By Counterforce Health Team in Oxervate (cenegermin) —

How to Get Oxervate (Cenegermin) Covered by Aetna CVS Health in North Carolina: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Oxervate Approved by Aetna CVS Health in North Carolina

Eligibility: Stage 2 or 3 neurotrophic keratitis with documented corneal sensitivity loss and failed artificial tears trial (≥14 days). Fastest path: Ophthalmologist submits prior authorization through CVS Caremark with complete clinical documentation including corneal sensitivity testing results. First step today: Contact your eye doctor to confirm diagnosis meets Aetna's criteria and gather all prior treatment records. Appeals in North Carolina go through internal review first, then external review via Smart NC within 120 days.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Oxervate prescriptions CVS Caremark provider portal Aetna Specialty Drug Policy
Formulary Tier Specialty tier (highest copay) Plan-specific formulary Aetna Drug Finder
Step Therapy Must try 2+ preservative-free artificial tears first Clinical documentation required Aetna Medical Policy
Age Limits ≥2 years old FDA labeling requirement FDA Prescribing Information
Diagnosis Codes Stage 2/3 neurotrophic keratitis ICD-10 documentation needed Aetna Clinical Criteria
Prescriber Requirements Ophthalmologist or neurologist Must be specialist CVS Caremark Guidelines
Appeals Deadline 180 days from denial North Carolina state law NC Department of Insurance

Step-by-Step: Fastest Path to Approval

1. Confirm Medical Necessity (Patient + Ophthalmologist)

Who does it: Your eye doctor
Document needed: Comprehensive eye exam with corneal sensitivity testing
Timeline: Same-day appointment
Key requirement: Must document Stage 2 (persistent epithelial defect) or Stage 3 (corneal ulcer) neurotrophic keratitis with decreased corneal sensitivity

2. Document Step Therapy Failures (Ophthalmologist)

Who does it: Your eye doctor's office
Documents needed: Treatment records showing failed trials of at least 2 preservative-free artificial tears for ≥14 days each
Timeline: Review existing records or document current failures
Submit via: Include in prior authorization packet

3. Submit Prior Authorization (Ophthalmologist's Office)

Who does it: Clinic staff or specialty pharmacy coordinator
Form needed: Aetna specialty drug prior authorization form
How to submit: CVS Caremark provider portal or fax
Timeline: 30-45 days for standard review, 72 hours for expedited
Required attachments: Clinical notes, corneal sensitivity test results, step therapy documentation

4. Enroll in Patient Assistance (Patient)

Who does it: You or clinic staff
Program: Dompé CONNECT to Care copay assistance
Timeline: Can be done while PA is pending
Benefit: Reduces copay to $100 maximum for commercially insured patients
Link: Patient Support Program

5. Coordinate Specialty Pharmacy (If Approved)

Who does it: CVS Specialty or designated pharmacy
Timeline: 2-3 days after approval
Delivery: Direct to patient's home
Storage: Requires refrigeration; single-use vials

When Alternatives Make Sense

Before pursuing an expensive appeal, consider whether Counterforce Health's evidence-backed approach might identify formulary alternatives that could work for your specific case. Sometimes a strategic pivot to a covered option—combined with proper documentation—can get you treatment faster than fighting for the original prescription.

Alternatives may make sense when:

  • Your diagnosis is borderline between Stage 1 and Stage 2 neurotrophic keratitis
  • You haven't completed adequate trials of conventional therapies
  • Your insurance has a history of consistently denying Oxervate (check with your pharmacy)
  • You need treatment urgently and can't wait for appeals processes

Contraindications for alternatives: If you have documented Stage 3 neurotrophic keratitis with corneal ulceration, conventional alternatives are unlikely to be effective, and pursuing Oxervate approval should remain the priority.

Typical Formulary Alternatives

Conventional Therapies (Usually Covered)

  • Preservative-free artificial tears: Refresh Plus, Systane Ultra, TheraTears
  • Lubricating ointments: Lacri-Lube, Refresh PM
  • Bandage contact lenses: With ophthalmologist supervision
  • Punctal plugs: To preserve natural tears

Advanced Options (May Require PA)

  • Autologous serum tears: Made from patient's own blood; compounded
  • Amniotic membrane grafts: Surgical placement over corneal defect
  • Tarsorrhaphy: Partial eyelid closure (reserved for severe cases)

Off-Label Considerations

Some ophthalmologists use topical cyclosporine or other immunomodulators off-label, though evidence for neurotrophic keratitis is limited compared to Oxervate's proven efficacy.

Pros and Cons Overview

Treatment Option Access Considerations Testing Requirements Monitoring Needs
Oxervate High copay, PA required, specialty pharmacy Corneal sensitivity testing Weekly ophthalmology visits during 8-week treatment
Artificial Tears Over-the-counter, immediate access None Self-monitoring for improvement
Autologous Serum Requires compounding pharmacy, moderate cost Blood draw, infectious disease screening Monthly follow-up
Amniotic Membrane Surgical procedure, hospital/ASC setting Pre-operative clearance Post-operative visits
From our advocates: We've seen patients successfully transition from failed artificial tears to amniotic membrane grafts while simultaneously appealing for Oxervate. This dual approach—treating the immediate problem while fighting for the best long-term solution—often yields better outcomes than waiting months for appeals to resolve.

Exception Strategy

When to Request a Formulary Exception

  • Oxervate is excluded from your specific plan's formulary
  • You're required to use a "preferred" specialty pharmacy that doesn't stock Oxervate
  • Your plan has quantity limits that don't align with FDA dosing (6 drops daily for 8 weeks)

Evidence That Helps Exception Requests

  1. Clinical superiority data: Reference the 72% healing rate with Oxervate vs. 33% with conventional therapy from the NGF0212 trial
  2. Guideline support: Cite international recommendations for cenegermin as first-line therapy for Stage 2/3 neurotrophic keratitis
  3. Prior failure documentation: Detailed records of inadequate response to all formulary alternatives
  4. Specialist letter: Strong medical necessity statement from your ophthalmologist

Exception Request Process

Submit through your plan's formulary exception pathway, typically found in your member portal under "pharmacy benefits" or "prescription coverage." Include all clinical documentation and a detailed letter from your ophthalmologist explaining why covered alternatives are medically inappropriate.

Appeals Playbook for North Carolina

Internal Appeal (Required First Step)

Timeline: Must file within 180 days of denial
Process: Submit through Aetna member portal or mail written appeal
Decision timeline: 30 days standard, 72 hours expedited
Required documents: Original denial letter, additional clinical evidence, prescriber letter

External Review via Smart NC

When to use: After exhausting internal appeals or for urgent situations
Timeline: File within 120 days of final internal denial
Contact: Smart NC at 1-855-408-1212
Process: Complete external review request form
Decision timeline: 45 days standard, 72 hours expedited
Authority: Binding decision on insurance company

Note: North Carolina's external review program is particularly strong for specialty drug denials. Smart NC staff can help you gather supporting evidence and navigate the process at no cost.

Expedited Appeals

Available when delay would "seriously jeopardize your life or ability to regain function." For neurotrophic keratitis with corneal ulceration, this standard is often met.

How to request: Clearly state urgency in appeal letter and have your ophthalmologist document that delay risks permanent vision loss or corneal perforation.

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documents
"Not medically necessary" Submit detailed clinical evidence Stage 2/3 diagnosis confirmation, corneal sensitivity test results
"Step therapy not completed" Document prior treatment failures Pharmacy records, clinical notes showing inadequate response
"Experimental/investigational" Cite FDA approval FDA prescribing information, clinical trial data
"Non-formulary drug" Request formulary exception Medical necessity letter, comparative effectiveness data
"Inadequate documentation" Resubmit complete packet All required forms, clinical notes, lab results

Costs & Savings Options

Commercial Insurance Patients

  • Dompé CONNECT to Care: Reduces copay to $100 maximum
  • Eligibility: Most commercial plans, income limits may apply
  • Application: Available through prescriber's office or patient support website

Medicare Patients

  • Coverage limitation: Medicare Part D typically excludes Oxervate
  • Workaround options: Medical benefit coverage (rare), manufacturer patient assistance program
  • Alternative: Medicare Advantage plans may have different coverage

Medicaid Patients

  • North Carolina Medicaid: Expanding in 2024, may improve access
  • Prior authorization: Required through NC Medicaid pharmacy program
  • Appeals: Separate process through Medicaid ombudsman

FAQ

How long does Aetna CVS Health prior authorization take in North Carolina?
Standard PA decisions take 30-45 days. Expedited reviews (for urgent medical situations) are completed within 72 hours. You can check status through the CVS Caremark provider portal.

What if Oxervate is completely excluded from my formulary?
Submit a formulary exception request with strong clinical justification. Include comparative effectiveness data showing Oxervate's superior healing rates (72% vs. 33% for conventional therapy) and documentation of failed alternatives.

Can I request an expedited appeal in North Carolina?
Yes, if delay would seriously jeopardize your health. For Stage 3 neurotrophic keratitis with corneal ulceration, this standard is often met. Both Aetna internal appeals and NC external reviews offer expedited options.

Does step therapy apply if I tried treatments outside North Carolina?
Yes, treatment history from other states counts toward step therapy requirements. Gather all medical records and pharmacy documentation to submit with your PA request.

What happens if my external review is denied?
The external review decision is binding on your insurance company. If denied, you've exhausted administrative remedies, though you may have legal options to pursue independently.

How do I find an ophthalmologist experienced with Oxervate in North Carolina?
Contact Dompé's medical affairs team for referrals to prescribers experienced with neurotrophic keratitis treatment in your area.

Can my optometrist prescribe Oxervate?
While some plans accept optometrist prescriptions, Aetna typically requires prescription by an ophthalmologist or neurologist for specialty drugs like Oxervate.

What if I can't afford the copay even with assistance?
Contact patient advocacy organizations like the Patient Access Network Foundation or CancerCare (they cover some eye conditions). Some may provide additional financial assistance for rare disease treatments.

Switching Logistics

If you need to try alternatives while appealing for Oxervate, coordinate carefully with your ophthalmologist:

  1. Document everything: Keep detailed records of alternative treatments, including start dates, dosing, and clinical response
  2. Maintain regular monitoring: Weekly visits during alternative therapy trials to document progress or lack thereof
  3. Don't abandon the appeal: Continue pursuing Oxervate approval even while trying alternatives
  4. Communicate with pharmacy: Keep CVS Specialty informed of your timeline so they can expedite dispensing if approval comes through

Re-trying for Oxervate Later

If your initial request is denied and alternatives fail, you can resubmit for Oxervate with stronger evidence:

Document during alternative trials:

  • Exact treatment regimens and durations
  • Objective measures of treatment response (or lack thereof)
  • Any complications or intolerance to alternatives
  • Photographic documentation of corneal status if available

Strengthen your resubmission:

  • Include all failed alternative therapy documentation
  • Request peer-to-peer review with Aetna's medical director
  • Consider engaging Counterforce Health to help craft a comprehensive, evidence-based appeal that addresses Aetna's specific denial reasons

Timeline considerations: Don't wait too long between attempts. Progressive corneal damage can make treatment more challenging, and insurers may question delays in seeking appropriate therapy.

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for the most current coverage policies and medical recommendations.

Need help with your appeal? Contact Smart NC at 1-855-408-1212 for free assistance with North Carolina insurance appeals, or visit the NC Department of Insurance website for forms and additional resources.

Sources & Further Reading

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