By Counterforce Health Team in Turalio (pexidartinib) —

How to Get Turalio (Pexidartinib) Covered by Blue Cross Blue Shield in Florida: Complete Appeals Guide with Templates

Answer Box: Quick Path to Turalio Coverage

To get Turalio (pexidartinib) covered by Blue Cross Blue Shield in Florida: 1) Ensure complete REMS enrollment (prescriber, patient, pharmacy), 2) Submit prior authorization with TGCT diagnosis documentation and surgical contraindications, 3) If denied, file internal appeal within 180 days with medical necessity letter. For external review, contact Florida DFS at 1-877-693-5236 within 4 months of final denial. Florida Blue requires prior authorization for specialty medications like Turalio.

Table of Contents

Understanding Your Denial Letter

When Blue Cross Blue Shield denies Turalio coverage, your denial letter contains critical information you'll need for appeals. Look for these key elements:

Decode the denial reason:

  • Prior authorization missing: You need pre-approval before filling the prescription
  • Not medically necessary: The plan questions whether Turalio is appropriate for your condition
  • Step therapy required: You must try other medications first
  • Non-formulary: Turalio isn't on your plan's preferred drug list
  • Quantity limits exceeded: The requested amount exceeds plan limits

Extract important deadlines:

  • Internal appeal deadline (typically 180 days from denial notice)
  • Expedited review options for urgent cases
  • External review timeframes (4 months after final internal denial in Florida)
Tip: Florida Blue processes specialty drug appeals differently depending on whether Turalio falls under your pharmacy benefit or medical benefit. Check your denial letter to confirm which department is handling your case.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Pre-approval required before dispensing Florida Blue ValueScript Guide Florida Blue
REMS Enrollment All parties must complete safety program Turalio REMS Program FDA/Daiichi Sankyo
TGCT Diagnosis Symptomatic, not amenable to surgery Medical records, imaging Clinical documentation
Specialty Pharmacy Must use certified network pharmacy Member portal or customer service Plan-specific
Liver Monitoring Baseline and ongoing LFTs required Lab results, monitoring plan FDA Label

Step-by-Step: Fastest Path to Approval

1. Complete REMS Enrollment (All Parties)

Who: Prescriber, patient, and pharmacy Documents needed: REMS enrollment forms, training completion Timeline: Must be completed before first prescription Submit via: Turalio REMS website

2. Gather Clinical Documentation

Who: Your healthcare team Documents needed:

  • TGCT diagnosis with imaging
  • Documentation of surgical contraindications
  • Baseline liver function tests
  • Previous treatment history Timeline: Before prior authorization submission

3. Submit Prior Authorization Request

Who: Prescribing physician or clinic staff Documents needed: PA form, clinical notes, lab results Submit via: Florida Blue provider portal or fax (verify current number with plan) Timeline: Allow 72 hours for standard review, 24 hours for expedited

4. Monitor Decision and Prepare for Appeals

Who: Patient and clinical team Timeline: Track deadlines from denial notice Next step: If denied, proceed to internal appeal within 180 days

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Missing TGCT diagnosis Submit pathology report and imaging Biopsy results, MRI/CT scans
Surgical options not addressed Document contraindications to surgery Surgeon's note, imaging showing inoperability
REMS enrollment incomplete Complete all program requirements REMS certificates for all parties
Liver monitoring gaps Provide monitoring plan and baseline labs LFT results, monitoring schedule
"Not medically necessary" Submit comprehensive medical necessity letter Clinical guidelines, failed treatments
From our advocates: We've seen denials overturned when providers clearly document why surgery would cause "severe morbidity or functional limitations" – the exact FDA language for Turalio's indication. Include specific functional assessments and surgical risk factors in your appeal.

Appeals Playbook for Florida Blue

Internal Appeal Process

Deadline: 180 days from denial notice Submit to: Address on denial letter or member/provider portal Required documents:

  • Completed appeal form
  • Medical necessity letter
  • Supporting clinical documentation
  • Copy of original denial letter

Timeline:

  • Standard review: 72 hours for future treatments
  • Expedited review: 24 hours for urgent cases

When Internal Appeals Fail

If Florida Blue upholds the denial after internal review, you have two options:

  1. External Review through Florida Department of Financial Services
  2. Formulary Exception request (if applicable)

Medical Necessity Letter Template

[Date]
[Florida Blue Medical Review Department]
[Address from denial letter]

RE: Appeal for Turalio® (pexidartinib) Coverage
Patient: [Full Name] | DOB: [MM/DD/YYYY]
Policy: [Number] | Member ID: [Number]
Diagnosis: Tenosynovial Giant Cell Tumor (ICD-10: D48.1)

Dear Medical Review Team,

I am appealing the denial of coverage for Turalio (pexidartinib) for my patient with symptomatic, diffuse tenosynovial giant cell tumor (TGCT). This medication is medically necessary and appropriate based on FDA approval and clinical guidelines.

**Clinical Background:**
[Patient name] has been diagnosed with diffuse TGCT affecting [location]. Imaging studies demonstrate [describe findings]. The patient experiences significant functional limitations including [specific symptoms and limitations].

**Why Surgery Is Contraindicated:**
Surgical resection is not appropriate for this patient because [specific reasons: diffuse disease, high risk of functional loss, previous surgical failures, anatomical considerations]. Attempting surgery would result in severe morbidity and functional limitations, precisely the patient population for whom Turalio was approved by the FDA.

**Medical Necessity:**
Turalio is FDA-approved specifically for "adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery." This patient meets these exact criteria.

**REMS Compliance:**
All REMS program requirements have been completed:
- Prescriber enrollment and training: [date]
- Patient enrollment and counseling: [date]  
- Certified pharmacy identified: [pharmacy name]
- Baseline liver function tests: [date and results]
- Monitoring plan established per FDA requirements

**Supporting Documentation Attached:**
- Diagnostic imaging reports
- Pathology report confirming TGCT
- Functional assessment
- Baseline laboratory results
- REMS enrollment confirmations
- FDA prescribing information

Without Turalio therapy, this patient faces progressive functional decline and continued morbidity. I respectfully request reconsideration of this denial and approval of Turalio coverage.

Sincerely,
[Physician Name, Credentials]
[Contact Information]

Peer-to-Peer Appeal Process

If your initial prior authorization is denied, your prescriber can request a peer-to-peer review with Florida Blue's medical director.

How to Schedule:

  1. Call the number provided in your denial letter
  2. Request a peer-to-peer review
  3. Provide your availability within normal business hours

Preparation Checklist:

  • Review patient's complete medical history
  • Have imaging and lab results readily available
  • Prepare talking points about surgical contraindications
  • Reference FDA labeling and clinical guidelines
  • Document the call date, time, and outcome

Key Talking Points:

  • Emphasize FDA-approved indication matches patient exactly
  • Highlight completed REMS requirements
  • Explain specific surgical contraindications
  • Reference baseline liver function and monitoring plan

External Review in Florida

If Florida Blue denies your internal appeal, you can request an external review through the Florida Department of Financial Services.

Eligibility: Must complete all internal appeals first (unless expedited) Deadline: Within 4 months (120 days) of final internal denial Cost: Free to consumers Contact: Florida DFS at 1-877-693-5236 or [email protected]

Required Documents:

  • Copy of final denial letter
  • All appeal correspondence
  • Medical records supporting necessity
  • External review request form

Timeline: Decision typically within 45 days (72 hours for expedited cases)

Note: External review decisions are binding on the insurance company. If the independent reviewer determines Turalio is medically necessary, Florida Blue must provide coverage.

Cost Assistance Programs

Even with insurance coverage, Turalio can be expensive. Several programs may help reduce your costs:

Daiichi Sankyo Patient Support:

  • DS Access Central provides coverage support and patient assistance
  • Financial assistance may be available for eligible patients

Specialty Pharmacy Benefits:

  • Many Florida Blue plans include specialty pharmacy programs with reduced copays
  • Contact member services to confirm your specific benefits

Foundation Grants:

  • Various patient advocacy organizations offer grants for rare disease medications
  • Check eligibility requirements and application deadlines

FAQ

How long does Florida Blue prior authorization take? Standard reviews: 72 hours. Expedited reviews for urgent cases: 24 hours. The clock starts when Florida Blue receives your complete request with all required documentation.

What if Turalio isn't on my formulary? You can request a formulary exception. Your doctor must demonstrate medical necessity and explain why formulary alternatives aren't appropriate for your condition.

Can I get an expedited appeal? Yes, if waiting for standard review would seriously jeopardize your health. Your doctor must document the urgency and request expedited processing.

Does step therapy apply to Turalio? Some Florida Blue plans require trying other treatments first. However, if those treatments are contraindicated or have failed, your doctor can request a step therapy override.

What happens if I start Turalio before approval? You'll be responsible for the full cost (~$23,850 for a 28-day supply). Always wait for approval unless your doctor determines it's medically urgent.

How do I find a REMS-certified pharmacy? Contact the Turalio REMS program or ask your prescriber for a list of certified pharmacies in your area.

Can I appeal if I live in Florida but have a different Blue Cross plan? Appeal rights vary by specific Blue Cross plan. Check your member handbook or contact your plan directly for appeals procedures.

What if my doctor isn't familiar with the appeals process? Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform identifies denial reasons and drafts point-by-point rebuttals aligned to your plan's specific requirements.

About Counterforce Health: Counterforce Health specializes in helping patients overcome insurance barriers for specialty medications like Turalio. The platform ingests denial letters and plan policies to create targeted appeals that address specific denial reasons with evidence-backed rebuttals. By identifying whether denials stem from prior authorization criteria, step therapy requirements, or medical necessity determinations, Counterforce Health helps clinicians submit cleaner appeals that reduce back-and-forth with insurers and improve approval rates.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance appeals and is not medical advice. Coverage policies vary by specific plan and individual circumstances. Always consult your healthcare provider about treatment decisions and contact your insurance plan directly for the most current coverage information and appeal procedures. For additional help with insurance issues in Florida, contact the Florida Department of Financial Services Consumer Helpline at 1-877-693-5236.

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