By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (Givosiran) Covered by Florida Blue Cross Blue Shield: Complete Forms, Appeals, and Approval Guide

Quick Answer: Getting Givlaari Covered by Florida Blue in 2024

Florida Blue requires prior authorization for Givlaari (givosiran) with specific medical criteria. Submit your request through Availity.com or call 1-877-719-2583. You'll need confirmed acute hepatic porphyria diagnosis with elevated PBG/ALA levels, genetic testing, and documented attack history. Most approvals come within 72 hours via AI review; complex cases go to medical specialists. If denied, you have 180 days to appeal internally, then can request external review through Florida Department of Financial Services.

Start today: Have your doctor gather lab results (PBG/ALA), genetic testing, and attack documentation before submitting the PA request.

Table of Contents

  1. Start Here: Verify Your Plan and Find the Right Forms
  2. Required Forms and Documentation
  3. Submission Portals and Online Access
  4. Fax and Mail Submission Details
  5. Specialty Pharmacy Network Requirements
  6. Support Lines and Contact Numbers
  7. Florida Appeal Rights and External Review
  8. Coverage Requirements at a Glance
  9. Common Denial Reasons and Solutions
  10. When to Escalate to State Regulators

Start Here: Verify Your Plan and Find the Right Forms

Before starting your Givlaari prior authorization, confirm your specific Florida Blue plan details. Florida Blue operates multiple plan types with varying coverage policies.

Check Your Plan Type

  1. Log into your member portal at floridablue.com using your member ID
  2. Review your formulary - Givlaari is typically classified as Tier 4 specialty drug
  3. Confirm PA requirements - All Florida Blue plans require prior authorization for Givlaari
  4. Verify in-network specialty pharmacy requirements
Note: Self-insured employer plans may have different criteria than standard Florida Blue policies. Check with your HR department if unsure.

Required Forms and Documentation

Prior Authorization Request

Florida Blue processes Givlaari PA requests through their medical drug management system. Your healthcare provider must submit:

Core Documentation:

  • Completed prior authorization request form
  • Medical records confirming acute hepatic porphyria diagnosis
  • Laboratory results showing elevated porphobilinogen (PBG) or delta-aminolevulinic acid (ALA)
  • Genetic testing results confirming AHP variant
  • Documentation of attack history and frequency
  • Current weight for dosing calculations (2.5 mg/kg monthly)

Additional Requirements:

  • Letter of medical necessity from prescribing physician
  • Chart notes documenting previous treatments and failures
  • Baseline liver function tests and renal function results
  • Prescriber agreement to ongoing monitoring requirements

Coverage Exception Request Form

If Givlaari is not covered under your specific plan, use Florida Blue's Coverage Exception Request Form available through their provider portal. This form requires:

  • Medical justification for the specific medication
  • Documentation of contraindications to formulary alternatives
  • Evidence of prior treatment failures with covered options

Submission Portals and Online Access

Primary Submission Methods

Availity Portal (Preferred)

  • Healthcare providers submit requests through Availity.com
  • Fastest processing with AI review system (90% approved within seconds for straightforward cases)
  • Real-time status tracking available
  • Electronic attachment upload for supporting documents

CoverMyMeds Integration

  • Alternative electronic submission pathway
  • Links directly to Florida Blue's PA system
  • Streamlined workflow for prescribers

Required Provider Accounts

Your healthcare provider needs:

  • Active Availity account with Florida Blue access
  • NPI registration in Florida Blue's system
  • Electronic prescribing capabilities for specialty medications
Tip: Ask your doctor's office if they're set up for electronic PA submissions. This significantly speeds up the process compared to fax or mail.

Fax and Mail Submission Details

Fax Submission

Florida Blue Prior Authorization Fax: Verify current fax number through provider portal or call 1-877-719-2583

Cover Sheet Requirements:

  • Patient name and member ID
  • Prescriber NPI and contact information
  • "URGENT - Givlaari Prior Authorization Request"
  • Complete page count

Mail Submission

Physical mail submissions should be sent to the address provided in your member materials. Include all documentation in a single envelope with clear labeling.

Recommended Mail Contents:

  • Cover letter summarizing the request
  • All required forms and documentation
  • Copy of member ID card
  • Return receipt requested for tracking

Specialty Pharmacy Network Requirements

Givlaari is classified as a limited distribution drug (LDD) requiring dispensing through Florida Blue's approved specialty pharmacy network.

Network Enrollment Process

  1. Prior authorization approval must be obtained first
  2. Specialty pharmacy selection from Florida Blue's approved network
  3. Patient enrollment in chosen pharmacy's program
  4. Coordination of care between prescriber, pharmacy, and patient

Administration Requirements

  • Givlaari must be administered by a healthcare professional
  • Subcutaneous injection monthly based on patient weight
  • Ongoing monitoring for liver and kidney function required
  • Injection site rotation and reaction monitoring

Support Lines and Contact Numbers

Member Services

Primary Florida Blue Number: Check the back of your member ID card

  • General coverage questions
  • Prior authorization status checks
  • Appeals assistance
  • Specialty pharmacy network information

Prior Authorization Specific

PA Hotline: 1-877-719-2583

  • Prior authorization submissions and status
  • Medical necessity questions
  • Expedited review requests
  • Provider-to-provider consultations

Pharmacy Benefits

Prime Therapeutics: 800-424-4947

  • Specialty drug coverage questions
  • Formulary information
  • Step therapy requirements
  • Quantity limit exceptions

Florida Appeal Rights and External Review

Internal Appeal Process

Timeline: 180 days from denial notice to file internal appeal

Required Steps:

  1. Submit written appeal with additional medical documentation
  2. Request peer-to-peer review between your physician and Florida Blue medical director
  3. Include new evidence or clarification of medical necessity
  4. Track appeal status through member portal or phone

External Review Rights

Florida Department of Financial Services External Review

  • Available after internal appeal denial
  • Request deadline: 4 months from final internal denial
  • Contact: 1-877-693-5236 (1-877-MY-FL-CFO)
  • Independent medical expert review
  • Binding decision on Florida Blue

Expedited Appeals

  • Available for urgent medical situations
  • 24-hour review timeline for expedited cases
  • Can pursue internal and external review simultaneously for urgent cases

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Age 18 years or older Birth date verification Florida Blue Policy
Diagnosis Confirmed acute hepatic porphyria Elevated PBG or ALA levels + genetic testing MCG Guideline
Attack History Severe/frequent attacks or prophylactic hemin use Medical records, hospital admissions Florida Blue Policy
Prescriber Healthcare professional agreement to monitoring LFT/renal function monitoring plan Coverage Criteria
Dosing 2.5 mg/kg subcutaneously monthly Current weight documentation FDA Labeling

Common Denial Reasons and Solutions

Missing Biochemical Confirmation

Denial Reason: No documented elevated ALA or PBG levels Solution: Submit recent laboratory results showing elevated porphobilinogen or delta-aminolevulinic acid levels during or between attacks

Insufficient Attack History

Denial Reason: Lack of documented severe attacks requiring medical intervention Solution: Provide hospital records, emergency department visits, or documentation of hemin therapy for acute episodes

Concurrent Hemin Use

Denial Reason: Patient still receiving prophylactic hemin therapy Solution: Document plan to discontinue prophylactic hemin after Givlaari stabilization, or provide medical justification for continued use

Non-Specialist Prescriber

Denial Reason: Prescription not from appropriate specialist Solution: Ensure prescription comes from hematologist, hepatologist, or other physician experienced in porphyria management

When to Escalate to State Regulators

Florida Department of Financial Services

Contact DFS Consumer Services when:

  • Florida Blue fails to respond within required timeframes
  • Procedural violations in the appeal process
  • Pattern of inappropriate denials
  • Need assistance navigating external review process

Contact Information:

  • Phone: 1-877-693-5236 (1-877-MY-FL-CFO)
  • Online: File complaints at myfloridacfo.com/division/consumers
  • Services: Consumer mediation, external review coordination, insurance law enforcement

Documentation for State Complaints

Include:

  • Complete timeline of PA requests and denials
  • All correspondence with Florida Blue
  • Medical documentation supporting necessity
  • Evidence of procedural violations or delays

Manufacturer Support and Financial Assistance

Alnylam Pharmaceuticals offers patient support through their Alnylam Assist program:

  • Financial assistance for eligible patients
  • Case management support for insurance approvals
  • Clinical educator resources for healthcare providers
  • Reimbursement support specialists

Contact Alnylam Assist at alnylamassist.com or through your healthcare provider for enrollment and eligibility screening.

From Our Advocates

We've seen Florida Blue approvals come through fastest when the medical team submits a complete package upfront - genetic testing, recent PBG/ALA levels, and a clear attack timeline. One patient's approval was delayed three weeks simply because the initial submission was missing the weight-based dosing calculation. Taking time to gather everything before the first submission saves significant time on the backend.

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Givlaari. Our platform analyzes denial letters and payer policies to create targeted, evidence-backed appeals that align with Florida Blue's specific requirements. By identifying the exact denial basis—whether it's PA criteria, medical necessity, or documentation gaps—we help patients and clinicians build stronger cases for coverage approval. Learn more at counterforcehealth.org.

When facing a Givlaari denial, Counterforce Health can help analyze your specific situation and craft a point-by-point rebuttal using Florida Blue's own coverage policies and the latest clinical evidence supporting Givlaari's use in acute hepatic porphyria.

Frequently Asked Questions

How long does Florida Blue take to approve Givlaari prior authorization? Most straightforward cases receive approval within 72 hours through Florida Blue's AI review system. Complex cases requiring specialist review may take up to 14 days.

What if Givlaari isn't on my formulary? Submit a formulary exception request with medical necessity documentation. Florida Blue processes these within 72 hours for standard cases or 24 hours for expedited requests.

Can I get expedited approval for urgent cases? Yes, Florida Blue offers expedited prior authorization for urgent medical situations. Your physician must document the urgency and potential harm from delays.

What counts as sufficient attack history? Florida Blue typically requires documentation of severe attacks requiring hospitalization, emergency care, or hemin therapy. The specific frequency requirements (often 2+ attacks in 6 months) should be confirmed with your current policy.

Do I need to stop hemin before starting Givlaari? Coverage policies vary on concurrent hemin use. Some require discontinuation of prophylactic hemin, while others allow a transition period. Check your specific plan requirements.

Sources and Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage policies vary by plan and may change. Always verify current requirements with Florida Blue directly and consult with your healthcare provider about appropriate treatment options. For personalized assistance with insurance appeals and coverage issues, contact the Florida Department of Financial Services Consumer Helpline at 1-877-693-5236.

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