By Counterforce Health Team in Fintepla (fenfluramine) —

Get Fintepla (Fenfluramine) Covered by Blue Cross Blue Shield in North Carolina: Complete Guide

Answer Box: Getting Fintepla Approved by BCBS North Carolina

Fintepla (fenfluramine) is covered by Blue Cross Blue Shield North Carolina but requires prior authorization and REMS enrollment. Here's your fastest path to approval:

  1. Enroll in REMS program - Both patient and prescriber must complete enrollment at FinteplarREMS.com with baseline echocardiogram
  2. Submit prior authorization - Include diagnosis documentation (Dravet/LGS), failed prior medications, and REMS certificates
  3. If denied, appeal within 180 days - Use North Carolina's external review through Smart NC for binding decisions

First step today: Contact your prescriber to begin REMS enrollment and gather documentation of previous anti-seizure medication trials.

Table of Contents

  1. Understanding BCBS Coverage for Fintepla
  2. REMS Program Requirements
  3. Prior Authorization Process
  4. Common Denial Reasons & Solutions
  5. Appeals Process in North Carolina
  6. Medical Necessity Letter Guide
  7. Cost and Financial Assistance
  8. FAQ
  9. Sources & Further Reading

Understanding BCBS Coverage for Fintepla

Blue Cross Blue Shield North Carolina covers Fintepla (fenfluramine) as a specialty medication on their 2024 formularies, but with significant restrictions. The drug appears on both 4-tier and 5-tier formularies with the following requirements:

  • Prior authorization required
  • Specialty tier placement (higher copays)
  • Quantity limits
  • Limited distribution (specialty pharmacy only)
  • Restricted access criteria

Coverage at a Glance

Requirement Details Where to Find
Prior Authorization Yes, required before dispensing BCBS NC Provider Portal
Formulary Tier Specialty (Tier 4 or 5) 2024 BCBS NC Formulary
REMS Program Mandatory enrollment FinteplarREMS.com
Specialty Pharmacy Limited distribution network Contact BCBS member services
Age Restrictions Per FDA labeling (2+ years) FDA Label

REMS Program Requirements

Before any prior authorization can be approved, both patient and prescriber must enroll in the Fintepla REMS program due to cardiac safety concerns.

Required Steps:

  1. Baseline Echocardiogram
    • Must be completed before starting Fintepla
    • Results submitted to REMS program
    • Required for insurance documentation
  2. REMS Enrollment
    • Prescriber certification at FinteplarREMS.com
    • Patient enrollment and education
    • Pharmacy must be REMS-certified
  3. Ongoing Monitoring
    • Echocardiogram every 6 months during treatment
    • Final echo 3-6 months after discontinuation
    • All results reported to REMS program
Note: Insurance prior authorization requests will be denied without proof of REMS enrollment and baseline echocardiogram completion.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Caregiver)

  • Insurance card and member ID
  • Complete list of previous anti-seizure medications tried
  • Dates of treatment and reasons for discontinuation
  • Recent seizure logs or frequency records

2. Schedule Baseline Echo (Prescriber)

  • Order echocardiogram before PA submission
  • Ensure results are normal or acceptable for Fintepla
  • Submit echo results to REMS program

3. Complete REMS Enrollment (Prescriber + Patient)

  • Prescriber completes certification online
  • Patient completes enrollment and education modules
  • Obtain REMS enrollment certificates

4. Submit Prior Authorization (Prescriber)

  • Use BCBS provider portal or fax submission
  • Include all required documentation (see checklist below)
  • Expect 5-10 business day review period

5. Follow Up (Clinic Staff)

  • Track submission status via provider portal
  • Respond promptly to any requests for additional information
  • Prepare for potential peer-to-peer review

Prior Authorization Checklist

  • Completed PA form with patient demographics
  • Diagnosis documentation (ICD-10: G40.833 for Dravet, G40.812 for LGS)
  • Previous medication trial history with dates and outcomes
  • REMS enrollment certificates (prescriber and patient)
  • Baseline echocardiogram results
  • Clinical notes supporting medical necessity
  • Seizure frequency documentation

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing REMS enrollment Complete enrollment before resubmission REMS certificates for prescriber and patient
Insufficient diagnosis documentation Provide detailed clinical notes EEG results, genetic testing (if available), developmental assessments
Step therapy not met Document failed trials of preferred ASMs Medication history with dates, doses, duration, and reasons for discontinuation
Missing echocardiogram Submit baseline cardiac evaluation Echo report showing acceptable cardiac function
Quantity limit exceeded Justify dosing based on weight/clinical need Weight-based dosing calculation, clinical rationale

From Our Advocates

We've seen cases where initial denials were overturned simply by including a comprehensive medication trial history. One family's appeal succeeded after documenting that their child had tried six different anti-seizure medications over two years, with clear documentation of seizure frequency before, during, and after each trial. The key was showing not just that medications were tried, but how they specifically failed to control seizures.

Appeals Process in North Carolina

North Carolina offers robust consumer protections for insurance denials through the Smart NC program within the Department of Insurance.

Internal Appeals (First Step)

Timeline: Must appeal within 180 days of denial notice Process: Submit appeal through BCBS member portal or by mail Decision: BCBS has 30 days for standard appeals, 72 hours for urgent

External Review (Final Step)

If your internal appeal is denied, you have 120 days to request external review through Smart NC.

Contact Smart NC:

External Review Process:

  1. Submit external review request form
  2. Smart NC assigns Independent Review Organization (IRO)
  3. Standard review: 45 days for decision
  4. Expedited review: 72 hours for urgent cases
  5. IRO decision is binding on BCBS
Tip: Smart NC provides free advocacy and can help you gather supporting documentation for your external review.

Medical Necessity Letter Guide

A strong medical necessity letter is crucial for approval. Here's what your prescriber should include:

Essential Components

Patient Information & Diagnosis

  • Full name, DOB, insurance ID
  • Primary diagnosis with ICD-10 code
  • Date of diagnosis and clinical course
  • Current seizure frequency and severity

Treatment History

  • Chronological list of previous anti-seizure medications
  • Duration of each trial and maximum dose reached
  • Reason for discontinuation (lack of efficacy, side effects)
  • Current medications and their limitations

Clinical Rationale for Fintepla

  • FDA approval for patient's specific condition
  • Expected clinical benefits based on trial data
  • Risk-benefit assessment
  • Plan for monitoring and follow-up

Supporting Evidence

  • Reference to FDA labeling
  • Cite relevant clinical studies
  • Include professional guidelines if applicable
  • Attach seizure logs or EEG reports

Sample Letter Opening

"I am writing to request prior authorization for Fintepla (fenfluramine) for my patient, [Name], who has treatment-resistant Dravet syndrome (ICD-10: G40.833). Despite trials of multiple anti-seizure medications over [timeframe], [Name] continues to experience [seizure frequency] with significant impact on quality of life and development..."

Cost and Financial Assistance

Fintepla's typical cash price is approximately $1,595 for a 30-mL bottle, but several assistance programs can help reduce costs:

Manufacturer Support

  • UCB Patient Assistance Program: Income-based free drug program
  • Commercial Insurance Copay Card: May reduce copays for eligible patients
  • Contact: Fintepla.com

Foundation Grants

  • Patient Advocate Foundation: Copay relief program
  • HealthWell Foundation: Disease-specific grants
  • Good Days: Chronic disease assistance

State Programs

  • North Carolina Medicaid: Coverage available with expansion (2024)
  • 340B Program: Reduced-cost medications through qualifying health centers

If you're struggling with coverage or appeals, Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, targeted rebuttals that align with each payer's specific criteria. Their platform helps identify denial reasons and drafts point-by-point responses using the right clinical evidence and procedural requirements.

FAQ

How long does BCBS prior authorization take in North Carolina? Standard prior authorizations take 5-10 business days. Urgent requests must be processed within 72 hours.

What if Fintepla isn't on my specific BCBS formulary? You can request a formulary exception with documentation of medical necessity and failed alternatives.

Can I get an expedited appeal if my child is having frequent seizures? Yes, both internal appeals and external reviews can be expedited for urgent medical situations in North Carolina.

Does step therapy apply if we tried medications in another state? Yes, medication trials from any licensed prescriber should count toward step therapy requirements.

What happens if the external review is denied? The IRO's decision is final for administrative appeals, though you may have other legal rights to pursue.

How often do external reviews succeed in North Carolina? While specific statistics vary, North Carolina's external review program has successfully overturned many denials for specialty medications with proper documentation.

Do I need a specialty pharmacy for Fintepla? Yes, Fintepla requires limited distribution through REMS-certified specialty pharmacies only.

What if my prescriber isn't familiar with the REMS program? Direct them to FinteplarREMS.com for enrollment and training materials.

Sources & Further Reading

For additional support with complex appeals and prior authorizations, Counterforce Health offers specialized assistance in navigating payer-specific requirements and creating compelling medical necessity documentation.

Disclaimer: This information is for educational purposes only and is not medical advice. Coverage policies and requirements may change. Always verify current information with your insurance plan and healthcare providers. For personalized assistance with your specific situation, consult with your healthcare team and consider contacting Smart NC at 1-855-408-1212.

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