By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (Givosiran) Covered by Cigna in North Carolina: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Givlaari Covered by Cigna in North Carolina

To get Givlaari (givosiran) approved by Cigna in North Carolina, you need: (1) Confirmed acute hepatic porphyria with elevated ALA/PBG levels or genetic testing, (2) Documentation of ≥2 attacks in 6 months requiring hospitalization/hemin, and (3) Prescription by a porphyria specialist. Fastest path: Submit the complete Givlaari Prior Authorization Form to Cigna Express Scripts at 1-833-547-2030 with attack history and biochemical proof. If denied, North Carolina's Smart NC external review provides strong patient protections with 72-hour expedited decisions.

Table of Contents

  1. Before You Start: Coverage Basics
  2. What You Need to Gather
  3. Step-by-Step: Fastest Path to Approval
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process: Internal and External Review
  6. Typical Timelines in North Carolina
  7. Renewal & Reauthorization
  8. FAQ: Most Common Questions
  9. Quick Reference Checklist

Before You Start: Coverage Basics

Givlaari (givosiran) requires prior authorization from Cigna and is classified as a specialty tier medication. The drug costs approximately $575,000 annually, making proper documentation crucial for approval.

First, verify these basics:

  • Your plan type (not self-funded ERISA plans for external review)
  • Formulary status via your Cigna member portal
  • Whether it's covered under medical or pharmacy benefit
  • In-network specialist requirements
Note: Cigna manages specialty drugs through Express Scripts/Accredo, so you'll work with their specialty pharmacy team for administration.

What You Need to Gather

Clinical Documentation Required

  • Diagnosis confirmation: ICD-10 codes E80.20-E80.29 (acute hepatic porphyria)
  • Biochemical evidence: Elevated urinary/plasma ALA or PBG levels within past year (include reference ranges)
  • Attack history: Documentation of ≥2 porphyria attacks in past 6 months requiring hospitalization, urgent care, or IV hemin
  • Prescriber credentials: Hematologist, hepatologist, or porphyria specialist information
  • Prior therapies: Records of hemin use, trigger avoidance attempts, supportive care

Administrative Documents

  • Insurance card and member ID
  • Givlaari Prior Authorization Form
  • Progress notes from specialist visits
  • Lab reports with dates and reference ranges
  • Hospital records from acute attacks

Step-by-Step: Fastest Path to Approval

1. Confirm Specialist Prescriber

Who: Patient/caregiver
Action: Ensure prescription comes from or includes consultation with a porphyria specialist
Timeline: Before PA submission
Source: Cigna specialty drug requirements

2. Complete Prior Authorization Form

Who: Prescriber's office
Action: Fill out complete Givlaari PA form with attack history, lab values, and clinical rationale
Timeline: Allow 2-3 business days for completion
Submit to: Fax 1-833-547-2030

3. Submit Supporting Documentation

Who: Clinic staff
Action: Include progress notes, lab results, hospital records, and medical necessity letter
Timeline: Same day as PA form submission
Required: All documents must show dates and reference ranges for lab values

4. Follow Up Within 72 Hours

Who: Patient or clinic
Action: Call 1-844-325-6251 to confirm receipt and check status
Timeline: 3 days post-submission
Document: Reference numbers and representative names

5. Track Decision Timeline

Who: Patient
Action: Standard decisions within 15 business days; expedited within 72 hours if urgent
Timeline: Mark calendar for follow-up calls
Escalate: If no response by day 14, request peer-to-peer review

Common Denial Reasons & How to Fix Them

Denial Reason Fix Strategy Required Documentation
Missing biochemical confirmation Submit ALA/PBG lab results with reference ranges Recent lab reports within past year
Insufficient attack history Document 2+ attacks requiring hospitalization/hemin Hospital records, emergency department visits
Non-specialist prescriber Add specialist consultation or transfer prescription Hematologist/hepatologist consultation notes
Continued hemin use Provide plan to discontinue prophylactic hemin Treatment timeline from specialist
Missing genetic confirmation Submit pathogenic gene mutation results if available Genetic testing reports (if ALA/PBG unavailable)

Appeals Process: Internal and External Review

Cigna Internal Appeals

  • Level 1: File within 180 days of denial
  • Timeline: 30 days for decision (72 hours if expedited)
  • Submit via: Cigna member portal or fax per denial letter
  • Level 2: File within 60 days of Level 1 denial

North Carolina Smart NC External Review

If Cigna's final internal appeal is denied, North Carolina residents have strong external review rights through Smart NC.

Eligibility:

  • State-regulated plan (not self-funded employer plans)
  • Completed Cigna's internal appeal process
  • Denial based on medical necessity or experimental treatment

Process:

  • Deadline: 120 days from final Cigna denial
  • Contact: Call Smart NC at 1-855-408-1212
  • Timeline: 45 days standard, 72 hours expedited
  • Outcome: Binding decision—if approved, Cigna must cover within 3 business days
From our advocates: We've seen several North Carolina patients successfully overturn Givlaari denials through Smart NC external review by emphasizing the specialist's clinical rationale and attack frequency documentation. The key was submitting comprehensive medical records that clearly showed the patient met all clinical criteria despite the initial denial.

Typical Timelines in North Carolina

Process Standard Timeline Expedited Timeline
Initial PA Decision 15 business days 72 hours
Level 1 Internal Appeal 30 days 72 hours
Level 2 Internal Appeal 30 days 72 hours
Smart NC External Review 45 days 72 hours

Expedited criteria: When delay would seriously jeopardize life or ability to regain function.

Renewal & Reauthorization

Initial Approval

  • Duration: 6 months
  • Requirements: Meet all initial criteria

Reauthorization Requirements

  • Duration: 12 months after initial period
  • Evidence needed:
    • Decreased attack frequency
    • Reduction in hospitalizations/urgent care visits
    • Lower ALA/PBG levels compared to baseline
    • No unacceptable toxicity
    • Continued specialist oversight

Calendar reminder: Submit reauth 30-45 days before expiration to avoid gaps in coverage.

FAQ: Most Common Questions

How long does Cigna prior authorization take in North Carolina? Standard PA decisions take up to 15 business days. Expedited requests (when delay jeopardizes health) receive decisions within 72 hours.

What if Givlaari is non-formulary on my plan? You can request a formulary exception through Cigna's standard PA process. The same clinical criteria apply, but you may need additional documentation of medical necessity.

Can I request an expedited appeal if my attacks are worsening? Yes. If delay in treatment would seriously jeopardize your health, request expedited review at each level—initial PA, internal appeals, and Smart NC external review.

Does step therapy apply to Givlaari? Most Cigna policies require documentation of prior hemin use or contraindications to hemin before approving Givlaari. This isn't formal step therapy but similar documentation requirements.

What if I've tried treatments outside North Carolina? Out-of-state medical records are acceptable. Ensure all documentation includes dates, dosages, outcomes, and reasons for discontinuation.

How much does Givlaari cost without insurance? The list price is approximately $575,000 annually. Alnylam Assist offers patient support programs that may help with costs.

Quick Reference Checklist

Before Submitting: □ Confirmed acute hepatic porphyria diagnosis
□ Elevated ALA/PBG levels documented within past year
□ ≥2 attacks in 6 months requiring hospitalization/hemin
□ Prescription from porphyria specialist
□ Complete PA form with all sections filled

Required Documents: □ Givlaari Prior Authorization Form
□ Lab reports with reference ranges
□ Hospital/emergency department records
□ Specialist consultation notes
□ Medical necessity letter

Submission: □ Fax to 1-833-547-2030
□ Follow up within 72 hours at 1-844-325-6251
□ Document reference numbers

If Denied: □ Request peer-to-peer review immediately
□ File Level 1 appeal within 180 days
□ Contact Smart NC at 1-855-408-1212 if final denial

Getting Givlaari approved can be complex, but North Carolina residents have strong appeal rights and support systems. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements.

For additional support, contact the North Carolina Department of Insurance Consumer Services Division or Smart NC's helpline for guidance through the appeals process.

Sources & Further Reading

This guide provides general information and should not replace professional medical or legal advice. Insurance policies and state regulations may change. Always verify current requirements with your insurer and healthcare provider.

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