By Counterforce Health Team in Tagrisso (osimertinib) —

How to Get Tagrisso (osimertinib) Covered by Humana in California: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Tagrisso (osimertinib) Covered by Humana in California

Humana requires prior authorization for Tagrisso (osimertinib) with documented EGFR mutation testing and clinical justification. The fastest path: have your oncologist submit a complete prior authorization request through Humana's provider portal with EGFR test results, treatment history, and medical necessity letter. If denied, file an internal appeal within 65 days, then escalate to California's Independent Medical Review (IMR) for a binding external review. Start today: Contact your oncologist's office to request they begin the prior authorization process and gather your EGFR mutation test results.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Set Your Goal: Understanding What Approval Requires
  3. Visit Preparation: Gathering Your Medical History
  4. Building Your Evidence Kit
  5. Medical Necessity Letter Structure
  6. Supporting Your Provider During Peer-to-Peer Review
  7. After Your Visit: Documentation and Follow-Up
  8. Appeals Process: From Internal Review to California IMR
  9. Common Denial Reasons and Solutions
  10. Costs and Financial Assistance
  11. FAQ

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Humana must approve before dispensing Humana PA Lists 72 hours standard, 24 hours expedited
EGFR Mutation Testing Lab confirmation of specific mutations FDA-approved companion diagnostic Before treatment starts
Medical Necessity Letter Oncologist justification Provider submits with PA request Part of initial submission
Formulary Status Check tier placement and restrictions Humana Drug List Annual updates
Appeal Deadline Internal appeal after denial 65 days from denial notice Standard: 7 days decision

Set Your Goal: Understanding What Approval Requires

Getting Tagrisso (osimertinib) covered by Humana in California requires a partnership between you and your oncologist. Humana's prior authorization criteria focus on confirming you have EGFR-mutated non-small cell lung cancer (NSCLC) and that Tagrisso is the appropriate treatment for your specific situation.

According to Humana's medical pharmacy policies, Tagrisso requires prior authorization through their Clinical Pharmacy Review process. The good news? Humana has one of the lowest prior authorization denial rates among major Medicare Advantage plans at approximately 3.5% in 2023.

Your role is to provide complete medical information and advocate for your treatment. Your oncologist's role is to submit the clinical evidence and medical justification that meets Humana's coverage criteria.

Visit Preparation: Gathering Your Medical History

Before meeting with your oncologist about Tagrisso coverage, prepare a comprehensive timeline of your cancer journey. This preparation strengthens your prior authorization request and helps your doctor write a compelling medical necessity letter.

Create your symptom and treatment timeline:

  • Date of initial NSCLC diagnosis
  • All imaging studies (CT scans, PET scans, brain MRI)
  • Biopsy results, especially EGFR mutation testing
  • Previous treatments tried (chemotherapy, radiation, other targeted therapies)
  • Specific reasons each treatment was discontinued (progression, side effects, intolerance)
  • Current performance status and quality of life impacts

Document functional impacts:

  • How your cancer affects daily activities
  • Work or disability status changes
  • Hospitalizations or emergency visits
  • Current symptoms and severity
Tip: Bring a written summary to your appointment. This ensures nothing important gets missed and helps your oncologist document medical necessity more effectively.

Building Your Evidence Kit

Strong evidence supporting your Tagrisso request should include both clinical documentation and guideline support. Work with your oncologist's office to compile these essential documents:

Laboratory and Diagnostic Evidence:

  • EGFR mutation test results (exon 19 deletion, L858R, or other sensitizing mutations)
  • Staging scans showing metastatic disease or post-surgical status
  • Pathology reports confirming NSCLC diagnosis
  • Recent imaging showing disease progression (if applicable)

Treatment History Documentation:

  • Previous therapy records with dates, doses, and outcomes
  • Documentation of treatment failures or intolerances
  • Contraindications to alternative therapies

Guideline Support: The NCCN Guidelines designate osimertinib as a Category 1 (preferred) recommendation for EGFR-mutated NSCLC in multiple settings:

  • First-line treatment for metastatic disease with sensitizing EGFR mutations
  • Adjuvant therapy after surgical resection
  • Consolidation therapy after chemoradiation for Stage III disease

Medical Necessity Letter Structure

Your oncologist's medical necessity letter is the cornerstone of your prior authorization request. Here's what should be included based on successful appeals:

Patient Information Section:

  • Full name, date of birth, and Humana member ID
  • ICD-10 diagnosis codes (e.g., C34.10 for malignant neoplasm of upper lobe, unspecified bronchus or lung)
  • Case or prior authorization reference number

Clinical Justification:

  • Specific EGFR mutation identified and testing method used
  • Disease stage and current status
  • Prior treatment history with specific drugs, doses, duration, and outcomes
  • Why alternative formulary options are inappropriate (contraindications, previous failures, or intolerances)

Treatment Plan:

  • Proposed osimertinib dosing (typically 80mg daily)
  • Expected duration of therapy
  • Monitoring plan for potential side effects
  • Treatment goals and expected outcomes

Supporting Evidence:

  • References to FDA approval and labeling
  • NCCN Guideline recommendations
  • Relevant clinical trial data supporting efficacy

Supporting Your Provider During Peer-to-Peer Review

If your initial prior authorization is denied, Humana may offer a peer-to-peer review where your oncologist speaks directly with a Humana medical director. You can support this process by:

Providing Availability Windows:

  • Give your oncologist's office several time slots when they're available for calls
  • Understand that these conversations often happen within 24-48 hours of scheduling

Preparing a Concise Case Summary:

  • One-page summary of your diagnosis, mutation status, and prior treatments
  • Clear explanation of why Tagrisso is medically necessary for your specific situation
  • Documentation of any urgent clinical factors

Key Points for Peer-to-Peer Discussion:

  • Specific EGFR mutation and FDA-approved indication
  • Previous treatment failures or contraindications to alternatives
  • Risk of disease progression without appropriate targeted therapy
  • Quality of life considerations

After Your Visit: Documentation and Follow-Up

After your oncologist submits your prior authorization request, stay actively involved in tracking its progress:

Save Important Documents:

  • Copy of the prior authorization request
  • Medical necessity letter
  • All supporting clinical documents
  • Humana's determination letter (approval or denial)

Use Patient Portal Communication:

  • Message your oncologist's office for status updates
  • Request copies of any additional information submitted to Humana
  • Ask for notification as soon as a decision is received

Track Timelines:

  • Standard prior authorization decisions: 72 hours
  • Expedited decisions (if urgent): 24 hours
  • Appeals deadline: 65 days from denial notice
Note: If your condition is urgent or rapidly progressing, ask your oncologist to request expedited review, which requires clinical justification for the urgency.

Appeals Process: From Internal Review to California IMR

If Humana denies your Tagrisso prior authorization, California offers robust appeal rights with high success rates for oncology medications.

Step 1: Internal Appeal (Redetermination)

  • Deadline: 65 days from denial notice
  • Timeline: Humana decides within 7 calendar days
  • How to file: Use Humana's appeal process or submit written request
  • What to include: Original denial letter, additional clinical evidence, updated medical necessity letter

Step 2: Independent Medical Review (IMR)

  • When to use: After internal appeal denial or if Humana doesn't respond within 30 days
  • Success rate: 55-61% overturn rate for oncology/specialty drug appeals in California
  • Timeline: 45 days for standard review, 7 days for expedited
  • How to file: Contact DMHC Help Center at 888-466-2219 or apply online at healthhelp.ca.gov
  • Cost: Free to patients (insurers pay for the review)

California's IMR Process: California's Department of Managed Health Care (DMHC) assigns independent physician experts in oncology to review denied cases. These reviewers evaluate whether the denied treatment is medically necessary based on current medical evidence and standards of care.

From our advocates: In our experience with EGFR-targeted therapy appeals, cases with complete molecular testing documentation and clear evidence of treatment failure or contraindications to alternatives have the strongest success rates. The key is presenting a complete clinical picture that demonstrates medical necessity according to current oncology standards.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
No EGFR mutation documented Submit FDA-approved test results NGS or PCR report showing specific mutation
Step therapy not completed Document contraindications or failures Medical records showing previous TKI trials
Not medically necessary Strengthen clinical justification Updated letter with guideline references
Quantity limits exceeded Justify dosing requirements Oncologist letter explaining dosing rationale
Non-formulary drug Request formulary exception Comparison showing why alternatives are inappropriate

Costs and Financial Assistance

While working through the approval process, explore financial assistance options:

AstraZeneca Patient Assistance:

Foundation Support:

  • Patient Advocate Foundation
  • CancerCare Co-Payment Assistance Foundation
  • HealthWell Foundation oncology fund

California-Specific Resources:

  • Covered California for marketplace plans
  • Medi-Cal coverage for eligible low-income patients

FAQ

How long does Humana prior authorization take for Tagrisso in California? Standard decisions take 72 hours, while expedited reviews (for urgent cases) are completed within 24 hours. Your oncologist can request expedited review if delays would jeopardize your health.

What if Tagrisso is not on Humana's formulary? You can request a formulary exception through Humana's coverage determination process. Your oncologist must demonstrate that formulary alternatives are less effective or cause adverse effects for your specific condition.

Can I request an expedited appeal in California? Yes, both Humana internal appeals and California IMR offer expedited timelines for urgent medical situations. Expedited IMR decisions are made within 7 days, often within 72 hours.

Does step therapy apply if I've already failed other EGFR inhibitors? Previous treatment failures should exempt you from step therapy requirements. Ensure your oncologist documents specific drugs tried, doses, duration, and reasons for discontinuation.

What happens if Humana approves Tagrisso but limits the quantity? If quantity limits don't match your prescribed dosing, your oncologist can request a quantity limit exception by demonstrating medical necessity for the specific dose and frequency.

How do I track my prior authorization status? Use Humana's member portal or call member services. Your oncologist's office can also check status through the provider portal and should keep you updated on any requests for additional information.

When to Contact California Regulators

If you experience delays or problems with Humana's appeal process, California's insurance regulators can help:

DMHC Help Center: 888-466-2219

  • File complaints about HMO or managed care plan delays
  • Get assistance with IMR applications
  • Report violations of appeal timelines

California Department of Insurance: 800-927-4357

  • For PPO or other non-HMO plans
  • Consumer assistance with insurance disputes

How Counterforce Health Can Help

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Tagrisso. Our platform analyzes denial letters and plan policies to identify the specific denial basis, then drafts point-by-point rebuttals aligned with your plan's own coverage rules. We pull the right clinical evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—and weave them into appeals that meet procedural requirements while tracking deadlines and required documentation.

For patients and clinicians navigating complex prior authorization requirements, Counterforce Health provides time-saving templates and cleaner submissions that reduce back-and-forth with insurers, helping you focus on what matters most: your treatment and recovery.

Disclaimer: This guide provides educational information about insurance coverage processes and is not medical advice. Always consult with your oncologist about treatment decisions and work with your healthcare team to navigate coverage requirements. Insurance policies and procedures change frequently—verify current requirements with Humana and California regulators.

Sources & Further Reading:

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