By Counterforce Health Team in Alecensa (alectinib) —

How to Get Alecensa (alectinib) Covered by Cigna in North Carolina: Complete Appeals Guide

Answer Box: Getting Alecensa (alectinib) Covered by Cigna in North Carolina

Eligibility: Cigna covers Alecensa for ALK-positive non-small cell lung cancer with prior authorization. Fastest approval path: Submit PA with ALK test results, diagnosis codes, and clinical notes through CoverMyMeds or fax to 1-866-873-8279. First step today: Gather your ALK pathology report and contact your oncologist to initiate the prior authorization request. If denied, you have 180 days for internal appeals and 120 days for North Carolina's Smart NC external review.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation
  5. Submission Process
  6. Appeals Process in North Carolina
  7. Common Denial Reasons & Solutions
  8. Cost Assistance Programs
  9. FAQ
  10. Printable Checklist

Who Should Use This Guide

This guide helps North Carolina patients with ALK-positive non-small cell lung cancer (NSCLC) navigate Cigna's approval process for Alecensa (alectinib). You'll also find this useful if you're a caregiver, oncology nurse, or clinic staff member handling prior authorizations.

Expected outcome: With proper documentation, most Alecensa requests are approved when ALK-positive status is confirmed and clinical criteria are met. If initially denied, appeals succeed frequently when pathology reports and treatment history are provided.

Member & Plan Basics

Coverage Requirements

  • Active Cigna coverage: Verify your plan is active and includes prescription drug benefits
  • Plan type: Most commercial Cigna plans cover Alecensa; Medicare Advantage plans may have additional requirements
  • Specialty pharmacy: Alecensa is typically dispensed through Express Scripts/Accredo specialty pharmacy
  • Prior authorization: Required for all Cigna plans covering Alecensa
Note: Self-funded employer plans may have different appeal rights. Check if your plan is state-regulated for North Carolina external review eligibility.

Clinical Criteria Requirements

Primary Requirements

Cigna's oncology coverage policy requires:

  • Age: 18 years or older
  • ALK-positive status: Confirmed by FDA-approved test
  • Diagnosis: Metastatic NSCLC or adjuvant treatment post-surgical resection
  • Clinical documentation: Treatment history, contraindications to alternatives

Step Therapy Considerations

  • Preferred first-line: Alecensa and brigatinib are typically preferred over crizotinib
  • Prior failures: Document any previous ALK inhibitor treatments and reasons for discontinuation
  • Intolerance: Provide specific adverse events that prevent use of step-therapy alternatives

Coding & Documentation

Essential Diagnosis Codes (ICD-10)

  • C34.10: Malignant neoplasm of upper lobe, unspecified bronchus or lung
  • C78.00: Secondary malignant neoplasm of lung, unspecified
  • C34.30-C34.32: Malignant neoplasm of lower lobe (specify laterality when possible)

Drug Identification

  • NDC: 50242-0130-01 (150 mg capsules, 240-count bottle)
  • No J-code: Alecensa is an oral medication without a permanent HCPCS J-code
  • Dosing: Standard dose is 600 mg twice daily with food

Required Documentation Packet

Your oncologist should include:

  • ALK test report: FDA-approved assay results confirming ALK rearrangement
  • Pathology report: Confirming NSCLC diagnosis and staging
  • Treatment history: Prior therapies tried, duration, and outcomes
  • Clinical notes: Current disease status, performance status, treatment goals
  • Lab results: Recent liver function tests, creatine phosphokinase levels

Submission Process

How to Submit Prior Authorization

Online (Fastest):

Fax:

  • Standard requests: 1-866-873-8279
  • Expedited requests: Mark "URGENT" and call 1-800-882-4462 after faxing

Required Timeline:

  • Standard review: Up to 5 business days
  • Expedited review: 24-72 hours for urgent cases
  • Member deadline: Submit within plan coverage period
Tip: Electronic submissions through CoverMyMeds typically process faster than fax submissions.

Appeals Process in North Carolina

Internal Appeals with Cigna

First-Level Appeal:

  • Deadline: 180 days from denial date
  • Timeline: 30 days for standard, 15 days for urgent cancer cases
  • Submission: Cigna appeals portal or fax to appeals unit

Second-Level Appeal:

  • Available if first-level denied
  • Same timeline and process as first-level

Smart NC External Review

North Carolina residents have strong appeal rights through the state's Smart NC program.

Eligibility:

  • Denial based on medical necessity, experimental treatment, or investigational status
  • State-regulated plan (not self-funded employer plans)
  • Exhausted internal appeals (unless expedited)

Timeline:

  • Request deadline: 120 days from Cigna's final denial
  • Decision timeline: 45 days for standard, 72 hours for urgent cancer cases
  • Implementation: Cigna must authorize within 3 business days if approved

How to File:

  • Phone: 855-408-1212 for guidance
  • Mail: Health Insurance Smart NC, 1201 Mail Service Center, Raleigh, NC 27699-1201
  • Required: Smart NC External Review Request Form with supporting medical records

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing ALK test Provide FDA-approved assay results Pathology report with ALK rearrangement confirmation
Step therapy not met Document failure/intolerance of preferred agents Treatment history, adverse event reports
Insufficient clinical information Submit comprehensive treatment notes Oncologist's detailed clinical assessment
Non-formulary status Request formulary exception Medical necessity letter, clinical guidelines
Quantity limits exceeded Justify dosing requirements FDA label, dosing rationale from oncologist

Medical Necessity Letter Template

When appealing, your oncologist should address:

  • Patient's specific diagnosis with ALK-positive confirmation
  • Prior treatment failures or contraindications to alternatives
  • Clinical rationale citing NCCN guidelines or FDA labeling
  • Urgency factors such as disease progression or symptom burden
From our advocates: We've seen appeals succeed when providers include specific ALK test methodology (FISH, IHC, NGS) and cite the exact NCCN guideline recommendation. This level of detail demonstrates medical necessity clearly to reviewers.

Cost Assistance Programs

Manufacturer Support

  • Genentech Access Solutions: Copay assistance and patient support programs
  • Eligibility: Commercial insurance patients may qualify for significant copay reduction
  • Application: Available through healthcare provider or patient services

Additional Resources

  • CancerCare: Financial assistance for cancer patients
  • Patient Advocate Foundation: Copay relief programs
  • North Carolina cancer support: Contact local cancer centers for state-specific programs

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeals processes for specialty medications like Alecensa. Our platform analyzes denial letters and generates targeted, evidence-backed appeals that align with payer-specific requirements, turning insurance obstacles into approved treatments. Visit www.counterforcehealth.org to learn how we can support your coverage journey.

FAQ

How long does Cigna prior authorization take for Alecensa in North Carolina? Standard reviews take up to 5 business days. Urgent requests marked for expedited review are processed within 24-72 hours.

What if Alecensa is not on my Cigna formulary? You can request a formulary exception with medical necessity documentation. Your oncologist must demonstrate why formulary alternatives are inappropriate.

Can I get an expedited appeal if my cancer is progressing? Yes. Mark appeals as "URGENT" and document clinical urgency. Expedited appeals are decided within 72 hours for cancer cases.

Does step therapy apply if I failed ALK inhibitors outside North Carolina? Treatment history from any location counts. Provide documentation of prior ALK inhibitor failures or intolerance.

What happens if Smart NC approves my external review? Cigna must authorize coverage within 3 business days of the Smart NC decision. The external review decision is binding.

How much does Alecensa cost without insurance? The wholesale acquisition cost is approximately $19,466 per 240-count bottle (150 mg capsules), according to drug pricing disclosures.

Printable Checklist

Before Starting

  • Active Cigna coverage verified
  • ALK-positive test results available
  • Treatment history documented
  • Oncologist contact information ready

For Prior Authorization

  • Complete prior authorization form
  • ALK test report attached
  • ICD-10 diagnosis codes included
  • Clinical notes from oncologist
  • Submit via CoverMyMeds or fax to 1-866-873-8279

If Denied

  • Review denial letter for specific reasons
  • File first-level appeal within 180 days
  • Gather additional supporting documentation
  • Consider expedited appeal if urgent

For External Review (North Carolina)

  • Complete Smart NC External Review Request Form
  • File within 120 days of final Cigna denial
  • Submit all medical records and denial letters
  • Contact Smart NC at 855-408-1212 for assistance

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult your healthcare provider and insurance plan documents for specific guidance.

For additional support with North Carolina insurance appeals, contact Smart NC at 855-408-1212 or visit the North Carolina Department of Insurance website.

When navigating complex prior authorization challenges, Counterforce Health provides specialized support to turn insurance denials into successful appeals through evidence-based advocacy and payer-specific expertise.

Sources & Further Reading

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