By Counterforce Health Team in Alecensa (alectinib) —

How to Get Alecensa (alectinib) Covered by Blue Cross Blue Shield in New York: Complete Appeals Guide and Success Strategies

Answer Box: Getting Alecensa (alectinib) Covered by Blue Cross Blue Shield in New York

Blue Cross Blue Shield of New York requires prior authorization for Alecensa (alectinib) in ALK-positive NSCLC patients. The fastest path to approval: (1) Submit ALK testing confirmation via FDA-approved methods (FISH, IHC, NGS), (2) Include complete staging and treatment history documentation, and (3) Have your oncologist submit the prior authorization through the BCBS provider portal with medical necessity justification. If denied, New York offers robust external appeal rights through the Department of Financial Services within 4 months of final denial.

Table of Contents

Coverage Requirements at a Glance

Requirement What it means Where to find it Source
Prior Authorization Required for all Alecensa prescriptions BCBS provider portal or member services BCBS PA lookup
ALK Testing FDA-approved FISH, IHC, or NGS confirmation Pathology report from certified lab FDA Alecensa label
Formulary Tier Specialty tier (varies by plan) Member portal or formulary document Contact member services to verify
Step Therapy May require crizotinib first-line Exception possible with contraindication Plan-specific policy
Age Requirement 18+ years FDA labeling FDA Alecensa label
Quantity Limits 240 capsules per 30 days (1,200 mg/day) Plan formulary BCBS specialty policies

Step-by-Step: Fastest Path to Approval

1. Confirm ALK-Positive Status

Who: Oncologist or pathologist
What: FDA-approved ALK testing (FISH, IHC, or NGS)
Timeline: Results typically available within 3-7 business days
Key: Ensure report includes test method, lab certification, and clear positive result

2. Gather Required Documentation

Who: Patient and oncology team
What: Complete medical records including:

  • Pathology report with ALK-positive confirmation
  • Staging information (imaging, surgical reports)
  • Prior treatment history and outcomes
  • Current performance status assessment
  • Lab monitoring plan (liver function, CPK)

3. Submit Prior Authorization

Who: Prescribing oncologist
How: BCBS provider portal or fax submission
Timeline: Decision within 72 hours for standard requests
Include: Medical necessity letter citing NCCN guidelines and FDA approval

4. Monitor Status and Follow Up

Who: Clinic staff or patient
What: Track PA status through provider portal
Timeline: Contact plan if no response within stated timeframe
Action: Request peer-to-peer review if additional clinical discussion needed

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing ALK test results Submit complete pathology report FDA-approved test confirmation from certified lab
Step therapy not met Request exception with medical justification Prior therapy records showing progression/intolerance
Insufficient clinical information Provide comprehensive oncology notes Complete treatment history, staging, performance status
Non-formulary status File formulary exception request Comparative effectiveness evidence vs. alternatives
Quantity limit exceeded Justify dosing based on FDA labeling Weight-based calculation, monitoring plan

Appeals Playbook for New York

Internal Appeal Process

  • Deadline: 180 days from denial notification
  • Timeline: 30 days for standard review, 72 hours for expedited
  • How to file: Submit through BCBS member portal or mail written request
  • Required: Denial letter, supporting medical records, physician attestation

External Review Through New York DFS

New York offers one of the strongest external appeal processes in the nation. If your internal appeal is denied, you can request an independent review.

Key Details:

  • Deadline: 4 months from final internal denial
  • Cost: $25 fee (waived for financial hardship or Medicaid)
  • Timeline: 30 days standard, 72 hours expedited for specialty drugs
  • Decision: Binding on the insurance company

How to File:

  1. Download the NY External Appeal Application
  2. Complete patient and physician sections
  3. Include physician attestation for expedited review if applicable
  4. Submit to: NY Department of Financial Services, 99 Washington Avenue, Box 177, Albany, NY 12210
  5. Fax: (800) 332-2729 or (888) 990-3991 for expedited

Medical Necessity Letter Requirements

Clinician Corner: Your medical necessity letter is the foundation of a successful appeal. Include these essential elements:

Required Components:

  • Patient identification: Name, DOB, member ID, diagnosis with ICD-10
  • ALK testing details: Method used, lab performing test, date, results
  • Clinical history: Disease staging, prior treatments, response/progression
  • Rationale: Why Alecensa is medically necessary for this specific patient
  • Guidelines support: NCCN Category 1 recommendation, FDA approval
  • Monitoring plan: Liver function tests, CPK monitoring schedule

Sample Language:

"Patient [Name] has confirmed ALK-positive metastatic NSCLC via [test method] performed at [lab] on [date]. Per NCCN guidelines, Alecensa is a Category 1 preferred first-line therapy for ALK-positive disease. Alternative agents are contraindicated due to [specific reasons]. Without Alecensa, the patient faces significant risk of disease progression and shortened survival."

Scripts & Templates

Patient Phone Script for BCBS

"Hello, I'm calling about prior authorization status for Alecensa, generic name alectinib, for member ID [number]. My oncologist submitted the request on [date]. Can you check the status and let me know if any additional information is needed? If there are concerns, I'd like to request a peer-to-peer review with the medical director."

Clinic Staff Peer-to-Peer Request

"This is [Name] from [Clinic] calling to request a peer-to-peer review for Alecensa prior authorization for patient [Name], member ID [number]. Dr. [Oncologist] is available today between [times] to discuss the medical necessity. The patient has ALK-positive NSCLC and meets NCCN criteria for first-line therapy."

When to Escalate: External Review

Consider external review when:

  • Internal appeal is denied despite strong medical evidence
  • BCBS cites "experimental" or "investigational" status (FDA-approved since 2015)
  • Plan applies inappropriate step therapy requirements
  • Delay in treatment could harm patient outcomes

Free Help Available:

  • Community Health Advocates: (888) 614-5400
  • NY DFS Consumer Hotline: (800) 342-3736
From Our Advocates: We've seen many Alecensa denials successfully overturned on external review when the appeal included comprehensive ALK testing documentation and clear evidence that alternative therapies were inappropriate. The key is thorough preparation and understanding that New York's external reviewers often side with patients when medical evidence supports the request.

Costs & Patient Assistance

Alecensa Pricing

  • Wholesale Acquisition Cost: approximately $19,466 per 240-count bottle
  • Annual cost: roughly $250,000+ without insurance coverage

Patient Assistance Options

  • Genentech Access Solutions: Copay assistance and patient support programs
  • Website: alecensa.com/hcp
  • Foundation grants: Available through organizations like CancerCare and Patient Advocate Foundation
  • State programs: New York residents may qualify for additional assistance through state pharmaceutical programs

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical documentation to craft targeted, evidence-backed rebuttals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes more effectively.

Frequently Asked Questions

How long does BCBS prior authorization take in New York? Standard decisions are made within 72 hours of receiving complete documentation. Expedited requests (when delay could harm health) are decided within 24 hours.

What if Alecensa is non-formulary on my BCBS plan? You can request a formulary exception by demonstrating that preferred alternatives are not medically appropriate. Include evidence of contraindications or prior treatment failures.

Can I request an expedited appeal? Yes, if your physician attests that delay could seriously jeopardize your health. Expedited appeals are decided within 72 hours for internal review and 72 hours (or 24 hours for non-formulary drugs) for external review.

Does step therapy apply if I've failed treatments outside New York? Treatment history from other states should be considered. New York law prohibits requiring patients to repeat step therapy for drugs they've tried within the past year.

What happens if my external appeal is approved? BCBS must cover the treatment and refund your $25 appeal fee. The decision is binding and cannot be overturned by the insurance company.

How do I find my specific BCBS plan's formulary? Log into your member portal or call the member services number on your insurance card. Each Blue Cross Blue Shield plan maintains its own formulary, so requirements may vary.

Can I continue current treatment during an appeal? If you're already receiving Alecensa and face a coverage denial, request "continuation of care" during your appeal to maintain uninterrupted treatment.

What if I have both Medicare and BCBS coverage? Coordination of benefits rules apply. Your primary insurer processes claims first, then secondary coverage may apply. Medicare Part D has its own appeal process separate from commercial BCBS plans.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan directly for coverage questions. For personalized assistance with complex denials and appeals, Counterforce Health offers specialized support in navigating insurance approval processes.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.