By Counterforce Health Team in Vyondys 53 (golodirsen) —

How to Get Vyondys 53 (golodirsen) Covered by Aetna CVS Health in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Vyondys 53 Covered by Aetna CVS Health in Michigan

Aetna CVS Health requires prior authorization for Vyondys 53 (golodirsen) with strict genetic and functional criteria. To get approved in Michigan: (1) Confirm your child has a DMD gene mutation amenable to exon 53 skipping through genetic testing, (2) Complete Aetna's Vyondys 53 precertification form with neuromuscular specialist documentation, and (3) Submit via CVS Caremark portal or fax to 1-888-267-3277. If denied, you have 60 days for internal appeals and 127 days for Michigan DIFS external review.

Start today: Download Aetna's Vyondys 53 precertification form and schedule genetic testing confirmation with your DMD specialist.

Table of Contents

  1. Verify Your Aetna Plan Coverage
  2. Required Forms and Documentation
  3. Submission Portals and Methods
  4. CVS Specialty Pharmacy Enrollment
  5. Appeals Process for Michigan Residents
  6. Common Denial Reasons and Solutions
  7. Michigan External Review Rights
  8. Support Resources and Contact Information
  9. FAQ

Verify Your Aetna Plan Coverage

Before starting the prior authorization process, confirm your specific Aetna plan details:

Check Your Formulary Status:

  • Log into your Aetna member portal or call 1-855-676-5772
  • Verify Vyondys 53 is listed as a specialty medication requiring prior authorization
  • Note your plan's specialty pharmacy requirements (typically CVS Specialty)

Confirm Network Requirements:

  • Ensure your neuromuscular specialist is in-network
  • Verify infusion center or hospital outpatient department is covered
  • Check if your plan requires CVS Caremark specialty pharmacy dispensing
Tip: Aetna considers Vyondys 53 medically necessary only for confirmed DMD with exon 53-skipping amenable mutations. Generic alternatives don't exist, but step therapy may require documenting failures with corticosteroids or other DMD treatments.

Required Forms and Documentation

Primary Prior Authorization Form

Aetna Vyondys 53 Injectable Medication Precertification Request

Essential Clinical Documentation

Requirement Documentation Needed Why It's Required
Genetic Testing Lab report confirming exon 53-skipping amenable DMD mutation FDA approval is mutation-specific
Functional Assessment 6-minute walk test showing ≥250 meters independently Ambulatory requirement for coverage
Specialist Involvement Neuromuscular specialist consultation notes Aetna requires specialist oversight
Age Verification Treatment initiation before age 16 Coverage criterion for initial approval
Baseline Labs Kidney function (cystatin C, protein-to-creatinine ratio) Monitoring requirement
Corticosteroid History Stable steroid therapy ≥6 months Standard DMD care documentation

Additional Requirements for Specific Situations

If Prior Gene Therapy (Elevidys):

  • Document clinical worsening post-gene therapy
  • Show ambulatory decline or functional deterioration
  • Must re-meet all initial approval criteria

For Continuation Requests:

  • Proof patient remains ambulatory (with or without assistance)
  • Evidence of treatment benefit or disease stabilization
  • Updated functional assessments

Submission Portals and Methods

CVS Caremark Provider Portal (Preferred Method)

For Aetna Plans with CVS Caremark:

  1. Access the CVS Caremark provider portal
  2. Upload completed precertification form
  3. Attach all supporting documentation
  4. Submit for review

Required Portal Information:

  • NCPDP number
  • NPI and DEA numbers
  • State license information
  • Practice FEIN

Alternative Submission Methods

Fax Submission:

  • Fax number: 1-888-267-3277
  • Include cover sheet with patient information
  • Confirm receipt within 24 hours

Phone Precertification:

  • Call: 1-866-752-7021 (TTY: 711)
  • Have all documentation ready
  • Request confirmation number
Note: CVS Caremark handles most Aetna specialty medications. Verify your specific plan uses CVS Caremark before submitting through their portal.

CVS Specialty Pharmacy Enrollment

Patient Enrollment Process

Step 1: Complete Enrollment Forms

  1. Download CVS Specialty DMD enrollment form
  2. Complete patient demographics and insurance information
  3. Fax to CVS Caremark Specialty Programs Case Review Unit: 1-855-330-1720

Step 2: Sarepta START Program

Infusion Coordination

Site of Care Requirements:

  • Outpatient hospital may be required for patients with:
    • Severe venous access issues
    • Behavioral complications
    • Medical instability (respiratory, cardiac, or renal)
  • Home infusion typically not covered for Vyondys 53

Monitoring Plan:

  • Weekly 30 mg/kg IV infusions (35-60 minutes)
  • 0.2 micron filter required
  • Monthly urine protein monitoring
  • Quarterly serum lab monitoring

Appeals Process for Michigan Residents

Internal Appeals with Aetna CVS Health

First Level Appeal (Redetermination):

  • Deadline: 60 calendar days from denial notice
  • Timeline: Decision within 7 calendar days
  • Contact: 1-855-676-5772

Expedited Appeals:

  • Eligibility: When delay would jeopardize life or health
  • Timeline: 72 hours for decision
  • Required: Physician letter documenting urgency

Required Appeal Documentation

Medical Necessity Letter Checklist:

  • Confirmed DMD diagnosis with genetic testing results
  • Documentation of exon 53-skipping amenable mutation
  • 6-minute walk test results (≥250 meters)
  • Specialist consultation notes
  • Prior therapy history and outcomes
  • Treatment goals and monitoring plan

Supporting Evidence:

  • FDA label for Vyondys 53
  • Peer-reviewed studies on exon skipping therapy
  • DMD treatment guidelines from neuromuscular societies

Peer-to-Peer Review Request

When to Request:

  • Initial denial for "not medically necessary"
  • Non-formulary status challenges
  • Quantity limit disputes

How to Request:

  • Call Aetna provider services: 1-866-752-7021
  • Request clinical pharmacist or medical director review
  • Prepare clinical rationale and guideline references

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
"Genetic testing not provided" Submit complete genetic lab report Exon 53-skipping amenable mutation confirmation
"Patient not ambulatory" Provide recent 6-minute walk test Results showing ≥250 meters independently
"Age exceeds criteria" Document treatment started before age 16 Medical records showing initiation date
"Prior gene therapy" Show clinical worsening post-Elevidys Functional decline documentation
"Not medically necessary" Comprehensive medical necessity letter Specialist attestation with clinical rationale
"Experimental/investigational" Cite FDA approval status FDA label and approval documents
From our advocates: We've seen denials overturned when families provide comprehensive genetic testing documentation upfront. One common issue is submitting incomplete mutation analysis - make sure your genetic report specifically identifies exon 53-skipping amenable mutations, not just general DMD confirmation.

Michigan External Review Rights

Michigan DIFS External Review Process

When You Can File:

  • After Aetna's final internal denial
  • Within 127 days of the final denial notice
  • For medical necessity disputes

How to File:

  1. Complete Michigan DIFS external review form (FIS 0018)
  2. Submit online, by mail, fax, or email
  3. Include all denial letters and medical records

Timelines:

  • Standard review: Decision within 60 days
  • Expedited review: Decision within 72 hours (requires physician letter)

Contact Information:

Expedited External Review

Eligibility for 72-Hour Review:

  • Delay would seriously jeopardize life or health
  • Urgent need for treatment initiation
  • Risk of permanent disability without immediate treatment

Required Documentation:

  • Physician letter explaining urgency
  • Medical records supporting immediate need
  • All prior appeal documentation

Support Resources and Contact Information

Aetna CVS Health Support

Member Services:

  • Phone: 1-855-676-5772 (TTY: 711)
  • Hours: 24/7 for urgent issues
  • Online: Aetna member portal for status tracking

Provider Services:

  • Phone: 1-866-752-7021
  • Fax: 1-888-267-3277
  • Portal: CVS Caremark provider portal

Manufacturer Support

Sarepta Therapeutics SareptAssist:

  • Phone: 1-888-727-3782
  • Website: vyondys53.com
  • Services: Insurance verification, copay assistance, appeals support

Michigan State Resources

Michigan Department of Insurance and Financial Services:

  • Consumer hotline: 877-999-6442
  • Complaint filing: Online at difs.state.mi.us
  • External review assistance: Form FIS 0018

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and procedural documentation for stronger submissions.

FAQ

How long does Aetna CVS Health prior authorization take for Vyondys 53 in Michigan? Standard decisions typically take 30-45 days. Expedited reviews are completed within 72 hours if urgency is documented by a physician.

What if Vyondys 53 is not on my Aetna formulary? You can request a formulary exception with supporting documentation from your neuromuscular specialist. Aetna will review medical necessity and may approve coverage at a preferred tier.

Can I request an expedited appeal in Michigan? Yes, both Aetna internal appeals and Michigan DIFS external reviews offer expedited timelines (72 hours) when delay would jeopardize health.

Does step therapy apply to Vyondys 53? Aetna may require documentation of stable corticosteroid therapy for ≥6 months and failure of other DMD treatments before approving Vyondys 53.

What happens if I've already tried gene therapy like Elevidys? You must document clinical worsening or functional decline post-gene therapy and meet all initial approval criteria again, including ambulatory requirements.

How do I transfer from another specialty pharmacy to CVS? Complete CVS Specialty enrollment forms and coordinate with your current pharmacy for prescription transfer. CVS will handle prior authorization transfer.

What if my 6-minute walk test is less than 250 meters? Aetna requires ≥250 meters independently for coverage. Work with your neuromuscular team to optimize function or explore alternative treatments.

Can I get help with Vyondys 53 copays in Michigan? Yes, Sarepta's SareptAssist program offers copay assistance. Additionally, check for Michigan-specific rare disease foundations and patient assistance programs.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on individual plan benefits, medical circumstances, and current policy requirements. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For additional help with insurance appeals and prior authorization, Counterforce Health offers specialized support for complex coverage challenges.

Last updated: Based on current Aetna policies and Michigan regulations. Insurance requirements may change - verify current forms and timelines with official sources.

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