By Counterforce Health Team in Givlaari (givosiran) —

Do You Qualify for Givlaari (givosiran) Coverage by Humana in New Jersey? Decision Tree & Next Steps

Answer Box: Getting Givlaari Covered by Humana in New Jersey

Most likely to qualify: Adults with confirmed acute hepatic porphyria (AHP) who've had 2+ attacks in 6 months, elevated ALA/PBG levels, and a hematologist/hepatologist prescriber. Fastest path: Submit prior authorization with attack history, lab results, and specialist documentation. First step today: Call your specialist to gather attack records and request ALA/PBG testing if not recent. Humana decides within 72 hours for standard requests, 24 hours for urgent cases.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible" - Document Checklist
  4. If "Possibly Eligible" - Tests to Request
  5. If "Not Yet" - Alternative Options
  6. If Denied - Appeal Path Chooser
  7. New Jersey External Review Process
  8. Coverage Requirements at a Glance
  9. Common Denial Reasons & How to Fix Them
  10. Frequently Asked Questions

How to Use This Decision Tree

This guide walks you through Humana's specific requirements for Givlaari (givosiran) coverage in New Jersey, helping you determine your likelihood of approval before submitting a prior authorization request.

Start here: Work through the eligibility triage below to understand where you stand. Each section provides specific next steps based on your situation, whether you're likely to be approved, need additional testing, or should prepare for an appeal process.

Note: Givlaari requires prior authorization for all Humana Medicare Advantage plans in 2024. The drug is not typically on standard formularies due to its specialized use for acute hepatic porphyria.

Eligibility Triage: Do You Qualify?

✅ Likely Eligible if you have ALL of these:

  • Confirmed AHP diagnosis (acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, or ALAD-deficiency porphyria)
  • Recent attack history: 2+ documented porphyria attacks in the past 6 months requiring medical intervention
  • Laboratory confirmation: Elevated urine ALA and PBG levels during symptomatic periods
  • Specialist prescriber: Hematologist, hepatologist, or neurologist managing your care
  • Prior therapy documentation: Records of hemin use, trigger avoidance, or other treatments

⚠️ Possibly Eligible if you have SOME of these:

  • Clinical AHP diagnosis but missing recent lab confirmation
  • Attack history but fewer than 2 documented episodes in 6 months
  • Primary care management without specialist involvement
  • Incomplete documentation of prior therapies or treatment failures

❌ Not Yet Eligible if you have:

  • No confirmed AHP diagnosis or only suspected based on symptoms
  • No recent attacks (none in past 6-12 months)
  • Active liver transplant planning or severe hepatic impairment
  • Primary prescriber who isn't a specialist in hematology, hepatology, or neurology

If "Likely Eligible" - Document Checklist

You're in the strongest position for approval. Gather these documents before submitting your prior authorization:

Required Clinical Documentation

1. Specialist Consultation Notes

  • Hematologist or hepatologist evaluation confirming AHP diagnosis
  • ICD-10 codes (E80.20 for unspecified porphyria, or specific subtypes)
  • Treatment plan and monitoring schedule

2. Attack History Records

  • Dates and details of each attack in past 6 months
  • Emergency department visits or hospitalizations
  • Treatments received (IV hemin, pain management, supportive care)
  • Impact on daily functioning and quality of life

3. Laboratory Results

  • Elevated ALA (aminolevulinic acid) levels during attacks
  • Elevated PBG (porphobilinogen) levels during attacks
  • Genetic testing results if available
  • Recent liver and kidney function tests

4. Prior Therapy Documentation

  • Hemin treatment records and response
  • Other medications tried and reasons for discontinuation
  • Trigger avoidance measures attempted

Submission Process

Submit via: Humana provider portal or contact Clinical Pharmacy Review at 800-555-2546

Timeline: Standard decisions within 72 hours; expedited reviews within 24 hours if medically urgent

Required forms: Use Humana's standard prior authorization form with all supporting clinical documentation attached

If "Possibly Eligible" - Tests to Request

You may qualify but need additional documentation. Work with your healthcare team to obtain:

Missing Laboratory Confirmation

  • Request ALA/PBG testing during your next symptomatic episode
  • Proper sample handling: Urine samples must be protected from light and kept refrigerated
  • Recommended labs: UTMB, Mayo Clinic, or ARUP laboratories for specialized porphyria testing

Specialist Referral

  • Get referred to a hematologist or hepatologist familiar with porphyria
  • Bring all records of previous attacks and treatments
  • Document treatment failures if you've tried hemin or other therapies

Attack Documentation

  • Keep detailed records of future episodes including dates, symptoms, treatments
  • Seek medical attention for attacks to create official documentation
  • Consider expedited review if you have frequent, severe attacks while gathering documentation

Timeline to reapply: 1-3 months after obtaining missing documentation

If "Not Yet" - Alternative Options

If you don't currently meet standard criteria, consider these approaches:

Exception Request Process

  • Medical necessity exception for patients with atypical presentations
  • Step therapy exception if standard treatments are contraindicated
  • Non-formulary coverage request with detailed clinical justification

Alternative Treatments to Document

  • Hemin therapy (Panhematin) for acute attacks
  • Symptom management medications and their limitations
  • Lifestyle modifications and trigger avoidance measures

Building Your Case

  • Maintain attack diary with dates, triggers, and severity
  • Document treatment failures and side effects from alternatives
  • Get genetic testing if not already completed to confirm AHP subtype

When you've established a clearer pattern of attacks and treatment needs, you can resubmit for coverage consideration.

If Denied - Appeal Path Chooser

Humana denials can be overturned through several appeal levels. Choose your path based on urgency and complexity:

Level 1: Internal Appeal (Redetermination)

Best for: Standard denials with clear documentation gaps

  • Timeline: 7 days for prescription drug appeals
  • How to file: Humana member services or provider portal
  • Required: Written appeal letter addressing denial reasons
  • Success tip: Include any missing clinical documentation

Level 2: Peer-to-Peer Review

Best for: Clinical disagreements about medical necessity

  • Timeline: Usually scheduled within 1-3 business days
  • How to request: Ask your prescriber to contact Humana's medical director
  • Preparation: Have attack records, lab results, and treatment history ready
  • Outcome: Often resolves coverage disputes when specialist explains clinical rationale

Level 3: Independent Review

Best for: Continued denials after internal appeals

  • Timeline: Must file within 60 days of final internal denial
  • Process: Follows Medicare guidelines for external review
  • Cost: No charge to member
  • Success rate: Approximately 50% when strong medical documentation supports necessity
From our advocates: We've seen Givlaari appeals succeed most often when the specialist clearly documents how frequent attacks impact the patient's ability to work or maintain daily activities, alongside objective measures like emergency department visits and hemin usage patterns. This composite approach helps reviewers understand both the clinical severity and real-world impact.

New Jersey External Review Process

For fully-insured plans (not Medicare Advantage), New Jersey offers additional appeal rights through the Independent Health Care Appeals Program (IHCAP).

IHCAP Eligibility and Process

  • Managed by: Maximus Federal Services
  • Filing deadline: 4 months from final internal denial
  • Review timeline: 45 days standard, 72 hours expedited
  • Filing fee: $25 (waivable for financial hardship)
  • Success rate: Approximately 50% for specialty drug appeals with robust documentation

Required Documentation

  • Final denial letter from insurance plan
  • Medical necessity letter from prescriber
  • Clinical records supporting AHP diagnosis and attack history
  • Evidence of prior treatment failures or contraindications

Submit online: IHCAP portal or mail to NJ Department of Banking and Insurance

Important: IHCAP only applies to fully-insured plans regulated by New Jersey. Medicare Advantage plans follow federal appeal processes.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Verification
Prior Authorization Required for all plans Humana formulary lookup Plan-specific
Specialist Prescriber Hematologist/hepatologist required PA criteria documents Provider directory
Attack History 2+ episodes in 6 months Medical records Chart documentation
Lab Confirmation Elevated ALA/PBG levels Laboratory reports Specialty lab results
Formulary Status Typically non-formulary Drug list search Annual formulary
Quantity Limits Weight-based dosing PA approval Clinical calculation

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"Insufficient attack history" Document all medical encounters for porphyria symptoms ER records, specialist visits, hemin treatments
"Missing laboratory confirmation" Obtain ALA/PBG testing during symptomatic period Specialty lab results with elevated values
"Non-specialist prescriber" Transfer care to hematologist/hepatologist Specialist consultation and ongoing management
"Experimental/investigational" Reference FDA approval and clinical guidelines FDA labeling, porphyria foundation guidelines
"Not medically necessary" Demonstrate impact on daily functioning Quality of life measures, work/school absences

Frequently Asked Questions

How long does Humana prior authorization take for Givlaari in New Jersey? Standard requests: 72 hours. Expedited requests: 24 hours. Appeals take 7 days for prescription drugs.

What if Givlaari is non-formulary on my Humana plan? You can request a formulary exception based on medical necessity. Include documentation showing why formulary alternatives aren't appropriate.

Can I request an expedited appeal if I'm having frequent attacks? Yes. Document how delays in treatment could cause serious harm to your health, and request expedited processing at each appeal level.

Does step therapy apply if I've tried treatments outside New Jersey? Treatment history from other states counts toward step therapy requirements. Provide complete records of prior therapies and outcomes.

What's the success rate for Givlaari appeals with Humana? While specific rates aren't published, appeals with comprehensive specialist documentation and clear attack history have higher success rates.

How much does Givlaari cost without insurance coverage? The wholesale acquisition cost is approximately $41,375 per vial, with total annual costs varying by patient weight and dosing requirements.

Can family members help with the appeal process? Yes, with proper authorization forms. Humana allows designated representatives to file appeals and communicate about coverage decisions.

What if I need Givlaari while traveling outside New Jersey? Coverage follows your Humana plan regardless of location. Ensure you have prior authorization before traveling and carry documentation of your approval.

Getting Givlaari covered by Humana requires careful preparation and documentation, but the appeals process in New Jersey provides multiple pathways to coverage for patients who truly need this specialized therapy. Counterforce Health helps patients navigate these complex prior authorization and appeal processes by analyzing denial letters and crafting evidence-based appeals that address specific payer requirements. The platform specializes in turning insurance denials into targeted rebuttals that align with each plan's own coverage criteria, helping patients access critical medications like Givlaari more efficiently.

The key to success is thorough documentation of your AHP diagnosis, attack history, and prior treatment attempts. Work closely with your specialist to gather all required evidence before submitting your initial request, and don't hesitate to use the appeal process if initially denied.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional help with New Jersey insurance appeals, contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467.

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