By Counterforce Health Team in Onivyde (irinotecan liposome) —

How to Get Onivyde (Irinotecan Liposome) Covered by Aetna CVS Health in Washington: Forms, Appeals, and Step-by-Step Approval Guide

Answer Box: Getting Onivyde Covered by Aetna CVS Health in Washington

Quick Path to Approval: Onivyde (irinotecan liposome) requires prior authorization from Aetna CVS Health for metastatic pancreatic adenocarcinoma. Your oncologist must document ECOG performance status 0-1, adequate biliary drainage, and prior gemcitabine-based therapy failure. Submit the Aetna prior authorization form via fax to 866-249-6155 for specialty oncology medications. If denied, Washington residents have 180 days to appeal through the state's external review process via the Office of the Insurance Commissioner.

First step today: Verify your Aetna plan covers specialty oncology drugs and request the current PA form from your oncologist.

Table of Contents

Start Here: Verify Your Plan & Find the Right Forms

Before starting the approval process, confirm these basics:

✓ Plan Verification

  • Log into your Aetna member portal or call member services at 1-800-872-3862
  • Verify your plan includes specialty oncology drug coverage
  • Check if CVS Caremark manages your prescription benefits

✓ Current Policy Requirements Aetna's Clinical Policy Bulletin 0902 covers Onivyde for metastatic pancreatic adenocarcinoma when:

  • Patient has ECOG performance status 0 or 1
  • Adequate biliary drainage is present
  • Previous gemcitabine-based therapy has failed
  • Used in combination with 5-fluorouracil and leucovorin
Note: Washington follows Aetna's national policies—no state-specific exceptions apply as of 2025.

Coverage at a Glance

Requirement What It Means Where to Document Source
Prior Authorization Required for all plans PA form + clinical notes Aetna PA Guide
Performance Status ECOG 0-1 documented Oncologist assessment Policy Bulletin 0902
Prior Therapy Gemcitabine failure/intolerance Treatment records Policy Bulletin 0902
Biliary Status Adequate drainage confirmed Imaging/procedure notes Policy Bulletin 0902

Prior Authorization Forms & Requirements

Required Form: Aetna Precertification Request for Prescription Drugs

Key Documentation Needed:

  • Complete patient demographics and insurance information
  • Prescriber details (NPI, DEA, license number)
  • Detailed diagnosis with ICD-10 codes
  • Previous treatment history and outcomes
  • Current performance status assessment
  • Biliary drainage status documentation

Clinician Corner: Medical Necessity Letter Checklist

Your oncologist should include these elements in the medical necessity letter:

✓ Clinical Problem

  • Metastatic pancreatic adenocarcinoma diagnosis
  • Current disease status and progression
  • Patient's functional status (ECOG 0-1)

✓ Prior Treatments

  • Specific gemcitabine-based regimens tried
  • Duration of treatment and response
  • Reasons for discontinuation (progression, toxicity)

✓ Current Rationale

  • Why Onivyde is medically necessary now
  • Expected benefit based on clinical trials
  • Monitoring plan and treatment goals

✓ Supporting Evidence

  • Reference to FDA labeling for approved indication
  • NCCN Guidelines for Pancreatic Adenocarcinoma (if accessible)
  • Relevant clinical trial data (NAPOLI-1, NAPOLI-3)

Submission Portals & Methods

Electronic Submission (Preferred)

  • Availity Provider Portal: Most efficient method for PA requests
  • EMR Integration: Many systems connect directly to Aetna's system
  • Turnaround: Most requests processed within 24 hours

Fax Submission

  • Specialty/Oncology Medications: 866-249-6155
  • Cover Sheet Requirements: Include patient name, DOB, member ID, and "URGENT" if expedited review needed
  • Confirmation: Call 866-814-5506 to confirm receipt

Required Attachments

  • Completed PA form with all sections
  • Medical necessity letter
  • Recent clinic notes (last 2-3 visits)
  • Pathology reports confirming diagnosis
  • Imaging showing metastatic disease
  • Documentation of prior therapy failures

CVS Specialty Pharmacy Enrollment

Onivyde is typically dispensed through CVS Specialty Pharmacy for Aetna members.

Enrollment Steps

  1. Complete Enrollment Form: CVS Specialty Oncology Form
  2. Provide Contact Preferences: Phone, text, and email for coordination
  3. Submit via Fax: Send completed form to CVS Specialty
  4. Coordination: CVS will contact your infusion center for delivery scheduling

Transfer from Another Pharmacy

  • Complete new enrollment form with prescriber
  • CVS Specialty will coordinate the transfer
  • Ensure PA approval transfers with the prescription
Tip: Enroll in CVS Specialty early in the PA process to avoid delays once approved.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit detailed clinical rationale Performance status, imaging, prior treatments
"Experimental/investigational" Reference FDA approval and guidelines FDA label, NCCN citation
"Step therapy not met" Document prior gemcitabine failure Treatment records, progression notes
"Non-formulary drug" Request formulary exception Medical necessity letter, alternative contraindications

Scripts for Common Situations

Patient Phone Script for Aetna Member Services: "I'm calling about a prior authorization denial for Onivyde, member ID [number]. My oncologist says this is medically necessary for my metastatic pancreatic cancer after gemcitabine failed. Can you tell me the specific reason for denial and what additional information is needed for an appeal?"

Clinic Staff Script for Peer-to-Peer Review: "We're requesting a peer-to-peer review for [patient name] regarding Onivyde denial. The patient has metastatic pancreatic adenocarcinoma with ECOG 0, documented gemcitabine failure, and meets all criteria in your Clinical Policy Bulletin 0902. When can our oncologist speak with your medical director?"

Appeals Process in Washington State

Washington provides strong consumer protections for insurance appeals.

Internal Appeals (First Level)

  • Timeline: File within 180 days of denial
  • Method: Written request to Aetna with additional documentation
  • Decision: 30 days for standard, 72 hours for expedited
  • Contact: Aetna Appeals Department (address on denial letter)

External Review (Independent)

If internal appeal fails, Washington residents can request external review:

✓ Who Handles It Washington Office of the Insurance Commissioner assigns an Independent Review Organization (IRO)

✓ Timeline to File 180 days from final internal denial

✓ How to Request

  • Complete external review request form
  • Submit to OIC or directly to Aetna
  • Include all medical records and denial letters

✓ Decision Timeline

  • Standard: 30 days maximum
  • Expedited: 72 hours if health at serious risk
  • Decision is binding on Aetna

When to Escalate

Contact the Washington OIC Consumer Advocacy at 1-800-562-6900 if:

  • Aetna doesn't respond within required timeframes
  • You need help understanding the appeals process
  • You believe the denial was handled improperly

Support Lines & Contacts

Aetna Contact Numbers

  • Member Services: 1-800-872-3862
  • Prior Authorization (Commercial): 1-888-632-3862
  • Prior Authorization (Medicare): 1-800-624-0756
  • Specialty Pharmacy: 866-814-5506

What to Ask When Calling

  • "What specific clinical criteria weren't met?"
  • "Can you provide the exact policy number and section?"
  • "What additional documentation would support approval?"
  • "Is expedited review available given the urgency?"

Washington State Resources

  • OIC Consumer Line: 1-800-562-6900
  • External Review Info: insurance.wa.gov/appeals
  • Complaint Filing: Online at insurance.wa.gov

Costs & Patient Assistance Programs

Manufacturer Support

IPSEN CARES Program

  • Copay assistance for eligible patients
  • Patient support services and care coordination
  • Enrollment form available online
  • May reduce out-of-pocket costs significantly

Additional Resources

  • CancerCare Financial Assistance: Grants for treatment costs
  • Patient Access Network Foundation: Copay assistance programs
  • Washington State Pharmaceutical Assistance: Income-based programs
From our advocates: "We've seen patients successfully appeal Onivyde denials by emphasizing the specific ECOG performance status documentation and providing detailed records of gemcitabine treatment failure. The key is matching your clinical documentation exactly to Aetna's published criteria in Policy Bulletin 0902."

FAQ

How long does Aetna CVS Health prior authorization take for Onivyde in Washington? Most requests are processed within 24 hours when submitted electronically with complete documentation. Paper/fax submissions may take 2-3 business days.

What if Onivyde is non-formulary on my plan? Request a formulary exception by documenting medical necessity and why formulary alternatives are inappropriate. Submit via the same PA process with additional justification.

Can I request an expedited appeal if my cancer is progressing? Yes, both Aetna and Washington state allow expedited reviews when health could be seriously jeopardized. Decisions typically come within 72 hours.

Does step therapy apply if I failed gemcitabine in another state? No, documented treatment failures from any location count toward meeting step therapy requirements. Ensure your oncologist includes all prior treatment records.

What happens if the external review upholds the denial? The IRO decision is binding, but you can still file a complaint with the Washington OIC if you believe the process was flawed or appeal to your employer if you have a self-funded plan.

How often should I check if requirements have changed? Review Aetna's precertification list quarterly, as policies can be updated. The current list is effective through 2025.

Timeline: From Submission to Approval

Day 1-2: Submit complete PA request → Day 2-3: Aetna review and decision → Day 4-7: If denied, file internal appeal → Day 30-37: Internal appeal decision → Day 38+: File external review if needed → Day 68+: Final IRO decision

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by identifying the specific denial basis and crafting evidence-backed rebuttals aligned to each plan's own rules. Our platform ingests denial letters, plan policies, and clinical notes to produce targeted appeals that meet procedural requirements while tracking deadlines and required documentation.

Getting Onivyde covered requires patience and persistence, but Washington's strong consumer protections and Aetna's clear clinical criteria create a pathway to approval. Focus on thorough documentation, use the right forms and contacts, and don't hesitate to escalate to the state regulator when needed. Counterforce Health can help streamline this process by automatically generating appeals that match your specific situation to Aetna's requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes and should not replace professional medical or legal advice. Insurance policies and state regulations can change. Always verify current requirements with your insurer and healthcare provider. For personalized assistance with insurance appeals, consult qualified professionals or contact the Washington Office of the Insurance Commissioner.

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