By Counterforce Health Team in Onivyde (irinotecan liposome) —

How to Get Onivyde (Irinotecan Liposome) Covered by Blue Cross Blue Shield in Washington: Prior Authorization Guide and Appeals Process

Answer Box: Getting Onivyde Covered in Washington

Blue Cross Blue Shield in Washington requires prior authorization for Onivyde (irinotecan liposome), typically covering it for metastatic pancreatic cancer when used in combination regimens like NALIRIFOX. Key requirements include ECOG performance status 0-1, documented diagnosis, and detailed clinical justification. If denied, you have strong appeal rights under Washington law, including external review by an Independent Review Organization within 72 hours for urgent cases.

Three steps to start today:

  1. Contact your BCBS plan to request the prior authorization form (or access via member portal)
  2. Have your oncologist document your diagnosis, ECOG status, and intended regimen
  3. If urgent, explicitly request expedited review citing potential health risks from delay

Table of Contents

  1. Why Washington State Rules Matter
  2. Prior Authorization Requirements
  3. Medical Necessity Criteria
  4. Step Therapy Protections
  5. Fastest Path to Approval
  6. Appeals Process and Deadlines
  7. External Review Rights
  8. Common Denial Reasons & Solutions
  9. Scripts for Calling BCBS
  10. When to Contact State Regulators
  11. FAQ

Why Washington State Rules Matter

Washington provides some of the strongest consumer protections in the country for insurance appeals, particularly for specialty cancer medications like Onivyde. Under RCW 48.43.535, all Blue Cross Blue Shield plans must offer:

  • Expedited appeals with 72-hour decisions for urgent situations
  • External review by independent medical experts after internal appeals
  • Binding decisions that insurers must honor if appeals are successful

These protections apply whether you have Premera Blue Cross, Regence BlueShield, or another BCBS plan in Washington. The key difference from other states is that Washington's external review process is particularly robust for oncology cases, often involving specialists from major medical centers.

Note: Self-funded employer plans (ERISA) may have different procedures, but many voluntarily follow Washington's external review process.

Prior Authorization Requirements

All BCBS plans in Washington require prior authorization for Onivyde due to its specialty status and high cost. Here's what you need to know:

Coverage at a Glance

Requirement Details Where to Find Timeline
Prior Auth Required Yes, for all indications BCBS formulary/member portal 14-30 days standard
Formulary Status Typically non-preferred/tier 4 Plan drug list Updated annually
Step Therapy Not required for pancreatic cancer Washington legislation pending N/A
Site of Care Infusion center/hospital outpatient Medical benefit Varies by plan
Age Restriction ≥18 years BCBS medical policies N/A

Medical Necessity Criteria

BCBS plans typically approve Onivyde when these criteria are met:

Core Requirements

  • Diagnosis: Metastatic pancreatic adenocarcinoma (ICD-10: C25.9)
  • Regimen: Must be used in combination (never as monotherapy)
    • NALIRIFOX: Onivyde + leucovorin + fluorouracil + oxaliplatin
    • Post-gemcitabine: Onivyde + fluorouracil + leucovorin
  • Performance Status: ECOG 0-1 for NALIRIFOX regimen
  • Provider: Must be prescribed by an oncologist

Documentation Needed

Your oncologist should include:

  • Pathology confirming pancreatic adenocarcinoma
  • Staging studies showing metastatic disease
  • Current ECOG performance status assessment
  • Intended treatment regimen and cycle count
  • Prior therapy history (if applicable)
Clinician Corner: When writing the medical necessity letter, emphasize that Onivyde in NALIRIFOX showed superior overall survival compared to nab-paclitaxel plus gemcitabine in the NAPOLI-3 trial. Include the specific regimen dosing and administration schedule.

Step Therapy Protections

Good news for Washington patients: proposed legislation (SB 5814/HB 1884) aims to eliminate step therapy requirements for metastatic cancer patients. Currently, most BCBS plans already don't require step therapy for Onivyde in pancreatic cancer.

If your plan incorrectly applies step therapy:

  • Reference the pending Washington legislation
  • Note that pancreatic cancer typically doesn't have effective "step" alternatives
  • Request a medical exception citing the aggressive nature of the disease

Fastest Path to Approval

Step-by-Step Process

  1. Verify Benefits (Patient/Clinic Staff)
    • Call BCBS member services or log into member portal
    • Confirm prior authorization requirements for your specific plan
    • Get the PA form number and submission method
  2. Gather Documentation (Clinic)
    • Pathology report
    • Staging scans (CT, MRI)
    • ECOG performance status note
    • Treatment plan with specific regimen
  3. Complete Prior Authorization (Prescriber)
    • Use BCBS-specific PA form
    • Submit via provider portal, fax, or mail
    • Include all supporting documentation
    • Mark "urgent" if applicable
  4. Follow Up (Patient/Clinic)
    • Track submission via provider portal
    • Call if no response within stated timeframe
    • Request peer-to-peer review if initially denied
  5. Appeal if Denied (Patient with Clinic Support)
    • File internal appeal within plan deadlines
    • Include additional clinical evidence
    • Request expedited review for urgent cases
  6. External Review (if Internal Appeals Fail)
    • Contact Washington Office of Insurance Commissioner
    • File for Independent Review Organization (IRO) review
    • Submit within 180 days of final internal denial
  7. Implementation (Once Approved)
    • Schedule infusion appointments
    • Coordinate with specialty pharmacy if required
    • Ensure ongoing authorization for multiple cycles

Appeals Process and Deadlines

Washington law provides clear timelines for appeals:

Internal Appeals

  • Standard: 30 days to file after denial
  • Decision: 30 days for plan to respond
  • Expedited: 72 hours for urgent situations

External Review

  • Filing window: 180 days after final internal denial
  • Standard decision: 30 days
  • Expedited decision: 72 hours for urgent cases

Required Documents for Appeals

  • Original denial letter
  • All medical records supporting the request
  • Letter from prescribing physician
  • Any additional clinical evidence

Contact the Washington Office of Insurance Commissioner at 800-562-6900 for assistance with the appeals process.

External Review Rights

Washington's external review process is particularly strong for oncology cases. After exhausting internal appeals, you can request review by an Independent Review Organization (IRO) that specializes in cancer care.

What Makes Washington Different

  • IRO reviewers often include oncologists from major medical centers
  • Reviews consider both medical necessity and plan policy reasonableness
  • Decisions are binding on the insurer
  • No cost to the patient for external review

How to Request External Review

  1. Complete internal appeals first (unless urgent)
  2. Contact your BCBS plan or the Washington OIC directly
  3. Submit request within 180 days of final internal denial
  4. Provide all relevant medical documentation

The IRO will review your case independently and can overturn the insurance company's denial if they find the treatment medically necessary.

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Key Documentation
"Not medically necessary" Emphasize FDA approval, clinical trial data NAPOLI-3 trial results, FDA label
"Experimental/investigational" Cite FDA approval and NCCN guidelines FDA approval letter, NCCN compendium
"Step therapy required" Reference Washington cancer legislation Cite SB 5814/HB 1884, cancer diagnosis
"ECOG status not documented" Submit current performance status assessment Oncologist's ECOG evaluation
"Combination not approved" Provide evidence for specific regimen Clinical trial data, FDA labeling

Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific denial basis and crafting targeted, evidence-backed responses that align with each plan's own policies and requirements.

Scripts for Calling BCBS

For Prior Authorization Status

"Hi, I'm calling to check on the status of a prior authorization request for Onivyde, also called irinotecan liposome. The request was submitted on [date] for [patient name], member ID [number]. Can you tell me the current status and expected decision date?"

For Expedited Review

"I need to request an expedited review for a prior authorization. This is for Onivyde for metastatic pancreatic cancer. Any delay in treatment could seriously harm the patient's health. What's the process for urgent review, and what documentation do you need?"

For Appeal Assistance

"I received a denial for Onivyde and want to file an appeal. Can you send me the appeal form and explain the deadline? I also want to know about Washington's external review process if the internal appeal isn't successful."

When to Contact State Regulators

Contact the Washington Office of Insurance Commissioner if:

  • Your BCBS plan doesn't respond within required timeframes
  • You're having trouble accessing the appeals process
  • You believe the plan is violating Washington insurance law
  • You need help with the external review process

Contact Information:

The OIC provides free consumer advocacy and can help navigate the appeals process, including connecting you with resources like template appeal letters and guidance on gathering supporting documentation.

FAQ

How long does BCBS prior authorization take in Washington? Standard prior authorization decisions are typically made within 14-30 days. Expedited reviews for urgent cases must be completed within 72 hours under Washington law.

What if Onivyde isn't on my BCBS formulary? You can request a formulary exception. Both Premera and Regence allow exceptions when formulary alternatives are ineffective, not tolerated, or contraindicated.

Can I get an expedited appeal if my case is urgent? Yes, Washington law requires expedited appeals for urgent situations. The decision must come within 72 hours if delay would seriously jeopardize your health.

Does step therapy apply to Onivyde for pancreatic cancer? Generally no. Washington has proposed legislation to eliminate step therapy for metastatic cancers, and most BCBS plans already don't require it for pancreatic cancer.

What happens if my internal appeal is denied? You can request external review by an Independent Review Organization (IRO). This is free to you and provides an independent medical expert review of your case.

Are there financial assistance programs for Onivyde? Check with Ipsen, the manufacturer, for patient assistance programs. Many pharmaceutical companies offer copay cards or foundation grants for eligible patients.

From our advocates: We've seen many Washington patients successfully overturn initial Onivyde denials by providing comprehensive ECOG documentation and citing the drug's FDA approval for their specific cancer type. The key is often in the details—making sure the medical necessity letter clearly explains why this particular regimen is essential for the patient's treatment plan.

For patients and healthcare providers seeking assistance with complex insurance appeals, Counterforce Health offers specialized support in transforming insurance denials into targeted, evidence-backed appeals. Their platform helps identify specific denial reasons and crafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements, significantly improving approval rates for specialty medications like Onivyde.

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 about treatment decisions and contact your insurance plan directly for specific coverage information. For personalized assistance with insurance appeals, consider consulting with qualified professionals or advocacy organizations.

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