By Counterforce Health Team in Alecensa (alectinib) —

A Realistic Alecensa (Alectinib) Approval Scenario with Cigna in Pennsylvania (From Request to Yes)

Answer Box: Getting Alecensa (Alectinib) Approved by Cigna in Pennsylvania

Quick Path to Approval: Cigna requires prior authorization for Alecensa (alectinib) in ALK-positive NSCLC. Submit documented ALK-positive test results, pathology confirming NSCLC, and prescriber attestation via Cigna's PA portal. Most approvals occur within 72 hours for metastatic cases; adjuvant use requires surgical history. If denied, Pennsylvania's external review program overturns ~50% of appeals. First step today: Verify ALK testing is complete and order molecular pathology report if missing.

Table of Contents

Patient Profile: Sarah's ALK-Positive NSCLC Journey

Sarah, a 54-year-old teacher from Pittsburgh, was diagnosed with stage IIIA non-small cell lung cancer (NSCLC) in March 2024. After successful surgical resection at UPMC, molecular testing revealed ALK-positive disease—making her eligible for Alecensa (alectinib) as adjuvant therapy.

Her Clinical Picture:

  • Diagnosis: T2N2M0 adenocarcinoma, completely resected
  • Biomarkers: ALK-positive by FISH testing (FDA-approved assay)
  • Surgery: Right upper lobectomy with mediastinal lymph node dissection
  • Tumor size: 5.2 cm (meets ≥4 cm criterion for adjuvant Alecensa)
  • Insurance: Cigna PPO through her school district

Sarah's oncologist recommended two years of adjuvant Alecensa based on the ALINA trial data, which showed 76% reduction in recurrence risk compared to chemotherapy.

Pre-Authorization Preparation

Sarah's care team assembled the required documentation before submitting to Cigna:

Essential Documents Gathered

Medical Records:

  • Pathology report confirming NSCLC adenocarcinoma
  • Surgical operative note documenting complete resection
  • Molecular pathology report showing ALK-positive status
  • Post-surgical imaging showing no residual disease
  • Performance status documentation (ECOG 0)

Insurance Verification:

  • Confirmed Cigna specialty drug coverage through Express Scripts/Accredo
  • Verified prior authorization requirement for Alecensa
  • Obtained current formulary status (Tier 4 specialty)

Letter of Medical Necessity

Dr. Martinez, Sarah's oncologist, drafted a comprehensive letter addressing Cigna's specific criteria:

Key Points Addressed:Patient age ≥18 years (Sarah is 54)ALK-positive NSCLC by approved test (FISH positive)Adjuvant setting following complete resectionTumor ≥4 cm or node-positive (5.2 cm tumor, N2 nodes)Treatment duration: 24 months as per FDA approval

Submission Process

Timeline: April 15, 2024

Sarah's clinic submitted the prior authorization through multiple channels:

Primary Submission Route

  1. Cigna eviCore Portal - Used for oncology drug PAs
  2. Express Scripts Specialty PA - Secondary route for specialty pharmacy
  3. Fax Backup - Sent to Cigna PA department as backup

Required PA Information

  • Patient demographics and Cigna ID
  • ICD-10 diagnosis codes (C78.00 - malignant neoplasm)
  • Prescriber information and DEA number
  • Drug details: Alecensa 150mg capsules, 600mg BID
  • Treatment duration: 24 months (adjuvant indication)

Submission confirmed via tracking number: PA2024041501

Initial Outcome: Denial

Timeline: April 18, 2024 (3 business days)

Cigna denied the initial request with the following rationale:

Denial Letter Excerpt: "Request does not meet medical necessity criteria. Insufficient documentation of prior systemic therapy failure. Adjuvant use requires demonstration that standard chemotherapy is inappropriate or contraindicated."

Analysis of Denial Reasoning

The denial revealed a misunderstanding of Alecensa's adjuvant indication. Cigna's policy actually supports adjuvant use without requiring chemotherapy failure, but the initial reviewer appeared to apply metastatic NSCLC criteria.

Red Flags Identified:

  • Reviewer may not have recognized adjuvant vs. metastatic indications
  • ALK-positive status documentation was present but possibly overlooked
  • Surgical documentation was complete but tumor size emphasis needed

The Appeal Strategy

Timeline: April 22, 2024

Dr. Martinez's team filed a Level 1 internal appeal within Cigna's 180-day window, focusing on correcting the clinical misinterpretation.

Appeal Documentation Package

Updated Medical Necessity Letter:

  • Emphasized adjuvant indication specifically
  • Referenced FDA approval for adjuvant ALK-positive NSCLC
  • Included ALINA trial data showing superiority to chemotherapy
  • Highlighted Pennsylvania's external review success rate (~50% overturn)

Supporting Evidence:

  • NCCN Guidelines excerpt supporting Alecensa as preferred adjuvant therapy
  • Molecular pathology report with ALK FISH results highlighted
  • Surgical pathology confirming complete R0 resection
  • Recent CT scan showing no evidence of disease

Peer-to-Peer Review Request

Timeline: April 25, 2024

Dr. Martinez requested a peer-to-peer discussion with Cigna's medical director:

Key Talking Points Used:

  • "Alecensa is FDA-approved for adjuvant ALK-positive NSCLC following complete resection"
  • "Patient meets all criteria: ALK-positive, tumor ≥4 cm, node-positive disease"
  • "ALINA trial showed 76% reduction in recurrence vs. chemotherapy"
  • "No requirement for prior systemic therapy failure in adjuvant setting"

Outcome: The Cigna medical director acknowledged the policy interpretation error and agreed to expedited review.

Resolution: Approval After Peer-to-Peer

Timeline: April 26, 2024

Cigna approved Alecensa for 12-month duration with renewal option:

Approval Terms

  • Drug: Alecensa 150mg capsules
  • Dose: 600mg twice daily with food
  • Duration: 12 months initially, renewable for second year
  • Pharmacy: Accredo Specialty Pharmacy
  • Monitoring: Liver function tests every 2 months

Total Time from Denial to Approval: 8 days

Cost Impact

  • Cigna Coverage: 80% after deductible
  • Patient Copay: $150/month with Genentech copay assistance
  • Annual Out-of-Pocket: Capped at $1,800 vs. $233,000 without coverage

What We'd Do Differently

Proactive Strategies for Future Cases

1. Emphasis on Indication-Specific Criteria

  • Lead with "adjuvant ALK-positive NSCLC" in all documentation
  • Reference specific FDA approval date (April 2024) for adjuvant use
  • Include ALINA trial citation in initial submission

2. Enhanced ALK Testing Documentation

  • Request molecular pathology report with ALK percentage/signal
  • Ensure FDA-approved test methodology is clearly stated
  • Include lab accreditation information (CLIA certification)

3. Surgical History Emphasis

  • Highlight tumor size measurement prominently
  • Include lymph node involvement details (N2 in Sarah's case)
  • Attach operative report summary with R0 resection confirmation

Common Pitfalls to Avoid

  • Don't assume reviewers understand adjuvant vs. metastatic criteria
  • Never submit without complete ALK testing documentation
  • Avoid generic medical necessity letters—use drug-specific language

Templates & Checklists

Pre-Submission Checklist

  • Patient age ≥18 years documented
  • ALK-positive test by FDA-approved method
  • NSCLC pathology report attached
  • Tumor size ≥4 cm OR node-positive disease
  • Complete surgical resection documented
  • Prescriber specialty (oncology/hematology) verified
  • Insurance benefits verification completed

Appeal Letter Template

RE: Prior Authorization Appeal - Alecensa (alectinib)
Member: [Name, ID]
Date of Service: [Date]
PA Reference: [Number]

Dear Cigna Medical Director,

I am appealing the denial of Alecensa (alectinib) for adjuvant treatment of ALK-positive NSCLC. The patient meets all criteria per Cigna Policy CNF_494:

1. Age ≥18 years: [Patient age]
2. ALK-positive NSCLC: [Test method, date, result]
3. Adjuvant setting: Following complete resection [date]
4. High-risk features: [Tumor size/nodal status]

This FDA-approved indication (April 2024) is supported by ALINA trial data showing 76% reduction in recurrence risk. Request approval for 24-month treatment course.

Sincerely,
[Prescriber name, credentials]

Pennsylvania-Specific Appeals Resources

If Cigna's internal appeals fail, Pennsylvania offers robust external review options:

Pennsylvania Insurance Department External Review

Expedited Review for Urgent Cases

  • Timeline: 72-hour decision for life-threatening situations
  • Requirements: Physician certification of urgency
  • Parallel Process: Continue internal appeals simultaneously

At Counterforce Health, we help patients navigate complex insurance appeals by turning denials into evidence-backed success stories. Our platform analyzes denial letters and generates targeted rebuttals using payer-specific criteria and clinical evidence. Visit our website to learn how we can help streamline your prior authorization process.

FAQ

How long does Cigna PA take for Alecensa in Pennsylvania? Standard prior authorization: 72 hours. Expedited (life-threatening): 24 hours. Complex cases requiring peer-to-peer may take 5-7 business days.

What if Alecensa is non-formulary on my Cigna plan? Request formulary exception with medical necessity documentation. Cigna has automatic exceptions for FDA-approved stage IV metastatic cancer drugs consistent with guidelines.

Can I request expedited appeal if treatment is delayed? Yes, if delay could seriously jeopardize life or health. Submit physician certification form with expedited appeal request.

Does step therapy apply to Alecensa? No step therapy requirement for Alecensa in ALK-positive NSCLC. However, Cigna requires Alecensa trial before approving Alunbrig (brigatinib).

What if I've already started treatment while appealing? Pennsylvania external review can order retroactive coverage if appeal succeeds. Keep all receipts and pharmacy records.

How do I contact Cigna for PA status updates? Call member services number on your ID card. Reference PA tracking number for fastest service.

Are there cost assistance programs for Alecensa? Genentech Access Solutions offers copay assistance and patient assistance programs for eligible patients.

What happens if external review denies my appeal? External review decisions are final and binding. Consider plan changes during next enrollment period or explore clinical trial options.

Disclaimer: This article provides educational information only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and clinical circumstances. Consult your healthcare provider and insurance representative for personalized guidance.

Sources & Further Reading:

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