By Counterforce Health Team in Fabrazyme (agalsidase beta) —

Getting Fabrazyme (Agalsidase Beta) Covered by Cigna in Michigan: Prior Authorization, Appeals, and Cost Assistance

Answer Box: Quick Path to Coverage

Getting Fabrazyme covered by Cigna in Michigan requires prior authorization through Express Scripts/Accredo, typically reviewed within 72 hours for standard requests. Your doctor submits clinical documentation via CoverMyMeds or by calling 800-882-4462. If denied, you have 180 days for internal appeals, then 127 days for Michigan's external review through DIFS. Start by having your prescriber check your formulary status at myCigna.com and initiate the PA request with complete Fabry disease documentation, including genetic testing and prior treatment failures.

Table of Contents

Understanding Cigna's Fabrazyme Coverage

Fabrazyme (agalsidase beta) is a high-cost enzyme replacement therapy for Fabry disease that typically requires prior authorization under Cigna plans managed by Express Scripts. The medication is placed in Tier 4 (Specialty) on Cigna's National Preferred 4-Tier Specialty formulary, meaning it carries the highest copay or coinsurance rates.

Coverage at a Glance

Requirement Details Where to Find It Source
Prior Authorization Required before coverage myCigna.com drug lookup Cigna PA Policy
Formulary Tier Tier 4 (Specialty) Cigna National Preferred formulary Cigna Formulary PDF
Specialty Pharmacy Accredo or Express Scripts required Member portal or ID card Cigna Specialty Pharmacy
Step Therapy May apply (verify with plan) PA review process Express Scripts PA FAQ
Quantity Limits Possible restrictions Drug lookup tool myCigna.com

Benefit Investigation: What to Ask

Before starting the prior authorization process, gather key information about your specific Cigna plan:

Call Cigna Member Services (number on your ID card) and ask:

  • Is Fabrazyme covered on my formulary?
  • What tier is it placed in, and what's my copay/coinsurance?
  • Is prior authorization required?
  • Are there step therapy requirements?
  • Which specialty pharmacy must I use?
  • What's my annual deductible status?

Document the representative's name, date, and reference number for your records.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Prescriber checks formulary status at myCigna.com using the "Price a Medication" tool
  2. Submit PA request via CoverMyMeds (fastest) or call 800-882-4462
  3. Include complete documentation: genetic testing, prior treatments, clinical notes
  4. Await decision within 72 hours (standard) or 24 hours (expedited)
  5. If approved, prescription processes through Accredo specialty pharmacy
  6. If denied, request peer-to-peer review or begin appeal process

Required Documentation

Your prescriber should include:

  • Confirmed Fabry disease diagnosis with genetic testing results
  • ICD-10 code E75.21 (Fabry disease)
  • Prior treatment history and failures/intolerances
  • Clinical rationale for Fabrazyme specifically
  • Dosing plan (1 mg/kg every 2 weeks)
  • Contraindications to alternative treatments
Clinician Corner: Medical necessity letters should reference FDA labeling for Fabrazyme and cite relevant guidelines from the American College of Medical Genetics. Include specific lab values (α-galactosidase A levels) and document any prior failures with oral chaperones like Galafold for amenable variants.

Cost Assistance Options

Manufacturer Support

Sanofi Patient Connection offers assistance for eligible patients:

  • Income requirement: ≤400% of Federal Poverty Level for free medication
  • Insurance status: Must have no coverage or coverage denial for Fabrazyme
  • Exclusions: Cannot use with Medicaid, Medicare, or other government programs
  • Contact: Visit Fabrazyme.com/resources-and-support or call Sanofi Patient Connection

Foundation Grants

NORD RareCare Program

  • Covers medication costs, insurance premiums, deductibles, and copayments
  • Annual awards on calendar-year basis
  • Requires U.S. citizenship or 6+ months residency
  • Contact: 203-433-2455

PAN Foundation

  • Up to $9,600 annually for health insurance premium assistance
  • Apply at panapply.org or call 866-316-7263
  • First-come, first-served basis

Additional Programs:

  • TAF (Assistance Foundation): 855-253-9223 for FDA-approved Fabry medications
  • Accessia: 800-366-7741 for medication and therapy support

Appeals Process in Michigan

Internal Appeals with Cigna

If your initial PA request is denied, you have 180 days to file an internal appeal:

  1. First-level appeal: Submit written disagreement with additional clinical evidence
  2. Second-level review: Independent medical review by Cigna
  3. Expedited appeals: Available for urgent medical situations (24-72 hour review)

Michigan External Review

After exhausting Cigna's internal appeals, you can request external review through Michigan's Department of Insurance and Financial Services (DIFS):

  • Timeline: 127 days from final internal denial to file
  • Process: Submit via DIFS External Review form online or by mail/fax
  • Review period: 60 days maximum (often faster)
  • Expedited option: 72 hours for urgent cases with physician letter
  • Contact: 877-999-6442 for assistance
Note: Michigan's external reviews are binding. If the Independent Review Organization overturns Cigna's denial, the insurer must provide coverage as directed.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Not medically necessary" Provide genetic testing, enzyme levels, symptom documentation
"Step therapy required" Document failures/contraindications to Galafold or other alternatives
"Non-formulary drug" Request formulary exception with clinical rationale
"Insufficient documentation" Submit complete medical records, specialist consultation notes
"Age restrictions" Cite FDA approval for patients ≥2 years with supporting evidence

Specialty Pharmacy Requirements

Cigna typically requires Fabrazyme to be dispensed through Accredo specialty pharmacy for coverage. Key considerations:

  • Enrollment: Your prescriber initiates enrollment with Accredo
  • Delivery: Home infusion or clinic administration options
  • Coordination: Accredo handles PA submission and insurance billing
  • Contact: Use MyAccredoPatients.com for status updates

Cash-pay pricing (if insurance fails): Approximately $1,100 per 5-mg vial and $7,600 per 35-mg vial, making insurance coverage critical for most patients.

Renewal and Annual Planning

Prior authorizations for Fabrazyme typically require renewal every 3-6 months:

  • Set calendar reminders 30 days before expiration
  • Annual plan changes may affect formulary status or copays
  • Document ongoing medical necessity with updated labs and clinical notes
  • Budget for potential changes in out-of-pocket costs

Counterforce Health helps patients and clinicians navigate complex prior authorization renewals by analyzing plan policies and creating targeted appeals that address specific payer requirements.

Scripts for Key Conversations

Calling Cigna Member Services

"I need to check coverage for Fabrazyme, spelled F-A-B-R-A-Z-Y-M-E, for Fabry disease. Can you tell me if it's covered, what tier it's on, if prior authorization is needed, and which specialty pharmacy I must use?"

Prescriber Office Request

"My Cigna plan requires prior authorization for Fabrazyme. Can you help submit the PA request through CoverMyMeds or by calling Cigna? I have my genetic testing results and previous treatment history ready to provide."

Peer-to-Peer Review

"I'm requesting a peer-to-peer review for my Fabrazyme denial. The patient has confirmed Fabry disease with genetic testing and has failed/cannot tolerate alternative treatments. When can we schedule this review?"

FAQ

How long does Cigna prior authorization take for Fabrazyme in Michigan? Standard reviews take 72 hours, expedited reviews 24 hours. No response within timelines equals automatic approval.

What if Fabrazyme is non-formulary on my Cigna plan? Request a formulary exception by having your prescriber submit clinical documentation showing medical necessity and failure of formulary alternatives.

Can I get expedited approval if I'm already on Fabrazyme? Yes, if interrupting treatment would jeopardize your health, request expedited review with physician documentation of medical urgency.

Does Michigan have special protections for rare disease medications? Michigan follows federal ACA protections and offers robust external review through DIFS with binding decisions from independent medical experts.

What happens if I miss the appeal deadline? Contact DIFS at 877-999-6442 to discuss options. In some cases, good cause exceptions may apply for late filings.

Can Counterforce Health help with my Fabrazyme appeal? Yes, Counterforce Health specializes in turning insurance denials into evidence-backed appeals by analyzing your specific plan policy and crafting targeted rebuttals that address Cigna's exact coverage criteria.

From our advocates: We've seen many Fabrazyme appeals succeed when families provide comprehensive documentation upfront—genetic testing, detailed symptom progression, and clear documentation of why alternatives won't work. Taking time to gather complete medical records before the initial PA request often prevents denials entirely.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For assistance with Michigan insurance appeals, contact DIFS at 877-999-6442.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.