By Counterforce Health Team in Alecensa (alectinib) —

Renewing Alecensa (alectinib) Coverage with Humana in New York: Annual Requirements, Timeline, and Appeals Process

Answer Box: Renewing Your Alecensa Coverage

Humana Medicare Advantage requires annual prior authorization renewal for Alecensa (alectinib) with updated clinical documentation. Start the renewal process 60 days before your current approval expires. Submit: updated ALK-positive test results, recent imaging showing stable disease or response (RECIST criteria), current lab values (CBC, LFTs, CPK), and physician attestation of ongoing medical necessity. If denied, New York residents have 4 months to file an external appeal through the Department of Financial Services.

Table of Contents

  1. Renewal Triggers: When to Start Early
  2. Evidence Update: What Documentation You Need
  3. Renewal Packet: Must-Include Documents
  4. Timeline: Submission Windows and Decision Times
  5. If Coverage Lapses: Bridge Options
  6. Annual Changes: What to Re-verify
  7. Personal Tracker Template
  8. Appeals Process for New York Residents
  9. FAQ

Renewal Triggers: When to Start Early

Humana Medicare Advantage plans require annual prior authorization renewal for Alecensa (alectinib), typically coinciding with your plan year anniversary. However, several triggers should prompt you to start the renewal process early:

Start 60-90 Days Before Expiration If:

  • Your oncologist notes any changes in disease status on recent scans
  • You've experienced new side effects requiring dose modifications
  • Lab values show trends that might raise questions (elevated LFTs, CPK)
  • Your Humana plan sends an Annual Notice of Changes (ANOC) indicating formulary modifications

Immediate Action Required If:

  • You receive a letter stating your current authorization expires in 30 days
  • Your pharmacy notifies you of coverage issues when filling your prescription
  • Humana requests additional clinical information for "continued coverage review"
Tip: Set a calendar reminder 90 days before your plan anniversary date. Most Alecensa approvals run January-December for Medicare Advantage plans.

Evidence Update: What Documentation You Need

Annual renewals require fresh evidence that Alecensa remains medically necessary and effective. Your oncology team must document:

Response to Therapy

  • Recent imaging results (within 3 months): CT chest/abdomen and brain MRI showing stable disease, partial response, or complete response per RECIST 1.1 criteria
  • Clinical benefit documentation: Performance status improvements, symptom control, quality of life measures
  • Comparison to baseline: Explicit mention of tumor measurements and changes since treatment initiation

Adverse Events and Management

  • Tolerability assessment: Documentation of any side effects and how they're managed
  • Dose modifications: If applicable, rationale for dose reductions and continued efficacy
  • Safety monitoring results: Recent lab values including CBC, comprehensive metabolic panel, liver function tests, and CPK levels

Adherence Documentation

  • Pharmacy fill records: Evidence of consistent medication pickup and adherence
  • Patient-reported adherence: Clinical notes documenting patient compliance with dosing schedule
  • Pill counts or adherence monitoring (if available through your practice)

Renewal Packet: Must-Include Documents

Your renewal submission to Humana must include specific documentation. Missing any component typically results in automatic denial.

Core Requirements

Document Source Notes
ALK-positive test results Original pathology report Must show ALK rearrangement by FISH, IHC, or NGS
Current imaging Radiology reports (within 90 days) Must include RECIST measurements and comparison
Physician letter of medical necessity Oncologist Template available through Counterforce Health
Recent lab values Laboratory reports CBC, CMP, LFTs, CPK within 30 days
Treatment history Clinical notes Documentation of prior therapies and failures
Current prescription Oncologist Confirming 600mg twice daily dosing

Letter of Medical Necessity Structure

Your oncologist's letter should follow this format:

  1. Patient identification: Name, DOB, Humana member ID, diagnosis with ICD-10 codes
  2. Clinical history: ALK-positive NSCLC staging, prior treatments attempted and outcomes
  3. Current status: Recent imaging results, performance status, symptom control
  4. Medical necessity rationale: Why Alecensa remains appropriate per NCCN guidelines
  5. Monitoring plan: Schedule for ongoing safety labs and imaging
  6. Alternative assessment: Why other ALK inhibitors are not appropriate

Timeline: Submission Windows and Decision Times

Understanding Humana's processing timeline helps prevent coverage gaps:

Standard Timeline

  • Submit renewal: 60 days before current approval expires
  • Humana review period: 14-30 days for standard prior authorization
  • Decision notification: Via mail and member portal
  • Appeal deadline: 60 days from denial date for internal appeal

Expedited Process

If your current approval expires within 30 days:

  • Expedited review: 72 hours for urgent requests
  • Required: Physician attestation that delay would cause serious harm
  • Submit via: Humana provider portal with "URGENT" designation
Note: New York residents have additional protections. If Humana delays beyond standard timelines, you can file a complaint with the Department of Financial Services.

If Coverage Lapses: Bridge Options

If your Alecensa renewal is delayed or denied, several options can prevent treatment interruption:

Immediate Steps

  1. Contact your oncology practice to inquire about manufacturer samples or bridge programs
  2. Request expedited appeal if denial was inappropriate
  3. Apply for Genentech patient assistance through ALECENSA Access Solutions

Temporary Coverage Options

  • Genentech Co-pay Assistance Program: May provide temporary supply during appeals (commercial insurance only)
  • Manufacturer bridge programs: Limited quantities available through oncology practices
  • Emergency prescription override: Some Humana plans allow one-time 30-day emergency fills

Escalation Steps

If bridge options are unavailable:

  1. File expedited internal appeal with Humana (72-hour turnaround)
  2. Request peer-to-peer review between your oncologist and Humana medical director
  3. File external appeal with New York Department of Financial Services if internal appeal fails

Annual Changes: What to Re-verify

Each year, Humana may modify coverage requirements. Review these elements annually:

Formulary Changes

  • Tier placement: Alecensa may move between specialty tiers, affecting cost-sharing
  • Prior authorization requirements: New criteria may be added
  • Step therapy protocols: Requirements to try other ALK inhibitors first may change
  • Quantity limits: Monthly supply restrictions may be modified

Plan Design Changes

Review your Annual Notice of Changes (ANOC) for:

  • Specialty pharmacy requirements: Must use Humana's designated specialty pharmacy
  • Site of care restrictions: Home infusion vs. clinic administration requirements
  • Cost-sharing modifications: Changes to copays or coinsurance percentages

Documentation Requirements

  • New forms: Humana may introduce updated prior authorization forms
  • Additional testing: New lab monitoring or genetic testing requirements
  • Provider network changes: Ensure your oncologist remains in-network

Personal Tracker Template

Use this template to track your renewal progress:

Renewal Year: ________ Current Approval Expires: ________ Renewal Submission Target: ________ (60 days prior)

Documentation Checklist

  • ALK-positive test results gathered
  • Recent imaging scheduled (within 90 days of submission)
  • Lab work ordered (CBC, CMP, LFTs, CPK)
  • Physician letter of medical necessity requested
  • Treatment history summary prepared
  • Current prescription confirmed

Submission Tracking

  • Date submitted: ________
  • Submission method: Portal / Fax / Mail
  • Confirmation number: ________
  • Expected decision date: ________
  • Decision received: ________ (Approved / Denied)

If Denied

  • Reason for denial: ________
  • Appeal filed date: ________
  • Appeal method: Internal / External
  • Appeal outcome: ________

Appeals Process for New York Residents

New York provides robust appeal rights for Humana Medicare Advantage denials:

Internal Appeal (First Step)

  • Deadline: 60 days from denial date
  • Submit to: Humana appeals department
  • Required documents: Original denial letter, additional clinical evidence, physician support letter
  • Timeline: 30 days for standard review, 72 hours for expedited

External Appeal (New York DFS)

If internal appeal fails:

  • Deadline: 4 months from final Humana denial
  • Submit to: New York Department of Financial Services
  • Fee: Maximum $25 (waived for financial hardship)
  • Timeline: 30 days standard, 72 hours expedited, 24 hours for ongoing drug therapy
  • Decision: Binding on Humana

Expedited Appeal Criteria

Request expedited review if:

  • Delay would seriously jeopardize your health
  • You're currently on Alecensa and facing treatment interruption
  • Your oncologist attests that immediate decision is medically necessary

Counterforce Health specializes in helping patients navigate complex insurance appeals for specialty medications like Alecensa. Their platform can help identify the specific denial reasons and craft targeted, evidence-backed appeals that align with Humana's own coverage policies. Visit www.counterforcehealth.org to learn more about their appeal assistance services.

FAQ

How long does Humana take to process Alecensa renewal requests? Standard prior authorization renewals take 14-30 days. Expedited requests (when current approval expires within 30 days) are processed within 72 hours.

What if my ALK test was done years ago? Original ALK-positive test results remain valid for renewal purposes. However, if you've had disease progression or new biopsies, Humana may request updated molecular testing.

Can I switch from another ALK inhibitor to Alecensa during renewal? Yes, but you'll need documentation of why the current ALK inhibitor is no longer appropriate (progression, intolerance, or contraindication) and why Alecensa is medically necessary.

Does step therapy apply to Alecensa renewals? Generally no for renewals if you're already stable on Alecensa. However, if you're switching ALK inhibitors, Humana may require step therapy unless you qualify for an exception.

What if my oncologist is no longer in Humana's network? You can continue treatment with an out-of-network oncologist during the renewal process, but may face higher costs. Consider requesting a network exception or transitioning care to an in-network provider.

How does the 2025 Medicare Part D $2,000 out-of-pocket cap affect Alecensa? Once you reach $2,000 in out-of-pocket drug costs, Humana covers 100% of remaining costs for the year, including Alecensa. This significantly reduces annual costs for specialty tier medications.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and medical circumstances. Always consult with your healthcare provider and insurance plan directly for specific coverage determinations. For personalized assistance with insurance appeals and prior authorizations, Counterforce Health provides specialized support for patients navigating complex coverage challenges.

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