By Counterforce Health Team in Givlaari (givosiran) —

Myths vs. Facts: Getting Givlaari (givosiran) Covered by Aetna (CVS Health) in North Carolina

Answer Box: Getting Givlaari (givosiran) covered by Aetna (CVS Health) in North Carolina requires prior authorization with specific documentation: elevated ALA/PBG levels during attacks, attack history requiring hospitalization or hemin, and specialist prescriber. Submit via CVS Caremark Specialty or Availity portal. If denied, North Carolina's Smart NC external review has an 81.7% overturn rate for specialty drugs. First step: Contact your specialist to gather attack documentation and biochemical evidence today.

Table of Contents

Why Myths About Givlaari Coverage Persist

Acute hepatic porphyria affects fewer than 1 in 100,000 people, making Givlaari (givosiran) one of the most specialized medications patients and even clinicians encounter. This rarity breeds misinformation about insurance coverage, especially for a treatment with a list price exceeding $575,000 annually.

In North Carolina, where Aetna (CVS Health) covers approximately 8% of the commercial insurance market alongside dominant players like Blue Cross Blue Shield, patients often receive conflicting advice about prior authorization requirements. The complexity increases when you factor in North Carolina's robust external review system through Smart NC, which many patients don't know exists.

Counterforce Health helps patients navigate these complexities by turning insurance denials into targeted, evidence-backed appeals. Their platform identifies denial reasons and drafts point-by-point rebuttals aligned to each plan's specific rules—exactly what's needed for rare disease medications like Givlaari.

Myth vs. Fact: Common Misconceptions

Myth 1: "If my doctor prescribes Givlaari, Aetna automatically covers it"

Fact: Givlaari requires prior authorization from Aetna CVS Health across all commercial plans. The prescription alone doesn't guarantee coverage—you need documented elevated ALA/PBG levels (≥4x normal), attack history requiring hospitalization or hemin, and a specialist prescriber.

Myth 2: "Any doctor can prescribe Givlaari for insurance approval"

Fact: Aetna typically requires a specialist prescriber—hepatologist, hematologist, geneticist, or porphyria specialist. Primary care physicians can initiate the process, but specialist involvement strengthens approval odds significantly.

Myth 3: "I need genetic testing before biochemical confirmation"

Fact: The opposite is true. Biochemical confirmation with elevated urinary ALA/PBG during attacks comes first. Genetic testing follows to identify the specific AHP subtype. Alnylam offers free genetic testing for eligible patients through their Alnylam Act program.

Myth 4: "If Aetna denies Givlaari, I'm out of options"

Fact: North Carolina offers exceptional appeal rights. After internal appeals, you can request external review through Smart NC, which has an 81.7% success rate for specialty drug denials. The process is free, and decisions are binding on insurers.

Myth 5: "Step therapy means I must fail multiple treatments first"

Fact: For Givlaari, "step therapy" typically means documented use or failure of hemin (Panhematin). If you've had hemin infusions for attacks or tried prophylactic hemin, this requirement is often satisfied.

Myth 6: "Givlaari is experimental, so it won't be covered"

Fact: Givlaari received FDA approval in November 2019 for acute hepatic porphyria in adults. It's not experimental—it's the only FDA-approved chronic prophylactic treatment for AHP.

Myth 7: "I can't afford Givlaari even with insurance"

Fact: Alnylam Assist provides copay support for commercially insured patients, potentially reducing out-of-pocket costs to $0. They also offer benefits investigation and appeal support.

Myth 8: "Appeals take months and rarely work"

Fact: In North Carolina, expedited external reviews are decided within 72 hours for urgent cases. Standard external reviews take 45 days maximum. With proper documentation, specialty drug appeals have high success rates.

What Actually Influences Approval

Understanding Aetna's actual criteria helps separate facts from fiction:

Required Documentation

Requirement Specific Details Where to Find It
Biochemical Evidence Elevated ALA/PBG ≥4x normal during attacks Lab reports from attack episodes
Attack History Documented attacks requiring hospitalization, urgent care, or IV hemin Medical records, ER notes, hospital discharge summaries
Specialist Involvement Hepatologist, hematologist, geneticist, or porphyria specialist Letter of medical necessity from specialist
ICD-10 Coding Primary AHP code (E80.21, E80.29, etc.) Chart notes with proper diagnostic coding
Prior Therapy Evidence of hemin use or failure/intolerance Infusion records, pharmacy records

Submission Process

Aetna processes Givlaari prior authorizations through CVS Caremark Specialty. Submit via:

Timeline Expectations

  • Complete PAs: 24-72 hours for approval
  • Incomplete submissions: Up to 30 days
  • Expedited reviews: 72 hours for urgent cases

Avoid These Critical Mistakes

1. Submitting Incomplete Attack Documentation

The Problem: Vague descriptions like "frequent attacks" without specific dates, locations, and treatments.

The Fix: Create a detailed attack log with dates, duration, symptoms, where treated (ER, hospital, clinic), and interventions received (hemin, medications, length of stay).

2. Missing Biochemical Evidence

The Problem: Relying only on clinical symptoms without lab confirmation.

The Fix: Ensure ALA/PBG levels were measured during or immediately after attacks. If not available, work with your specialist to obtain these during the next episode or request genetic testing through Alnylam Act.

3. Using the Wrong Prescriber

The Problem: Having a primary care physician submit the initial request without specialist involvement.

The Fix: Connect with a hepatologist, hematologist, or geneticist familiar with porphyria. Many academic medical centers have porphyria specialists.

4. Inadequate Medical Necessity Letter

The Problem: Generic letters that don't address Aetna's specific criteria.

The Fix: The letter should explicitly state:

  • Confirmed AHP diagnosis with subtype
  • Attack frequency and severity
  • Prior treatments tried and outcomes
  • Why Givlaari is medically necessary
  • Patient meets all FDA indication criteria

5. Giving Up After Initial Denial

The Problem: Accepting the first denial without understanding appeal rights.

The Fix: In North Carolina, you have 180 days to file internal appeals, followed by external review through Smart NC. Many denials are overturned with proper documentation.

Your Quick Action Plan

Step 1: Gather Essential Documentation (Do Today)

Contact your healthcare providers to collect:

  • Lab results showing elevated ALA/PBG during attacks
  • Hospital records from AHP-related admissions
  • Emergency department visit notes
  • Hemin infusion records
  • Current weight and recent liver function tests

Step 2: Connect with a Specialist (This Week)

If you don't have one already, request referral to:

  • Hepatologist at a major medical center
  • Hematologist with porphyria experience
  • Geneticist familiar with metabolic disorders

Many North Carolina academic centers (Duke, UNC, Wake Forest) have specialists familiar with porphyria.

Step 3: Initiate Prior Authorization (Within 2 Weeks)

Work with your specialist's office to:

From Our Advocates: One North Carolina patient had their initial Givlaari denial overturned within 30 days by submitting a chronological attack timeline showing 4 ER visits and 2 hospitalizations over 8 months, with documented ALA/PBG levels during each episode. The external review cited clear medical necessity based on attack frequency and biochemical evidence. While outcomes vary, thorough documentation significantly improves appeal success rates.

Resources and Support

North Carolina-Specific Resources

  • Smart NC External Review: 1-855-408-1212
  • NC Department of Insurance: Consumer assistance for insurance disputes
  • External Review Request Form: Available on NCDOI website

Aetna (CVS Health) Contacts

  • CVS Caremark Specialty: 866-814-5506
  • Prior Authorization Fax: 888-267-3277
  • Member Services: Number on your insurance card

Manufacturer Support

  • Alnylam Assist: 1-833-256-2748
  • Free Genetic Testing: Alnylam Act Program
  • CVS Specialty Enrollment: 1-800-237-2767

Clinical Resources

  • American Porphyria Foundation: Patient education and specialist directory
  • Porphyria.com: Clinical information and testing guidance

When facing insurance challenges with rare disease treatments like Givlaari, remember that Counterforce Health specializes in turning denials into successful appeals by identifying specific denial reasons and crafting targeted rebuttals that align with each payer's unique criteria.

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 guidance specific to your situation. Coverage policies and requirements may change.

Sources & Further Reading

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