By Counterforce Health Team in Myozyme (alglucosidase alfa) —

How to Get Myozyme (Alglucosidase Alfa) Covered by Aetna (CVS Health) in Michigan: Complete Authorization & Appeal Guide

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

Aetna (CVS Health) requires prior authorization for Myozyme (alglucosidase alfa) for Pompe disease. Success requires: (1) confirmed Pompe diagnosis via enzyme assay and genetic testing, (2) prescription from a metabolic/lysosomal storage disease specialist, and (3) proper documentation submission. If denied, you have internal appeal rights plus Michigan's external review through DIFS within 127 days. Start today: Have your specialist submit the PA request with complete diagnostic proof to Aetna's medical drug prior authorization team.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all alglucosidase alfa Aetna provider portal Aetna CPB 0442
Confirmed Diagnosis Enzyme assay + genetic testing for Pompe Lab reports required Aetna CPB 0442
Specialist Prescriber Metabolic/LSD specialist required Provider credentials Aetna CPB 0442
Formulary Status Typically requires PA regardless of tier Plan formulary Verify with Aetna member services
Site of Care Review Hospital vs. infusion center approval PA submission CVS Specialty coordination
Appeal Deadline (Internal) 180 days from denial Denial letter Aetna member handbook
External Review (Michigan) 127 days from final denial DIFS forms Michigan DIFS

Step-by-Step: Fastest Path to Approval

1. Confirm Pompe Diagnosis (Patient + Specialist)

Who does it: Specialist orders tests
Documents needed: GAA enzyme assay, genetic testing for GAA variants
Timeline: 2-4 weeks for results
Source: Mayo Clinic Labs GAA Testing

2. Gather Clinical Documentation (Specialist)

Who does it: Specialist's office
Documents needed: Clinic notes, functional assessments, weight-based dosing calculation
Timeline: 1-2 days to compile
Key requirement: Document infantile-onset vs. late-onset classification per FDA labeling

3. Submit Prior Authorization (Specialist)

Who does it: Specialist or authorized staff
How to submit: Aetna provider portal or medical drug PA form
Timeline: Submit within 2-3 business days
Include: All diagnostic proof, specialist credentials, medical necessity letter

4. CVS Specialty Enrollment (Specialist + Patient)

Who does it: Specialist initiates, patient confirms
Forms needed: CVS Specialty enrollment form
Timeline: Parallel to PA submission
Fax: 1-800-323-2445

5. Await PA Decision (Patient monitors)

Timeline: 30-45 days standard, 72 hours if expedited
What to expect: Approval with site-of-care specifications or denial with reason codes
Next step: If approved, coordinate infusion; if denied, proceed to appeal

6. Appeal if Denied (Patient + Specialist)

Timeline: Must start within 180 days of denial
Process: Internal appeal first, then Michigan external review if needed
Success factors: Address specific denial reasons with additional evidence

7. External Review if Necessary (Patient)

When: After final internal denial from Aetna
Deadline: 127 days from final denial letter
Process: File with Michigan DIFS
Decision: Binding on Aetna within 60 days (72 hours if expedited)

Clinician Corner: Medical Necessity Documentation

For Healthcare Providers: Aetna's approval hinges on comprehensive documentation that clearly establishes medical necessity per their published criteria.

Essential Elements for Medical Necessity Letter

Diagnosis Confirmation

  • GAA enzyme activity results showing deficiency
  • Genetic testing report with two pathogenic GAA variants
  • Clear statement: "Patient has confirmed Pompe disease (ICD-10: E74.02)"

Clinical Presentation

  • Infantile-onset: Age at symptom onset, cardiomyopathy presence, motor development
  • Late-onset: Progressive weakness pattern, respiratory involvement, CK levels
  • Current functional status with objective measures

Treatment Plan

  • Weight-based dosing calculation (20 mg/kg every 2 weeks per FDA label)
  • Proposed infusion site and monitoring plan
  • Expected outcomes and monitoring parameters

Specialist Credentials

  • Board certification in relevant specialty
  • Experience with lysosomal storage disorders
  • Institution capabilities for safe infusion per FDA requirements

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"No confirmed Pompe diagnosis" Submit complete diagnostic workup Enzyme assay + genetic testing reports
"Not prescribed by specialist" Verify prescriber credentials Board certification, LSD experience documentation
"Experimental/investigational" Cite FDA approval for Pompe FDA label, clinical guidelines
"Dosing outside guidelines" Justify weight-based calculation Current weight, FDA dosing table, specialist rationale
"Site of care not appropriate" Document safety requirements Facility capabilities, patient risk factors

Appeals Process: Aetna Internal & Michigan External Review

Aetna Internal Appeals

First Level Appeal

  • Deadline: 180 days from denial letter date
  • How to file: Aetna member portal or written request
  • Timeline: 30 days for standard, 72 hours for urgent
  • Include: Additional clinical evidence addressing denial reasons

Second Level Appeal (if applicable)

  • Automatic: Some plans require two internal levels
  • Timeline: Additional 30 days
  • Peer-to-peer: Request physician-to-physician review

Michigan External Review

When Aetna issues a final denial, Michigan law provides independent review rights.

Eligibility Requirements

  • Completed Aetna's internal appeal process
  • Filed within 127 days of final denial
  • Service is a covered benefit under the plan

Filing Process

  • Online: DIFS External Review Form
  • Paper: FIS 0018 form via fax or mail
  • Include: All denial letters, medical records, prescriber support letter

Decision Timeline

  • Standard: 60 days maximum
  • Expedited: 72 hours with physician urgency statement
  • Binding: Aetna must comply with favorable decisions
Note: Michigan's 127-day deadline is longer than the federal 120-day minimum, giving patients extra time to file external reviews.

CVS Specialty Enrollment & Patient Support

Since many Aetna plans require CVS Specialty as the designated pharmacy for Myozyme, enrollment runs parallel to prior authorization.

Enrollment Steps

  1. Prescriber Referral: Complete CVS Specialty enrollment form
  2. Insurance Verification: CVS confirms coverage and copay
  3. Infusion Coordination: Often through Coram (CVS Health company)
  4. Patient Account Setup: Online portal for refill management

Sanofi Patient Support Programs

Commercial Insurance Copay Program

  • Significant copay reduction for eligible patients
  • Cannot be used with government insurance (Medicare, Medicaid)
  • Enrollment through prescriber or Sanofi patient support

Patient Assistance Program (PAP)

  • Free drug for qualifying uninsured/underinsured patients
  • Income-based eligibility requirements
  • Requires separate application with financial documentation

Benefits Investigation

  • Insurance coverage verification
  • Prior authorization assistance
  • Coordination between Sanofi, CVS, and Aetna

Costs & Financial Assistance Options

Typical Costs

  • Myozyme: ~$1,026 per 50-mg vial (cash price varies by state)
  • Monthly cost varies significantly based on patient weight and dosing

Financial Support Resources

  1. Sanofi Copay Program: For commercial insurance patients
  2. Sanofi PAP: Free drug for qualifying patients
  3. Independent Foundations: HealthWell Foundation, Patient Access Network
  4. State Programs: Michigan may have rare disease support programs
Tip: Apply for multiple programs simultaneously, as funding availability changes frequently and some have waiting lists.

When to Escalate to Michigan DIFS

Contact Michigan DIFS if you encounter:

  • Aetna delays beyond published timelines
  • Denial of expedited review for urgent cases
  • Failure to process external review properly
  • Pattern of inappropriate denials

Michigan DIFS Contact

  • Phone: 877-999-6442 (toll-free consumer hotline)
  • Website: DIFS Consumer Services
  • Complaint Portal: Online complaint filing available

FAQ: Common Questions

Q: How long does Aetna prior authorization take for Myozyme in Michigan? A: Standard PA decisions: 30-45 days. Expedited reviews (urgent medical need): 72 hours. Timeline starts when Aetna receives complete documentation.

Q: What if Myozyme isn't on Aetna's formulary? A: Aetna covers Myozyme under their lysosomal storage disorder policy regardless of formulary status, but prior authorization is required. Non-formulary status doesn't mean automatic denial.

Q: Can I request an expedited appeal if my infusions are delayed? A: Yes. If delaying treatment would seriously jeopardize your health, request expedited internal appeal (72 hours) and expedited external review in Michigan (72 hours) with physician support letter.

Q: Does Michigan's external review cost anything? A: No. Michigan DIFS external review is free to patients. The Independent Review Organization (IRO) decision is binding on Aetna.

Q: What happens if I move from Michigan to another state during treatment? A: Continue current appeals in Michigan if already filed. New state's external review laws will apply to future denials. Notify CVS Specialty of address change for shipping.

Q: Can family members help with the appeal process? A: Yes, with proper authorization. Michigan law allows authorized representatives to file appeals on your behalf. Complete appropriate consent forms.

Counterforce Health helps patients navigate complex insurance approval processes for specialty medications. Our platform analyzes denial letters and creates targeted, evidence-based appeals that address specific payer requirements. By turning insurance denials into strategic appeals, we help patients get the medications they need while reducing the administrative burden on healthcare providers. Learn more about our comprehensive appeal support services.

The insurance approval process can feel overwhelming, but Michigan patients have strong appeal rights and multiple support resources. Whether you're just starting the prior authorization process or facing a denial, the key is thorough documentation and understanding your timeline for each step. With proper preparation and persistence, most patients with confirmed Pompe disease can successfully obtain Myozyme coverage through Aetna.

When working with complex specialty drug approvals, having expert guidance can make the difference between approval and denial. Counterforce Health's platform specializes in creating compelling appeals that speak directly to payer requirements, helping patients and providers navigate these challenging processes more effectively.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance processes and should not be considered medical or legal advice. Insurance policies and state regulations change frequently. Always verify current requirements with your insurer and healthcare providers. For urgent medical situations, contact your healthcare provider immediately.

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