By Counterforce Health Team in Exondys 51 (eteplirsen) —

How to Get Exondys 51 (Eteplirsen) Covered by UnitedHealthcare in Ohio: Complete Prior Authorization and Appeals Guide 2025

Answer Box: Getting Exondys 51 Covered by UnitedHealthcare in Ohio

Quick Path to Approval: Exondys 51 (eteplirsen) requires prior authorization through UnitedHealthcare's OptumRx. You'll need genetic testing confirming exon 51 amenable DMD mutation, ambulatory status without assistive devices, and either NSAA score >17 or Time to Rise <7 seconds. Start by gathering these documents and submitting through your neurologist 60-90 days before treatment. If denied, Ohio gives you two internal appeals plus external review through the Ohio Department of Insurance within 180 days.

First Step Today: Call UnitedHealthcare at the number on your insurance card to confirm your specific plan's prior authorization requirements and request the submission portal access for your provider.

Table of Contents

Why Ohio State Rules Matter for Your Coverage

Ohio's insurance laws provide crucial protections that can help you get Exondys 51 approved when UnitedHealthcare initially denies coverage. The state's step therapy override law and external review process create pathways around common denial reasons.

Key Ohio Protections:

  • 180-day external review window after final internal denial
  • Step therapy exemptions for patients who've failed similar treatments
  • Expedited appeals (72 hours) for urgent medical needs
  • Independent medical review by certified specialists
Note: These protections apply to most Ohio health plans, but self-funded employer plans governed by federal ERISA law may have different procedures. Check with your HR department if you have employer coverage.

UnitedHealthcare Prior Authorization Requirements

Exondys 51 requires prior authorization through UnitedHealthcare's OptumRx before your prescription can be filled. Here's exactly what you need:

Coverage at a Glance

Requirement What It Means Where to Find It Timeline
Genetic Testing Confirmed exon 51 amenable DMD mutation Neurologist or genetic counselor Must be on file
Ambulatory Status Walking without assistive devices Neurologist evaluation Within 6 months
Functional Assessment NSAA score >17 OR Time to Rise <7 seconds Neurologist testing Within 6 months
Gene Therapy History No prior Elevidys OR documented decline after gene therapy Treatment records Current status
Prescriber Requirements Neurologist or DMD specialist Provider credentials Ongoing

Step-by-Step: Fastest Path to Approval

  1. Schedule Neurologist Evaluation (Patient)
    • Document: Updated NSAA score and Time to Rise test
    • Submit: Through specialist's office
    • Timeline: Complete 30 days before PA submission
  2. Gather Genetic Testing (Clinic)
    • Document: Laboratory report confirming exon 51 amenable mutation
    • Submit: Include with PA application
    • Timeline: Must be current and on file
  3. Complete Baseline Assessments (Clinic)
    • Document: Cardiac function (echo or MRI), kidney function tests
    • Submit: As supporting documentation
    • Timeline: Within 12 months of treatment start
  4. Submit Prior Authorization (Prescriber)
  5. Prepare for Peer-to-Peer (Prescriber)
    • Document: Medical necessity letter emphasizing functional status
    • Timeline: Usually offered if initial review is unfavorable
    • Outcome: Often resolves coverage disputes

When working with patients navigating complex prior authorization requirements like these, Counterforce Health helps turn insurance denials into targeted, evidence-backed appeals by analyzing the specific denial reasons and crafting point-by-point rebuttals aligned to each plan's own rules.

Medical Necessity Letter Checklist

Your neurologist's letter should include:

  • Diagnosis: Duchenne muscular dystrophy with ICD-10 code G71.01
  • Genetic confirmation: Laboratory results showing exon 51 amenable mutation
  • Functional status: Current NSAA score or Time to Rise results
  • Treatment rationale: Why Exondys 51 is medically necessary
  • Monitoring plan: Cardiac and renal function assessments
  • Alternative treatments: Why other DMD therapies aren't appropriate

Step Therapy Override Process in Ohio

Ohio's step therapy law gives you three ways to bypass requirements to try cheaper drugs first:

Medical Exception Criteria

Contraindication or Adverse Reaction The required drug is contraindicated according to FDA prescribing information or will likely cause an adverse reaction.

Prior Treatment Failure
You've previously tried the required drug or similar medication under your current or previous health plan, and it was discontinued due to lack of efficacy or adverse events.

Stability on Current Treatment You're stable on a medication selected by your healthcare provider, regardless of whether it was prescribed under your current or previous plan.

Documentation Requirements

  • Provider request: Must be submitted by your prescribing healthcare provider
  • Clinical justification: Clear explanation of which exception criterion applies
  • Supporting evidence: Treatment history, adverse reaction documentation, or stability records

Timeline Protections

  • Urgent requests: 48-hour response required
  • Standard requests: 10 calendar days maximum
  • Automatic approval: If UnitedHealthcare doesn't respond within deadlines
  • Appeals process: Available if initially denied, with clinical peer review

Appeals Process: Internal and External Review

When UnitedHealthcare denies Exondys 51 coverage, Ohio gives you multiple levels of appeal:

Internal Appeals with UnitedHealthcare

First Level Appeal

  • Deadline: 21 calendar days from denial notice
  • How to file: UnitedHealthcare provider portal or written submission
  • Timeline: 5-10 business days (72 hours for urgent cases)
  • What to include: Updated medical records, specialist evaluation, treatment history

Second Level Appeal

  • Deadline: 21 calendar days from first-level denial
  • Process: Same submission methods as first level
  • Review: Different medical reviewers examine your case
  • Outcome: Final internal decision from UnitedHealthcare

Ohio External Review Process

After exhausting internal appeals, you can request an independent medical review:

Eligibility Requirements

  • Completed all internal appeals with UnitedHealthcare
  • Denial involves medical necessity or experimental treatment determination
  • Request filed within 180 days of final internal denial

How to Request

What Happens Next

  • Independent Review Organization (IRO) assigned to your case
  • Medical experts review your records and UnitedHealthcare's denial
  • Decision is binding on UnitedHealthcare if coverage is approved
  • You can submit additional supporting documentation within 10 business days
Important: Even if UnitedHealthcare claims your case isn't eligible for external review, the Ohio Department of Insurance can independently determine eligibility and order a review.

Practical Scripts and Templates

Patient Phone Script for UnitedHealthcare

"Hi, I'm calling about prior authorization for Exondys 51, eteplirsen, for my son/daughter with Duchenne muscular dystrophy. Can you please confirm the specific requirements for our plan and provide the submission portal information for our neurologist? I also need to know if there are any step therapy requirements and how to request an override if needed."

Clinic Staff Script for Peer-to-Peer

"I'm requesting a peer-to-peer review for [patient name] regarding the denial of Exondys 51. This patient has confirmed exon 51 amenable DMD with genetic testing, maintains ambulatory function without assistive devices, and meets the functional criteria in your policy. I can provide additional clinical documentation during our discussion."

When to Contact Ohio Regulators

Contact the Ohio Department of Insurance if:

  • UnitedHealthcare misses appeal deadlines
  • You're told external review isn't available when it should be
  • The insurer requests inappropriate documentation
  • You need help understanding your appeal rights

Contact Information:

Additional Support Resources

  • UHCAN Ohio (Universal Health Care Action Network): Consumer advocacy and assistance
  • OSHIIP (Ohio Senior Health Insurance Information Program): Medicare-related issues for those 65+

Cost Assistance and Support Programs

Even with insurance coverage, Exondys 51 may have significant out-of-pocket costs. Here are assistance options:

Manufacturer Support

  • Sarepta Therapeutics Patient Services: Financial assistance programs and copay support
  • Eligibility: Varies by insurance type and household income
  • Contact: Through your specialty pharmacy or Sarepta directly

Foundation Grants

  • Patient Advocate Foundation: Copay relief for qualifying patients
  • HealthWell Foundation: Disease-specific assistance programs
  • National Organization for Rare Disorders (NORD): Rare disease patient assistance

Ohio-Specific Programs

Contact the Ohio Department of Health for state programs that may assist with specialty medication costs.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in Ohio? Standard PA decisions take 5-10 business days. Urgent cases must be decided within 72 hours. If UnitedHealthcare doesn't respond within required timeframes, the request is considered approved.

What if Exondys 51 is non-formulary on my plan? Non-formulary drugs can still be covered through medical necessity appeals. Your neurologist will need to document why Exondys 51 is medically necessary and why formulary alternatives aren't appropriate.

Can I request an expedited appeal? Yes, if delays would seriously jeopardize your health. Your physician must certify the urgent medical need. Expedited appeals receive decisions within 72 hours.

Does step therapy apply if I've failed treatments outside Ohio? Yes, Ohio's step therapy override law recognizes prior treatment failures under previous health plans, not just your current Ohio coverage.

What documents do I need for an external review? Gather your insurance denial letters, medical records, genetic testing results, functional assessments, and any correspondence with UnitedHealthcare. The Ohio Department of Insurance will guide you on specific requirements.

How much does Exondys 51 cost without insurance? The typical U.S. cash price is approximately $7,822 for a 10 mL vial (pricing varies by pharmacy). Most patients require multiple vials per infusion based on weight.

What happens if the external review denies coverage? External review decisions are final for the administrative process, but you retain rights to pursue other remedies such as regulatory complaints or legal action if appropriate.

Can I continue treatment while appeals are pending? Ask your specialty pharmacy about emergency or bridge supplies while coverage decisions are pending, especially given DMD's progressive nature and the risk of permanent harm from treatment interruption.

From our advocates: "We've seen families succeed by starting the prior authorization process early—often 60-90 days before the planned treatment start. Having all genetic testing, functional assessments, and baseline cardiac/renal studies completed before submission significantly reduces back-and-forth delays. The key is treating this like a comprehensive medical file that tells the complete story of why Exondys 51 is necessary."

For families facing complex denials or needing help crafting comprehensive appeals, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and drafting point-by-point rebuttals aligned to each plan's own requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and state regulations may change. Always consult with your healthcare provider and insurance company for the most current requirements. For specific legal questions about your coverage rights, consider consulting with a healthcare attorney familiar with Ohio insurance law.

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