By Counterforce Health Team in Givlaari (givosiran) —

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

Answer Box: Quick Path to Givlaari Coverage

Humana requires prior authorization for Givlaari (givosiran) in Washington. You'll need: confirmed acute hepatic porphyria (AHP) diagnosis with elevated ALA/PBG labs, ≥2 attacks in past 6 months, specialist prescriber, and documented hemin use/failure. First step today: Call Humana member services (number on your ID card) to request a prior authorization form, then contact your hepatologist to submit within 24-48 hours. If denied, you have 65 days to appeal and can request Washington's external review for state-regulated plans.

Table of Contents

  1. Eligibility Triage: Do You Qualify?
  2. Coverage Requirements at a Glance
  3. Step-by-Step: Fastest Path to Approval
  4. Medical Necessity Letter Template
  5. Common Denial Reasons & Solutions
  6. Appeals Process for Washington Residents
  7. Cost Assistance Programs
  8. FAQ

Eligibility Triage: Do You Qualify?

Use this decision tree to determine your likelihood of Humana approval for Givlaari (givosiran):

✅ Likely Eligible

You have all of these:

  • Confirmed AHP diagnosis (genetic testing or elevated ALA/PBG during attacks)
  • ≥2 documented acute attacks in past 6 months requiring medical intervention
  • Specialist prescriber (hepatologist, hematologist, or neurologist)
  • Evidence of hemin use, failure, or contraindication
  • Recent lab work showing elevated ALA/PBG levels

Next step: Proceed directly to prior authorization submission.

⚠️ Possibly Eligible

You have most requirements but missing:

  • Recent ALA/PBG lab results (>12 months old)
  • Complete attack documentation
  • Specialist involvement

Next step: Work with your healthcare team to gather missing documentation before submitting.

❌ Not Yet Eligible

You're missing key requirements:

  • No confirmed AHP diagnosis
  • Fewer than 2 documented attacks in 6 months
  • No prior therapy documentation

Next step: Discuss with your doctor about establishing proper diagnosis and treatment history.

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed Source
AHP Diagnosis Biochemically confirmed acute hepatic porphyria ALA/PBG lab results, genetic testing Humana PA criteria
Attack Frequency ≥2 attacks in past 6 months ER records, hospital admissions, hemin logs Medicare PA requirements
Specialist Prescriber Hepatologist, hematologist, or neurologist Provider credentials, consultation notes Humana provider requirements
Prior Therapy Hemin use or documented failure Treatment records, intolerance notes FDA labeling requirements
Appeals Deadline 65 days from denial (2025 Medicare rule) Denial letter, appeal forms Washington OIC appeals guide

Step-by-Step: Fastest Path to Approval

1. Verify Your Humana Plan Type

Who does it: You
Timeline: Same day
Call Humana member services and ask: "Is this a Medicare Advantage, Part D, or commercial plan?" This determines your appeal rights.

2. Request Prior Authorization Form

Who does it: You or your clinic
Timeline: 24 hours
Contact Humana to request the Medicare Prescription Drug Coverage Determination Form. Ask about expedited review if you're having frequent attacks.

3. Gather Required Documentation

Who does it: You and your healthcare team
Timeline: 1-3 days
Collect:

  • Recent ALA/PBG lab results (within 12 months)
  • Attack logs with dates and interventions
  • Hemin treatment records
  • Specialist consultation notes
  • Insurance card and patient ID

4. Specialist Submits Medical Necessity Letter

Who does it: Your hepatologist/specialist
Timeline: 24-48 hours
Use our template below. Submit via Humana provider portal or fax.

5. Track Your Request

Who does it: You
Timeline: Ongoing
Monitor via Humana member portal. Standard decisions: 72 hours; expedited: 24 hours.

6. If Denied, File Appeal Immediately

Who does it: You with specialist support
Timeline: Within 65 days
Follow our appeals guide below for Washington-specific options.

Medical Necessity Letter Template

Clinician Corner: Use this template as a starting point for your Givlaari prior authorization request. Customize with patient-specific details and attach all supporting documentation.
[Provider Letterhead]
[Date]

Humana Medical Director
[Address from denial letter or PA form]

Re: Prior Authorization Request for Givlaari (givosiran)
Patient: [Full Name]
Member ID: [Number]
Date of Birth: [MM/DD/YYYY]

Dear Medical Director,

I am writing to request prior authorization for Givlaari (givosiran) for my patient with confirmed acute hepatic porphyria (AHP).

**Patient Diagnosis:**
[Patient name] has biochemically confirmed [specific AHP type: AIP/HCP/VP/ADP] documented by:
- Elevated urinary ALA: [value] mg/24h (reference range: [range]) dated [MM/DD/YYYY]
- Elevated urinary PBG: [value] mg/24h (reference range: [range]) dated [MM/DD/YYYY]
- [If available] Genetic testing: [gene] pathogenic variant

**Attack History:**
The patient has experienced ≥2 acute porphyric attacks in the past 6 months:
- [Date]: [Description - ER visit, hospitalization, hemin treatment]
- [Date]: [Description - intervention required]
- [Additional attacks as documented]

**Prior Therapy and Failure:**
- Hemin (Panhematin) used [frequency/dates] with [outcome: inadequate response/side effects]
- [Other treatments tried]: [outcomes]
- Current attack frequency despite standard care: [frequency]

**Medical Necessity for Givlaari:**
Givlaari is FDA-approved for AHP in adults and is medically necessary for this patient because:
- Recurrent, debilitating attacks despite standard therapy
- Significant impact on quality of life and hospitalizations
- Expected reduction in attack frequency and hemin utilization per clinical trials

**Dosing and Monitoring:**
- Weight-based dosing: 2.5 mg/kg subcutaneously monthly ([patient weight] kg = [dose] mg)
- Monthly monitoring: liver function tests, homocysteine levels
- Administration by healthcare professional per FDA labeling

**Clinical Rationale:**
This patient meets all established criteria for Givlaari therapy and represents appropriate use of this targeted RNA interference therapy for AHP attack prevention.

Supporting documentation attached:
- Laboratory results (ALA/PBG)
- Attack documentation
- Treatment history
- [Additional relevant records]

I am available for peer-to-peer discussion if needed. Please contact me at [phone] with any questions.

Sincerely,
[Physician Name, MD]
[Credentials]
[Contact Information]

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Evidence
Insufficient biochemical evidence Submit recent ALA/PBG labs with reference ranges Labs dated within 12 months showing elevation
Inadequate attack frequency Provide detailed attack logs with medical interventions ER records, hospital admissions, specialist notes
Missing specialist involvement Ensure hepatologist/hematologist submits request Consultation notes, specialist credentials
No prior hemin documentation Document hemin use, failure, or contraindication Treatment logs, hospital records, intolerance notes
Non-formulary status Request formulary exception with medical necessity Complete clinical documentation per template
From our advocates: We've seen denials overturned when prescribers include specific ALA/PBG values with reference ranges and clearly document the number of attacks requiring medical intervention. The key is being precise about biochemical confirmation and attack frequency—payers want to see objective evidence, not just clinical impressions.

Appeals Process for Washington Residents

For Humana Medicare Plans

Timeline: 65 days from denial notice

  1. Level 1: Plan Redetermination
    • Submit via Humana member portal or mail
    • Include strengthened medical necessity letter
    • Decision within 7 days (standard) or 72 hours (expedited)
  2. Level 2: Independent Review Entity (IRE)
    • Federal Medicare contractor reviews case
    • Automatic if Level 1 upholds denial
    • Independent medical experts make decision

For Commercial Humana Plans

Washington External Review Process

If your Humana plan is state-regulated (non-Medicare), you can use Washington's Independent Review Organization (IRO) process:

  1. Complete Internal Appeals First
    • File with Humana per your plan's process
    • Wait for final internal denial
  2. Request External Review
    • Submit to Humana (they assign IRO via Washington OIC portal)
    • Timeline: 180 days from final internal denial
    • IRO assigned within 3 business days
  3. Submit Supporting Evidence
    • You have 5 business days to provide additional information
    • Include specialist letters, peer-reviewed studies, treatment guidelines
    • Counterforce Health can help with evidence compilation
  4. IRO Decision
    • Standard: 30 days
    • Expedited: 72 hours (if delay would jeopardize health)
    • Decision is binding on Humana

When to Request Expedited Review

Request expedited processing if:

  • You're having frequent attacks (>1 per month)
  • Recent hospitalizations for AHP
  • Your health could be seriously jeopardized by waiting

Getting Help

Cost Assistance Programs

Givlaari's list price is approximately $575,000 annually (~$41,375 per vial), making financial assistance crucial:

Manufacturer Support

Foundation Grants

  • NORD (National Organization for Rare Disorders): Patient assistance programs
  • HealthWell Foundation: Copay assistance for rare diseases
  • Patient Access Network Foundation: Specialty drug coverage

State Resources

  • Washington Apple Health (Medicaid): May cover for eligible patients
  • Washington Prescription Drug Program: Additional state assistance

FAQ

Q: How long does Humana PA take in Washington?
A: Standard prior authorization decisions within 72 hours; expedited within 24 hours for urgent cases.

Q: What if Givlaari is non-formulary on my plan?
A: Request a formulary exception with medical necessity documentation. Your prescriber must show that covered alternatives aren't appropriate.

Q: Can I request an expedited appeal?
A: Yes, if waiting could seriously jeopardize your health. Document frequent attacks or recent hospitalizations.

Q: Does step therapy apply if I've failed hemin outside Washington?
A: Prior treatment failures from any location count. Provide complete documentation of hemin use and outcomes.

Q: What happens if my appeal is denied?
A: For Medicare plans, it goes to an Independent Review Entity. For commercial plans, you can use Washington's external IRO review.

Q: Can I continue treatment while appealing?
A: If you're new to the plan, ask about transition fills. Otherwise, you may need to pay out-of-pocket during appeals.

Q: How can Counterforce Health help?
A: Counterforce Health specializes in turning insurance denials into targeted appeals, helping patients and clinicians compile evidence-based medical necessity letters that address specific payer criteria.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always verify current requirements with Humana and consult with your healthcare provider about treatment decisions. For personalized assistance with insurance appeals, consider consulting with healthcare coverage specialists like Counterforce Health, which helps patients navigate complex prior authorization and appeals processes.

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