By Counterforce Health Team in Givlaari (givosiran) —

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

Quick Answer: Getting Givlaari Approved by Humana in California

Givlaari (givosiran) requires prior authorization from Humana, typically requiring documented acute hepatic porphyria (AHP) with elevated ALA/PBG levels, ≥2 attacks in 6 months, and specialist involvement. If denied, you have 65 days to appeal and can request California's Independent Medical Review (IMR) if Humana upholds the denial. Start by gathering your biochemical confirmation, attack logs, and hemin use records, then work with your specialist to submit a comprehensive medical necessity letter.

First step today: Contact your prescribing specialist to request a prior authorization submission with complete AHP documentation.

Table of Contents

Understanding Your Denial Letter

When Humana denies Givlaari coverage, your denial letter will include specific reason codes. The most common reasons include:

  • Insufficient documentation of biochemical confirmation (elevated ALA/PBG levels)
  • Missing attack frequency records (need ≥2 attacks in prior 6 months)
  • Lack of specialist involvement or consultation
  • Incomplete hemin use documentation
  • Non-formulary status requiring exception request
Important: You have 65 days from the denial date to file an appeal with Humana, per updated 2025 Medicare regulations.

Common Fixable Issues

Before filing an appeal, check if your denial stems from easily correctable documentation gaps:

Missing Labs: Submit recent (within 12 months) urine or plasma tests showing elevated aminolevulinic acid (ALA) and/or porphobilinogen (PBG) levels with reference ranges included.

Attack Documentation: Provide detailed logs of AHP attacks including dates, symptoms, medical interventions (ER visits, hospitalizations), and outcomes.

Prescriber Qualification: Ensure Givlaari is prescribed by or in consultation with a porphyria specialist (hematologist, hepatologist, or gastroenterologist).

Hemin History: Include complete records of IV hemin use, dosing, dates, and clinical response or reasons for discontinuation.

Coverage Requirements at a Glance

Requirement What Humana Needs Where to Find It
Confirmed AHP Diagnosis Genetic testing + elevated ALA/PBG Lab reports, genetic counselor notes
Attack Frequency ≥2 attacks in past 6 months Hospital records, ER visits, specialist notes
Biochemical Evidence Elevated urinary ALA/PBG within 12 months Laboratory results with reference ranges
Specialist Involvement Prescription by porphyria specialist Consultation notes, referral documentation
Prior Hemin Use Documentation of IV hemin therapy Infusion logs, pharmacy records
ICD-10 Coding E80.21 (AIP), E80.29 (HCP/VP) Medical records, billing statements

Step-by-Step: Fastest Path to Approval

1. Gather Essential Documentation (Patient/Caregiver)

Collect insurance cards, recent lab results showing elevated ALA/PBG, attack logs, and all prior denial letters.

2. Contact Your Specialist (Within 24-48 hours)

Request your porphyria specialist submit a prior authorization with comprehensive medical necessity letter.

3. Submit Complete Package (Clinic Staff)

Include biochemical confirmation, attack frequency documentation, hemin use records, and specialist consultation notes via Humana Provider Portal or fax to 877-486-2621.

4. Request Expedited Review (If Urgent)

For patients with frequent attacks or recent hospitalizations, request 24-hour expedited review through your specialist.

5. Track Your Request (Patient)

Standard decisions come within 72 hours; expedited within 24 hours. Check status via Humana member portal.

6. If Denied, File Appeal Immediately (Within 65 days)

Submit appeal with additional supporting evidence through Humana's appeals process.

7. Request California IMR (If Appeal Denied)

File Independent Medical Review application with California DMHC within 6 months of final denial.

Medical Necessity Letter Essentials

Clinician Corner: Documentation Checklist

Your medical necessity letter should include these critical elements:

Patient Information:

  • Confirmed AHP subtype with genetic testing results
  • ICD-10 diagnosis codes (E80.21 for AIP, E80.29 for HCP/VP)
  • Current weight for dosing calculations (2.5 mg/kg monthly)

Clinical History:

  • Detailed attack frequency with specific dates and interventions
  • Biochemical confirmation with actual ALA/PBG values and reference ranges
  • Complete hemin use history including dates, doses, and clinical response

Treatment Rationale:

  • Why Givlaari is medically necessary for this patient
  • Any contraindications or intolerances to hemin therapy
  • Expected clinical outcomes (reduced attack frequency, fewer hospitalizations)

Monitoring Plan:

  • Follow-up schedule with specialist
  • Laboratory monitoring plan (liver function, homocysteine levels)
  • Safety assessments per FDA labeling

Counterforce Health specializes in helping patients and clinicians build evidence-backed appeals for complex specialty medications like Givlaari, turning insurance denials into targeted rebuttals aligned with payer policies and clinical guidelines.

First-Level Appeal Process

Filing Your Humana Appeal

Timeline: 65 days from denial notice date

Submission Methods:

  • Online: Humana member portal
  • Phone: Contact member services number on your ID card
  • Mail: Address provided in denial letter
  • Fax: 877-486-2621 (verify current number)

Required Documentation:

  • Original denial letter
  • Updated medical necessity letter addressing denial reasons
  • Additional clinical evidence (recent labs, specialist notes)
  • Any new attack documentation since initial submission

Decision Timeline:

  • Pre-service appeals: 30 calendar days
  • Post-service appeals: 60 calendar days
  • Expedited appeals: 24 hours (for urgent situations)

California External Review (IMR)

If Humana upholds their denial, California residents can request an Independent Medical Review through the Department of Managed Health Care (DMHC).

California IMR Success Rates

California's IMR system achieves a 68% success rate for specialty oncology drugs and 50-70% success rates for well-documented specialty drug appeals—significantly higher than other states.

Filing an IMR

Eligibility: After exhausting Humana's internal appeals process Timeline: 6 months from final Humana denial Cost: Free to patients

How to File:

  • Online: dmhc.ca.gov
  • Phone: 888-466-2219
  • The DMHC will assign your case to independent physician experts in porphyria or rare diseases

Decision Timeline:

  • Standard review: 45 days
  • Expedited review: 7 days for urgent cases

Binding Decision: If the IMR overturns Humana's denial, the plan must authorize coverage within 5 business days.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Supporting Documents
"Insufficient biochemical evidence" Submit recent ALA/PBG labs with reference ranges Laboratory reports within 12 months
"Inadequate attack frequency" Provide detailed attack logs with medical interventions ER records, hospital admissions, specialist notes
"Non-specialist prescriber" Obtain specialist consultation or co-signature Porphyria specialist consultation notes
"Missing hemin documentation" Submit complete hemin use history Infusion logs, pharmacy records, treatment outcomes
"Not medically necessary" Strengthen clinical rationale with guidelines FDA labeling, porphyria treatment guidelines

Cost Assistance Options

Alnylam Assist Program: Provides financial support and prior authorization assistance for eligible patients. Contact: alnylamassist.com or 1-833-256-9526.

Foundation Support: Organizations like the National Organization for Rare Disorders (NORD) and HealthWell Foundation offer grants for rare disease medications.

California State Programs: Medi-Cal expansion may cover Givlaari for eligible low-income patients through managed care plans.

Frequently Asked Questions

Q: How long does Humana prior authorization take in California? A: Standard requests receive decisions within 72 hours; expedited requests within 24 hours for urgent medical situations.

Q: What if Givlaari is non-formulary on my Humana plan? A: You can request a formulary exception with supporting clinical documentation showing medical necessity and lack of effective formulary alternatives.

Q: Can I request an expedited appeal for Givlaari? A: Yes, if delay in treatment could jeopardize your health due to frequent AHP attacks or recent hospitalizations.

Q: Does step therapy apply to Givlaari? A: Many plans require trial of hemin therapy first. Document any hemin failures, intolerances, or contraindications to support step therapy override.

Q: What happens if my IMR is denied? A: IMR decisions are binding, but you may explore formulary alternatives, manufacturer assistance programs, or coverage through different benefit pathways.

Q: How much does Givlaari cost without insurance? A: List price is approximately $575,000 annually, with per-vial costs around $41,375 (weight-based dosing varies total cost).

From Our Advocates

"We've seen California patients successfully overturn Givlaari denials by focusing on three key areas: comprehensive attack documentation with specific dates and interventions, recent biochemical evidence showing elevated ALA/PBG levels, and clear specialist involvement in the treatment decision. The state's IMR process is particularly effective when clinical evidence strongly supports medical necessity."

Getting Givlaari approved requires persistence and thorough documentation, but California's patient-friendly appeal system provides multiple pathways to coverage. Counterforce Health helps patients navigate these complex processes by creating targeted, evidence-backed appeals that address specific payer criteria and maximize approval chances.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Coverage policies and appeal processes may change; verify current requirements with your insurer and state regulators.

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