By Counterforce Health Team in Fabrazyme (agalsidase beta) —

How to Get Fabrazyme (agalsidase beta) Covered by Aetna in Michigan: Prior Authorization Guide with Appeal Forms

Answer Box: Getting Fabrazyme Covered by Aetna in Michigan

Fabrazyme (agalsidase beta) requires prior authorization from Aetna in Michigan. The fastest path to approval: (1) Submit PA through Aetna's Availity portal with genetic testing confirmation and specialist prescription, (2) Include documented Fabry disease progression and prior therapy failures, (3) If denied, file internal appeal within 180 days. Michigan residents have 127 days for external review through DIFS after exhausting Aetna's internal process. Most approvals come within 24-72 hours when properly documented.

Table of Contents

  1. Before You Start: Verify Your Coverage
  2. Gather Required Documentation
  3. Submit Your Prior Authorization Request
  4. Follow-Up and Timeline Expectations
  5. Common Denial Reasons and Solutions
  6. Appeals Process: Internal and External
  7. Medical Necessity Documentation
  8. Costs and Patient Assistance
  9. FAQ
  10. Sources and Further Reading

Before You Start: Verify Your Coverage

Check Your Plan Type and Formulary Status

First, confirm whether Fabrazyme falls under your pharmacy or medical benefit. Most Aetna plans route specialty infusions like Fabrazyme through CVS Specialty Pharmacy as a medical benefit, but this varies by plan design.

Key verification steps:

  • Log into your Aetna member portal or call the number on your ID card
  • Request your plan's formulary and confirm Fabrazyme's tier status
  • Verify if your plan requires step therapy with oral treatments first
  • Check if you need a specialty pharmacy referral
Note: According to Aetna's clinical policy CPB 0442, step therapy with oral chaperone therapy (like Galafold) is not explicitly required before Fabrazyme approval.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for most Aetna plans Aetna Precertification Lists
Age Requirement ≥2 years old Aetna CPB 0442
Diagnosis Confirmation Genetic testing or enzyme assay required Aetna CPB 0442
Prescriber Requirement Specialist typically preferred Verify with plan
Site of Care Infusion center or hospital outpatient Aetna Site of Care Policy

Gather Required Documentation

Essential Documents Checklist

For the patient:

  • Insurance card and member ID
  • Copy of Fabry disease diagnosis (ICD-10: E75.21)
  • Genetic testing results confirming GLA gene mutation
  • Alpha-galactosidase A enzyme assay results (if applicable)
  • Documentation of symptoms and organ involvement
  • Prior treatment history and outcomes

For the prescriber:

  • Complete medical records showing disease progression
  • Laboratory results (kidney function, cardiac studies, pain assessments)
  • Documentation of failed or contraindicated alternative therapies
  • Letter of medical necessity
  • Prescription with specific dosing (typically 1 mg/kg every 2 weeks)

Fabry Disease Diagnostic Requirements

According to clinical guidelines, diagnostic confirmation varies by sex:

For males: Biochemical enzyme assay measuring alpha-galactosidase A activity is typically sufficient, but genetic testing should follow to identify the specific variant.

For females: DNA/GLA gene testing is mandatory, as enzyme levels may appear normal despite having Fabry disease.

Submit Your Prior Authorization Request

Step-by-Step Submission Process

1. Access Aetna's Portal (Preferred Method)

  • Use Availity portal for fastest processing
  • Select Novologix for specialty drugs like Fabrazyme
  • Submit at least 2 weeks before planned treatment start

2. Alternative Submission Methods

  • Phone: Call the number on the member's ID card
  • Fax: Use provider-specific fax numbers (verify current number)
  • Electronic: Through EMR system or EDI

3. Required Form Information

  • Patient demographics and insurance information
  • Prescriber NPI and contact details
  • Diagnosis code (E75.21 for Fabry disease)
  • Requested medication, strength, and dosing schedule
  • Clinical justification and supporting documentation
Tip: Aetna approves over 95% of eligible prior authorizations within 24 hours when complete documentation is provided.

Follow-Up and Timeline Expectations

Standard Processing Times

Review Type Timeline When to Use
Standard PA 30-45 days maximum Routine requests
Expedited PA 72 hours Urgent medical need
Appeal (Internal) 30-60 days After denial
External Review 60 days (Michigan) After internal appeal exhausted

When and How to Follow Up

Week 1: Check submission status through Availity portal or call provider services Week 2: If no response, call to confirm receipt and processing status Week 3+: Escalate to expedited review if medically urgent

Sample follow-up script: "I'm calling to check the status of a prior authorization for Fabrazyme for [patient name], member ID [number]. The request was submitted on [date]. Can you provide the current status and expected decision timeline?"

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
Lack of genetic confirmation Submit GLA gene testing results Laboratory report showing pathogenic variant
Insufficient disease progression Document organ involvement Kidney biopsy, cardiac MRI, pain scales
Step therapy not completed Request medical exception Letter explaining contraindications to alternatives
Non-formulary status File formulary exception Comparative effectiveness data
"Not medically necessary" Provide comprehensive clinical rationale Guidelines, FDA label, specialist letter

Overturning "Not Medically Necessary" Denials

When Aetna cites medical necessity concerns, your response should include:

  • Disease progression documentation: eGFR decline, cardiac changes, worsening pain
  • FDA labeling support: Fabrazyme is FDA-approved for Fabry disease
  • Guideline references: Cite relevant treatment guidelines
  • Alternative therapy failures: Document why other options aren't suitable

Appeals Process: Internal and External

Aetna Internal Appeals

Filing deadline: 180 days from denial notice Decision timeline: 30-60 days for standard; 72 hours for expedited How to file: Through member portal, phone, or written request

Required for appeal submission:

  • Original denial letter
  • Member ID and contact information
  • Additional medical documentation
  • Updated letter of medical necessity
  • Request for peer-to-peer review (if desired)

Michigan External Review Process

If Aetna's internal appeal is denied, Michigan residents can request external review through the Department of Insurance and Financial Services (DIFS).

Key details:

  • Filing deadline: 127 days after final adverse determination
  • Timeline: 60 days for standard review; 72 hours for expedited
  • Cost: Free to patients
  • Decision: Binding on Aetna

How to file:

  1. Online: DIFS External Review Form
  2. Mail: Complete FIS 0018 form and mail to DIFS Office of General Counsel – Appeals Section, P.O. Box 30220, Lansing, MI 48909-7720
  3. Phone assistance: 877-999-6442

Required documents:

  • Aetna's final denial letter
  • Insurance policy or ID card
  • Medical records and bills
  • Physician letter of medical necessity
Important: For expedited external review (72 hours), include a physician letter stating that delay would jeopardize the patient's life, health, or maximum function.

Medical Necessity Documentation

Clinician Corner: Letter of Medical Necessity Checklist

Patient identification and diagnosis:

  • Full name, DOB, member ID
  • Confirmed Fabry disease with genetic testing results
  • ICD-10 code: E75.21
  • Date of diagnosis and current symptoms

Clinical rationale:

  • Specific organ involvement (kidney, heart, nervous system)
  • Disease progression despite current management
  • Why Fabrazyme is the most appropriate treatment
  • Expected clinical outcomes and monitoring plan

Prior therapy documentation:

  • Previous treatments attempted and duration
  • Reasons for discontinuation or failure
  • Contraindications to alternative therapies
  • Response to any previous enzyme replacement therapy

Supporting evidence:

  • Reference to FDA labeling for Fabrazyme
  • Relevant clinical guidelines
  • Peer-reviewed literature supporting use
  • Dosing rationale (1 mg/kg every 2 weeks)

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to craft point-by-point rebuttals. Their platform helps identify the specific denial basis and pulls the right clinical evidence to support approval requests.

Sample Appeal Letter Framework

[Date]

Aetna Medical Director
[Address from denial letter]

RE: Appeal for Fabrazyme (agalsidase beta)
Member: [Name], ID: [Number]
Denial Date: [Date]

Dear Medical Director,

I am appealing your denial of Fabrazyme for my patient with confirmed Fabry disease. The denial cited [specific reason from letter].

Patient History:
[Age]-year-old [male/female] diagnosed with Fabry disease on [date] via genetic testing showing [specific mutation]. Current manifestations include [kidney dysfunction, cardiac involvement, neuropathic pain].

Medical Necessity:
Fabrazyme is FDA-approved for Fabry disease and is medically necessary to prevent irreversible organ damage. Without treatment, this patient faces progressive kidney failure, cardiac complications, and potential stroke.

Prior Therapies:
[Document any previous treatments, outcomes, and reasons for change]

Clinical Evidence:
Fabrazyme has demonstrated efficacy in reducing GL-3 deposits and stabilizing organ function in clinical trials. Treatment guidelines support enzyme replacement therapy for patients with classic Fabry disease.

Request:
Please approve Fabrazyme 1 mg/kg IV every 2 weeks for 12 months with appropriate monitoring.

Sincerely,
[Physician name, credentials, NPI]

Costs and Patient Assistance

Understanding Fabrazyme Costs

Fabrazyme is expensive, with cash prices around:

  • $1,100 per 5-mg vial
  • $7,600 per 35-mg vial

For a typical adult patient (70 kg), the monthly cost can exceed $15,000 without insurance coverage.

Financial Assistance Options

Sanofi Patient Assistance Programs:

  • Fabrazyme Connect: Copay assistance and patient support services
  • Income-based free drug programs for eligible patients
  • Prior authorization support and appeals assistance

Additional Resources:

  • National Organization for Rare Disorders (NORD) patient assistance
  • HealthWell Foundation grants for rare disease treatments
  • State pharmaceutical assistance programs in Michigan

Michigan-Specific Resources:

  • Michigan Department of Health and Human Services prescription assistance
  • Community health centers with sliding fee scales
  • Hospital charity care programs

From Our Advocates

"We've seen many Fabrazyme appeals succeed when families include comprehensive genetic testing results and document specific organ involvement. One key tip: if your initial request is denied for 'lack of medical necessity,' focus your appeal on quantifiable disease progression metrics like declining kidney function or cardiac changes. Insurance medical directors respond well to objective clinical data paired with clear treatment guidelines."

FAQ

How long does Aetna prior authorization take for Fabrazyme in Michigan? Standard requests take 30-45 days maximum, but over 95% of complete submissions are approved within 24-72 hours. Expedited requests for urgent medical situations are decided within 72 hours.

What if Fabrazyme is not on my Aetna formulary? You can request a formulary exception by demonstrating medical necessity and providing documentation that preferred alternatives are inappropriate or have failed.

Can I request an expedited appeal if my Fabrazyme is denied? Yes, if delay would jeopardize your health. Include a physician letter stating the urgent medical need, and Aetna must decide within 72 hours.

Does Michigan require step therapy before Fabrazyme approval? According to Aetna's clinical policy, step therapy with oral chaperone medications is not explicitly required before Fabrazyme approval, though individual plans may vary.

What happens if Aetna denies my internal appeal? Michigan residents can file for external review through DIFS within 127 days. This independent review is binding on Aetna and free to patients.

How often do I need to renew Fabrazyme prior authorization? Typically annually, though some plans may require more frequent reviews. Start the renewal process 60-90 days before expiration.

Can my doctor request a peer-to-peer review? Yes, physicians can request to speak directly with Aetna's medical director to discuss the case. This is often helpful for complex denials.

What if I need Fabrazyme while traveling outside Michigan? Coordinate with CVS Specialty Pharmacy for out-of-state infusions, or work with Counterforce Health to ensure proper documentation for temporary location changes.

Sources and Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult your healthcare provider for medical decisions and review your specific insurance policy for coverage details. For personalized assistance with complex denials, consider consulting with specialized advocacy services.

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