By Counterforce Health Team in Alecensa (alectinib) —

Blue Cross Blue Shield Florida Coverage Criteria for Alecensa (Alectinib): Complete Guide to Prior Authorization Requirements

Answer Box: Getting Alecensa Covered by Blue Cross Blue Shield in Florida

To get Alecensa (alectinib) covered by Blue Cross Blue Shield in Florida, you need: (1) confirmed ALK-positive non-small cell lung cancer with molecular testing documentation, (2) prior authorization approval through your provider, and (3) prescription filled through an approved specialty pharmacy. Fastest path: Have your oncologist submit PA with complete ALK test results, staging, and treatment history via the Florida Blue provider portal or call 1-877-719-2583. Standard review takes 14 days; expedited review available for urgent cases within 72 hours.

Table of Contents

Policy Overview: How Florida Blue Handles Specialty Drugs

Florida Blue (Blue Cross Blue Shield of Florida) covers Alecensa as a specialty medication requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug falls under pharmacy benefits rather than medical benefits, meaning it's subject to formulary placement and quantity limits.

Plan Coverage Variations:

  • Commercial plans: Standard PA requirements with 14-day review timeline
  • Medicare Advantage: May have additional step therapy requirements
  • Medicaid managed care: Coverage varies by specific managed care organization

You can find your specific formulary and PA requirements on the Florida Blue member portal using your member ID.

Medical Necessity Requirements for Alecensa

FDA-Approved Indications

Alecensa is covered for patients with ALK-positive non-small cell lung cancer (NSCLC) in two settings:

  • Metastatic disease: First-line or after progression on crizotinib
  • Adjuvant therapy: Following complete surgical resection

Required Clinical Criteria

Your oncologist must document:

  1. Confirmed ALK rearrangement using approved testing methods (FISH or next-generation sequencing)
  2. Histologically confirmed NSCLC with complete pathology report
  3. Appropriate disease staging with imaging documentation
  4. Performance status assessment (ECOG 0-2 typically required)
Note: Off-label uses may require additional clinical evidence and literature support for coverage consideration.

Step Therapy and Exception Pathways

Standard Step Therapy Sequence

Most Florida Blue plans require patients to try crizotinib (Xalkori) first for metastatic ALK-positive NSCLC before approving Alecensa, unless you qualify for an exception.

Exception Criteria:

  • Medical contraindication to crizotinib (documented allergy, drug interactions)
  • Previous intolerance with specific adverse events documented
  • Clinical superiority needed (e.g., CNS metastases where Alecensa shows better penetration)
  • Prior failure on crizotinib with progression documentation

Documenting Step Therapy Exceptions

Your physician should include:

  • Specific contraindications with clinical rationale
  • Previous trial details (dates, duration, reason for discontinuation)
  • Supporting literature citations for clinical scenarios

Prior Authorization Process

Submission Methods

  1. Online portal: Florida Blue provider portal (fastest processing)
  2. Phone: 1-877-719-2583 for provider services
  3. Electronic systems: Availity or CoverMyMeds platforms

Review Timelines

  • Standard review: Up to 14 business days
  • Expedited review: 72 hours for urgent medical need
  • Incomplete submissions: Additional 14 days after missing information provided
Tip: Submit early in the week to avoid weekend processing delays that could extend timelines.

Required Documentation Checklist

Essential Clinical Documents

  • ALK testing results with methodology specified (FISH/NGS)
  • Complete pathology report confirming NSCLC diagnosis
  • Staging documentation with imaging reports (CT, PET, brain MRI)
  • Treatment history including prior therapies and outcomes
  • Performance status assessment and current clinical status

For Adjuvant Cases

  • Surgical pathology confirming complete resection (R0)
  • Post-operative staging documentation
  • Adjuvant chemotherapy history if applicable

Laboratory Requirements

  • Baseline liver function tests (ALT, AST, bilirubin)
  • Complete blood count with differential
  • Creatine kinase baseline (Alecensa monitoring requirement)

Appeals Process for Denials

Internal Appeal (First Level)

Timeline: Must be filed within 180 days of denial notice Review period: 30 days for prospective decisions, 60 days for retrospective How to file: Submit through Florida Blue member portal or call member services

External Review (Independent Review)

If your internal appeal is denied, Florida uses the federal external review process:

  • Administrator: MAXIMUS Federal Services
  • Timeline to request: 60 days from final internal denial
  • Decision timeline: 45 days (standard) or 72 hours (expedited)
  • Contact: 1-888-866-6205 for forms and submission

How to Request External Review:

  1. Call MAXIMUS at 1-888-866-6205 to request forms
  2. Submit completed request by fax (1-888-866-6190) or mail
  3. Include all supporting clinical documentation
  4. Specify if expedited review is needed for urgent medical situations

Costs and Financial Assistance

Alecensa Pricing and Coverage

Alecensa's wholesale acquisition cost is approximately $19,466 per 240-capsule bottle (30-day supply), making financial assistance crucial for most patients.

Available Support Programs

  • Genentech Patient Foundation: Income-based assistance for uninsured/underinsured patients
  • Co-pay assistance: Up to $25,000 annually for commercially insured patients
  • Florida Blue specialty pharmacy: May offer cost-sharing reductions through preferred networks

Contact Genentech Patient Access at 1-855-692-6729 to explore assistance options while your PA is pending.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing ALK test Submit molecular testing report FISH or NGS results with positive ALK rearrangement
Step therapy not met Request medical exception Contraindication letter or prior crizotinib failure documentation
Incomplete staging Provide full staging workup CT chest/abdomen/pelvis, brain imaging, PET if indicated
Non-formulary status Request formulary exception Medical necessity letter with clinical rationale
Quantity limit exceeded Request quantity override Dosing rationale and monitoring plan

Clinician Corner: Medical Necessity Letter Template

Essential Elements to Include:

  1. Patient demographics and ALK-positive NSCLC diagnosis with staging
  2. Clinical rationale for Alecensa over alternatives
  3. Prior treatment history including response and tolerability
  4. Supporting guidelines (NCCN, FDA label, peer-reviewed literature)
  5. Monitoring plan including liver function and CPK surveillance
  6. Expected outcomes and treatment goals
From our advocates: "We've seen the highest approval rates when oncologists include specific NCCN guideline references and clearly document why first-generation ALK inhibitors aren't appropriate. A well-structured medical necessity letter can turn a routine denial into an approval, especially when CNS involvement or prior crizotinib intolerance is documented."

Counterforce Health: Streamlining Your Appeal Process

If you're facing a denial or complex prior authorization requirements, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with your insurer's specific criteria, pulling the right clinical evidence and regulatory citations to support your case.

FAQ

How long does Florida Blue prior authorization take for Alecensa? Standard review takes up to 14 business days. Expedited review for urgent medical need can be completed within 72 hours.

What if Alecensa isn't on my Florida Blue formulary? You can request a formulary exception by having your physician submit a medical necessity letter explaining why Alecensa is clinically superior to covered alternatives.

Can I appeal if step therapy is required? Yes, you can request a step therapy exception if you have contraindications to first-line therapy or if your physician documents clinical reasons why Alecensa is medically necessary as first-line treatment.

Does Florida Blue require specialty pharmacy for Alecensa? Yes, Alecensa must typically be filled through Florida Blue's preferred specialty pharmacy network. Your approval letter will specify approved dispensing locations.

What happens if my appeal is denied? You can request an external review through MAXIMUS Federal Services within 60 days of your final internal denial. This independent review is binding on Florida Blue if approved.

How much does Alecensa cost with Florida Blue coverage? Costs vary by plan, but specialty tier copays typically range from $100-500 monthly. Manufacturer co-pay assistance can reduce out-of-pocket costs significantly for eligible patients.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on your specific insurance plan and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For additional assistance with insurance appeals in Florida, contact the Florida Department of Financial Services Consumer Helpline at 1-877-693-5236.

Getting the right cancer treatment shouldn't be a battle with insurance. With proper documentation, understanding of Florida Blue's requirements, and persistence through the appeals process when necessary, patients can successfully obtain coverage for Alecensa. Counterforce Health is here to help navigate complex prior authorization requirements and turn denials into approvals through evidence-based advocacy.

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