By Counterforce Health Team in Gilenya (fingolimod) —

How to Get Gilenya (Fingolimod) Covered by Aetna (CVS Health) in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Gilenya Covered by Aetna (CVS Health) in Michigan

Gilenya (fingolimod) requires prior authorization from Aetna (CVS Health) for relapsing multiple sclerosis. Your neurologist must submit a specialty medication precertification request with baseline EKG, ophthalmology exam, vaccination records, and documentation of prior therapy failures. Submit via the Availity portal or specialty medication request form at least 2 weeks before needed. If denied, you have 45 days for internal appeals, then 127 days for Michigan DIFS external review. Start today: Call the member services number on your insurance card to verify coverage and get your prior authorization requirements.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Aetna plans Aetna Precertification Lists
Specialty Pharmacy Must fill at CVS Specialty CVS Caremark member portal
Neurologist Prescription Must be prescribed by/with neurologist consultation Aetna Specialty Medication Guidelines
Baseline Testing EKG, eye exam, labs, vaccinations FDA prescribing information
Step Therapy May require trying other MS drugs first Plan formulary documents
Age Requirement Adults and pediatrics ≥10 years Aetna medical policy

Step-by-Step: Fastest Path to Approval

1. Verify Your Coverage (Patient - Same Day)

Call the member services number on your Aetna insurance card. Ask specifically about:

  • Gilenya formulary status and tier
  • Prior authorization requirements
  • Your current deductible and copay
  • Whether step therapy applies to your plan

2. Schedule Baseline Testing (Neurologist - 1-2 Weeks)

Your neurologist must order these tests before submitting the prior authorization:

  • EKG (within 30-90 days of starting treatment)
  • Comprehensive ophthalmology exam with dilated fundus examination
  • Laboratory tests: CBC with differential, liver function tests
  • Varicella zoster virus (VZV) immunity testing or vaccination records
Note: The first-dose monitoring plan is crucial - Gilenya can cause bradycardia, requiring 6-hour observation after the initial dose.

3. Gather Prior Therapy Documentation (Neurologist - 3-5 Days)

Document previous disease-modifying therapies (DMTs) with:

  • Medication names and dates of use
  • Reasons for discontinuation (ineffective, intolerance, contraindications)
  • Clinical notes showing disease activity despite treatment

4. Submit Prior Authorization (Neurologist - Same Day)

Use the Aetna Specialty Medication Precertification Request form or submit electronically via:

  • Preferred: Availity portal (Novologix module for specialty drugs)
  • Fax: 1-866-249-6155
  • Timeline: Submit at least 2 weeks before needed treatment start date

5. Follow Up (Patient/Neurologist - 3-5 Business Days)

Aetna typically responds within 30-45 business days for standard requests. For urgent cases, request expedited review (≤72 hours for Medicare plans).

6. Enroll with CVS Specialty (Patient - After Approval)

Once approved, CVS Specialty will contact you to:

  • Confirm shipping address and delivery preferences
  • Review storage requirements and side effects
  • Set up automatic refills and payment method
  • Schedule first-dose monitoring appointment

7. Start Treatment (Patient/Neurologist - Coordinated)

Your first dose must be administered under medical supervision with continuous cardiac monitoring for at least 6 hours.

Required Medical Documentation

Medical Necessity Letter Checklist

Your neurologist's prior authorization request should include:

Diagnosis Documentation:

  • Confirmed relapsing forms of multiple sclerosis
  • ICD-10 code (typically G35)
  • Recent MRI showing disease activity or clinical relapses

Prior Treatment History:

  • Names and dates of previous DMTs tried
  • Duration of each treatment
  • Specific reasons for discontinuation with clinical details
  • Documentation of treatment failures or intolerance

Clinical Rationale:

  • Current disease activity (relapses, MRI lesions, EDSS progression)
  • Why Gilenya is medically necessary for this patient
  • Treatment goals and expected outcomes

Safety Monitoring Plan:

  • First-dose monitoring protocol
  • Ongoing cardiac and ophthalmologic surveillance plan
  • Laboratory monitoring schedule
From our advocates: We've seen many Gilenya approvals succeed when neurologists clearly document not just what prior treatments failed, but how they failed - including specific dates of relapses, MRI progression, or intolerable side effects. This clinical detail makes the medical necessity case much stronger.

Submission Process and Portals

Electronic Submission (Preferred)

  • Availity Portal: availity.com
    • Use the Novologix module for specialty medications
    • Fastest processing times
    • Real-time status updates
    • Requires provider registration

Paper/Fax Submission

For Michigan Medicaid Plans

If you have Aetna Better Health of Michigan (Medicaid):

  • Submit requests via the provider portal
  • Different criteria may apply for Medicaid coverage
  • Include Waiver of Liability form if required

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing baseline testing Submit all required test results EKG, eye exam, labs, vaccination records
Incomplete step therapy Document prior DMT failures with dates and reasons Detailed treatment history with outcomes
Insufficient medical necessity Provide peer-to-peer review request Clinical notes showing active disease
Non-formulary status Request formulary exception Medical necessity letter explaining why alternatives won't work
Quantity limits exceeded Justify dosing with clinical rationale FDA prescribing information and patient-specific factors

Scripts for Common Situations

Patient calling Aetna member services: "Hi, I need to verify coverage for Gilenya for multiple sclerosis. Can you tell me if prior authorization is required, what tier it's on, and my expected copay? My member ID is [number]."

Clinic requesting peer-to-peer review: "I'm requesting a peer-to-peer review for a Gilenya denial. The patient has relapsing MS with documented failures on [specific prior treatments]. When can we schedule this with your medical director?"

Appeals Process in Michigan

Internal Appeals with Aetna (First Step)

Timeline: 45 days from denial notice How to Submit:

Michigan External Review (Second Step)

Timeline: 127 days after Aetna's final denial How to Submit:

Required Documents:

  • Copy of Aetna's final denial notice
  • Reasons for disagreeing with the denial
  • Supporting medical records
  • Treating provider certification (for experimental/investigational denials)

Decision Timeline: 60 days maximum (often faster) Expedited Review: 72 hours for urgent cases with physician letter

Important: Michigan's external review decisions are binding. If the Independent Review Organization overturns Aetna's denial, they must cover the treatment.

For questions about the Michigan appeal process, call DIFS at 877-999-6442 (Mon-Fri, 8 AM-5 PM).

Patient Support and Cost Assistance

Manufacturer Support Programs

Novartis Patient Assistance:

  • Copay cards for eligible commercial insurance patients
  • Patient assistance program for uninsured/underinsured
  • Visit the Novartis patient support website for current programs

Generic Options

Multiple generic fingolimod products are now available, which may have different formulary placement or lower costs than brand-name Gilenya.

State and Federal Programs

Michigan Medicaid: Covers Gilenya with prior authorization through Aetna Better Health Medicare Part D: Coverage varies by plan; check your formulary

When to Contact Michigan Regulators

Contact the Michigan Department of Insurance and Financial Services (DIFS) if:

  • Aetna doesn't respond to appeals within required timeframes
  • You believe the denial violates Michigan insurance law
  • You need help understanding your appeal rights

DIFS Consumer Hotline: 877-999-6442 Online Complaint: michigan.gov/difs

The Michigan Attorney General's Health Care Division may also assist with insurance-related issues, particularly if there are patterns of inappropriate denials.

Frequently Asked Questions

Q: How long does Aetna prior authorization take for Gilenya? A: Standard requests take 30-45 business days. Expedited requests (urgent medical need) are decided within 72 hours for Medicare plans.

Q: What if Gilenya isn't on my Aetna formulary? A: Request a formulary exception by documenting medical necessity and why preferred alternatives aren't appropriate for your specific case.

Q: Can I fill Gilenya at my local pharmacy? A: No, Aetna requires specialty medications like Gilenya to be filled through CVS Specialty pharmacy. They'll contact you after prior authorization approval.

Q: Does step therapy apply if I've tried MS drugs outside Michigan? A: Yes, document all prior MS treatments regardless of where you received them. Out-of-state treatment records are valid for step therapy requirements.

Q: What's the difference between a formulary exception and a prior authorization? A: Prior authorization is required even for formulary drugs to ensure appropriate use. A formulary exception is needed if the drug isn't covered at all on your plan.

Q: Can my doctor request an expedited appeal? A: Yes, if waiting for the standard appeal timeline would seriously jeopardize your health. This requires a physician letter explaining the urgency.

Q: How much will Gilenya cost with Aetna coverage? A: Costs vary by plan. It's typically a high-tier specialty drug with significant copays, but manufacturer copay assistance may be available.

Q: What happens if I miss the appeal deadline? A: Michigan allows 127 days for external review requests, which is longer than many states. However, missing this deadline typically means you cannot pursue external review.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful, evidence-backed appeals. Our platform analyzes denial letters, identifies the specific basis for denial, and creates targeted rebuttals aligned with each payer's own policies. For medications like Gilenya, we help gather the right clinical evidence - from FDA labeling to peer-reviewed studies - and weave them into compelling appeals that address payer requirements while tracking deadlines and required documentation.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for decisions about your specific situation. For official information about Michigan insurance appeals, visit michigan.gov/difs.

Sources & Further Reading

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