your attack logs, lab results showing elevated ALA/PBG, and genetic testing if available. Submit PA through the UnitedHealthcare provider portal with specialist attestation. If denied, Illinois law guarantees external review within 4 months through the Illinois Department of Insurance.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist & Submission
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternatives & Exception Requests
  6. If Denied: Illinois Appeal Path Chooser
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & How to Fix Them
  9. Illinois External Review Process
  10. Patient Assistance & Cost Support
  11. FAQ

How to Use This Decision Tree

This guide helps you determine if you qualify for Givlaari coverage through UnitedHealthcare in Illinois and shows you the exact steps to take based on your situation. Work through the eligibility questions below, then follow the path that matches your results.

Before you start, gather these documents:

  • Insurance card and member ID
  • Recent lab results (urinary ALA/PBG levels)
  • Attack logs or emergency room visits for porphyria
  • Genetic testing results (if completed)
  • List of previous treatments tried

Eligibility Triage: Do You Qualify?

Work through these questions to determine your qualification level:

Primary Requirements Checklist

✓ Age & Diagnosis

  • Are you 18 years or older?
  • Do you have confirmed acute hepatic porphyria (any subtype)?
  • Do you have ICD-10 code E80.21 (acute intermittent porphyria) or related codes documented?

✓ Biochemical Confirmation

  • Have you had urinary ALA/PBG levels tested within the past year?
  • Were your levels elevated above the upper limit of normal during or after an attack?

✓ Attack History

  • Have you experienced ≥2 documented AHP attacks in the past 6 months?
  • Do you have medical records of these attacks (ER visits, hospitalizations, clinic notes)?

✓ Prior Therapy

  • Have you tried hemin (Panhematin) for acute attacks or prophylaxis?
  • If yes, did it fail to prevent attacks or cause intolerable side effects?
  • Do you have documentation of this trial/failure?

✓ Prescriber Requirements

  • Is your prescriber a specialist (hematologist, hepatologist, or gastroenterologist)?
  • Are they willing to provide medical necessity documentation?

Your Qualification Level:

"Likely Eligible" = Yes to all primary requirements
"Possibly Eligible" = Missing 1-2 requirements but have strong clinical need
"Not Yet" = Missing multiple requirements or no specialist involvement

If "Likely Eligible": Document Checklist & Submission

You meet UnitedHealthcare's core criteria. Here's your submission pathway:

Required Documents for Prior Authorization

Clinical Documentation:

  • Specialist letter confirming AHP diagnosis
  • Lab reports showing elevated urinary ALA/PBG (>upper limit of normal)
  • Attack logs with dates, severity, treatments used
  • Genetic testing results (if available via Alnylam Act program)

Prior Therapy Evidence:

  • Hemin trial documentation with dates, doses, outcomes
  • Records of treatment failures or contraindications
  • Emergency department visits for acute attacks

Prescription Details:

  • Givlaari 2.5 mg/kg monthly subcutaneous injection
  • Site of care plan (clinic administration)
  • Monitoring plan (monthly liver function tests first 6 months)

Submission Process

  1. Submit via UnitedHealthcare Provider Portal
    • Log into UHCprovider.com
    • Use Prior Authorization tool under "Pharmacy Services"
    • Upload all documents as PDFs
  2. Expected Timeline
    • Initial PA decision: 2-3 business days
    • Expedited review available for urgent cases: ≤72 hours
  3. Follow-Up Required
    • Monitor portal for approval/denial notification
    • If approved, coordinate with OptumRx specialty pharmacy for delivery
From our advocates: We've seen cases where patients with clear AHP diagnosis and elevated labs still received initial denials due to incomplete attack documentation. Keep detailed logs of every attack—date, duration, symptoms, treatments used, and outcomes. This documentation often makes the difference between approval and denial.

If "Possibly Eligible": Tests to Request

You may qualify but need additional documentation. Here's what to obtain:

Missing Biochemical Confirmation

  • Request urinary ALA/PBG testing during or immediately after your next attack
  • Free genetic testing available through Alnylam Act program
  • Timeline to re-apply: 30-60 days after obtaining results

Insufficient Attack History

  • Start detailed attack logging immediately
  • Document triggers, symptoms, duration, treatments
  • Consider prophylactic hemin trial if attacks are frequent
  • Timeline to re-apply: 3-6 months of documented attacks

Specialist Requirement

  • Request referral to hematologist, hepatologist, or gastroenterologist
  • Bring all previous records and lab results
  • Timeline to re-apply: 2-4 weeks after specialist evaluation

If "Not Yet": Alternatives & Exception Requests

While building your case for Givlaari, consider these options:

Immediate Alternatives

  • Hemin (Panhematin) for acute attack management
  • Trigger avoidance education and lifestyle modifications
  • Glucose infusions for acute episodes

Building Your Exception Case

  • Document all alternative treatments tried and failed
  • Gather expert opinions from multiple specialists
  • Consider Counterforce Health for complex appeal assistance

Preparing for Future Application

  • Establish care with porphyria specialist
  • Complete comprehensive genetic testing
  • Maintain detailed symptom diary

If Denied: Illinois Appeal Path Chooser

Illinois provides robust appeal rights with specific timelines:

Level 1: Internal Appeal with UnitedHealthcare

Timeline: Must file within 180 days of denial Process:

  • Submit via UnitedHealthcare member portal
  • Include additional clinical evidence
  • Request peer-to-peer review with specialist Decision timeframe: 15 business days (24 hours if expedited)

Level 2: Illinois External Review

Timeline: Must file within 4 months of final internal denial Process:

  • Submit Illinois external review form to Illinois Department of Insurance
  • Independent physician reviewer evaluates case
  • Decision timeframe: 45 days (72 hours if expedited)

Illinois Department of Insurance Contact:

Note: Illinois has a shorter external review deadline (4 months) compared to many states. Don't delay if you receive a final denial.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans UnitedHealthcare provider portal OptumRx PA List
Age Restriction 18+ years FDA label Givlaari prescribing information
Diagnosis Confirmation Elevated ALA/PBG + genetic testing Lab reports Porphyria Foundation testing guidelines
Attack History ≥2 attacks in past 6 months Medical records UnitedHealthcare policy
Specialist Prescriber Hematologist, hepatologist, or gastroenterologist Provider credentials UnitedHealthcare PA requirements
Prior Therapy Hemin trial/failure documented Treatment records FDA label contraindications

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Missing biochemical confirmation Submit elevated ALA/PBG lab results Urinary porphyrin studies during attack
Insufficient attack history Provide detailed attack logs ER records, hospitalization notes
No hemin trial documented Show hemin failure or contraindication Treatment records, adverse reaction notes
Non-specialist prescriber Transfer care to qualified specialist Referral to hematologist/hepatologist
Continuation with hemin Demonstrate hemin inadequacy Attack frequency despite hemin use

Illinois External Review Process

If UnitedHealthcare denies your internal appeal, Illinois law guarantees an independent review:

Eligibility for External Review

  • Completed UnitedHealthcare's internal appeal process
  • Received final adverse benefit determination
  • Filing within 4 months of final denial date

Expedited External Review Available If:

  • Delay would seriously jeopardize life or health
  • Denial involves ongoing treatment for life-threatening condition
  • Request involves experimental/investigational treatment

How to File

  1. Complete Illinois external review form
  2. Attach supporting documents:
    • Copy of UnitedHealthcare's final denial letter
    • Medical records supporting medical necessity
    • Specialist letters explaining need for Givlaari
  3. Submit to Illinois Department of Insurance External Review Unit
    • Fax or mail (contact info on form)
    • Call 877-527-9431 for assistance

What Happens Next

  • IDOI forwards request to UnitedHealthcare (1 business day)
  • UnitedHealthcare confirms eligibility (5 business days)
  • Independent Review Organization assigned (1 business day)
  • Clinical reviewer makes binding decision (45 days maximum)

Patient Assistance & Cost Support

Alnylam Assist Programs

Commercial Copay Program

  • Available for UnitedHealthcare commercial plans
  • May reduce out-of-pocket costs to $0
  • Enroll through Alnylam Assist
  • Call 1-833-256-2748

Patient Assistance Program

  • Free drug for eligible uninsured/underinsured patients
  • Income-based qualification
  • Apply through same Alnylam Assist program

Additional Resources

  • Illinois Attorney General Health Care Helpline: 1-877-305-5145
  • Independent charitable foundations (Alnylam Assist can provide referrals)

For complex appeals involving high-cost specialty medications like Givlaari, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters, plan policies, and clinical notes to create point-by-point rebuttals aligned with payer requirements, significantly improving approval rates for specialty therapies.

FAQ

How long does UnitedHealthcare prior authorization take for Givlaari in Illinois? Standard PA decisions: 2-3 business days. Expedited review for urgent cases: ≤72 hours. Submit through the UnitedHealthcare provider portal.

What if Givlaari is not on my UnitedHealthcare formulary? Givlaari requires prior authorization but has no quantity limits on OptumRx formularies. Non-formulary status may require step therapy documentation or medical exception request.

Can I request an expedited appeal if I'm having frequent attacks? Yes. If delay would seriously jeopardize your health, request expedited internal appeal (24-hour decision) and expedited external review (72-hour decision) in Illinois.

Does step therapy apply if I've tried hemin outside Illinois? Yes. Document all prior hemin trials regardless of location. UnitedHealthcare accepts out-of-state treatment records for step therapy requirements.

What happens if the external review approves my case? The decision is binding on UnitedHealthcare. They must cover Givlaari as directed by the independent reviewer, subject to your plan's cost-sharing terms.

How much does Givlaari cost with UnitedHealthcare coverage? Costs vary by plan. With coverage, you pay deductible/coinsurance. Alnylam's copay program may reduce this to $0 for commercial plans. List price is approximately $575,000 annually.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan. Consult your healthcare provider for medical decisions and contact UnitedHealthcare directly for plan-specific coverage details.

Sources & Further Reading

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