By Counterforce Health Team in Onivyde (irinotecan liposome) —

Getting Onivyde (Irinotecan Liposome) Covered by Blue Cross Blue Shield in Georgia: A Complete Prior Authorization and Appeal Guide

Quick Answer: Blue Cross Blue Shield Georgia requires prior authorization for Onivyde (irinotecan liposome). Submit documentation showing metastatic pancreatic cancer, prior gemcitabine failure, ECOG 0-1 status, and proposed NALIRIFOX regimen. If denied, file internal appeal within 60 days, then external review through Georgia Department of Insurance within 60 days of final denial. Start by calling the number on your insurance card to request PA forms.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required All Onivyde requests need approval before treatment BCBS provider portal (verify with your plan)
FDA-Approved Indication Metastatic pancreatic cancer after gemcitabine-based therapy OR first-line with NALIRIFOX FDA approval letter
Combination Therapy Only Must use with 5-FU/leucovorin (second-line) or NALIRIFOX (first-line) Onivyde prescribing information
Performance Status ECOG 0-1 required Most BCBS policies
Dosing Limits Typically 70 mg/m² every 2 weeks Plan-specific formulary
J-Code J9205 for billing Medicare/commercial billing

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who does it: Patient and oncology team
Timeline: 1-2 days

Collect these essential documents:

  • Pathology report confirming metastatic pancreatic adenocarcinoma
  • Treatment history showing prior gemcitabine-based therapy (if second-line)
  • Recent ECOG performance status assessment
  • Current lab results (CBC, comprehensive metabolic panel, liver function)
  • Insurance card and member ID

2. Contact Blue Cross Blue Shield Georgia

Who does it: Patient or clinic staff
Timeline: Same day

Call the member services number on your insurance card to:

  • Confirm prior authorization requirements for your specific plan
  • Request PA forms or portal access
  • Verify in-network oncology providers and infusion centers

3. Complete Prior Authorization Request

Who does it: Prescribing oncologist
Timeline: 2-3 business days

Submit through the BCBS provider portal or fax with:

  • Completed PA form
  • Medical necessity letter (see template below)
  • Supporting clinical documentation
  • FDA labeling excerpt or NCCN guideline reference

4. Follow Up on Decision

Who does it: Patient and clinic
Timeline: 7-30 days (varies by plan type)

  • Standard decisions: typically within 15 business days
  • Expedited decisions: within 72 hours if urgent
  • Check status through member portal or by calling

5. If Approved: Coordinate Treatment

Who does it: Oncology team and specialty pharmacy
Timeline: 1-2 weeks

Confirm:

  • Infusion center is in-network
  • Specialty pharmacy arrangements
  • Patient financial responsibility

6. If Denied: File Internal Appeal

Who does it: Patient with oncologist support
Timeline: Must file within 60 days of denial

Submit appeal with additional evidence addressing specific denial reasons.

7. If Still Denied: Request External Review

Who does it: Patient
Timeline: Within 60 days of final internal denial

File with Georgia Department of Insurance for independent review.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Key Documents
"Not medically necessary" Cite FDA approval and NCCN guidelines FDA label, NAPOLI-1/3 trial data
"Step therapy not met" Document prior gemcitabine failure or contraindication Treatment records, progression notes
"Experimental/investigational" Reference FDA approval for pancreatic cancer FDA approval letter
"Off-label use" Confirm indication matches FDA labeling Pathology report, staging studies
"Missing clinical information" Submit complete treatment history Chart notes, lab results, imaging
"ECOG status not documented" Provide recent performance status assessment Oncologist's clinical note
From Our Advocates: We've seen cases where patients were initially denied because the PA request listed "irinotecan" instead of specifically "irinotecan liposome injection (Onivyde)." Always use the exact drug name and NDC number to avoid confusion with standard irinotecan formulations.

Appeals Process for Blue Cross Blue Shield Georgia

Internal Appeal (First Level)

  • Deadline: 60 calendar days from denial date
  • Timeline: 30 days for standard review, 72 hours for expedited
  • How to file: Online portal, mail, or fax (check denial letter for specific instructions)
  • Required: Written request, additional medical evidence, provider letter

Expedited Internal Appeal

  • When to use: Urgent medical need where delay could harm patient
  • Timeline: 72 hours for decision
  • How to request: Call member services and submit written request citing urgency

External Review (Independent Medical Review)

The Georgia Department of Insurance's decision is binding on Blue Cross Blue Shield and ends the administrative process.

Medical Necessity Letter Template

Patient Information Section

  • Full name, DOB, member ID
  • Diagnosis: Metastatic pancreatic adenocarcinoma (ICD-10: C25.9)
  • Date of diagnosis and current staging

Clinical Justification

"I am requesting prior authorization for Onivyde (irinotecan liposome injection) in combination with [5-fluorouracil and leucovorin OR oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX)] for the treatment of metastatic pancreatic adenocarcinoma.

FDA Indication: Onivyde is FDA-approved for this exact indication, both as second-line therapy after gemcitabine-based treatment and as first-line therapy in the NALIRIFOX regimen.

Prior Treatments: [Detail specific gemcitabine-based regimens tried, dates, and reasons for discontinuation - progression, toxicity, etc.]

Performance Status: Patient maintains ECOG performance status of [0 or 1] with adequate organ function as demonstrated by recent laboratory studies.

Clinical Rationale: Based on the NAPOLI-1 and NAPOLI-3 clinical trials, Onivyde in combination therapy has demonstrated superior overall survival compared to standard alternatives."

Supporting Evidence

  • Reference NCCN Guidelines listing as preferred regimen
  • Attach relevant lab results and imaging studies
  • Include treatment timeline and response assessments

When to Escalate to External Review

Consider external review when:

  • Internal appeals have been exhausted
  • Clinical evidence strongly supports medical necessity
  • Denial appears to contradict FDA labeling or established guidelines
  • Patient's health could deteriorate without treatment

Georgia-Specific Process:

  1. Contact Georgia Department of Insurance Consumer Services at 1-800-656-2298
  2. Request external review application form
  3. Submit within 60 days of final internal denial
  4. Include physician certification for expedited review if urgent

For additional consumer assistance, contact Georgians for a Healthy Future, a nonprofit that provides guidance on insurance appeals and can refer you to legal aid if needed.

Cost Support Options

Manufacturer Programs

  • Ipsen Cares: Prior authorization support, appeals assistance, and copay cards for eligible patients
  • Patient assistance programs: Available for uninsured and underinsured patients

Financial Assistance

  • CancerCare Copay Assistance Foundation
  • Patient Advocate Foundation
  • Leukemia & Lymphoma Society (covers some solid tumor patients)

Buy-and-Bill Considerations

Onivyde is typically covered under medical benefit (not pharmacy benefit). Confirm:

  • J-code J9205 is covered by your plan
  • In-network infusion center requirements
  • Prior authorization for administration codes

Frequently Asked Questions

Q: How long does Blue Cross Blue Shield prior authorization take in Georgia? A: Standard reviews typically take 15 business days, though this can vary by plan type. Expedited reviews for urgent cases must be completed within 72 hours.

Q: What if Onivyde isn't on my plan's formulary? A: You can request a formulary exception by demonstrating medical necessity and that covered alternatives are inappropriate. Include documentation of failed prior therapies or contraindications to standard treatments.

Q: Can I get an expedited appeal if my cancer is progressing? A: Yes. If waiting for a standard decision could harm your health, you can request expedited review. Call member services immediately and submit written documentation of the urgent medical need.

Q: Does step therapy apply if I received gemcitabine outside Georgia? A: Treatment history from any location should count toward step therapy requirements. Provide complete medical records showing prior therapy attempts and outcomes.

Q: What's the difference between internal and external appeals in Georgia? A: Internal appeals are reviewed by Blue Cross Blue Shield. External appeals are conducted by independent physicians through the Georgia Department of Insurance and are binding on the insurer.

Q: How much does Onivyde cost without insurance? A: Costs vary significantly based on dosing and treatment center, but can exceed $10,000 per cycle. Ipsen Cares offers patient assistance programs for eligible individuals.

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Onivyde. Our platform analyzes denial letters, identifies the specific coverage barriers, and generates evidence-backed appeals tailored to each payer's requirements. By combining clinical expertise with payer-specific knowledge, we help patients and providers navigate the prior authorization process more effectively, reducing delays in accessing critical cancer treatments.

For patients facing Onivyde denials in Georgia, Counterforce Health can help craft targeted appeals that address Blue Cross Blue Shield's specific criteria while incorporating the strongest clinical evidence for pancreatic cancer treatment.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by individual plan and circumstances. Always consult with your healthcare provider about treatment decisions and contact your insurance company or the Georgia Department of Insurance for plan-specific guidance. For immediate assistance with insurance appeals, consider contacting Counterforce Health or other patient advocacy services.

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