By Counterforce Health Team in Fintepla (fenfluramine) —

How to Get Fintepla (fenfluramine) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Prior Authorization Guide

Answer Box: Getting Fintepla Covered by Blue Cross Blue Shield in Pennsylvania

Blue Cross Blue Shield plans in Pennsylvania require prior authorization for Fintepla (fenfluramine) with specific REMS program enrollment and cardiac monitoring documentation. The fastest path to approval involves: (1) completing REMS enrollment with baseline echocardiogram, (2) documenting diagnosis of Dravet syndrome or Lennox-Gastaut syndrome, and (3) showing failed trials of preferred anti-seizure medications. If denied, Pennsylvania's new external review program has overturned roughly 50% of denials in 2024. Start today by verifying your specific Blue Cross Blue Shield plan's formulary status and gathering prior therapy documentation.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. REMS Program & Cardiac Monitoring
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Reasons & How to Fix Them
  10. Pennsylvania Appeals Process
  11. Costs & Patient Assistance
  12. Frequently Asked Questions

Who Should Use This Guide

This guide helps patients with Dravet syndrome or Lennox-Gastaut syndrome (LGS) and their healthcare providers navigate Blue Cross Blue Shield prior authorization for Fintepla in Pennsylvania. You'll need this if:

  • Your neurologist has prescribed Fintepla for treatment-resistant seizures
  • You have Blue Cross Blue Shield coverage in Pennsylvania (including Highmark Blue Shield or Independence Blue Cross)
  • You've received a denial or want to avoid common approval pitfalls
  • You're preparing for a potential appeal

Expected outcome: With proper documentation, most medically appropriate Fintepla requests can achieve approval, either initially or through the appeals process.

Member & Plan Basics

Coverage Requirements

  • Active Blue Cross Blue Shield coverage in Pennsylvania
  • Prescription drug benefits that include specialty medications
  • Meeting your plan's deductible requirements (if applicable)

Plan Types in Pennsylvania

  • Highmark Blue Shield (western/central PA) - requires electronic submission via Availity Essentials
  • Independence Blue Cross (Philadelphia region) - may require step therapy documentation
  • Medicare Advantage Blue plans - follow Medicare Part D guidelines with Blue-specific requirements
Note: Self-funded employer plans may have different requirements and aren't covered by Pennsylvania's external review program.

Clinical Criteria Requirements

Approved Indications

Fintepla is FDA-approved for:

  • Dravet syndrome (seizures associated with)
  • Lennox-Gastaut syndrome (seizures associated with)

Step Therapy Requirements

Most Blue Cross Blue Shield plans require documentation of:

Previous Medication Required Documentation
Clobazam Trial duration, dosing, reason for discontinuation
Valproate Efficacy/tolerability issues, contraindications
Stiripentol Previous use in Dravet syndrome specifically
Cannabidiol (Epidiolex) Trial results, side effects

Dosing Documentation

  • Weight-based dosing per FDA labeling
  • Starting dose: 0.1 mg/kg twice daily
  • Maximum dose: 0.7 mg/kg twice daily (26 mg/day maximum)

REMS Program & Cardiac Monitoring

Required REMS Enrollment

Before Blue Cross Blue Shield will approve Fintepla, you must complete enrollment in the FINTEPLA REMS program:

  1. Prescriber certification - Healthcare provider completes training
  2. Patient enrollment form - Submit with baseline cardiac assessment
  3. Pharmacy certification - Only REMS-certified pharmacies can dispense

Echocardiography Requirements

  • Baseline echocardiogram before starting treatment
  • Every 6 months during treatment
  • 3-6 months after discontinuation
  • Submit all ECHO results to REMS program and include in prior authorization
Critical: Blue Cross Blue Shield requires proof of REMS enrollment and baseline ECHO results for approval.

Documentation Packet

Provider Letter of Medical Necessity Must Include:

  • Confirmed diagnosis with ICD-10 codes (G40.83 for Dravet, G40.81 for LGS)
  • Previous anti-seizure medication trials with specific drugs, doses, durations, and outcomes
  • Current seizure frequency and impact on daily functioning
  • Clinical rationale for Fintepla based on FDA labeling
  • Cardiac monitoring plan and REMS compliance confirmation

Required Attachments:

  • REMS enrollment confirmation
  • Baseline echocardiogram report
  • Medical records documenting diagnosis
  • Prior medication trial documentation
  • Current seizure diary or clinical notes

Submission Process

Highmark Blue Shield (Western/Central PA)

  • Electronic submission required via Availity Essentials
  • Processing time: Approximately 1 day for most requests
  • Status checking: Through Availity portal

Independence Blue Cross (Philadelphia)

  • Submit through IBX provider portal
  • Formulary exception process if step therapy requirements not met
  • 72-hour review for exception requests with supporting documentation

Common Rejection Reasons:

  • Missing REMS enrollment documentation
  • Incomplete echocardiogram results
  • Insufficient prior medication trial documentation
  • Wrong diagnosis codes or missing clinical notes

Specialty Pharmacy Requirements

Fintepla is only available through certified specialty pharmacies. Blue Cross Blue Shield preferred vendors typically include:

  • Accredo Specialty Pharmacy
  • BioPlus Specialty Pharmacy
  • AllianceRx Walgreens Prime
Tip: Verify your plan's preferred specialty pharmacy network before approval to avoid delays.

Billing Information:

  • HCPCS Code: J3490 (unclassified drug)
  • NDC: 70176-0033-01 (submit as 70176003301)
  • Unit: ML (milliliters)

After Submission: What to Expect

Timeline for Decisions:

  • Standard review: 3-5 business days
  • Expedited review: 24-72 hours (if urgent medical need)
  • Complex cases: Up to 14 days

Status Monitoring:

  1. Confirmation number - Record for tracking
  2. Check status every 2-3 business days
  3. Provider communication - Ensure clinic has current contact information

Common Denial Reasons & How to Fix Them

Denial Reason How to Fix
Missing REMS documentation Submit REMS enrollment confirmation and ECHO results
Insufficient prior trials Provide detailed medication history with specific reasons for failure
Not medically necessary Include seizure frequency data and functional impact documentation
Step therapy not completed Request step therapy exception with contraindication documentation
Diagnosis not supported Submit genetic testing results (for Dravet) or EEG findings

Pennsylvania Appeals Process

If your initial request is denied, Pennsylvania offers multiple appeal levels:

Internal Appeals (Required First Step)

  • Timeline: 30 days from denial date
  • Standard review: 30 days for decision
  • Expedited review: 72 hours for urgent cases
  • Submit to: Your specific Blue Cross Blue Shield plan's appeals department

Pennsylvania External Review (New 2024 Program)

After exhausting internal appeals, you can request a state external review:

  • Success rate: Approximately 50% of denials overturned in 2024
  • Timeline: File within 4 months of final denial
  • Process: Pennsylvania Insurance Department External Review
  • Cost: Free to consumers
  • Decision binding: Insurers must comply with favorable decisions
From our advocates: "We've seen several cases where patients received Fintepla coverage after external review, even when internal appeals failed. The key was providing comprehensive seizure logs and demonstrating how previous medications either failed or caused intolerable side effects. Pennsylvania's independent reviewers tend to focus heavily on medical necessity and FDA-approved indications."

Getting Help with Appeals:

  • Pennsylvania Insurance Department Consumer Services: 1-877-881-6388
  • Pennsylvania Health Law Project: Free assistance for complex appeals
  • Counterforce Health: Specialized platform that helps turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned to your plan's specific requirements.

Costs & Patient Assistance

Typical Costs:

  • Cash price: Approximately $1,595 for 30-mL bottle (varies by pharmacy)
  • With insurance: Depends on formulary tier and deductible

Financial Assistance Options:

  • UCB Patient Assistance Program: Fintepla.com patient resources
  • Copay assistance: May be available for commercially insured patients
  • Foundation grants: Epilepsy Foundation and similar organizations

Frequently Asked Questions

How long does Blue Cross Blue Shield prior authorization take in Pennsylvania? Standard processing is 3-5 business days for Highmark and up to 72 hours for Independence Blue Cross exception requests. Expedited reviews are available for urgent medical needs.

What if Fintepla is not on my formulary? You can request a formulary exception by providing clinical documentation showing medical necessity and why formulary alternatives are inappropriate.

Can I get an expedited appeal if my child is having frequent seizures? Yes, both internal and external appeals offer expedited review processes. Document the urgent medical need and seizure frequency in your request.

Does step therapy apply if we've tried medications outside Pennsylvania? Yes, medication trials from other states count toward step therapy requirements. Provide complete documentation from previous providers.

What happens if Pennsylvania's external review finds in my favor? The insurer must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal process.

How do I know if my Blue Cross Blue Shield plan is self-funded? Check your insurance card or contact member services. Self-funded employer plans aren't subject to Pennsylvania insurance regulations and have different appeal processes.

Checklist: Before You Start

  • Insurance card with member ID
  • Confirmed diagnosis of Dravet syndrome or LGS
  • Complete list of previous anti-seizure medications tried
  • Baseline echocardiogram scheduled/completed
  • REMS program enrollment initiated
  • Contact information for prescribing neurologist
  • Recent seizure logs or clinical notes

Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals that align with your plan's own rules, significantly improving approval rates for specialty medications like Fintepla.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with your specific Blue Cross Blue Shield plan and consult with your healthcare provider for medical decisions. For personalized assistance with complex cases, consider consulting with insurance advocacy services or legal professionals specializing in healthcare coverage.

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