By Counterforce Health Team in Gilenya (fingolimod) —

How to Get Gilenya (fingolimod) Covered by Aetna in New York: 2025 Prior Authorization Guide

Answer Box: Getting Gilenya Covered by Aetna in New York

Aetna requires prior authorization for Gilenya (fingolimod) with specific criteria: relapsing MS diagnosis, neurologist prescription, age 10+, and documented safety monitoring plan. First step: Have your neurologist submit a PA request through Aetna's Availity portal with complete medical records. If denied: You have 180 days to appeal internally, then 4 months for New York's external review through the Department of Financial Services. Timeline: Standard decisions take 30-45 days; expedited appeals for urgent cases get decided within 72 hours.

Table of Contents

  1. Aetna's Coverage Policy Overview
  2. Prior Authorization Requirements
  3. Step Therapy and Medical Exceptions
  4. Required Diagnostics and Monitoring
  5. CVS Specialty Pharmacy Requirements
  6. Evidence to Support Medical Necessity
  7. Appeals Process in New York
  8. Common Denial Reasons and Solutions
  9. Cost Assistance Options
  10. FAQ

Aetna's Coverage Policy Overview

Aetna (CVS Health) covers Gilenya (fingolimod) for relapsing forms of multiple sclerosis, but prior authorization is mandatory across all plan types—Commercial, Medicare, and Medicaid. The drug is classified as a specialty medication and must be dispensed through CVS Specialty pharmacies.

Your specific coverage depends on your plan type:

  • Commercial plans: Standard PA criteria apply with 12-month approvals
  • Medicare plans: Follow CMS guidelines with additional documentation requirements
  • Medicaid managed care: State-specific criteria may apply alongside federal requirements
Tip: Download your current formulary from Aetna's website to check Gilenya's tier placement and any quantity limits before starting the PA process.

Prior Authorization Requirements

Aetna's 2024 criteria for Gilenya approval include these non-negotiable requirements:

Requirement Details Documentation Needed
Diagnosis Relapsing MS, active secondary progressive MS, or clinically isolated syndrome ICD-10 codes, MRI reports, clinical notes
Age 10 years or older Date of birth verification
Prescriber Neurologist (by or in consultation) Prescriber credentials, consultation notes
Generic trial For brand Gilenya: must fail generic fingolimod first Prior therapy records, intolerance documentation
Swallowing assessment For Tascenso ODT: documented inability to swallow capsules Clinical evaluation notes

Contact numbers for PA submission:

  • Commercial plans: 1-888-632-3862
  • Medicare plans: 1-800-624-0756
  • CVS Specialty: 1-866-814-5506

Step Therapy and Medical Exceptions

While current MS treatment guidelines don't mandate strict step therapy, Aetna may require trials of first-line agents like interferons or glatiramer acetate before approving Gilenya.

Medical exception pathways allow you to skip step therapy if you have:

  • Contraindications to first-line therapies (document allergies, drug interactions)
  • Previous failures on required medications (provide dates, dosages, outcomes)
  • Intolerance with documented side effects requiring discontinuation
  • High disease activity warranting immediate high-efficacy treatment
Clinician Corner: When requesting a step therapy exception, include specific details: "Patient experienced severe injection site reactions to glatiramer acetate requiring ER visit on [date]" rather than general statements about "intolerance."

Required Diagnostics and Monitoring

Gilenya requires extensive safety monitoring that must be documented for PA approval:

Pre-treatment requirements:

  • Baseline ECG (within 6 months) to assess cardiac rhythm
  • Complete blood count to check lymphocyte levels
  • Liver function tests (AST, ALT, bilirubin)
  • Ophthalmology exam to screen for macular edema risk
  • Vaccination status (live vaccines contraindicated)

First-dose monitoring plan:

  • 6-hour observation with hourly vital signs
  • Repeat ECG at 6 hours post-dose
  • Extended monitoring if heart rate <45 bpm or new AV block develops
  • Facility capability for cardiac emergency management

Ongoing monitoring:

  • Ophthalmology follow-up at 3-4 months, then annually
  • CBC monitoring for lymphopenia
  • Liver function monitoring every 6 months

CVS Specialty Pharmacy Requirements

Gilenya is restricted to CVS Specialty pharmacies—you cannot fill it at regular retail locations. This "site of care" requirement is part of Aetna's coverage policy.

Key steps:

  1. Enrollment: Your doctor must enroll you with CVS Specialty
  2. Coordination: CVS Specialty coordinates PA submission with your prescriber
  3. Delivery: Medication ships directly to your home with temperature control
  4. Support: Access to specialty pharmacists for education and monitoring

CVS Specialty contact: 1-800-237-2767

For patients in New York, this restriction cannot be appealed to use other specialty pharmacies, as it's written into most Aetna plan designs.

Evidence to Support Medical Necessity

Strong PA requests include evidence-based justification referencing:

Clinical guidelines:

FDA labeling:

Peer-reviewed evidence:

  • Pivotal trial data (FREEDOMS, FREEDOMS II studies)
  • Real-world effectiveness studies
  • Comparative effectiveness research vs. other DMTs

When documenting medical necessity, structure your letter to address each PA criterion with supporting evidence and specific patient factors.

Appeals Process in New York

If Aetna denies your Gilenya PA request, New York offers robust appeal rights with strict timelines:

Internal Appeals (Required First Step)

  • Timeline: 180 days from denial to file
  • Process: Submit through Aetna member portal or by phone
  • Documentation: Include new clinical information, peer-reviewed studies, guideline citations
  • Expedited option: Available for urgent medical situations

New York External Appeals

After internal appeal denial, you can request independent external review through the New York Department of Financial Services:

Timeline Process Cost
4 months to file after final internal denial Submit DFS external appeal form $25 fee (waived for Medicaid/hardship)
72 hours for expedited decisions Independent medical expert review Refunded if you win
30 days for standard decisions Binding decision on insurer $75 annual cap on fees

Required forms: New York External Appeal Application

Submit to:

  • Fax: (800) 332-2729
  • Mail: Department of Financial Services, PO Box 7209, Albany, NY 12224
From our advocates: We've seen several Gilenya denials overturned on external appeal when patients included recent MRI showing new lesions and documentation of inadequate response to first-line therapies. The key is presenting a clear timeline of disease progression despite prior treatment attempts.

Common Denial Reasons and Solutions

Denial Reason How to Overturn
Missing first-dose monitoring plan Submit detailed protocol from neurologist's office including facility capabilities and emergency procedures
Incomplete baseline testing Provide all required lab results, ECG, and ophthalmology reports with dates within required timeframes
Step therapy not met Document contraindications, failures, or intolerance to required first-line agents with specific clinical details
"Not medically necessary" Include peer-reviewed evidence, treatment guidelines, and patient-specific factors supporting fingolimod use
Quantity limits exceeded Justify dosing based on FDA labeling and clinical response, include prescriber attestation

Cost Assistance Options

Even with insurance approval, Gilenya can be expensive. Consider these assistance programs:

Manufacturer support:

Foundation grants:

  • National MS Society financial assistance
  • HealthWell Foundation specialty drug grants
  • Patient Access Network Foundation

State programs:

  • New York State of Health premium tax credits
  • Medicaid expansion coverage for qualifying individuals

FAQ

How long does Aetna prior authorization take in New York? Standard PA decisions take 30-45 days. Expedited reviews for urgent cases are completed within 72 hours. Submit requests at least two weeks before you need to start treatment.

What if Gilenya is non-formulary on my plan? Request a formulary exception with documentation that covered alternatives are ineffective or contraindicated. Include clinical evidence supporting Gilenya's necessity for your specific situation.

Can I request an expedited appeal? Yes, if your doctor attests that delay would seriously jeopardize your health. For specialty drug denials, expedited external appeals in New York are decided within 24 hours.

Does step therapy apply if I failed therapies outside New York? Yes, prior therapy failures from any location count toward step therapy requirements. Provide complete medical records documenting previous treatments and outcomes.

What happens if I miss doses during the appeal process? If you've been off Gilenya for more than 14 days, you'll need to repeat first-dose monitoring when restarting. Plan accordingly during appeals.

How do I find an advocate to help with my appeal? Contact Community Health Advocates at 888-614-5400 for free assistance with insurance appeals in New York.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters, identifies the specific denial basis, and drafts evidence-backed rebuttals aligned to each payer's own coverage policies—including the complex PA requirements for specialty medications like Gilenya.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently. Always consult your healthcare provider and insurance plan documents for the most current requirements. For personalized assistance with New York insurance appeals, contact the Department of Financial Services at (800) 400-8882.

Sources & Further Reading

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