By Counterforce Health Team in Onivyde (irinotecan liposome) —

Aetna (CVS Health) Coverage Criteria for Onivyde (Irinotecan Liposome) in North Carolina: What Counts as "Medically Necessary"?

Answer Box: Getting Onivyde Covered by Aetna (CVS Health) in North Carolina

Aetna requires prior authorization for Onivyde (irinotecan liposome) with strict medical necessity criteria. You must have metastatic pancreatic adenocarcinoma, ECOG performance status 0-1, adequate biliary drainage, and documented failure of gemcitabine-based therapy. Submit PA via Aetna's provider portal or fax to 866-249-6155. If denied, use North Carolina's Smart NC external review (31-41% overturn rate for specialty drugs). First step today: Gather clinical notes documenting prior gemcitabine failure and current performance status.

Table of Contents

Policy Overview

Aetna (CVS Health) classifies Onivyde as a specialty oncology medication requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug falls under Aetna's medical policy MP-0902 for antineoplastic agents and must meet specific clinical criteria to be considered medically necessary.

Plan Types and Coverage:

  • Commercial Plans: Standard PA requirements apply with CVS Specialty Pharmacy dispensing
  • Medicare Advantage: Follow CMS guidelines with additional Aetna requirements
  • Medicaid (North Carolina): Subject to state formulary restrictions and federal rebate considerations

All Aetna members in North Carolina have access to the same internal appeals process, with additional protection through the state's Smart NC external review program for state-regulated plans.

Coverage at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization Always required Complete PA form + clinical notes Aetna PA List
Formulary Status Tier 4 specialty May require step therapy Plan-specific formulary
Step Therapy Gemcitabine failure required Prior therapy records Aetna Medical Policy
Quantity Limits 70 mg/m² max per cycle BSA calculation + dosing plan FDA prescribing information
Site of Care Infusion center only Provider enrollment with CVS CVS Specialty requirements
Diagnosis Codes C25.x (pancreatic cancer) Pathology report + staging ICD-10 documentation

Indication Requirements

FDA-Approved Indications Covered by Aetna:

  1. First-line treatment of metastatic pancreatic adenocarcinoma in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX regimen)
  2. Second-line treatment after gemcitabine-based therapy in combination with fluorouracil and leucovorin

Required Clinical Documentation:

  • Histologically confirmed pancreatic adenocarcinoma
  • Radiographic evidence of metastatic or locally advanced disease
  • ECOG performance status 0-1 (documented within 30 days)
  • Adequate biliary drainage if previously obstructed
  • Nutritional status assessment by treating oncologist
Note: Off-label uses may be covered if supported by recognized compendia (NCCN, Micromedex) and peer-reviewed literature, but require additional justification.

Step Therapy & Exceptions

Standard Step Therapy Requirements: For second-line use, patients must have documented failure, intolerance, or contraindication to gemcitabine-based chemotherapy. Aetna's policy requires specific documentation:

  • Treatment dates and regimen details
  • Reason for discontinuation (progression, toxicity, or contraindication)
  • Clinical notes supporting the decision to switch therapies

Exceptions Available:

  • Medical contraindications to gemcitabine
  • Documented intolerance with specific adverse events
  • Rapid disease progression during gemcitabine therapy

State-Specific Protections: North Carolina patients with stage IV cancer may qualify for step therapy override provisions if delays would compromise treatment outcomes.

Quantity and Frequency Limits

Maximum Dosing Limits:

  • Standard dose: 70 mg/m² intravenously every 2 weeks
  • UGT1A1*28 homozygotes: Start at 50 mg/m², may increase to 70 mg/m² if tolerated
  • Absolute maximum: 70 mg/m² per dose (exceeding this limit results in automatic denial)

Renewal Requirements:

  • Clinical benefit documented by imaging or tumor markers
  • Acceptable toxicity profile with ongoing monitoring
  • Maintained performance status (ECOG 0-2)
  • Absence of disease progression while on therapy

Quantity Limit Overrides: Requests exceeding standard limits require peer-to-peer review with Aetna's medical director and exceptional clinical justification.

Required Diagnostics

Pre-Authorization Labs (within 14 days):

  • Complete blood count with differential
  • Comprehensive metabolic panel including bilirubin
  • UGT1A1 genotyping (recommended for dosing)

Imaging Requirements:

  • Baseline CT or MRI demonstrating metastatic disease
  • Recent imaging within 30 days of PA submission
  • Prior imaging showing progression on gemcitabine (if applicable)

Documentation Timing: All diagnostic tests must be current and relevant to the treatment decision. Aetna may request additional testing if initial results are outdated or incomplete.

Site of Care & Specialty Pharmacy

Dispensing Requirements: Onivyde is dispensed exclusively through CVS Specialty Pharmacy for Aetna members. The infusion center must:

  • Complete CVS Specialty enrollment
  • Coordinate delivery scheduling
  • Maintain proper storage and handling protocols

Site of Care Restrictions:

  • Covered: Hospital outpatient departments, certified infusion centers
  • Not covered: Home infusion, retail pharmacies, physician offices without infusion certification

Coordination Process:

  1. Prescriber submits PA to Aetna
  2. Separately enroll with CVS Specialty Pharmacy
  3. CVS coordinates drug delivery to approved infusion site
  4. Site schedules patient for administration

Evidence to Support Medical Necessity

Clinical Guidelines to Reference:

Key Clinical Data:

  • NAPOLI-1 trial: Demonstrated survival benefit in gemcitabine-refractory patients
  • NAPOLI-3 trial: Showed superiority of NALIRIFOX over standard first-line therapy
  • Real-world evidence from specialty pharmacy networks

Documentation Best Practices: Include specific citations in your medical necessity letter, referencing page numbers and recommendation levels from guidelines. Counterforce Health specializes in crafting evidence-based appeals that align with payer-specific requirements and can help identify the most compelling clinical data for your case.

Fastest Path to Approval

Step-by-Step Process

1. Pre-Submission Preparation (Clinic)

  • Gather all required clinical documentation
  • Complete UGT1A1 testing if not already done
  • Obtain recent imaging and lab results
  • Timeline: 1-2 days

2. Submit Prior Authorization (Clinic)

  • Use Aetna's PA form
  • Submit via provider portal or fax to 866-249-6155
  • Include comprehensive medical necessity letter
  • Timeline: Same day submission

3. CVS Specialty Enrollment (Clinic)

  • Complete separate enrollment with CVS Specialty
  • Provide infusion site details and scheduling preferences
  • Timeline: 1-2 business days

4. Aetna Review Process

  • Standard review: 5-14 business days
  • Expedited review available for urgent cases (72 hours)
  • Timeline: Varies by urgency

5. Approval and Coordination (All parties)

  • CVS Specialty coordinates drug delivery
  • Schedule patient infusion appointment
  • Confirm insurance coverage details
  • Timeline: 2-3 business days

6. Treatment Initiation (Patient)

  • Arrive at infusion center as scheduled
  • Confirm drug availability and insurance authorization
  • Begin treatment per protocol
  • Timeline: Same day

7. Ongoing Management (Clinic/Patient)

  • Monitor for efficacy and toxicity
  • Submit renewal PAs as needed (typically every 3-6 months)
  • Timeline: Ongoing throughout treatment

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit medical necessity letter with guidelines NCCN guidelines, FDA label, clinical notes
"Experimental/investigational" Provide FDA approval documentation FDA approval letter, prescribing information
"Step therapy not met" Document gemcitabine failure/intolerance Prior therapy records, progression notes
"Quantity exceeds limits" Request peer-to-peer review BSA calculations, dosing rationale
"Non-formulary drug" File formulary exception request Medical necessity, no alternatives
"Site of care not approved" Confirm infusion center credentials CVS Specialty enrollment, site certification
From our advocates: We've seen Aetna denials overturned most successfully when the medical necessity letter specifically addresses their published criteria point-by-point. Include exact language from their medical policy and demonstrate how your patient meets each requirement with specific clinical data.

Appeals Playbook for North Carolina

Internal Appeals Process

Level 1 Internal Appeal

  • Deadline: 60 days from denial notice
  • Submit to: Aetna member services or provider portal
  • Decision timeline: 30 days (72 hours if expedited)
  • Required: Written appeal letter, additional clinical documentation

Level 2 Internal Appeal

  • Automatic: Proceeds if Level 1 denied
  • Decision timeline: 30 days
  • Consider: Peer-to-peer review request

North Carolina External Review

Smart NC External Review

  • Eligibility: State-regulated plans (not self-funded ERISA plans)
  • Deadline: 120 days from final internal denial
  • Contact: Smart NC at 855-408-1212
  • Cost: Free to patients
  • Success rate: 31-41% overturn rate for specialty drugs

Expedited External Review

  • Timeline: 72 hours for urgent oncology cases
  • Criteria: Delay would jeopardize health or life
  • Process: Can bypass internal appeals for urgent situations

The external review decision is binding on Aetna—if overturned, they must provide coverage within 3 business days.

Costs & Savings Options

Manufacturer Support:

  • Ipsen Patient Assistance Program
  • Onivyde Copay Savings Card (commercial insurance)
  • Free drug program for uninsured patients

Foundation Grants:

  • Patient Advocate Foundation
  • CancerCare Financial Assistance
  • HealthWell Foundation

State Programs:

  • North Carolina Cancer Fund
  • Medicaid expansion (effective 2024) for additional coverage

Contact information and eligibility requirements can be found on each organization's official website.

FAQ

How long does Aetna PA take in North Carolina? Standard prior authorization takes 5-14 business days. Expedited reviews for urgent oncology cases are completed within 72 hours.

What if Onivyde is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and lack of effective alternatives. Include clinical guidelines and prior therapy failures.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Your oncologist must provide written documentation of medical urgency.

Does step therapy apply if I failed gemcitabine outside North Carolina? Yes, prior therapy records from any location are acceptable as long as they're properly documented and verifiable.

What happens if Smart NC overturns my denial? Aetna must provide coverage within 3 business days. The external review decision is legally binding.

Can I use a different specialty pharmacy? No, Aetna requires CVS Specialty Pharmacy for Onivyde dispensing. Your infusion center must coordinate with CVS directly.

When Coverage Gets Complex

For patients facing repeated denials or complex clinical situations, specialized appeals support can make a significant difference. Counterforce Health helps patients and clinicians navigate insurance denials by creating targeted, evidence-backed appeals that speak directly to each payer's specific requirements. Their platform analyzes denial letters and plan policies to craft point-by-point rebuttals that significantly improve approval rates for specialty oncology medications like Onivyde.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always consult with your healthcare provider and insurance company for the most current information. For assistance with insurance appeals in North Carolina, contact Smart NC at 855-408-1212.

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