By Counterforce Health Team in Elevidys (delandistrogene moxeparvovec-rokl) —

How to Get Elevidys (Delandistrogene Moxeparvovec-rokl) Covered by UnitedHealthcare in Texas: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Elevidys Covered by UnitedHealthcare in Texas

Fastest path to approval: Elevidys requires prior authorization from UnitedHealthcare with strict eligibility criteria including genetic DMD confirmation, anti-AAV antibody titer ≤1:400, and treatment at a designated center. If denied, Texas offers binding external review through Independent Review Organizations (IRO) within 4 months.

First step today: Call UnitedHealthcare at the number on your member ID card to request the current Elevidys prior authorization form and clinical criteria. Simultaneously, have your neuromuscular specialist order anti-AAVrh74 antibody testing and gather genetic confirmation of your DMD mutation.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Prior Authorization Checklist
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Process in Texas
  6. Cost and Financial Support
  7. When to Escalate
  8. FAQ

Coverage Requirements at a Glance

Requirement What it means Where to find it
Prior Authorization Mandatory approval before treatment UHC Provider Portal
Age Eligibility 4 years and older FDA label, UHC medical policy
Genetic Confirmation DMD gene mutation documented Genetic testing report required
Anti-AAV Antibodies Titer ≤1:400 required Lab testing within 30-90 days
Center of Excellence Treatment at designated facility UHC approved facility list
Hepatic Monitoring Detailed liver function plan Pre/post infusion protocol
ICD-10 Code G71.01 (Duchenne/Becker MD) Medical records

Step-by-Step: Fastest Path to Approval

1. Verify Benefits and Get Forms

Who does it: Patient or clinic staff
Action: Call UnitedHealthcare member services (number on ID card) to confirm Elevidys is covered under your plan and request the specific prior authorization form
Timeline: Same day
Source: UHC Prior Authorization Guidelines

2. Order Required Testing

Who does it: Neuromuscular specialist
Action: Order anti-AAVrh74 antibody titer testing and ensure recent genetic confirmation of DMD mutation
Timeline: Results in 1-2 weeks
Key requirement: Anti-AAV titer must be ≤1:400 for approval

3. Gather Clinical Documentation

Who does it: Clinic staff with physician oversight
Action: Compile comprehensive medical records including diagnosis confirmation, functional status, prior treatments, and baseline labs
Timeline: 3-5 business days
Critical elements: Letter of medical necessity, genetic report, liver function tests

4. Confirm Treatment Center

Who does it: Clinic staff
Action: Verify your planned infusion center is on UnitedHealthcare's approved gene therapy facility list
Timeline: 1-2 days
Backup plan: If not approved, identify nearest designated center

5. Submit Prior Authorization

Who does it: Healthcare provider
Action: Submit complete PA packet through UHC provider portal or designated submission method
Timeline: Allow 30 days for decision
Source: UHC Specialty Drugs PA

6. Request Peer-to-Peer if Needed

Who does it: Prescribing physician
Action: If initial review looks unfavorable, request peer-to-peer review with UHC medical director
Timeline: Within 21 days of outpatient denial
Advantage: Often resolves issues faster than formal appeals

7. Prepare for Appeals if Denied

Who does it: Patient with provider support
Action: If denied, immediately file internal appeal and prepare for Texas external review if needed
Timeline: 60 days for internal appeal, 4 months for Texas IRO
Source: Texas Department of Insurance

Prior Authorization Checklist

Essential Documentation

Patient Demographics & Insurance

  • Complete member information and policy details
  • ICD-10 diagnosis code: G71.01 (Duchenne or Becker muscular dystrophy)
  • Prescribing physician credentials (neuromuscular specialist)

Genetic and Diagnostic Confirmation

  • Genetic testing report confirming pathogenic DMD gene mutation
  • Clinical notes documenting Duchenne muscular dystrophy phenotype
  • Current age verification (≥4 years)

Laboratory Requirements

  • Anti-AAVrh74 antibody titer ≤1:400 (within 30-90 days)
  • Baseline liver function tests (AST, ALT, bilirubin)
  • Complete blood count and renal function
  • Cardiac evaluation (ejection fraction ≥40%)

Treatment History

  • Documentation of current corticosteroid therapy
  • Prior DMD treatments and responses
  • Any previous gene therapy exposure (typically excluded)

Safety and Monitoring Plan

  • Detailed hepatic monitoring protocol
  • Steroid management plan for post-infusion period
  • Emergency response procedures for infusion reactions

Facility Requirements

  • Confirmation of treatment at UHC-approved gene therapy center
  • Center capabilities for DMD gene therapy administration
  • 24/7 access to specialized care for complications
Tip: Counterforce Health helps patients and clinicians create comprehensive appeal packages by analyzing denial letters and building targeted, evidence-backed responses that address each specific denial reason.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing genetic confirmation Submit detailed genetic testing report DMD gene mutation with specific variant information
Anti-AAV titer too high Retest after waiting period or appeal medical necessity Recent titer ≤1:400 or clinical justification for treatment despite higher titer
Not at approved center Transfer care or get center designation Proof of treatment at UHC-approved gene therapy facility
Inadequate monitoring plan Submit comprehensive safety protocol Detailed hepatic monitoring and steroid management plan
Age restrictions Provide current age documentation Birth certificate or medical records confirming age ≥4 years
Missing specialist oversight Ensure neuromuscular specialist involvement Credentials and treatment plan from qualified specialist

Appeals Process in Texas

Internal Appeals with UnitedHealthcare

Level 1 Internal Appeal

  • Deadline: 60 days from denial notice
  • Timeline: UHC decision within 30 days (pre-service) or 60 days (post-service)
  • Expedited option: Available for urgent cases where delay could jeopardize health
  • How to file: UHC Provider Portal or written submission to address on denial letter

Peer-to-Peer Review

  • When to request: Within 3 business days (inpatient) or 21 days (outpatient) of denial
  • Process: Your specialist speaks directly with UHC medical director
  • Advantage: Often faster resolution than written appeals

Texas External Review (IRO)

If UnitedHealthcare upholds the denial after internal appeals, Texas law provides access to binding external review:

Eligibility

  • Available for medical necessity denials
  • Must complete UHC internal appeals first (unless urgent)
  • Applies to state-regulated plans (not ERISA self-funded plans)

Filing Deadline

  • 4 months from final internal denial
  • Can request expedited review for urgent cases

Timeline

  • Standard review: ~20 days
  • Expedited review: ~5 days for urgent cases
  • Binding result: If IRO overturns denial, UHC must comply

How to Request

  • Forms provided with UHC's final denial letter
  • Submit to Texas Department of Insurance
  • No cost to patient (UHC pays IRO fees)

Contact Information

  • Texas Department of Insurance: 1-800-252-3439
  • Office of Public Insurance Counsel: 1-877-611-6742

Cost and Financial Support

Manufacturer Support Programs

Elevidys Patient Access Program

Additional Resources

Foundation Grants

  • Patient advocacy organizations may offer emergency grants
  • Check with Parent Project Muscular Dystrophy for current programs

State Programs

  • Texas may have specialty drug assistance programs
  • Contact Texas Health and Human Services for Medicaid options

When to Escalate

Contact Texas regulators if UnitedHealthcare:

  • Misses statutory deadlines for appeal decisions
  • Fails to provide required appeal information
  • Denies access to external review when eligible

Texas Department of Insurance

  • Consumer Helpline: 1-800-252-3439
  • File complaints for procedural violations
  • Request assistance with appeal process

Office of Public Insurance Counsel (OPIC)

  • Help line: 1-877-611-6742
  • Free consumer assistance with insurance disputes
  • Guidance on appeals and external review

For patients who need help navigating complex denials, Counterforce Health specializes in turning insurance denials into successful appeals by creating targeted rebuttals that address each specific denial reason with evidence-backed arguments.

FAQ

How long does UnitedHealthcare prior authorization take for Elevidys in Texas? Standard PA decisions take up to 30 days for pre-service requests. Expedited review is available for urgent cases and typically decided within 72 hours.

What if my anti-AAV antibody titer is above 1:400? Most payers, including UHC, typically deny coverage when titers exceed 1:400. You can appeal with additional clinical justification or retest after a waiting period to see if titers decrease.

Can I get Elevidys if I'm not ambulatory? Yes, the FDA approved Elevidys for people with Duchenne aged 4 and up regardless of ambulation status. Ensure your PA documentation reflects current FDA labeling.

Does step therapy apply to Elevidys? Elevidys is typically not subject to step therapy since it's a one-time gene therapy. However, documentation of current standard-of-care treatments (like corticosteroids) is usually required.

What happens if my preferred center isn't UHC-approved? You may need to transfer care to an approved gene therapy center or work with your current center to obtain UHC designation. The PA will likely be denied if treatment isn't at an approved facility.

Can I request expedited appeal in Texas? Yes, expedited appeals are available when delay could seriously jeopardize your health. Both UHC internal appeals and Texas IRO external review offer expedited options.

How much does Elevidys cost without insurance? The list price is approximately $3.2 million for the one-time treatment. This makes insurance coverage essential for most families.

What if I have an ERISA self-funded employer plan? ERISA plans follow federal appeal rules rather than Texas state requirements. You'll use the federal external review process instead of Texas IRO.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and work with qualified professionals for insurance navigation. Coverage policies and appeal procedures may change; verify current requirements with your specific plan and state regulators.

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