By Counterforce Health Team in Alecensa (alectinib) —

Work With Your Doctor to Get Alecensa (alectinib) Approved by UnitedHealthcare in New York: Complete Provider Collaboration Guide

Answer Box: Your Path to Alecensa Coverage

Getting Alecensa (alectinib) approved by UnitedHealthcare in New York requires teamwork with your oncologist. The fastest path: confirm your ALK-positive NSCLC diagnosis is documented, gather complete treatment history, and have your provider submit prior authorization with molecular pathology reports. If denied, New York offers binding external appeals through the Department of Financial Services within 60 days. Start today: Call your oncologist's office to request your complete medical records and schedule a coverage planning visit.

Table of Contents

  1. Set Your Goal: Understanding Approval Requirements
  2. Visit Preparation: What to Document
  3. Building Your Evidence Kit
  4. Letter of Medical Necessity Structure
  5. Supporting Peer-to-Peer Reviews
  6. After Your Visit: Documentation Strategy
  7. Respectful Persistence: Follow-Up Timeline
  8. Appeals Process in New York
  9. Cost-Saving Resources
  10. FAQ

Set Your Goal: Understanding Approval Requirements

UnitedHealthcare treats Alecensa as a specialty oncology drug requiring prior authorization. Success depends on documenting three key elements:

Core Requirements:

  • ALK-positive NSCLC diagnosis confirmed by FDA-approved companion diagnostic
  • Complete surgical resection (for adjuvant use) or metastatic disease (for advanced NSCLC)
  • Oncologist prescribing with specialty pharmacy coordination
Note: UnitedHealthcare's Oncology Medication Clinical Coverage Policy recognizes NCCN Categories 1, 2A, and 2B as medically necessary.

Your partnership with your provider centers on gathering documentation that meets UnitedHealthcare's molecular oncology testing requirements and FDA companion diagnostic standards.

Visit Preparation: What to Document

Before meeting with your oncologist, create a comprehensive timeline that addresses common prior authorization questions.

Symptom and Treatment History

Document chronologically:

  • Initial symptoms and diagnosis date
  • All prior cancer treatments (surgery, chemotherapy, radiation)
  • Response to each treatment and reasons for discontinuation
  • Current functional status and performance level
  • Any treatment-related side effects or complications

Key Questions to Prepare

  1. "What specific ALK test was performed, and do we have the full molecular pathology report?"
  2. "Have I tried any ALK inhibitors before? If so, why didn't they work?"
  3. "What stage is my cancer, and why is Alecensa the right choice now?"
  4. "Are there any UnitedHealthcare-preferred alternatives we should consider first?"

Functional Impact Documentation

UnitedHealthcare may evaluate your performance status. Be ready to discuss:

  • Daily activity limitations
  • Work or school impact
  • Quality of life changes
  • Caregiver needs

Building Your Evidence Kit

Work with your care team to assemble a complete evidence package before prior authorization submission.

Essential Documents Checklist

Medical Records:

  • Complete pathology report with NSCLC confirmation
  • ALK testing results (FISH, IHC, or NGS with FDA-approved methodology)
  • Staging documentation (imaging reports, surgical notes)
  • Treatment timeline with dates, regimens, and outcomes
  • Recent labs (CBC, CMP, liver function tests)

Insurance Documentation:

  • UnitedHealthcare member ID card
  • Summary of benefits and coverage
  • Prescription drug list (formulary) for your specific plan
  • Any prior denial letters
Tip: Request a copy of your complete medical record from each provider involved in your cancer care. This ensures nothing is missed during PA submission.

Published Guidelines Support

Your oncologist should reference specific guidelines in the prior authorization:

For Metastatic ALK+ NSCLC:

  • NCCN Non-Small Cell Lung Cancer Guidelines (Category 1 recommendation)
  • FDA prescribing information for Alecensa

For Adjuvant ALK+ NSCLC:

  • FDA approval for tumors ≥4 cm or node-positive disease
  • ALINA trial data showing 65% reduction in recurrence risk

Letter of Medical Necessity Structure

Partner with your oncologist to ensure the medical necessity letter addresses UnitedHealthcare's specific requirements.

Required Elements

Patient Information Section:

  • Full name, date of birth, UnitedHealthcare member ID
  • Diagnosis with ICD-10 codes
  • Prescribing oncologist credentials and contact information

Clinical Rationale Section:

1. Diagnosis: "ALK-positive non-small cell lung cancer confirmed by [specific test name] on [date]"
2. Stage and Risk: "[Pathologic/clinical stage] with [tumor size/nodal status]"
3. Treatment History: "Previous therapies include [list with dates and outcomes]"
4. Medical Necessity: "Alecensa is indicated per FDA labeling and NCCN Category 1 recommendation for..."
5. Monitoring Plan: "Patient will be monitored per FDA prescribing information with regular liver function tests and clinical assessments"

Supporting References:

  • FDA prescribing information
  • Relevant NCCN guideline sections
  • Key clinical trial publications (ALEX, ALINA studies)

Clinician Corner: Documentation Best Practices

For Oncologists: UnitedHealthcare's companion diagnostic policy requires clear documentation that ALK testing used FDA-approved methodology. Include:

  • Exact test name and platform
  • Laboratory performing the test (with CLIA certification)
  • Date of testing and specimen source
  • Complete result interpretation

Supporting Peer-to-Peer Reviews

If UnitedHealthcare requests a peer-to-peer review, you can support your oncologist's preparation.

Before the Call

Provide your oncologist with:

  • One-page summary of your case
  • List of your availability windows for urgent decisions
  • Any specific concerns about treatment delays
  • Insurance-specific talking points from denial letter

During the Review Process

Your role:

  • Stay accessible for additional questions
  • Be prepared to provide supplemental documentation quickly
  • Understand that peer-to-peer reviews typically occur within 72 hours of request

Key Messages for Your Provider

Help your oncologist emphasize:

  • NCCN Category 1 or 2A status for your specific situation
  • Why UnitedHealthcare-preferred alternatives aren't suitable
  • Clinical urgency if cancer is progressing
  • Compliance with FDA companion diagnostic requirements

After Your Visit: Documentation Strategy

Effective post-visit documentation strengthens your case and prepares for potential appeals.

What to Save

From Each Appointment:

  • Visit summary with updated treatment plan
  • Any new test results or imaging reports
  • Provider communications about insurance status
  • Prescription information and pharmacy coordination details

Portal Communication Best Practices

When messaging your provider through patient portals:

Effective: "I received a denial letter dated [date] for Alecensa PA request. The reason cited was [specific reason]. Could you help me understand what additional documentation might strengthen an appeal?"

Less Effective: "Insurance denied my drug. What do we do now?"

Progress Documentation

Keep a simple log:

  • Date of PA submission
  • Expected decision timeline
  • Any requests for additional information
  • Provider communications about next steps

Respectful Persistence: Follow-Up Timeline

Maintain appropriate communication cadence while advocating effectively for your care.

Standard Timeline

Week 1-2: Allow normal processing time (UnitedHealthcare typically responds within 15 business days for standard PA requests)

Week 3: If no response, contact provider's office to check submission status

Week 4+: Request provider follow up with UnitedHealthcare directly

Escalation Strategy

When to escalate:

  • No response after 30 days
  • Denial without clear rationale
  • Clinical situation becomes urgent
  • Multiple rounds of "need more information"

How to escalate politely:

  1. Request case manager assignment
  2. Ask provider to initiate peer-to-peer review
  3. Contact UnitedHealthcare member services for status update
  4. Consider expedited appeal if clinically urgent
From our advocates: We've seen cases where persistence pays off. One patient's Alecensa approval came on the third submission after their oncologist provided additional molecular testing details and NCCN guideline citations that weren't in the initial request. The key was maintaining detailed documentation throughout the process.

Appeals Process in New York

New York offers robust appeal rights for UnitedHealthcare coverage denials.

Internal Appeals

Timeline: 180 days from denial date (20 days for expedited) Process: Submit through UnitedHealthcare member portal or by mail Decision Time: 30 days standard, 72 hours expedited

External Appeals Through New York DFS

Eligibility: After internal appeal denial for fully insured plans Timeline: 60 days from internal denial to file Cost: No filing fee Process: Submit online at DFS portal or mail to NY DFS, External Appeals, 517 Broadway, 2nd Fl, Albany, NY 12207

Required Documents:

  • All denial letters
  • Medical records supporting necessity
  • Physician letter explaining why Alecensa is medically necessary
  • Treatment history and alternatives tried

Decision Timeline:

  • Standard: 45 days maximum
  • Urgent: 72 hours for life-threatening situations
  • Binding: If approved, UnitedHealthcare must cover at lowest cost-share tier

When to Request Expedited Review

Qualifying situations:

  • Cancer progression requiring immediate treatment
  • Risk of serious adverse health consequences
  • Provider certification that delay would be detrimental

Cost-Saving Resources

While working on coverage approval, explore financial assistance options.

Manufacturer Support

Genentech Access Solutions: 1-800-675-3770

  • Copay assistance for eligible commercially insured patients
  • Patient assistance program for uninsured/underinsured
  • Bridge programs during insurance transitions

Foundation Grants

CancerCare Co-Payment Assistance Foundation Leukemia & Lymphoma Society Patient Financial Aid National Organization for Rare Disorders (NORD)

State Resources

New York State Essential Plan: May offer different formulary coverage Medicaid: Expanded eligibility in New York may provide alternative coverage

FAQ

How long does UnitedHealthcare prior authorization take for Alecensa in New York? Standard PA decisions are made within 15 business days. Expedited requests (for urgent medical needs) are decided within 72 hours. New York law requires insurers to meet these timelines.

What if Alecensa is not on my UnitedHealthcare formulary? Non-formulary drugs can still be covered with medical necessity documentation. Your oncologist should request a formulary exception citing FDA approval and NCCN guidelines for ALK-positive NSCLC.

Can I appeal if UnitedHealthcare requires step therapy first? Yes. Your oncologist can request a step therapy exception if they document that preferred alternatives are medically inappropriate, contraindicated, or likely to cause adverse reactions.

Does UnitedHealthcare cover Alecensa for adjuvant (post-surgery) treatment? Coverage follows FDA approval for adjuvant treatment of ALK-positive NSCLC with tumors ≥4 cm or node-positive disease after complete surgical resection.

What happens if my external appeal is denied in New York? External appeal decisions by New York DFS are binding and final. If denied, explore manufacturer patient assistance programs or clinical trials as alternatives.

How do I verify my UnitedHealthcare plan is eligible for New York external appeals? External appeals apply to fully insured plans. Self-funded employer plans (ERISA) are limited to internal appeals and federal external review. Check your Summary Plan Description or call UnitedHealthcare member services.

About Counterforce Health: Counterforce Health helps patients and clinicians navigate insurance denials by creating evidence-backed appeals tailored to specific payer policies. Our platform identifies denial reasons and drafts targeted rebuttals using the right medical literature, clinical guidelines, and procedural requirements to improve approval rates.

For additional support with your Alecensa coverage appeal, Counterforce Health's platform can help generate targeted documentation that addresses UnitedHealthcare's specific prior authorization criteria and New York's external appeal requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific UnitedHealthcare plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For official appeals assistance in New York, contact the Department of Financial Services Consumer Assistance Unit at 1-800-400-8882.

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