By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Blue Cross Blue Shield in Virginia: Complete Appeals Guide

Answer Box: Getting Givlaari Covered in Virginia

Fastest path to approval: Ensure your specialist documents at least 2 acute hepatic porphyria attacks in the past 6 months with elevated ALA/PBG levels, submit prior authorization through the BCBS Virginia provider portal with complete attack history and genetic testing results, and be prepared to appeal through Virginia's Bureau of Insurance external review if denied. First step today: Contact your prescribing physician to gather attack documentation and request they initiate the prior authorization process. Virginia offers expedited external review for urgent cases within 72 hours.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Reasons & How to Fix Them
  10. Virginia Appeals Process
  11. Quick Reference Checklist
  12. Frequently Asked Questions

Who Should Use This Guide

This guide helps Virginia patients with acute hepatic porphyria (AHP) and their healthcare providers navigate Blue Cross Blue Shield coverage for Givlaari (givosiran). You'll need this if you:

  • Have confirmed AHP with recurring attacks
  • Are experiencing denials or delays in coverage
  • Want to understand the approval process before starting
  • Need to appeal a prior authorization denial

Expected outcome: With proper documentation, many patients successfully obtain coverage. Virginia's external review process provides an additional safety net, with independent medical experts reviewing denials.

Member & Plan Basics

Coverage Requirements

Active BCBS Virginia coverage is essential. Verify your plan includes prescription drug benefits and specialty pharmacy coverage. Givlaari requires prior authorization across all BCBS Virginia plans.

Plan type considerations:

  • Commercial plans: Standard PA process applies
  • Medicare Advantage: May have additional step therapy requirements
  • Medicaid managed care: Contact plan directly for specific criteria

Deductible and Cost-Sharing

Givlaari's wholesale acquisition cost is approximately $41,375 per vial, with annual costs potentially exceeding $500,000. Check your specialty drug tier and out-of-pocket maximums. The Alnylam Assist program offers copay assistance for eligible patients.

Clinical Criteria Requirements

Primary Indication

Givlaari is FDA-approved for acute hepatic porphyria in adults to reduce attack frequency. BCBS Virginia typically requires:

Age requirement: 18 years or older

Confirmed AHP diagnosis with one of these subtypes:

  • Acute intermittent porphyria (AIP)
  • Hereditary coproporphyria (HCP)
  • Variegate porphyria (VP)
  • ALA dehydratase deficiency porphyria (ADP)

Attack Frequency Documentation

Critical requirement: Document at least 2 porphyria attacks within the past 6 months, where attacks are defined as episodes requiring:

  • Hospitalization
  • Emergency department visits
  • Intravenous hemin administration
  • Urgent healthcare intervention

Biochemical Confirmation

Essential lab evidence:

  • Elevated urinary porphobilinogen (PBG) during attacks (typically >5x upper limit of normal)
  • Elevated aminolevulinic acid (ALA) levels
  • Random urine samples collected during or shortly after attacks are sufficient
Note: Standard porphyrin tests do NOT include ALA and PBG. Request specific ALA/PBG testing.

Prescriber Requirements

Prescription must be from or in consultation with:

  • Hematologist
  • Hepatologist
  • Porphyria specialist
  • Physician experienced in treating AHP

Coding and Billing Information

HCPCS and NDC Codes

HCPCS Code: J0223 (blood-modifying agent) Formulation: 189mg/ml vial Dosing: 2.5 mg/kg monthly subcutaneous injection

ICD-10 Diagnosis Codes

  • E80.21 - Acute intermittent (hepatic) porphyria
  • E80.29 - Other porphyria (for HCP, VP, ADP)

Administration Requirements

Givlaari must be administered by a healthcare professional and billed under the medical benefit, not pharmacy benefit.

Documentation Packet Essentials

Provider Note Elements

Your physician's documentation should include:

Problem statement:

  • Specific AHP subtype diagnosis
  • Attack frequency and severity
  • Functional impact on daily life
  • Previous hospitalizations

Clinical history:

  • Genetic testing results (if available)
  • Laboratory values during attacks
  • Trigger identification attempts
  • Response to previous treatments

Medical Necessity Letter Components

A comprehensive letter should address:

  1. Patient demographics and diagnosis
  2. Attack documentation with specific dates and interventions required
  3. Laboratory evidence of elevated ALA/PBG during symptomatic periods
  4. Treatment failures with conventional management
  5. Clinical rationale for Givlaari therapy
  6. Dosing plan based on patient weight
  7. Monitoring strategy for safety and efficacy
Clinician Corner: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to craft point-by-point rebuttals aligned with each payer's specific requirements.

Required Attachments

  • Hospital records from recent attacks
  • Emergency department visit summaries
  • Laboratory results showing elevated ALA/PBG
  • Genetic testing reports (if completed)
  • Previous treatment records including hemin use
  • Specialist consultation notes

Submission Process

Correct Forms and Portals

Provider submission: Use the BCBS Virginia provider portal for prior authorization requests. Verify you're using the current PA form version, as outdated forms cause automatic rejections.

Required fields that commonly cause rejections:

  • Incomplete patient demographics
  • Missing prescriber NPI numbers
  • Inadequate clinical justification
  • Incorrect HCPCS codes
  • Missing attack frequency documentation

Timeline Expectations

  • Initial review: 5-7 business days for standard requests
  • Expedited review: 24-72 hours for urgent cases
  • Additional information requests: May extend timeline by 5-10 days

Specialty Pharmacy Requirements

Authorized Distributors

Givlaari requires sourcing through approved specialty pharmacies:

  • Accredo Health (primary network)
  • CVS Specialty Pharmacy
  • PANTHERx Specialty Pharmacy
  • PANTHERx Rare Pharmacy

Transfer Process

  1. Approval confirmation from BCBS Virginia
  2. Prescription routing to approved specialty pharmacy
  3. Patient enrollment in pharmacy's patient support program
  4. Delivery coordination with administering healthcare facility

After Submission: What to Expect

Confirmation and Tracking

  • Record confirmation numbers for all submissions
  • Check status weekly through provider portal
  • Document all communications with BCBS Virginia representatives

Potential Outcomes

  • Approval: Proceed to specialty pharmacy enrollment
  • Partial approval: May include quantity limits or duration restrictions
  • Denial: Review denial reason and prepare appeal strategy

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Insufficient attack history Provide detailed hospital records, ED visits, and hemin administration logs with specific dates
Missing biochemical confirmation Submit lab results showing elevated ALA/PBG during attacks; request testing if not available
Non-specialist prescriber Obtain consultation note from hematologist, hepatologist, or porphyria specialist
Concurrent hemin use Document plan to discontinue prophylactic hemin after Givlaari stabilization
Incomplete documentation Submit comprehensive medical necessity letter with all required clinical elements

Virginia Appeals Process

Internal Appeals

Timeline: File within 180 days of denial notice Process: Submit through BCBS Virginia member portal or by mail Documentation: Include all original materials plus additional supporting evidence

External Review Through Virginia Bureau of Insurance

If your internal appeal is denied, Virginia offers an independent external review process:

Eligibility: Available after completing BCBS Virginia's internal appeals process Timeline: 120 days from final internal denial to file external review Form: Submit Form 216-A to Virginia Bureau of Insurance Cost: No charge to patients

Contact information: Virginia Bureau of Insurance Consumer Services Division Phone: 1-877-310-6560

Expedited External Review

Available for urgent cases where delays could seriously jeopardize health:

  • Standard cases: 72 hours for urgent medical necessity
  • Experimental treatment: 6 business days
  • Cancer treatment: Special expedited process available
From our advocates: One patient with AIP had initial coverage denied due to "insufficient attack frequency." By working with their hepatologist to compile a comprehensive timeline of ED visits and hemin treatments over 18 months, plus genetic testing confirmation, the external review overturned the denial within 45 days. The key was demonstrating the pattern of severe attacks despite conventional management.

Quick Reference Checklist

Before You Start

  • Confirm active BCBS Virginia coverage with specialty drug benefits
  • Gather insurance card and member ID
  • Collect attack history documentation from past 6-12 months
  • Obtain recent ALA/PBG lab results
  • Secure specialist consultation or referral

Documentation Packet

  • Complete prior authorization form
  • Medical necessity letter from prescriber
  • Hospital/ED records from recent attacks
  • Laboratory evidence of elevated ALA/PBG
  • Genetic testing results (if available)
  • Previous treatment failure documentation

Submission

  • Submit through correct BCBS Virginia portal
  • Verify all required fields completed
  • Obtain confirmation number
  • Schedule follow-up status check

If Denied

  • Review denial letter for specific reasons
  • Gather additional supporting documentation
  • File internal appeal within 180 days
  • Consider external review if internal appeal fails

Frequently Asked Questions

How long does BCBS Virginia prior authorization take for Givlaari? Standard reviews typically take 5-7 business days. Expedited reviews for urgent cases can be completed within 24-72 hours.

What if Givlaari isn't on my plan's formulary? Most BCBS Virginia plans require prior authorization rather than complete exclusion. If truly non-formulary, request a formulary exception with medical necessity documentation.

Can I request an expedited appeal in Virginia? Yes, Virginia offers expedited external review for cases where delays could seriously impact health. Your physician must certify the urgency.

Does step therapy apply to Givlaari? Typically no, as Givlaari is the only FDA-approved chronic preventive therapy for AHP. However, plans may require documentation of previous hemin use for acute attacks.

What's the cost with insurance coverage? Costs vary by plan. With approval, you'll pay your plan's specialty drug copay or coinsurance. The Alnylam Assist program may help reduce out-of-pocket costs.

How often do I need reauthorization? Initial approvals are typically for 12 months, with reauthorization required annually. Continuation criteria usually focus on reduced attack frequency and tolerability.

What if my employer plan is self-funded? Self-funded plans may opt into Virginia's external review process. If not, federal external review through HHS may be available. The Virginia Bureau of Insurance can help direct you.

Can family members get genetic testing covered? Genetic counseling and testing for at-risk family members may be covered separately. Check with your plan's genetic testing policies.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to identify the specific denial basis and crafts point-by-point rebuttals aligned with each payer's requirements, incorporating the right clinical evidence and procedural details to improve approval rates.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change over time. Always verify current requirements with your specific BCBS Virginia plan and consult with your healthcare provider for medical decisions. For personalized assistance with coverage appeals, consider consulting with Counterforce Health or other qualified advocacy services.

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