By Counterforce Health Team in Translarna (ataluren) —

How to Get Translarna (Ataluren) Covered by Aetna CVS Health in Michigan: Complete Requirements Guide

Quick Answer: Getting Translarna Covered by Aetna CVS Health in Michigan

Translarna (ataluren) requires prior authorization from Aetna CVS Health in Michigan. The fastest path to approval: (1) Submit PA request through Availity portal with genetic testing confirming nonsense mutation DMD, (2) Include ambulatory status documentation and medical necessity letter, (3) Use CVS Caremark Specialty Pharmacy for dispensing. If denied, you have 180 days to appeal internally, then 127 days for Michigan external review through DIFS. Start today: Contact your prescriber to initiate the prior authorization process at least two weeks before needed.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation
  5. Submission Process
  6. Specialty Pharmacy Requirements
  7. After Submission: What to Expect
  8. Common Denial Reasons & Solutions
  9. Appeals Process in Michigan
  10. Cost Savings Options
  11. FAQ

Who Should Use This Guide

This guide is for Michigan residents with Aetna CVS Health insurance seeking coverage for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD). You'll need this if:

  • Your child has confirmed nonsense mutation DMD and is still ambulatory
  • Your neurologist or specialist has recommended Translarna therapy
  • You've received a denial and need to understand the appeal process
  • You're preparing a prior authorization request

Expected outcome: With proper documentation, many specialty medication appeals succeed when clinical criteria are met and regulatory requirements are satisfied.

Member & Plan Basics

Coverage Requirements

  • Active Aetna CVS Health coverage in Michigan (commercial, Medicare Advantage, or Medicaid)
  • Specialty pharmacy benefit included in your plan
  • Prior authorization required - no exceptions for Translarna

Plan Type Considerations

Plan Type Key Details Contact
Commercial Standard PA process, 180-day appeal window 1-888-632-3862
Medicare Advantage CMS guidelines apply, expedited appeals available 1-800-624-0756
Medicaid State Medicaid rules plus Aetna requirements 1-800-642-3195
Important: Verify your specialty pharmacy benefits are active before starting the PA process.

Clinical Criteria Requirements

Primary Eligibility

✅ Confirmed nonsense mutation in dystrophin gene via genetic testing
✅ Ambulatory status (able to walk independently)
✅ Age 2 years or older (based on historical trial criteria)
✅ Specialist prescriber (neurologist, geneticist, or pediatric specialist)

Regulatory Status Alert

As of 2024-2025: Translarna is under FDA review in the US following resubmission of the New Drug Application. The European marketing authorization was not renewed in March 2025 due to insufficient efficacy evidence. Your appeal should acknowledge current regulatory status while emphasizing individual medical necessity.

Step Therapy Considerations

Aetna typically requires documentation of:

  • Corticosteroid therapy (prednisone, deflazacort) unless contraindicated
  • Physical therapy and supportive care measures
  • Rationale for why standard treatments are insufficient

Coding & Documentation

ICD-10 Codes

  • Primary: G71.0 (Muscular dystrophy)
  • Supporting documentation: Genetic test results specifying nonsense mutation

HCPCS/Billing Codes

Currently no permanent J-code assigned. Use:

  • J3490 (Unclassified drugs) or J9999 (Not otherwise classified)
  • Include clear documentation identifying Translarna (ataluren) for nmDMD

Required Documentation Packet

Clinical Notes Must Include:

  • Confirmed DMD diagnosis with genetic testing results
  • Current ambulatory assessment with date
  • Previous treatments tried and outcomes
  • Dosing rationale based on weight/BSA
  • Treatment goals and monitoring plan

Medical Necessity Letter Components:

  • Patient's specific nonsense mutation details
  • Ambulatory functional status
  • Previous therapy failures or contraindications
  • Expected clinical benefits
  • Safety monitoring plan

Submission Process

Step-by-Step Submission

  1. Gather all documentation (genetic testing, clinical notes, prior therapies)
  2. Submit via Availity portal (recommended) or EMR system
  3. Allow 2+ weeks processing time before therapy start date
  4. Follow up within 5-7 days to confirm receipt

Required Forms

  • Aetna Prior Authorization Request (current version from Aetna precertification lists)
  • Medical necessity letter from prescribing physician
  • Genetic testing report confirming nonsense mutation
  • Clinical notes documenting ambulatory status
Tip: Submit through Availity portal for fastest processing - over 95% of eligible PAs are processed within 24 hours when complete.

Specialty Pharmacy Requirements

Network Pharmacy

CVS Caremark Specialty Pharmacy is Aetna's designated specialty pharmacy in Michigan:

  • Location: Troy, Michigan facility
  • Phone: 1-800-753-2777
  • Services: Home delivery, clinical support, benefits coordination

Transfer Process

  1. Obtain prior authorization approval first
  2. Contact CVS Caremark Specialty to initiate transfer
  3. Provide insurance information and prescription details
  4. Coordinate delivery to home or prescriber office

After Submission: What to Expect

Timeline Expectations

  • Standard decision: 30-45 days
  • Expedited review: 72 hours (if urgent medical need)
  • Confirmation: You'll receive written notice of approval or denial

Status Tracking

  • Record confirmation number from submission
  • Check status via Availity portal or phone
  • Document all communications for potential appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Experimental/Investigational" Cite FDA review status, published safety data Clinical trial data, safety studies
"Not medically necessary" Emphasize ambulatory preservation goals Functional assessments, progression data
"Step therapy not met" Document corticosteroid trial/failure Treatment history, contraindications
"Genetic confirmation missing" Provide complete genetic testing report Laboratory report with mutation details

Appeals Process in Michigan

Internal Appeals (Aetna)

  • Deadline: 180 calendar days from denial
  • Decision time: 45 business days
  • Expedited: 36-72 hours for urgent cases
  • Submit via: Availity portal or member services

External Review (Michigan DIFS)

If internal appeal is denied:

  • Deadline: 127 days from Aetna's final denial
  • Decision time: 60 calendar days
  • Contact: Michigan DIFS at 877-999-6442
  • Forms: Online External Review Request or paper submission
Note: Michigan's external review decisions are binding on Aetna CVS Health.

Cost Savings Options

Financial Assistance

  • Manufacturer programs: Check PTC Therapeutics patient assistance (verify current availability)
  • Foundation grants: Research rare disease foundations for DMD support
  • State programs: Michigan may offer additional rare disease assistance

Copay Considerations

  • Specialty tier: Typically highest copay tier
  • Out-of-pocket maximum: Applies to annual limits
  • Medicare: Part D coverage rules apply for Medicare Advantage plans

FAQ

How long does Aetna CVS Health PA take in Michigan? Standard decisions take 30-45 days. Submit at least two weeks before needed therapy start date.

What if Translarna is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. The appeal process remains the same.

Can I request an expedited appeal in Michigan? Yes, if delaying treatment would seriously harm your health. Your doctor must provide a supporting letter stating urgency.

Does step therapy apply if treatments were tried outside Michigan? Yes, document all prior therapies regardless of location. Include medical records from previous providers.

What happens if both internal and external appeals are denied? You have 60 days to seek judicial review in Michigan circuit court, though this is rarely pursued for coverage decisions.

From our advocates: We've seen families succeed with Translarna appeals when they provide comprehensive genetic documentation and clearly demonstrate the child's current ambulatory status. One family's neurologist included quarterly functional assessments showing gradual decline, which helped establish medical necessity for preserving remaining function. The key was painting a complete clinical picture rather than just meeting minimum requirements.

When to Get Professional Help

Consider working with healthcare advocates or legal assistance if:

  • Multiple appeals have been denied
  • Your child's condition is rapidly progressing
  • You're facing complex insurance issues
  • Documentation requirements seem overwhelming

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with payer requirements, pulling the right medical citations and clinical evidence for medications like Translarna.

Sources & Further Reading

Medical Disclaimer: This guide provides general information about insurance coverage processes and should not replace professional medical advice. Always consult with your healthcare provider about treatment decisions. Insurance coverage policies change frequently - verify current requirements with Aetna CVS Health and your healthcare team. For personalized assistance with your specific situation, contact Counterforce Health or speak with a healthcare advocate.

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