By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (Givosiran) Covered by Humana in Texas: Prior Authorization Guide and Appeals Process

Quick Answer: Getting Givlaari Covered by Humana in Texas

Givlaari (givosiran) requires prior authorization from Humana Medicare Advantage plans in Texas. To get approved, you need: (1) confirmed acute hepatic porphyria diagnosis with genetic testing, (2) at least 2 documented attacks requiring medical intervention in the past 6 months, (3) elevated urine ALA/PBG levels, and (4) prescription from a hematologist, hepatologist, or neurologist. Submit your PA request via fax to 1-833-547-2030 with complete clinical documentation. If denied, you have 65 days to file an internal appeal, followed by independent external review through Texas Department of Insurance if needed.

Table of Contents

Plan Types & Coverage Implications

Humana operates multiple plan types in Texas, each with different coverage pathways for Givlaari:

Medicare Advantage (Part C): Most common Humana coverage in Texas. Givlaari requires prior authorization across all MA plans, with standard 30-day decision timelines for non-urgent requests and 24-hour turnaround for expedited reviews when delay could harm your health.

Medicare Part D: For prescription drug coverage, Humana follows CMS guidelines with 7-day standard appeals and 72-hour expedited reviews. Appeals can be filed within 65 days of receiving a denial notice.

Dual Eligible Special Needs Plans (D-SNP): Available for Texas residents with both Medicare and Medicaid. These plans include additional transition coverage—up to 31 days of temporary supply for new members while prior authorization is processed.

Note: ERISA self-funded employer plans follow federal appeal rules rather than Texas state regulations, so verify your specific plan type before starting the appeals process.

Formulary Status & Tier Placement

Givlaari is not included on Humana's standard formulary due to its specialized use for acute hepatic porphyria. Instead, coverage requires individual prior authorization review for medical necessity.

Coverage Approach:

This non-formulary status means you can't simply pay a higher copay to access Givlaari. Every prescription requires full prior authorization approval demonstrating medical necessity.

Prior Authorization Requirements

Humana requires specific clinical documentation for Givlaari approval:

Coverage at a Glance

Requirement What It Means Where to Find Documentation
Prescriber Specialty Hematologist, hepatologist, gastroenterologist, or neurologist Medical license verification, specialist referral
AHP Diagnosis Confirmed acute hepatic porphyria (any subtype) Genetic testing results, specialist notes
Attack History ≥2 documented attacks in past 6 months Hospital records, urgent care visits, hemin administration logs
Biochemical Proof Elevated urine PBG/ALA levels within past year Lab results with reference ranges
Dosing Alignment 2.5 mg/kg monthly per FDA labeling Prescriber's dosing rationale, patient weight

Required Documentation Checklist

Clinical Evidence:

  • Genetic testing confirming AHP subtype (AIP, VP, HCP, or ADP)
  • Laboratory reports showing elevated urinary porphobilinogen (PBG) or aminolevulinic acid (ALA)
  • Medical records documenting at least 2 porphyria attacks requiring hospitalization, urgent care, or IV hemin within 6 months
  • Current medication list and history of previous treatments

Administrative Requirements:

  • Prescription from qualified specialist (age 18+ years)
  • Patient weight for dosing calculations
  • Insurance information and member ID
Tip: The Alnylam Act program provides free genetic testing for eligible patients, which can strengthen your prior authorization request.

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis (Patient + Specialist)

Timeline: 2-4 weeks

  • Schedule appointment with hematologist, hepatologist, or gastroenterologist
  • Complete genetic testing if not already done (free through Alnylam Act if eligible)
  • Gather attack history documentation from past 6 months

2. Collect Biochemical Evidence (Specialist)

Timeline: 1-2 weeks

  • Order urine PBG/ALA testing (ideally during or shortly after an attack)
  • Ensure lab results include reference ranges
  • Document any hemin use or hospitalizations

3. Submit Prior Authorization (Specialist Office)

Timeline: Same day

4. Follow Up (Patient + Specialist)

Timeline: 7 days standard, 24 hours expedited

  • Track submission through Humana provider portal
  • Contact Humana member services if no response within timeline
  • Prepare appeal documentation if needed

5. Set Up Specialty Pharmacy (If Approved)

Timeline: 3-5 business days

  • Coordinate with Humana's contracted specialty pharmacy network
  • Complete patient enrollment and insurance verification
  • Schedule monthly injection appointments with healthcare provider

Specialty Pharmacy Requirements

Givlaari must be dispensed through Humana's specialty pharmacy network due to its high cost and specialized handling requirements.

Network Requirements:

  • Prescriptions filled only at Humana-contracted pharmacies
  • Non-network fills result in full patient cost responsibility
  • Monthly supply coordination with healthcare provider for injections

Patient Enrollment Process:

  1. Humana approves prior authorization
  2. Specialty pharmacy contacts patient within 24-48 hours
  3. Insurance verification and benefit explanation
  4. Coordinate delivery and injection scheduling
  5. Ongoing clinical monitoring and refill management

Appeals Process for Texas Residents

If your initial prior authorization is denied, Texas residents have strong appeal rights through multiple levels of review.

Internal Appeals (Humana)

Timeline: 65 days to file from denial date Decision: 7 days standard, 72 hours expedited How to File:

  • Online through MyHumana member portal
  • Phone: 800-867-6601
  • Fax: Use Appeal/Complaint/Grievance Form (number provided on form)

Required Documentation:

  • Original denial letter
  • Prescriber's medical necessity letter
  • Additional clinical evidence (attack frequency, failed alternatives)
  • Request for expedited review if delay could harm health

External Review (Texas Department of Insurance)

If Humana denies your internal appeal, Texas law provides independent external review through the Texas Department of Insurance (TDI).

Timeline: 4 months to file from final internal denial Decision: 20 days standard, 5 days for urgent cases Process:

  1. Humana provides IRO request form with final denial
  2. Submit form to TDI-contracted Independent Review Organization
  3. IRO reviews medical necessity using independent experts
  4. Decision is binding—Humana must comply if overturned

Texas Resources:

  • TDI Consumer Hotline: 1-800-252-3439
  • Office of Public Insurance Counsel (OPIC): 1-877-611-6742
  • IRO Information Line: 1-866-554-4926
Important: Medicare Advantage and Medicare Part D plans follow federal appeal rules, not Texas state IRO process. However, Texas TDI can still assist with complaint resolution.

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing biochemical confirmation Submit recent urine PBG/ALA results with reference ranges Lab reports from certified facility
Insufficient attack history Document all attacks, including those not requiring hospitalization Medical records, urgent care visits, hemin logs
Non-specialist prescriber Transfer prescription to hematologist, hepatologist, or neurologist Specialist consultation notes
Continuation with hemin Demonstrate medical necessity for combination therapy Clinical rationale from specialist
Dosing concerns Justify weight-based dosing per FDA labeling Patient weight, dosing calculations, safety monitoring plan

Clinician Corner: Medical Necessity Letter Essentials

Key Components for Strong Appeals:

  • Problem Statement: "Patient has genetically confirmed [AIP/VP/HCP] with recurrent attacks despite trigger avoidance"
  • Prior Treatments: Document hemin use, hospitalizations, failed prophylactic measures
  • Clinical Rationale: Reference FDA labeling, porphyria treatment guidelines, and attack reduction evidence
  • Monitoring Plan: Hepatic function, renal function, homocysteine levels per prescribing information

Cost Considerations & Patient Assistance

Givlaari's annual cost can exceed $575,000, making patient assistance crucial for many families.

Manufacturer Support:

  • Alnylam Assist provides copay assistance and insurance navigation
  • Free genetic testing through Alnylam Act program
  • Patient support specialists for prior authorization assistance

Additional Resources:

  • National Organization for Rare Disorders (NORD) patient assistance programs
  • American Porphyria Foundation advocacy and support
  • State pharmaceutical assistance programs (check Texas Health and Human Services)

When to Escalate: Texas Regulatory Resources

If standard appeals don't resolve your coverage issue, Texas provides additional regulatory oversight:

File Complaints With:

When to Contact Regulators:

  • Humana violates appeal timelines
  • Denial appears to contradict medical evidence
  • Pattern of inappropriate denials for rare disease medications

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests the denial letter, plan policy, and clinical notes, then identifies the denial basis and drafts a point-by-point rebuttal aligned to the plan's own rules. For complex cases like Givlaari coverage, Counterforce Health can help navigate the specific requirements of Humana's prior authorization process while ensuring all clinical evidence is properly presented.

FAQ

How long does Humana prior authorization take for Givlaari in Texas? Standard prior authorization decisions are made within 30 days for Medicare Advantage plans and 7 days for Part D. Expedited reviews (when delay could harm health) are decided within 24-72 hours depending on plan type.

What if Givlaari is denied as "not medically necessary"? Request an internal appeal within 65 days, including a detailed medical necessity letter from your specialist. If denied again, Texas residents can request independent external review through the Texas Department of Insurance IRO process.

Can I get temporary coverage while my appeal is pending? New Humana members may qualify for a 30-day transition supply of non-formulary drugs during their first 90 days. For urgent situations, request expedited appeals and emphasize how delays could worsen your condition.

Does step therapy apply to Givlaari? Most Humana policies require documentation of prior treatments (hemin use, trigger avoidance) but don't mandate specific step therapy protocols. However, you must demonstrate that conventional management has been insufficient.

What counts as a "qualifying attack" for prior authorization? Attacks requiring medical intervention—hospitalization, urgent care visits, or IV hemin administration. Document all attacks in the past 6 months, including dates, symptoms, treatments received, and healthcare providers involved.

How do I find a specialist who can prescribe Givlaari in Texas? Contact the American Porphyria Foundation for specialist referrals, or ask your primary care doctor for referrals to hematologists, hepatologists, or gastroenterologists experienced with porphyria.

Sources & Further Reading

Disclaimer: This article provides educational information about insurance coverage and is not medical advice. Coverage decisions depend on individual medical circumstances and plan specifics. Always consult with your healthcare provider about treatment options and work directly with your insurance company for coverage determinations. For assistance with insurance issues in Texas, contact the Texas Department of Insurance consumer hotline at 1-800-252-3439.

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