By Counterforce Health Team in Tagrisso (osimertinib) —

Renewing Tagrisso (Osimertinib) Approval with Humana in Pennsylvania: 2025 Guide to Timing, Documentation, and Appeals

Answer Box: Renewing Your Tagrisso Coverage with Humana in Pennsylvania

Tagrisso (osimertinib) renewal with Humana requires prior authorization every 6-12 months. Start the renewal process 30-45 days before your current approval expires. You'll need updated EGFR mutation testing, response assessment imaging, and a medical necessity letter from your oncologist. In Pennsylvania, if renewal is denied, you have 65 days to appeal through Medicare's process (not the state external review). First step today: Contact your oncologist's office to schedule renewal documentation review and confirm your current approval expiration date.

Table of Contents

  1. When to Start Your Renewal
  2. Updated Evidence Required
  3. Complete Renewal Documentation
  4. Submission Timeline and Process
  5. If Coverage Lapses
  6. Annual Plan Changes to Monitor
  7. Personal Renewal Tracker
  8. Appeals Process for Denied Renewals
  9. FAQ

Renewal Timing: When to Start the Process

Most Humana prior authorizations for Tagrisso are approved for 6-12 months, depending on your specific plan and clinical situation. Here's when to act:

Start Renewal 30-45 Days Early

  • Check your current approval: Look for the expiration date on your most recent prior authorization letter or call Humana member services
  • Schedule oncology visit: Book your follow-up appointment 6-8 weeks before expiration
  • Order imaging: CT scans or PET scans should be completed within 30 days of renewal submission
Tip: Set a calendar reminder 60 days before your approval expires to begin scheduling appointments and gathering documentation.

Warning Signs to Start Early

  • New side effects or dose reductions
  • Any changes in cancer staging or progression
  • Switch to a different Humana plan during open enrollment
  • Changes in your oncology practice or treating physician

Evidence Update: What's Changed Since Initial Approval

Your renewal must demonstrate continued medical necessity and appropriate response to therapy. Humana requires updated clinical evidence showing:

Treatment Response Documentation

  • Imaging results: Most recent CT chest/abdomen/pelvis or PET scan showing stable disease or response
  • Performance status: ECOG or Karnofsky performance score
  • Symptom assessment: Patient-reported outcomes and quality of life measures
  • Biomarker monitoring: Any new molecular testing or liquid biopsy results

Safety and Tolerability Updates

  • Adverse event log: Documentation of side effects and management strategies
  • Dose modifications: Any reductions due to toxicity with clinical justification
  • Cardiac monitoring: EKGs and echocardiograms if required by protocol
  • Pulmonary function: Chest imaging to rule out interstitial lung disease

Adherence Documentation

  • Pharmacy records: Prescription fill dates and quantities
  • Pill counts: If requested by your oncologist
  • Patient diary: Self-reported adherence and missed doses

Complete Renewal Documentation Package

Required Clinical Documents

  1. Updated medical necessity letter from your oncologist
  2. Recent imaging reports (within 30-60 days)
  3. Laboratory results including CBC, CMP, liver function tests
  4. EGFR mutation confirmation (original test results)
  5. Treatment timeline showing duration of therapy and response

Medical Necessity Letter Checklist

Your oncologist's renewal letter should include:

  • Current disease status: Stable, responding, or progressing
  • Treatment duration: How long you've been on Tagrisso
  • Clinical benefit: Objective response or disease stabilization
  • Continued appropriateness: Why Tagrisso remains the best option
  • Alternative therapies considered: Why other options are not suitable
  • Monitoring plan: Ongoing safety and efficacy assessments
Clinician Corner: Reference the FDA prescribing information and NCCN guidelines to support continued therapy rationale in your medical necessity letter.

Submission Timeline and Decision Process

Humana Processing Timeline

Step Timeline Action Required
Submission Day 0 Submit complete renewal packet
Initial review 7-14 days Humana reviews for completeness
Clinical review 14-30 days Medical director evaluation
Decision issued 30 days maximum Approval or denial letter sent
Appeal deadline 65 days from denial Submit internal appeal if denied

How to Submit Your Renewal

  1. Provider portal: Most efficient method for oncology practices
  2. Fax submission: Check current fax number with Humana (verify with provider services)
  3. Mail: Use certified mail for important deadlines
  4. Phone follow-up: Call 3-5 days after submission to confirm receipt

If Coverage Lapses: Bridge Options

Immediate Steps if Approval Expires

  1. Contact your pharmacy: Ask about emergency supplies (usually 3-7 days)
  2. Call Humana urgently: Request expedited review if clinically appropriate
  3. Explore manufacturer support: AstraZeneca's patient assistance programs

AstraZeneca Patient Support Resources

  • Tagrisso Co-Pay Savings Program: Call 800-236-9933 for eligible patients
  • MyAccess360: Comprehensive support at 1-844-275-2360
  • Emergency supply requests: May be available for established patients during coverage gaps
Note: These programs have specific eligibility requirements and may not be available for all Medicare patients.

Temporary Coverage Strategies

  • 90-day prescription fills: When approved, can reduce renewal frequency
  • Mail-order pharmacy: Often provides better coverage and automatic refill reminders
  • Hospital emergency supplies: For urgent situations while appeals are pending

Annual Plan Changes to Monitor

Formulary Updates to Track

Humana updates its formulary annually and mid-year. Key changes that could affect your Tagrisso coverage:

  • Tier placement: Movement between specialty tiers affects cost-sharing
  • Prior authorization criteria: Requirements may become more or less stringent
  • Specialty pharmacy network: Approved pharmacies may change
  • Quantity limits: Monthly supply restrictions may be modified

2025 Humana Changes

Based on current information, Tagrisso remains covered on Humana formularies through 2025 with continued prior authorization requirements. However, monitor for:

  • Network pharmacy changes: Verify your specialty pharmacy remains in-network
  • Documentation requirements: May be updated annually
  • Appeal procedures: Could be streamlined as part of Humana's commitment to reduce prior authorization burdens

Personal Renewal Tracker Template

Renewal Checklist

  • Current approval expiration date: ___________
  • Renewal start date (45 days early): ___________
  • Oncology appointment scheduled: ___________
  • Imaging ordered: ___________
  • Lab work completed: ___________
  • Medical necessity letter requested: ___________
  • Renewal packet submitted: ___________
  • Humana confirmation received: ___________
  • Decision received: ___________

Key Contact Information

  • Oncologist's office: ___________
  • Humana member services: ___________
  • Specialty pharmacy: ___________
  • Prior authorization department: ___________

Appeals Process for Denied Renewals

Medicare Advantage Appeals (Humana Plans)

Important: Pennsylvania's state external review process does not apply to Medicare Advantage plans like Humana. You must use the federal Medicare appeals process.

Appeal Levels and Timelines

  1. Redetermination (Internal Appeal)
    • Deadline: 65 days from denial notice
    • Timeline: Decision within 30 days (7 days for expedited)
    • Submit to: Humana appeals department
  2. Reconsideration (Independent Review)
    • Deadline: 60 days from redetermination
    • Timeline: Decision within 30 days
    • Reviewer: Qualified Independent Contractor (QIC)
  3. Administrative Law Judge Hearing
    • Threshold: $180 minimum (2024)
    • Timeline: 90 days for decision
    • Format: Phone, video, or in-person hearing

Expedited Appeals

Request expedited review if:

  • Delay could seriously jeopardize your health
  • You're currently on Tagrisso and coverage is interrupted
  • Your oncologist supports urgent need

Timeline: 72 hours for expedited decisions at each level.

FAQ

Q: How often does Humana require Tagrisso renewal? A: Most approvals are for 6-12 months, depending on your clinical situation and plan type. Check your approval letter for the specific expiration date.

Q: What if my EGFR mutation status changes? A: New mutations or resistance patterns require updated molecular testing and may change coverage criteria. Your oncologist should submit comprehensive genomic profiling results.

Q: Can I switch specialty pharmacies during renewal? A: Yes, but verify the new pharmacy is in Humana's network and can handle specialty medications. Transfer prescriptions before your current supply runs out.

Q: What if I move to a different state during treatment? A: Contact Humana immediately to update your address and confirm continued coverage. Some network providers and pharmacies may change.

Q: Does step therapy apply to renewals? A: Generally no, if you're already stable on Tagrisso. However, new plan requirements or clinical changes might trigger step therapy requirements.

Q: How do I request an expedited renewal? A: Your oncologist must document urgent medical need. Submit the request with clinical justification for why standard timelines could harm your health.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that turn insurance denials into approvals. We specialize in oncology medications like Tagrisso, ensuring patients get the treatments they need without unnecessary delays.

For additional support with your Tagrisso renewal or appeal, Counterforce Health can help streamline the documentation process and improve your chances of approval.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for personalized guidance. Coverage decisions may vary based on individual circumstances and plan specifics. For official Pennsylvania insurance assistance, contact the Pennsylvania Insurance Department or call 1-877-881-6388.

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