By Counterforce Health Team in Enhertu (fam-trastuzumab deruxtecan-nxki) —

How to Get Enhertu Covered by Blue Cross Blue Shield in Florida: Complete PA Guide & Appeal Templates

Answer Box: Getting Enhertu Covered by Florida Blue Cross Blue Shield

Fast Track to Approval: Florida Blue requires prior authorization for Enhertu (fam-trastuzumab deruxtecan-nxki) with HER2-positive documentation and proof of prior trastuzumab-based therapy failure. Your first step today: Have your oncologist submit a PA request through Availity.com with complete HER2 testing results and treatment history. Standard approval takes 72 hours; expedited reviews for urgent cases take 24 hours. If denied, you have 180 days to appeal internally, then 4 months for external review through Florida's Department of Financial Services at 1-877-693-5236.

Table of Contents

  1. Florida Blue Plan Types & Coverage Impact
  2. Enhertu Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Specialty Pharmacy Network Requirements
  5. Cost-Share Considerations
  6. Step-by-Step: Fastest Path to Approval
  7. Common Denial Reasons & Solutions
  8. Appeals Process for Florida Blue
  9. When to Escalate to State Review
  10. FAQ: Your Top Questions Answered

Plan Types & Coverage Impact

Florida Blue operates multiple plan types that affect your Enhertu coverage pathway:

Commercial Plans (HMO/PPO): Most require prior authorization through the standard process. PPO plans may offer more flexibility in specialty pharmacy choice, while HMO plans typically require referrals from your primary care physician to oncology.

Medicare Advantage: Subject to additional CMS guidelines and may have different formulary tiers. Medicare members often face stricter step therapy requirements.

Medicaid Plans: Coverage varies by specific Medicaid managed care plan. Some may have additional state-level requirements or different appeal timelines.

Tip: Check your member ID card to identify your specific plan type, as this determines which formulary and PA criteria apply to your situation.

Enhertu Formulary Status & Tier Placement

Enhertu is classified as a Limited Distribution Drug (LDD) on Florida Blue formularies, meaning:

  • Specialty tier placement: Typically on the highest cost-sharing tier
  • Prior authorization required: No exceptions for any indication
  • Restricted pharmacy network: Must use designated specialty pharmacies
  • Quantity limits: Aligned with FDA dosing recommendations

The exact tier placement isn't published in public formularies but is confirmed as requiring PA across all Florida Blue commercial and Medicare plans. Verify your specific plan's formulary for current status.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before first dose Provider portal at Availity.com Florida Blue PA Policy
HER2 Testing Must document positive status Pathology report or chart notes BCBS Medical Policy
Step Therapy Prior trastuzumab-based therapy Treatment history documentation BCBS Clinical Criteria
Specialty Pharmacy LDD network only Florida Blue pharmacy directory Specialty Pharmacy List
Appeals Deadline 180 days from denial Denial letter instructions Florida Blue Appeals

Prior Authorization Requirements

Florida Blue's PA criteria for Enhertu are comprehensive and must be met completely:

Clinical Documentation Required

HER2 Status Confirmation: Submit pathology reports showing HER2-positive results via IHC (3+) or ISH amplification. For HER2-low breast cancer, provide documentation of IHC 1+ or 2+ with negative ISH.

Diagnosis Verification: Include ICD-10 codes matching FDA-approved indications:

  • Unresectable/metastatic HER2-positive breast cancer
  • HER2-positive gastric or gastroesophageal junction adenocarcinoma
  • HER2-mutant non-small cell lung cancer

Prior Therapy Documentation: Chart notes must show progression or intolerance on at least one prior trastuzumab-based regimen, unless rapid progression occurred during or within 6 months of adjuvant/neoadjuvant therapy.

Prescriber Qualification: Must be prescribed by or in consultation with an oncologist.

Interstitial Lung Disease Monitoring

Florida Blue requires documentation of ILD monitoring protocols:

  • Baseline chest imaging and pulmonary function assessment
  • Ongoing surveillance plan with regular symptom monitoring
  • Provider acknowledgment of ILD risk and management protocols

Specialty Pharmacy Network Requirements

Enhertu's Limited Distribution Drug status means strict pharmacy requirements:

Authorized Dispensers Only: Your prescription must go through a Florida Blue-contracted specialty pharmacy that has manufacturer authorization to dispense Enhertu.

Provider-Administered Setup: Since Enhertu is infused, your oncology practice coordinates with the specialty pharmacy for delivery to the infusion center.

Patient Enrollment Process:

  1. Oncologist submits PA request
  2. Upon approval, specialty pharmacy contacts patient for insurance verification
  3. Pharmacy coordinates delivery schedule with infusion center
  4. Patient receives notification of scheduled administration

Find contracted specialty pharmacies through Florida Blue's provider directory.

Cost-Share Considerations

Understanding your financial responsibility helps with planning:

Specialty Tier Coinsurance: Typically 25-40% of drug cost after deductible Annual Out-of-Pocket Maximum: Protects against unlimited costs Manufacturer Support: Daiichi Sankyo offers copay assistance programs for eligible patients

Note: Starting Enhertu without PA approval makes you responsible for the full cost, which can exceed $15,000 per cycle.

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient & Clinic)

  • Insurance card and member ID
  • Complete pathology report showing HER2 status
  • Treatment history with dates of prior therapies
  • Chart notes documenting progression or intolerance

2. Oncologist Submits PA Request (Clinic)

  • Log into Availity.com provider portal
  • Complete PA form with all required clinical data
  • Attach supporting documentation
  • Timeline: Submit during business hours for fastest processing

3. Florida Blue Review Process (Florida Blue)

  • Standard review: 72 hours from complete submission
  • Expedited review: 24 hours for urgent medical situations
  • AI-enhanced processing may provide faster decisions

4. Approval Notification (All Parties)

  • Provider receives approval notification
  • Patient gets coverage confirmation
  • Specialty pharmacy begins coordination process

5. Specialty Pharmacy Setup (Patient & Pharmacy)

  • Pharmacy contacts patient for benefit verification
  • Delivery scheduled to infusion center
  • Patient completes any required enrollment forms

6. Treatment Initiation (Patient & Clinic)

  • Confirm approval is active before first infusion
  • Provide approval documentation to infusion center
  • Begin ILD monitoring protocols

7. Ongoing Authorization Management (Clinic)

  • Monitor for authorization expiration (typically 6 months)
  • Submit renewal requests 30 days before expiration
  • Document treatment response and continued medical necessity

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Missing HER2 testing Submit complete pathology report IHC/ISH results with interpretation
Insufficient prior therapy Document trastuzumab-based regimen failure Treatment dates, progression notes
ILD risk not addressed Provide monitoring plan Baseline imaging, surveillance protocol
Non-oncologist prescriber Add oncology consultation Specialist evaluation and recommendation
Incomplete clinical notes Submit comprehensive documentation Diagnosis, staging, treatment goals

Appeals Process for Florida Blue

If your initial PA is denied, Florida's appeal process provides multiple levels of review:

Internal Appeals (First Level)

  • Deadline: 180 days from denial date
  • Timeline: Standard appeals decided within 30 days; expedited within 72 hours
  • Submission: Through member portal or written request
  • Required: Original denial letter, additional clinical documentation, physician letter of medical necessity

Expedited Internal Appeals

For urgent situations where delays could jeopardize health:

  • Timeline: 24-72 hours for decision
  • Criteria: Immediate medical need or serious deterioration risk
  • Process: Physician must attest to urgency

External Review (Final Level)

If internal appeals fail:

  • Deadline: 4 months after final internal denial
  • Contact: Florida Department of Financial Services at 1-877-693-5236
  • Process: Independent medical review by external organization
  • Cost: Free to patient
  • Timeline: 72 hours for standard, 24 hours for expedited
From Our Advocates: "We've seen Florida Blue approvals increase significantly when physicians include specific language about why formulary alternatives are inappropriate for the patient's particular cancer subtype and treatment history. The key is connecting the clinical dots between HER2 status, prior therapy failures, and why Enhertu specifically addresses this patient's medical needs."

When to Escalate to State Review

Contact Florida's Division of Consumer Services if:

  • Florida Blue fails to meet appeal deadlines
  • You're not receiving required denial explanations
  • The appeals process isn't being followed properly

Contact Information:

  • Phone: 1-877-693-5236
  • Online: Submit complaints through Florida Department of Financial Services
  • Email: Consumer assistance available through DFS website

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies and crafting evidence-based rebuttals. Our platform helps patients and clinicians navigate complex prior authorization requirements and appeal processes, significantly improving approval rates for specialty medications like Enhertu.

FAQ: Your Top Questions Answered

Q: How long does Florida Blue PA take for Enhertu? A: Standard reviews take 72 hours from complete submission. Expedited reviews for urgent cases take 24 hours. Incomplete submissions restart the timeline.

Q: What if Enhertu isn't on my formulary? A: Enhertu requires PA on all Florida Blue plans but isn't excluded. Submit a formulary exception request with medical necessity documentation if listed as non-covered.

Q: Can I request an expedited appeal? A: Yes, if delays could seriously jeopardize your health. Your physician must document the urgent medical need and potential consequences of delayed treatment.

Q: Does step therapy apply if I failed trastuzumab outside Florida? A: Yes, prior therapy from any location counts. Provide complete treatment records showing dates, doses, and progression or intolerance documentation.

Q: What happens if I switch Florida Blue plans mid-treatment? A: Starting January 2026, Florida Blue must honor existing PAs for 90 days when you switch between their plans, allowing time for new authorization.

Q: How much will Enhertu cost with Florida Blue coverage? A: Costs depend on your specific plan's specialty tier coinsurance (typically 25-40%) and whether you've met your deductible. Contact member services for personalized estimates.

Q: Can I use any specialty pharmacy for Enhertu? A: No, Enhertu is a Limited Distribution Drug requiring specific Florida Blue-contracted pharmacies authorized by the manufacturer. Your provider will coordinate with an approved pharmacy.

Q: What if Florida Blue denies my appeal? A: You can request external review through Florida's Department of Financial Services within 4 months. This independent medical review is free and can overturn Florida Blue's decision.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current requirements with Florida Blue and consult your healthcare provider for medical decisions. For personalized assistance with insurance appeals and prior authorization challenges, Counterforce Health provides specialized support in navigating payer policies and improving approval outcomes.

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