By Counterforce Health Team in Onivyde (irinotecan liposome) —

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

Answer Box: Getting Onivyde (Irinotecan Liposome) Covered by Aetna (CVS Health) in Ohio

Onivyde (irinotecan liposome) requires prior authorization from Aetna (CVS Health) for both first-line NALIRIFOX and second-line therapy in pancreatic cancer. First step: Have your oncologist submit a specialty drug PA request through Aetna's Availity portal or by calling 1-855-240-0535. Include metastatic pancreatic adenocarcinoma diagnosis, ECOG performance status, and prior therapy history. If denied, you can appeal through Aetna's internal process, then request external review through the Ohio Department of Insurance within 180 days. Ohio residents get free external review with binding decisions.

Table of Contents

  1. Coverage at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Prior Authorization Forms and Submission
  4. Specialty Pharmacy Enrollment
  5. Common Denial Reasons and Solutions
  6. Appeals Process for Ohio Residents
  7. Support Contacts and Resources
  8. Costs and Financial Assistance
  9. Frequently Asked Questions

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Yes, for specialty oncology drugs Aetna Precertification List Aetna Policy
Medical Necessity FDA-approved use for pancreatic cancer Aetna CPB 0902 Clinical Policy
Formulary Status Specialty tier, CVS Specialty required Plan formulary document Member Portal
Appeals Deadline 180 days for external review Ohio DOI External Review Ohio Law

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Requirements

Who: Patient or clinic staff
Action: Log into your Aetna member portal or call the number on your ID card to confirm:

  • Onivyde requires prior authorization
  • Which benefit covers it (medical vs. pharmacy)
  • Current formulary tier

2. Gather Required Documentation

Who: Oncologist and clinic staff
Documents needed:

  • Recent oncology consultation note
  • Pathology report confirming pancreatic adenocarcinoma
  • Imaging showing metastatic disease
  • ECOG performance status documentation
  • Prior chemotherapy history and outcomes
  • Current lab values (CBC, comprehensive metabolic panel)

3. Submit Prior Authorization Request

Who: Prescribing oncologist
Method: Availity provider portal (preferred) or call 1-855-240-0535
Timeline: Submit at least 2 weeks before planned treatment start
Form: Use Aetna's Prescription Drug PA form

4. Enroll with CVS Specialty

Who: Oncologist
Action: Complete CVS Specialty Oncology Enrollment Form
Timeline: Can be done simultaneously with PA submission

5. Consider Manufacturer Support

Who: Patient and oncologist
Action: Complete IPSEN CARES enrollment
Benefits: Benefits verification, copay assistance, patient assistance programs

6. Monitor and Follow Up

Who: Patient or clinic staff
Action: Track PA status through provider portal or by calling Aetna
Timeline: Standard decisions within 30-45 days; expedited within 72 hours if urgent

7. Appeal if Denied

Who: Oncologist with patient consent
Action: Submit internal appeal with additional clinical justification
Timeline: Must appeal within plan-specified timeframe (typically 60-180 days)

Prior Authorization Forms and Submission

For Aetna Commercial and Medicare Plans

Primary Form: Medical Exception/Prior Authorization/Precertification Request for Prescription Drugs

Submission Methods:

  • Online (fastest): Availity provider portal with NovoLogix specialty drug tool
  • Phone: 1-855-240-0535 (M-F, 8 AM-6 PM CT)
  • Fax: Use plan-specific fax number from provider portal (varies by product)

For Aetna Better Health of Ohio (Medicaid)

Form: Ohio Prior Authorization Form
Phone: 1-855-364-0974 (TTY 711)
Fax: 1-855-734-9389
Mailing Address: Aetna Better Health of Ohio, 7400 West Campus Road, New Albany, OH 43054

Note: For urgent requests, call the PA department directly rather than relying on fax submission.

Required Clinical Information

When submitting your PA request, include:

  • Diagnosis: ICD-10 code for metastatic pancreatic adenocarcinoma (C25.0-C25.9)
  • Line of therapy: First-line NALIRIFOX or second-line after gemcitabine failure
  • Performance status: ECOG 0-2 with documentation
  • Prior treatments: Specific regimens tried, duration, and reason for discontinuation
  • Dosing plan: Complete NALIRIFOX regimen details
  • Contraindications: Any factors making alternatives inappropriate

Specialty Pharmacy Enrollment

Onivyde must be dispensed through CVS Specialty for most Aetna plans. Your oncologist needs to complete the CVS Specialty Oncology Injectable and Infused Medication Enrollment Form.

Key sections to complete:

  • Patient demographics and insurance information
  • Prescriber details with original signature (no stamps)
  • Complete diagnosis and clinical information
  • Prescription details including administration site
  • Authorization for CVS Specialty to assist with PA submissions

Transfer from another specialty pharmacy: CVS Specialty will coordinate the transfer, but confirm your existing PA remains valid or request a new one if needed.

Clinician Corner: Medical Necessity Letter Checklist

When writing a medical necessity letter for Onivyde, include:

✓ Problem statement: Metastatic pancreatic adenocarcinoma with specific staging
✓ Prior treatments: Detailed history of previous therapies and outcomes
✓ Clinical rationale: Why Onivyde/NALIRIFOX is appropriate for this patient
✓ Guideline support: Reference to FDA approval and NCCN guidelines
✓ Alternative assessment: Why other covered options are inappropriate
✓ Dosing plan: Complete regimen with monitoring plan
✓ Performance status: ECOG score with supporting documentation

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create point-by-point rebuttals that align with payer-specific requirements, potentially saving weeks in the approval process.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Cite Aetna CPB 0902 approval criteria FDA label, clinical notes, performance status
"Off-label use" Clarify FDA-approved indication Current FDA labeling for NALIRIFOX
"Step therapy required" Document prior therapy failures Treatment history, progression notes
"Non-formulary" Request formulary exception Medical necessity letter, alternative assessment
"Experimental/investigational" Reference FDA approval FDA approval letter, clinical guidelines

Appeals Process for Ohio Residents

Internal Appeals with Aetna

  1. First-level appeal: Submit within 60-180 days of denial (check your plan documents)
  2. Required documents: Original denial letter, additional clinical evidence, provider letter
  3. Timeline: 30 days for standard review, 72 hours for expedited
  4. Submission: Use same channels as original PA request

External Review Through Ohio Department of Insurance

After exhausting Aetna's internal appeals, Ohio residents can request free external review:

Eligibility: Medical necessity denials after internal appeal
Deadline: Within 180 days of final internal denial
Contact: Ohio Department of Insurance at 1-800-686-1526
Process: Complete external review request form, provide medical records
Timeline: 30 days for standard review, 72 hours for expedited
Decision: Binding on Aetna if overturned

Important: Self-funded employer plans may follow federal ERISA rules instead of Ohio external review. Call ODI to confirm your plan's appeal rights.

Aetna's External Review Program

For some plans, use Aetna's external review process:

Phone: 1-877-848-5855
Fax: 1-860-975-1526
Mailing Address: External Review, Aetna, PO Box 818000, Cleveland, OH 44181-8000

Support Contacts and Resources

Aetna Contact Numbers

  • Pharmacy PA: 1-855-240-0535
  • General pharmacy services: 1-888-792-3862
  • Member services: Number on your ID card
  • Provider services: 1-888-632-3862

Ohio-Specific Resources

  • Ohio Department of Insurance Consumer Hotline: 1-800-686-1526
  • Aetna Better Health of Ohio Provider Services: 1-855-364-0974

Manufacturer Support

  • IPSEN CARES: Benefits verification and financial assistance
  • Enrollment fax: 1-888-525-2416
  • Patient Access Manager: Contacts within 1 business day of complete enrollment

Costs and Financial Assistance

Insurance Coverage

Onivyde is typically covered under the medical benefit as a buy-and-bill therapy (J-code J9205). Copays vary by plan design but can be substantial for specialty oncology drugs.

Financial Assistance Options

IPSEN CARES Copay Program: May reduce out-of-pocket costs for eligible commercially insured patients
Patient Assistance Program: For uninsured or underinsured patients who meet income requirements
Foundation Grants: Various cancer-focused foundations offer medication assistance

Tip: Enroll in IPSEN CARES early in the process. Their Patient Access Manager can identify all available assistance programs and help with benefits verification.

When to Escalate

Contact the Ohio Department of Insurance if:

  • Aetna denies external review eligibility incorrectly
  • Appeals deadlines are not honored
  • You believe Aetna is not following its own policies

File a complaint: ODI online complaint form or call 1-800-686-1526

For complex cases involving multiple denials or policy interpretation issues, consider working with a patient advocacy service like Counterforce Health, which specializes in creating targeted appeals that address payer-specific denial reasons.

Frequently Asked Questions

How long does Aetna prior authorization take in Ohio?
Standard PA decisions take 30-45 days. Expedited reviews for urgent cases are completed within 72 hours. Submit requests at least 2 weeks before planned treatment start.

What if Onivyde is non-formulary on my plan?
Request a formulary exception by demonstrating medical necessity and that covered alternatives are inappropriate. Include clinical justification and guideline support.

Can I request an expedited appeal if treatment is urgent?
Yes. Mark requests as "urgent" and document that delay could seriously jeopardize health. Both Aetna and Ohio external review offer expedited timelines.

Does step therapy apply if I failed treatments outside Ohio?
Prior treatment history from other states should count toward step therapy requirements. Provide complete documentation of previous therapies and outcomes.

What's the difference between medical and pharmacy benefit coverage?
Onivyde is typically covered under the medical benefit as an infused drug (J-code J9205), but some plans may cover it under pharmacy benefit through specialty pharmacy.

How do I transfer from another specialty pharmacy to CVS Specialty?
Complete a new CVS Specialty enrollment form. CVS will coordinate the transfer, but confirm your existing PA remains valid for the new pharmacy.

Sources and Further Reading

Disclaimer: This information is for educational purposes and should not replace professional medical advice. Insurance coverage and requirements can change. Always verify current policies with your insurer and consult your healthcare provider for medical decisions. For personalized assistance with insurance appeals, consider contacting the Ohio Department of Insurance or a qualified patient advocacy service.

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