By Counterforce Health Team in Givlaari (givosiran) —

How to Get Givlaari (givosiran) Covered by Cigna in Florida: Complete Appeals Guide

Answer Box: Getting Givlaari (givosiran) Covered by Cigna in Florida

Cigna requires prior authorization for Givlaari (givosiran) in Florida with strict medical necessity criteria. To get approved: (1) Your specialist must document confirmed acute hepatic porphyria with elevated ALA/PBG levels and at least one attack in the past 6 months, (2) Submit via Cigna's provider portal or fax with complete clinical documentation, and (3) If denied, you have 180 days to appeal internally, then request external review through Florida's Department of Financial Services. Start today by asking your porphyria specialist to gather your attack history and lab results.

Table of Contents

Cigna's Coverage Policy Overview

Cigna covers Givlaari (givosiran) as a specialty medication requiring prior authorization across all plan types in Florida—HMO, PPO, and Medicare Advantage. The drug is typically managed through Express Scripts specialty pharmacy network, though most Florida plans require provider administration rather than home delivery.

Key policy details:

  • Initial approval: Up to 6 months
  • Renewal: Up to 12 months with documented clinical benefit
  • Plan types affected: All commercial and Medicare Advantage plans
  • Formulary status: Specialty tier with prior authorization required
Note: Always verify your specific plan's formulary and coverage policies, as employer groups may have variations from standard Cigna policies.

Medical Necessity Requirements

Cigna requires strict adherence to FDA-approved indications and specific clinical criteria for Givlaari coverage:

Core Requirements

  • Age: Patient must be 18 years or older
  • Diagnosis: Confirmed acute hepatic porphyria (any subtype: acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, or ALA dehydratase deficiency)
  • Prescriber: Must be prescribed by or in consultation with a porphyria specialist
  • Attack history: At least one documented porphyria attack in the past 6 months requiring hospitalization, urgent care, or IV hemin

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior authorization Pre-approval required Complete PA form with clinical notes Cigna PA Policy
Specialist involvement Porphyria expert consultation Specialist consultation notes Coverage Position Criteria
Attack documentation Recent severe symptoms Hospital records, ER visits, hemin use Medical Policy
Lab confirmation Elevated ALA/PBG levels Urine or plasma lab results Diagnostic Guidelines

Step Therapy and Exceptions

Unlike many specialty medications, Givlaari typically doesn't require step therapy through other prophylactic treatments, as it's the only FDA-approved chronic preventive therapy for acute hepatic porphyria. However, Cigna may require documentation of:

Previous treatments tried:

  • Hemin (Panhematin) for acute attacks
  • Trigger avoidance strategies
  • Supportive care measures

Medical exceptions are available if standard criteria aren't met but clinical need is documented. Your specialist should include:

  • Reasons why alternative approaches are insufficient
  • Clinical rationale for Givlaari specifically
  • Expected outcomes and monitoring plan

Quantity and Frequency Limits

Cigna's quantity limits for Givlaari align with FDA dosing guidelines:

  • Maximum dose: 2.5 mg/kg subcutaneously
  • Frequency: Once every 30 days (monthly)
  • Supply limit: Up to 2 vials per month (based on patient weight)
  • Renewal criteria: Documented reduction in attack frequency or severity

For renewal approval, your specialist must demonstrate:

  • Decreased number of porphyria attacks
  • Reduced need for hemin therapy
  • Improved quality of life measures
  • Acceptable safety profile

Required Diagnostics and Documentation

Proper documentation is crucial for Givlaari approval. Cigna requires specific lab values and clinical evidence:

Essential Lab Work

  • Urine porphobilinogen (PBG): Must be elevated above normal (>4 mg/day or mg/L)
  • Urine aminolevulinic acid (ALA): Typically 20-200 mg/L during attacks
  • Timing: Labs should be from within the past year, ideally during or shortly after symptoms

Clinical Documentation Checklist

✓ Confirmed AHP diagnosis with genetic testing (if available)
✓ Attack history with dates, symptoms, and treatments
✓ Hospital records or ER visits for acute episodes
✓ Previous hemin use documentation
✓ Specialist consultation notes
✓ Current symptoms and functional impact
✓ Treatment goals and monitoring plan

Tip: Keep copies of all porphyria-related lab results. Emergency departments often need this information, and it strengthens future authorization requests.

Site of Care and Specialty Pharmacy Rules

Critical for Florida patients: Most Cigna plans in Florida require Givlaari to be administered in a healthcare provider setting, not delivered through specialty pharmacies like Accredo or Express Scripts for home use.

Provider Administration Requirements

  • Must be given in clinic, hospital outpatient, or infusion center
  • Provider must "buy and bill" through medical benefit
  • Patient cannot receive drug directly for home injection
  • Monthly administration visits required

Specialty Pharmacy Limitations

According to current Florida policies, Givlaari is generally excluded from home delivery through:

  • Accredo specialty pharmacy
  • Express Scripts specialty pharmacy
  • Other mail-order specialty services

Exception: Some specific plan designs may allow specialty pharmacy access—always verify with your individual plan benefits.

Evidence to Support Medical Necessity

When submitting appeals or initial requests, include evidence-based support for Givlaari therapy:

Key Clinical References

  • FDA prescribing information for approved indication
  • American Gastroenterological Association practice update on acute hepatic porphyria
  • Porphyria Foundation emergency guidelines for healthcare professionals
  • Peer-reviewed studies on givosiran efficacy in reducing attack frequency

Clinician Corner: Medical Necessity Letter Checklist

Problem statement: Clearly describe AHP diagnosis and impact on patient's life
Prior treatments: Document hemin use, hospitalizations, and inadequate control
Clinical rationale: Explain why Givlaari is medically necessary for this patient
Guideline support: Reference FDA approval and clinical evidence
Dosing plan: Specify weight-based dosing and administration schedule
Monitoring: Outline safety monitoring and efficacy assessment plan

Sample Medical Necessity Narrative

"This 35-year-old patient has genetically confirmed acute intermittent porphyria with recurrent severe attacks. Over the past 8 months, she has experienced 3 attacks requiring hospitalization and IV hemin administration (dates: [specific dates]). Urinary PBG levels during her most recent attack were 150 mg/L (normal <4 mg/L). Despite trigger avoidance and supportive care, attacks continue to significantly impact her quality of life and work capacity. Givlaari (givosiran) is FDA-approved for adults with AHP to reduce attack frequency and is the only chronic prophylactic therapy available. The requested dose of 2.5 mg/kg monthly aligns with FDA labeling. Expected outcomes include reduced attack frequency and decreased need for emergency hemin therapy."

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Insufficient attack history Provide detailed records of all attacks in past 12 months Hospital records, ER visits, hemin administration logs
Missing lab confirmation Submit elevated ALA/PBG results Urine or plasma porphyrin studies with reference ranges
Non-specialist prescriber Obtain porphyria specialist consultation Consultation notes from hepatologist, geneticist, or porphyria center
Lack of medical necessity Strengthen clinical narrative with guidelines FDA label, AGA guidelines, peer-reviewed studies
Incorrect dosing request Verify weight-based calculation Patient weight, dosing calculation, FDA dosing table

Florida Appeals Process

If Cigna denies your Givlaari request, Florida law provides specific appeal rights and timelines:

Step 1: Internal Appeal (First Level)

  • Timeline: 180 days from denial notice to file
  • How to file: Written appeal to Cigna (address in denial letter)
  • Decision timeframe: 30 days for standard, 72 hours for expedited
  • Required: Denial letter, additional clinical evidence, prescriber support

Step 2: Internal Appeal (Second Level)

  • Timeline: Available if first level is denied
  • Process: Automatic or upon request (check your plan)
  • Decision timeframe: Similar to first level

Step 3: External Review

  • When available: After exhausting internal appeals
  • Timeline: 4 months after final internal denial to request
  • How to request: Through Florida Department of Financial Services
  • Cost: Free to consumer
  • Decision timeframe: 45 days standard, 72 hours expedited
Important: For urgent medical situations, you can request expedited appeals and may be able to pursue external review simultaneously with internal appeals.

Contact Information for Appeals

  • Cigna Customer Service: Number on your insurance card
  • Florida Insurance Consumer Helpline: 1-877-MY-FL-CFO (1-877-693-5236)
  • External Review Request: Submit through Florida DFS consumer portal

Costs and Patient Assistance

Givlaari's high cost (approximately $575,000 annually) makes patient assistance crucial:

Financial Support Options

  • Alnylam Assist: Manufacturer's patient support program offering copay assistance and financial aid
  • Foundation grants: National Organization for Rare Disorders (NORD), HealthWell Foundation
  • State programs: Florida may have additional rare disease support programs

For detailed assistance information, visit Alnylam Assist or speak with your specialty pharmacy coordinator.

FAQ

How long does Cigna prior authorization take in Florida?
Standard reviews take up to 72 hours, while expedited reviews for urgent cases are completed within 24 hours.

What if Givlaari is non-formulary on my plan?
You can request a formulary exception through Cigna's standard process, requiring your physician to certify that formulary alternatives are inappropriate.

Can I request an expedited appeal?
Yes, if your health condition could be seriously jeopardized by delays, you can request expedited internal and external reviews.

Does step therapy apply if I've used hemin outside Florida?
Previous hemin use anywhere should count toward meeting Cigna's criteria, but ensure all documentation is submitted with your request.

What happens if my appeal is successful?
Cigna must authorize coverage and reimburse any covered services you paid for during the appeal process.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-based advocacy. Our platform analyzes denial letters and insurance policies to create targeted appeals that address each payer's specific requirements, helping patients access life-changing medications like Givlaari more efficiently.

When navigating complex prior authorization requirements, having expert support can make the difference between denial and approval. Counterforce Health specializes in transforming insurance obstacles into clear pathways to treatment access.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for specific coverage determinations. For official Florida insurance regulations and appeal procedures, contact the Florida Department of Financial Services.

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